F1000research 248187

The International Decision Support Initiative
Health Technology Assessment Toolkit

n Set the scene for HTA n Compile the best HTA evidence
n Make HTA an inclusive process n Build capacity to support HTA
n Ensure political commitment n Set up a transparent and consistent
process
2
Acknowledgements
This work was produced by the International Decision Support Initiative
(www.idsihealth.org), which supports countries to get the best value for money from
health spending. iDSI receives funding support from the Bill & Melinda Gates
Foundation, the UK Department for International Development, and the Rockefeller
Foundation.
Authors
Mairi Jeffery Y-Ling Chi Madeleine Stewart
Toolkit contributors and reviewers (in alphabetical order)
Diana Beatriz Bayani Kalipso Chalkidou Francoise Cluzeau
Tony Culyer Samantha Diamond Laura Downey
Shalu Jain Mohamed Gad Sam Hollingworth
Karthik Balajee Laksham Phung Lam Toi Ryan Li
Rong Liu Nancy Njeru Anthony Kamau Njuguna
Timothy Panga Pempa Pempa Roman Perez-Velasco
Sonam Phuntsho Pilar Pinilla Dominguez Francis Ruiz
Khairol Sabtu Ambrish Singh Roza Sn
3
Contents
Introduction to the HTA Toolkit................................................................................ 6

i. Why do we need Health Technology Assessment? ........................................... 7
ii. What is HTA?..................................................................................................... 7
iii. Aims of the Toolkit ............................................................................................ 8
Glossary of terms ...................................................................................................... 9
Building Block 1 - Setting the Scene for HTA ....................................................... 12

i. Introduction ....................................................................................................... 13
ii. Having a plan ................................................................................................... 13
Categories of health technology ......................................................................... 13
Starting small...................................................................................................... 15
Country example: Ghana HTA pilot study .......................................................... 15
iii. Situational analysis ......................................................................................... 16
Finding who is working on HTA in your country ................................................. 16
Stakeholder analysis .......................................................................................... 17
Examples of relevant questions to identify stakeholders ................................... 17
Capacity for economic evaluation ...................................................................... 19
Finding regional support ..................................................................................... 19
Regional HTA Networks ..................................................................................... 20
iv. Institutionalisation ........................................................................................... 21
Benefits of institutionalisation ............................................................................. 21
What aspects of HTA need to be institutionalised? ............................................ 21
Institutional arrangements .................................................................................. 21
Three models of HTA institutions developed for Romania ................................. 22
Advantages and disadvantages ......................................................................... 23
Building Block 2 - Compiling the best HTA evidence ......................................... 25

i. Introduction ....................................................................................................... 26
ii. The process ..................................................................................................... 26
iii. Types of evidence ........................................................................................... 26
iv. Cost-effectiveness analysis ............................................................................ 28
What are QALYs and DALYs? ........................................................................... 29
v. ix. Reference case ........................................................................................... 30
iDSI Reference Case Principles ......................................................................... 31
vi. Retrieving available evidence ......................................................................... 32
Literature reviews ............................................................................................... 32
Literature search: inclusion and exclusion criteria ............................................. 33
Example of a PICO in a literature search ........................................................... 33
Grey literature research ..................................................................................... 34
4
vii. Identifying gaps in the evidence .................................................................... 36
Conducting primary research ............................................................................. 36
Guide to Economic Analysis and Research (GEAR) Online Resource .............. 37
Adapting existing studies ................................................................................... 37
Example: Considering the adaptation of evidence on economic evaluation ...... 38
Building Block 3 - A transparent and consistent process of HTA ...................... 41

i. Introduction ....................................................................................................... 42
ii. The steps of HTA ............................................................................................. 42
iii. Topic selection for HTA .................................................................................. 43
Country example: Topic selection in Thailand ................................................... 44
iv. Analysis .......................................................................................................... 44
v. Appraisal ......................................................................................................... 45
vi. Decision-making ............................................................................................. 46
Country example: Poland HTA Process ............................................................. 47
Cost-Effectiveness Thresholds .......................................................................... 47
Country example: Ireland’s Cost-effectiveness Thresholds ............................... 49
vii. Monitoring and Evaluation ............................................................................. 50
Challenges to creating monitoring mechanisms ................................................ 50
Building Block 4 - Building capacity to support HTA .......................................... 52

i. Introduction ....................................................................................................... 53
ii. Building capacity .............................................................................................. 53
Individual, Node, Network and Enabling Environment (INNE) Model ................ 54
iii. Human resources ........................................................................................... 55
iv. Training and recruitment ................................................................................. 56
Examples of regional and Global Training Programs specialised in HTA .......... 58
Finding support .................................................................................................. 58
iDSI..................................................................................................................... 59
Building Block 5 - Ensuring political commitment for HTA ................................ 60

i. Introduction ....................................................................................................... 61
ii. Who should support HTA? .............................................................................. 61
iii. Raising awareness ......................................................................................... 62
iv. Legislative framework ..................................................................................... 63
Lessons from the legislative process to support HTA in Lithuania ..................... 64
v. Committing resources ..................................................................................... 65
Process for funding HTA .................................................................................... 66
vi. Be patient ....................................................................................................... 69
Building Block 6 - Making HTA an inclusive process .......................................... 71

i. Introduction ....................................................................................................... 72
ii. Identifying relevant stakeholders ..................................................................... 72
Patient/interest groups ....................................................................................... 73
CONITEC’s public consultation process ............................................................ 74
Medical Professionals ........................................................................................ 75
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Industry............................................................................................................... 75
Media organisations and journalists ................................................................... 76
iii. Modalities of engagement of stakeholders ..................................................... 77
Stakeholder engagement: consultation vs participation ..................................... 78
iv. Challenges of stakeholder engagement ......................................................... 80
Challenges in stakeholder engagement ............................................................. 80
Country example: NICE policy on COIs ............................................................. 82
v. Communication ............................................................................................... 82
Example: HITAP’s Communication Strategy ...................................................... 84
vi. Appeal process ............................................................................................... 84
Citing the HTA Toolkit as a source ........................................................................ 86
6
Introduction to the HTA Toolkit
6
i. Why do we need Health Technology
Assessment?
All health systems, regardless of country or income level, waste large amounts of
money. The WHO estimates that 20-40% of all healthcare expenditure is wasted as
a result of inappropriate use of medicines, inefficient resource allocation and
weaknesses in essential functions1.
This is a concern in the context of Universal Health Coverage (UHC). Many LMICs
are on the path to UHC, pledging to increase investment in essential health services
in order to meet the needs of their populations. They need to put their limited
resources to maximum benefit for their population. Decisions are now taken that
will shape the development of their healthcare systems for decades to come, which
means that it is an important time to ensure those decisions are sustainable and
based on the best quality evidence.
This is where building a sustainable and locally relevant Health Technology

Assessment (HTA) mechanism for priority setting can support progress
toward UHC.
ii. What is HTA?

HTA attempts systematically to document the expected consequences of new health
technologies such as drugs, medical equipment, diagnostic techniques and public
health programs. HTA helps you to decide whether a health technology is good
value for money or cost-effective for your local health system. It also allows you to
compare different policy-scenarios and select what is best for your health system.
Some of the big decisions HTA can inform include the creation of an Essential
Medicines List and a Health Benefits Package for UHC.
Typically, the term ‘HTA’ refers to individual studies on a specific technology.

However, increasingly, HTA is used to refer to a more systematic ‘process at the
systems level to inform priority setting and decision-making, i.e. as a tool for priority
setting with its explicit consideration of costs and benefits’2. In this toolkit, we are
interested in this latter definition of HTA. When referring to individual studies, we will
1
p.xi, WHO (2010). World Health Report:
http://apps.who.int/iris/bitstream/10665/44371/1/9789241564021_eng.pdf
2
Grieve, E., Hesselgreaves, H., Wu, O., Chalkidou, K., Ruiz, F., Smith, P., ... & Briggs, A. (2017). The
Value of Health Technology Assessment: a mixed methods framework. F1000Research, 6.
7
use the abbreviation ‘hta’ (in small caps); in contrast to ‘HTA’ when discussing
institutionalisation.
iii. Aims of the Toolkit

iDSI has developed this toolkit to support technical staff from Ministries of Health and
other government agencies by providing guidance on how to build a sustainable and
locally HTA mechanism for priority setting in health. While the toolkit is primarily
intended for technical staff with some knowledge of HTA and decision-making
processes in health, we have tried to make it accessible to lay readers as well.
The toolkit is organised around six key ‘building blocks’, illustrated by real world
examples and populated by an ample number of external references. These building
blocks are not designed to be read chronologically or in any particular order, so
users can read each building block separately. We anticipate that some countries will
be more advanced on some topics than others: country A might be have suitable
trained capacity but lack in political commitment and building the institutional support
to HTA, whereas country B might already have high political commitment but low
availability of evidence and capacity. As a result, we invite readers to freely navigate
between the different building blocks based on your own needs.
8
Glossary of Terms
9
Cost-effectiveness analysis: A form of economic analysis that compares different
health interventions on their relative costs and outcomes (effects), using a single,
non-monetary outcome measure such as deaths averted, quality-adjusted life years
gained.
Cost-effectiveness threshold: the ceiling incremental cost-effectiveness ratio

(ICER) beyond which interventions are no longer considered cost-effective, reflecting
the maximum value decision makers attach to health.
Disability-adjusted life year: A measure of overall disease burden, expressed as

the number of years lost due to ill-health, disability or early death.
External/development partners: Terms widely used in the field of international

development aid to describe any organisation working in partnership with national
and local government bodies; including international organisations, bilateral
organisations, non-governmental organisations, civil society organisations and
donors.
Health technology (or health intervention): Any method used to promote health,
prevent and treat disease, and improve rehabilitation and palliative care.
Technologies in this context include but are not limited to: medicines, vaccines,
medical equipment, diagnostic and treatment methods, surgery, psychosocial
interventions, public health interventions, and so on.
Health Technology Assessment: a systematic, transparent and multidisciplinary

process that summarises information about the medical, social, economic and ethical
issues related to the use of a health intervention.
iDSI Reference Case: a guide to the planning, conduct and reporting of economic
evaluations.
Incremental cost-effectiveness ratio: a summary measure of the cost-

effectiveness of a health care intervention, obtained by the ratio of the difference in
the mean costs of a technology compared with the next best alternative to the
differences in the mean outcomes.
Industry (referring to ‘healthcare industry’): Private sector organisations, or groups

of organisations, providing goods and services to prevent and treat disease. These
include pharmaceutical companies, private health insurers, and private healthcare
providers.
Institutionalisation: The embedding of certain rules and norms, and associated

actions and processes, within a health system.
Methods and process guide: A core set of guiding principles and instructions to
ensure uniform engagement in a given activity.
10
Modelling: The use of a single or set of mathematic equations to predict certain
parameters or outcomes of interest.
Multiple-criteria decision analysis: a method for guiding decision-making by

making explicit the criteria of relevance, the importance attached to each, and how to
use such information in a framework for assessing the available alternatives.
Opportunity costs: the value of the next best alternative(s) forgone as a result of a
given course of action. For example, the health benefits that could have been
achieved had the money been spent on the next best alternative healthcare
intervention.
Priority setting: The process of ensuring that limited health budgets are allocated to
the uses that have the greatest value.
Proof of concept: evidence which establishes that an idea, invention, process or

model is feasible.
Quality-adjusted life-year: a measure of the state of health of a person or group in

which the benefits, in terms of length of life, are adjusted to reflect the quality of life.
One QALY is equal to 1 year of life in perfect health.
Stakeholder: a person, group or organisation that has interest or concern in an

organisation.
Systematic literature review (or systematic review): research that summarises

the evidence on a clearly formulated question according to a predefined protocol.
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Building Block 1
Setting the Scene for HTA
12
i. Introduction
This building block will help you to:
• understand how HTA can be used to inform policy-making in your country

• identify relevant upcoming health decisions
• locate existing HTA activities and assess your country’s capacity
• identify relevant stakeholders
• find regional support
• appreciate the benefits of having a co-ordinated and institutionalised
framework for HTA.
ii. Having a plan

HTA can be used to assess a wide range of different health technologies. The World
Health Organization defines a health technology as the "application of organized
knowledge and skills in the form of devices, medicines, vaccines, procedures and
systems developed to solve a health problem and improve quality of lives"3.
Health technology does not only refer to devices, it covers a wide range of
interventions like those listed in the table below.
Categories of health technology

Drugs: e.g., aspirin, beta-blockers, antibiotics, cancer chemotherapy
Biologics: e.g., vaccines, blood products, cellular and gene therapies
Devices, equipment and supplies: e.g., cardiac pacemakers, magnetic resonance imaging
(MRI) scanners, surgical gloves, diagnostic test kits, mosquito netting
Medical and surgical procedures: e.g., acupuncture, psychotherapy, coronary angiography,

gall bladder removal, bariatric surgery, caesarean section
Public health programs: e.g., water purification systems, immunization programs, smoking
prevention programs
Support systems: e.g., clinical laboratories, blood banks, electronic health record systems,
telemedicine systems, drug formularies
Organisational and managerial systems: e.g., medication adherence programs,

prospective payments using diagnosis-related groups
4
Source: Goodman et al. (2014)
3
http://www.who.int/health-technology-assessment/about/healthtechnology/en/
4
Goodman et al. (2014). HTA 101 Introduction to Health Technology Assessment
https://www.nlm.nih.gov/nichsr/hta101/HTA_101_FINAL_7-23-14.pdf
13
Linking HTA to policy-making is essential. For instance, HTA can be used as an
input to come up with coverage decisions, health benefits package, standard
treatment guidelines, quality standards, provider payment, essential medicines lists,
decisions pertaining to investments in quality training or health community workers.
This list is not exhaustive.
HTA is not suitable for addressing all health systems problems. HTA will not help
with general health system problems involving financing issues (e.g. domestic
resource mobilisation) or planning the health workforce. You will need to think about
your health system first and move onto thinking about HTA when there are specific
spending issues that need to be addressed.
A helpful place to start is to identify upcoming decision problems that HTA can
inform. Think about:
• What are some of the biggest health problems currently affecting your country? (e.g.
high maternal mortality, high out of pocket spending).
• What are the most pressing issues discussed in health and supported by the high
levels of leadership (e.g. Minister of Health, Prime Minister or President)?
• What are the big health policy issues that the Ministry of Health has planned for the
near future?
• Is there currently enough supporting evidence to inform these decisions?
• How are those decisions typically taken in other countries?
Answering these questions will help find the right ‘fit’ for HTA in your country. Big
incoming health decisions (e.g. the development of a UHC program) can be windows
of opportunity for initial work on HTA and a nudge towards evidence-based priority
setting.
Source: Priority-setting for Universal Health Coverage
14
Starting small
Glassman et al. (2012) find that ‘starting small with a vision of scaling up is the most
practical mitigating strategy’ for introducing HTA5. The demand for HTA might initially
be for specific small and isolated decision problems. However, technical staff and
policy-makers should use this ‘pilot’ approach to generate confidence in the
legitimacy of the HTA approach and raise awareness about how HTA can be used to
maximise value for money, with the final objective of scaling up capacity for many
applications of HTA methods and gaining economies of scale and scope. It is
important to keep this final objective in mind, otherwise the lessons, data collected,
skills, and experience from conducting the pilot study might be lost and also to
enable an optimal location and concentration of HTA skills at the earliest opportunity.
An initial demand might be expressed by technical staff from the Ministry of Health or
by other players in the healthcare system. For instance, many LMICs depend on
external funding and policy advice from donors and other partners to support their
health systems. External partners might express interest in HTA as a mechanism to
prioritise investments in the country. Moreover, as countries’ GDP per capita
increases, they are expected to transition from aid and increasingly take over
external partners’ activities. This creates a good opportunity to build an HTA process
and increase strategic planning of investments to ensure that every dollar, rupee, or
rand is spent in a way that buys the most health possible.
Country example: Ghana HTA pilot study
The Ghanaian Technical Working Group, supported by the International

Decision Support Initiative (iDSI), carried out an HTA pilot study on the cost-
effective management of hypertension (an example of a health topic
characterised by high spending and a high disease burden).
It was seen as an opportunity to build on previous efforts to establish a

Ghanaian HTA organisation, in order to inform the future decisions of the
Ghanaian Ministry of Health and the National Health Insurance Authority.
It highlighted the importance of HTA as a way of supporting UHC and having

more optimal resource allocation to be highlighted; discussions with
stakeholders found that there was support and commitment to move ahead
with HTA.
5
Glassman et al. (2012). Priority-Setting Institutions in Health: Recommendations from a Center for
Global Development Working Group. Global Heart Vol.7(1)
https://www.sciencedirect.com/science/article/pii/S2211816012000105
15
6
Source: Chalkidou et al. (2017)
iii. Situational analysis

A first step in laying foundations for institutionalising HTA is to carry out a situational
analysis. A situational analysis will typically document the following: the HTA
activities that already exist in your country; who is currently working on those
activities; which stakeholders need to be involved; the existing capacity for economic
evaluation; and finally, where you can find regional support.
Finding who is working on HTA in your country
It is likely that there are already existing HTA-related processes in your country
(perhaps in a university). However, it might be scattered across different agencies,
individuals in universities, sections of industry or departments within the Ministry of
Health. For instance, in Hungary, htas were carried out in a health economics
association, which a few years after its creation had already gathered over 50
specialists; and had gained sufficient visibility to engage with the government and
support the creation of an HTA department7.
You should be aware that HTA might not be explicitly labelled as such but take on
other names such as ‘cost-effectiveness analysis’ or ‘priority-setting’. For instance,
the 2015 WHO HTA survey found that two thirds of countries reported having a
national organization, department, unit or committee that produced HTA reports for
the Ministry of Health – however, few countries actually referred to this process as
“HTA”8.
A good starting point is to conduct a situational analysis to make an inventory of the

country’s existing efforts. This situational analysis will seek to answer the following
questions:
• Who is already working on HTA or similar types of evaluation?

• What type of data do they use?
• Are there examples where costing tools or economic evaluation (including cost-
effectiveness analyses) have been used to inform policies?
6
Chalkidou, K., Lord, J. and Gad, M. (2017). Improving the quality and efficiency of healthcare
services in Ghana through HTA. https://f1000research.com/documents/6-1886
7
Doherty, J. (2015). Effective capacity-building strategies for health technology assessment: a rapid
review of international experience. http://www.idsihealth.org/wp-content/uploads/2016/03/Doherty-
2016-Effective-CB-for-HTA_reviewFINAL-24-2-16.pdf
8
WHO (2015). 2015 Global Survey on Health Technology Assessment by National Authorities
http://www.who.int/health-technology-assessment/MD_HTA_oct2015_final_web2.pdf
16
• How were these activities funded?
• If relevant, what technical support did they receive from external partners or other
academics?
• Are there any active health economics societies or networks in your country?
• Are there any examples of institutions that employ staff with the following skills:
health economics, statistics, epidemiology, pharmacology, policy analysis, systematic
review?
These questions can be answered by organising an HTA awareness-raising event

and by interviews with key stakeholders (identified at that event or through other
contacts within the Ministry of Health). There also may be HTA skills in the private
sector, for example in the pharmaceutical industry. A review of previous and current
health financing activities may also help identify areas where HTA has been or is
currently used. Country-based health economists can be identified through
international networks such as the International Society For Pharmacoeconomics
and Outcomes Research (ISPOR) or HTAsiaLink or through discussions with
external partners (if relevant – see list of regional support).
Stakeholder analysis
In many LMICs, decisions in the healthcare sector are typically made on the basis of
considerations other than systematic consideration as in HTA. Common examples
are decisions based on historical allocation patterns of funding, expert opinion from a
particular clinical speciality, or advice from self-interested politically influential
people. Consequently, using HTA to inform decisions is likely to challenge or
interfere with existing practice and existing interest groups, creating ‘winners’ and
‘losers’ as well as in helping to identify those who those might be most obstructive.
Stakeholder analysis is the process of gathering information to determine whose

interests should be taken into account when developing or implementing a new
policy9. It should be carried out as part of laying the groundwork for introducing HTA,
in order to identify who might support or block the process and develop strategies to
mitigate the effects of opposition.
Examples of relevant questions to identify stakeholders
Politicians & politically appointed decision-makers:
• What and who dominates the discourse regarding UHC?

• What and who dominates discourse on health technologies?
Policy and professional decision-makers (civil service/bureaucracy)
9
Schmeer, K. (2000). Stakeholder Analysis Guidelines.
http://www.who.int/workforcealliance/knowledge/toolkit/33.pdf
17
• What are the procedures of the essential medicines committee?
• Who is responsible for the development of basic packages?
• Who is responsible for procurement?
Health service managers
• What are the most influential health facilities in the country and why?
Health professional groups
• Which are the most powerful and influential medical professional associations?
Who are the key educationally influential people in such organisations?
Private sector – Industry
• What are the main means through which industry and government interact?
• In what ways and for whom might HTA be seen as an advantage?
Courts and the judiciary
• What is the role of the courts in health coverage decisions or health policy
decisions?
• Are there relevant existing cases or lawsuits?
Patients/consumers and the public
• Are there particularly strong, visible NGOs?

• Are there patient organisations bringing together all NGOs for patient access?
• How might one avoid having particularly strong advocates dominate over smaller
patient voices?
• What links do these NGOs’ have to supply industries like the pharmaceutical and
medical devices industries?
Academic institutions, researchers and research managers
• Who conducts health system and policy research or operational research in the
country?
• Where does the funding for this kind of research come from?
Funders and development partners
• Which development partners operating in the country have interests aligned with
priority-setting in particular or health system reform in general?
• And which might be opposed to an HTA approach or seek to ‘capture’
• it?
Source: Stakeholder checklist
Ideally, stakeholders, such as patient groups, policy-makers, physicians, academics,

the healthcare industry, external partners/donors and the public will be involved at
several stages of HTA. Identifying relevant stakeholders at the start of the process
18
will help to identify any training needs some groups may have as well as building a
truly inclusive process.
Capacity for economic evaluation
Having a well-trained local technical capacity with skills in economic evaluation and
in producing and using htas is key to HTA institutionalisation. Lack of capacity is one
of the constraints on the development of HTA in Europe10. The problem is likely to be
more acute in LMICs. You will need to identify the capacity your country already has:
• What are the academic or governmental groups that can undertake and understand
hta studies?
• What has the private sector to offer?
• What funding might be available for HTA?
• What training is available for HTA in your country or region?
iDSI has developed a capacity assessment questionnaire to support countries in the

assessment of their existing local HTA technical capacity to undertake HTA. As a
first step, you should seek to identify a list of potential institutions that might be of
interest for future HTA development, i.e. institutions with technical expertise in health
economics or related fields such as epidemiology, medical demography, statistical
analyses, and/or heath policy research. This includes the following:
• Technical departments within the Ministry of Health or National Health Insurance

Fund
• Academic departments in local universities or education institutions
• Other groups (including in the Industry) that work on economic evaluation or have
expertise in a related field
The questionnaire seeks to assess technical capacity to conduct HTA; and identify
potential skill gaps at each institution that require capacity-building support.
Finding regional support
Support for introducing HTA might be available from global or regional networks.
This could take many forms, for example, technical assistance to support the
development of economic evaluation, doing situational analyses or designing
roadmaps for implementing HTA. You should consult their work portfolio or contact
them directly with specific queries.
10
Sorenson, C., Drummond, M., & Kanavos, P. (2008). Ensuring value for money in health care: the
role of health technology assessment in the European Union (No. 11). WHO Regional Office Europe.
19
Regional HTA Networks
International
Disease Control Priorities Network (DCPN)– produces publications on
cost-effectiveness of interventions at the global level, but also engages with
countries (e.g. Ethiopia) - http://dcp-3.org/country-work/overview
Health Technology Assessment International (HTAi) – active members
–in MoHs, academia, industry- across 65 countries www.htai.org
International Network of Agencies for Health Technology Assessment
(INATHA) - network of 49 HTA agencies in 30 countries around the world
with more than 2,100 staff. http://www.inahta.org/
International Decision Support Initiative (iDSI) – a global network of
health, policy and economic expertise specialised in providing support to
countries on priority setting and evaluation http://www.idsihealth.org/
International Health Economics Association (IHEA) – facilitates work
and communication across a large network of health economists in the
world. https://www.healtheconomics.org/
International Society for Pharmacoeconomics and Outcomes
Research (ISPOR)– the largest global network working on health
economics and outcomes research. It is also organised around regional
initiatives, chapters and groups. https://www.ispor.org/
African Region
The African Health Economics and Policy Association (AfHEA) and
Collaborative Africa Budget Reform Initiative (CABRI) are not HTA
networks, but might be able to support countries through their network.
The Americas Region

Regional Network of Health Technology Assessments for the
Americas (RedETSA) - http://redetsa.org/
South-East Asia Region
HTAsiaLink – comprised of 15 institutions, organises yearly meetings and
collaborative projects among members: http://www.htasialink.org/
European Region
European Network for Health Technology Assessment (EUnetHTA) –
network of 35 institutions in Europe, hosted by the Danish Centre for HTA
(DACEHTA) in Copenhagen http://www.eunethta.eu/
Eastern Mediterranean Region
A group at the WHO Eastern Mediterranean Regional Office (EMRO)
focuses on HTA (on Ezcollab): https://ezcollab.who.int/hmdem/hta
20
iv. Institutionalisation
Benefits of institutionalisation
Institutionalising HTA neither means nor requires the creation of a stand-alone HTA
agency; it simply means establishing accepted processes, norms and rules of HTA,
developing critical skills, experience and knowledge and building effective working
relationships between relevant policy-makers and academic/research institutions to
support the use of HTA11. You can encourage ‘HTA thinking’ without needing the
institutional framework by supporting the use of good-quality evidence to inform
healthcare decision-making.
Institutionalisation ensures that HTA becomes part of the decision-making process in

the health system, even if it is initially just limited to a range of policies or a specific
disease area (e.g. only for the introduction of new medicines). It ensures that
decisions taken using HTA can be updated and revised and that HTA is not just a
one-off exercise. It can also help with developing sustainable financing and training
mechanisms for HTA.
What aspects of HTA need to be institutionalised?
• The nature and role of the HTA focal point (e.g. institution or department or team);
• Scope of activities envisaged by the HTA function (i.e. the services to be provided),
and the extent to which these are coordinated by a single HTA focal point;
• Funding and staffing;
• The disposition of analytical capacity (‘internal’, i.e. within the HTA focal point,
external, e.g. within academic centres, or hybrid models);
• The nature and scope of the appraisal function;
• Locus of decision-making and linkage to policy and priority setting
• Technical training
12
Source: adapted from Lopert et al. (2017)
Institutional arrangements
HTA should be a dynamic and continuous process. The model of HTA institutions
will differ between countries. Some countries have found it easier to create a clearly
11
Lopert et al. (2017). Deliverable 1: Situational analysis of Romanian HTA
12
Lopert et al. (2017). Deliverable 2: Designing an institutional framework for HTA in Romania
21
identifiable HTA organisation that is separate from the Ministry of Health and that
provides independent assessments and guidance (and in some jurisdictions may
actually make decisions). Others have chosen to rely on an institutionalised HTA
framework that is composed of multiple organisations, with clearly defined roles and
responsibilities.
You will need to identify different possible institutional arrangements and establish
what will work best for your country, whether this involves one or more units within
the MoH or an independent body. There are trade-offs between those options,
mainly on cost, link with other health agencies, transparency and visibility. For
instance, it might be cheaper to incorporate HTA within an existing department rather
than setting up an entirely new department, but harder to ensure transparency of
decision-making13.
In Romania, institutionalisation of HTA is an on-going process. The table below sets

out three models of HTA agency that were developed for Romania:
Three models of HTA institutions developed for Romania
In recent years, there has been interest in Romania to extend the scope of
work around HTA. Romania currently has an HTA agency, the National
Agency for Medicines & Medical Devices, that focuses on pharmaceuticals
for reimbursement decisions. The NAMMD is the only agency in the Ministry
of Health that possesses sufficient capacity to conduct HTA, although it only
employs 6 full-time staff (the director, two physicians, one pharmacist, one
statistician and one economist). A situational analysis conducted in 2016-
2017 concluded that the main challenges with broadening of HTA activities
in the context of Romania included (i) lack of technical capacity in the
country, (ii) fragmentation in the system, (iii) need for improving the
pharmaceutical evaluation framework and (iv) need for a framework on best
practice principles and governance standards for HTA. Given those
challenges, an assessment was conducted to understand what the best
institutional framework for expanding the scope of HTA in the country.
Three models were outlined:
Model 1 - Establishment of separate HTA agency at arm’s length from the

Ministry of Health
• Small co-ordinating unit within the MoH - responsible for
13
22
regulatory/legislative reforms
• Standalone HTA ‘agency’ – responsible for HTA for medicines, non-drug
technologies and interventions, developing and updating methods, managing
processes; engaging stakeholders; contracting with external academic groups
to engage additional analytical expertise; managing appraisal committees and
processes
Model 2 - Evaluation processes managed from within the existing NAMMD

HTA unit
• A Romanian HTA ‘entry point’ - a coordinating unit within the MoH with
responsibility for regulatory/legislative reforms/updates
• An HTA unit at the NAMMD - responsibility for HTA for medicines, non-drug
technologies and interventions. All evaluation processes are managed from
within the NAMMD HTA unit, although some key coordination activities remain
within the MoH.
Model 3 - A network of HTA processes centred and supported from within

the Ministry of Health
• A ‘hub and spoke’ structure with a network of HTA processes centred and
supported from within the Ministry of Health
• A Romanian HTA ‘entry point’ - a coordinating unit within the Ministry of
Health with responsibility for regulatory/legislative reforms/updates
• The NAMMD HTA unit retaining key responsibility for HTA for medicines and
vaccines
• A second HTA unit within the MoH with responsibility for HTA of non-drug
interventions and other programmes
• All three models feature the need for contracted academic/external evaluation
groups, an underlying regulatory framework and independent expert appraisal
committees responsible for evidence appraisal.
Advantages and disadvantages
There are advantages and disadvantages of each of the three models

presented. All the models recognise and utilise external HTA expertise,
which is an advantage.
Model 1 appears to be more at ‘arm’s length’ than Models 2 and 3, and it

centralises processes within a single entity. However, there is significant
administrative costs to establishing a new agency, which would require a
massive scale-up of resources to be effective, which takes time.
Model 2 also centralises processes into a single entity, but appears less at
‘arm’s length’ and therefore less independent and transparent.
Model 3’s initial separation of drug and non-drug HTA processes promotes
prioritisation and rapid introduction of rigorous HTA for medicines, while
enabling external evaluation resources to focus on technologies in areas of
specific interest or expertise. However, it may appear to stakeholders to be
not adequately independent, meaning that legislative framework and
governance arrangements are critical to ensure independence of expert
23
committees and transparency of operations.
14
Source: adapted from Lopert et al. (2017)
14
24
Building Block 2
Compiling the best HTA evidence
25
i. Introduction
This building block covers:
• the type of evidence needed for HTA

• the use of literature reviews
• spotting gaps in the evidence relevant for your HTA
• developing or using a Reference Case for economic evaluation
• adapting existing research from similar countries in your region
• how to link up with universities to conduct primary research.
ii. The process

Wherever possible, one should seek to ensure that best-quality evidence is used to
make decisions. For this, you need to be familiar with:
i) The type of evidence that is needed for the given topic;

ii) Evidence that has been generated by previous published and unpublished
studies;
iii) How to identify data gaps;
iv) At a more advanced level, how to adapt studies or conduct primary data
collection/research to produce the necessary data.
iii. Types of evidence

There are different types of evidence or evaluation criteria commonly used in htas.
Evidence can be categorised into features relating to the disease under
consideration (the ‘burden of disease’) or into characteristics relating to the
technology being assessed15.
In a hta, an individual technology can be evaluated using several different, but

overlapping, criteria. The following figure depicts key areas of information needed for
HTA.
15
Angelis et al. (2017). Using health technology assessment to assess the value of new medicines:
results of a systematic review and expert consultation across eight European countries.
http://eprints.lse.ac.uk/69521/1/Angelis_Using%20health%20technology%20assessment%20to%20as
sess%20the%20value%20of%20new%20medicines_published_2017%20LSERO.pdf
26
Source: Downey et al. (2018)16
However, it is worth noting that economic evaluation often forms the ‘backbone’ of
hta. The table below lists the type of economic evaluation frequently encountered in
hta studies. CEA is most often used among the listed options.
Type of economic evaluation used in htas
Cost-of-illness analysis: a determination of the economic impact of an illness or

condition (typically on a given population, region, or country) e.g., of smoking,
arthritis, or diabetes, including associated treatment costs
Cost-effectiveness analysis (CEA): a comparison of costs in monetary units with

outcomes in quantitative non-monetary units such as Quality Adjusted Life Years
(QALYs) or averted Disability Adjusted Life Years (DALYs), reduced mortality or
morbidity. This is often termed cost-utility analysis (CUA) and you should give
thought to whether your preferred outcome measure should be some indicator of
16
Downey, L., Rao, N., Guinness, L., Asaria, M., Prinja, S., Sinha, A., ... &
Chalkidou, K. (2018). Identification of publicly available data sources to inform the
conduct of Health Technology Assessment in India. F1000Research, 7.
27
health gain or loss or some indicator of the utility of such gains or losses. An
advantage of the health gain/loss approach is that it is more readily understandable
by clinicians and the public and easier to validate.
A Budget-impact analysis (BIA) can be conducted in addition to a CEA to

determine the impact of implementing or adopting a particular technology or
technology-related policy on a designated budget, e.g., for a drug formulary or
health plan.
Cost-consequence analysis: a form of cost-effectiveness analysis that presents

costs and outcomes in discrete categories, without aggregating or weighting them
Cost-benefit analysis (CBA): compares costs and benefits, both of which are
quantified in common monetary units.
17
Source: based on Goodman et al. (2014)
Other considerations may relate to ethical and equity aspects, including concerns
over the distribution of the benefits or breadth of the effects (benefits not accruing to
the health sector). Daniels and colleagues (2016) highlight the need for an expanded
HTA process that accounts for equity, budget impact, ethical issues and financial
protection18. The Reference Case for Economic Evaluation (discussed in this
building block) indicates that all available evidence relevant to the decision problem
should be included.
iv. Cost-effectiveness analysis

Cost-effectiveness analysis (CEA) is widely used in hta, and typically synthesizes
evidence on the costs and health effects of specific interventions. The results of a
CEA are usually presented in the form of an Incremental Cost-Effectiveness Ratio
(ICER).
An ICER is calculated as follows:
𝐶! − 𝐶!
𝐼𝐶𝐸𝑅 =
𝐻! − 𝐻!
17
Goodman et al. (2014). HTA 101 Introduction to Health Technology Assessment.
18
Daniels, N., Porteny, T., & Urritia, J. (2016). Expanded HTA: enhancing fairness
and legitimacy. International journal of health policy and management, 5(1), 1.
28
Or in other words, ICER is the difference in costs between two alternative
interventions divided by the difference in health produced by the two. Health effects
are usually expressed in terms of QALYs or DALYs. However, some studies use
other types of health effects, e.g. number of vaccinated children or persons tested for
HIV. General quality of life outcomes, such as QALYs and DALYs, are often used as
they capture health effects on length and quality of life, allow for comparisons
between disease states and allow you to check with those mainly affected whether
the indicator is an adequate representation of the effect of the treatment (for
example, whether some important aspect of the activities of daily living has been
omitted).
What are QALYs and DALYs?
Quality Adjusted Life Years
QALYs have been used in the assessment of health interventions for over 30
years. A QALY is an indicator that combines information on the morbidity and
mortality resulting from a treatment. As a result, QALYs incorporate information
on utilities derived from different states of health, or health-related quality of life
weights.
Disability Adjusted Life Years
DALYs are primarily a measure of disease burden and unlike the QALY, they
incorporate an age-weighting function assigning different weights to life years
lived at different ages. The origins of disability and quality of life weights differ
significantly from QALYs.
DALYs are calculated using the sum of years of life lost (YLLs) and years of
life lived with disability (YLDs). The impact of interventions on DALYs (i.e. the
DALYs prevented by an intervention) is measured by calculating the DALYs in
two scenarios: with and without the intervention19. One DALY represents one
year of healthy life lost due to disease, either through death or disability.
20
Source: Sassi (2006)
The health impact of interventions can be measured directly, although decision

analytic modelling is most often used to extract the long-term impact from short-term
19
Fox-Rushby J, Hanson K. 2001. Calculating and presenting disability adjusted life years (DALYs) in
cost-effectiveness analysis. Health Policy and Planning 16: 326–31.
20
Sassi, F. (2006). Calculating QALYs, comparing QALY and DALY calculations. Health policy and
planning, 21(5), 402-408.
29
clinical trial results. This typically involves modelling the effects (and sometimes the
costs) of what would be expected to happen to patients after the clinical trial period is
over21. Markov modelling is most often used for CEAs: those models are employed
to represent ‘stochastic’ or random processes that evolve over time22. Those models
are often used to model different disease states and transition probabilities.
ICERs are usually expressed in terms of $/QALYs gained or $/DALYs averted.

These common measures allow you to compare a given intervention with a set of
existing interventions reported in the literature, or with a fixed cost-effectiveness
threshold that informs whether the intervention under consideration can be
considered good value for money (see the building block ‘Setting up a transparent
and consistent process of HTA’ for more information). ICERs are context dependent
(especially with regard to your local health system’s constraints and social values,
some of which may be reflected in costs and others in benefits). ICERs for a given
intervention are likely to vary widely between different contexts: it is therefore very
important that policy-makers ensure that studies are conducted on the ground or, if
they are taken from other settings, that they are relevant to the local health systems.
v. ix. Reference case

Studies considered in the HTA process might present differences in terms of
methodological approaches and reporting. This is unavoidable, as different methods
will be more appropriate to specific research questions (and their corresponding field
of enquiry), available data, resources and time. This is a big challenge for any
country wanting to develop a workable HTA system.
From the onset, you should think of developing a Reference Case (RC) and methods
guidance to address such challenges23. A RC defines a set of core principles to
ensure that the research used has been based on best practice and that findings are
accurately interpreted. A RC provides grounding for standardising as much as
possible of the research, or at least of the reporting of the data. It allows the reader
to understand the trade-offs made by the researchers, and potential impact of such
trade-offs on the interpretation of the results.
A RC can also guide the planning, conduct and reporting of research in more
granular details. Developing a RC helps setting out the expectation for any economic
21
Drummond, M. F., Sculpher, M. J., Claxton, K., Stoddart, G. L., & Torrance, G. W. (2015). Methods
for the economic evaluation of health care programmes. Oxford university press.
22
Briggs, A., & Sculpher, M. (1998). An introduction to Markov modelling for economic
evaluation. Pharmacoeconomics, 13(4), 397-409.
23
Wilkinson, T. et al. (2016). The International Decision Support Initiative Reference Case for
Economic Evaluation: An Aid to Thought. Value in Health 19
30
evaluation and local preferences (e.g. for DALYs/QALYs, discount rate, attitude to
addressing/capturing equity impacts etc.).
The Bill and Melinda Gates Foundation commissioned the development of a RC for
LMICs, which was put together by the iDSI24. The iDSI RC threefold structure
comprises: principles outlining the characteristics of economic evaluations,
methodological specifications, and reporting standards25. The iDSI RC can be
contextualised according to a country’s values and characteristics. For instance,
Thailand, Egypt, Bhutan and Malaysia have developed or are currently developing
their own Reference Case for Economic Evaluation26.
iDSI Reference Case Principles

1. An economic evaluation should be communicated clearly and transparently to allow the
decision maker(s) to interpret the methods and results
2. The comparators against which costs and effects are measured should accurately
reflect the decision problem.
3. An economic evaluation should consider all available evidence relevant to the decision
problem
4. The measure of health outcome should be appropriate to the decision problem, should
capture positive and negative effects on length and quality of life, and be generalisable
across disease states
5. All differences between the intervention and the comparator in expected resource use
and costs of delivery to the target population(s) should be incorporated into the
evaluation
6. The time horizon used in an economic evaluation should be of sufficient length to

capture all costs and effects relevant to the decision problem; an appropriate discount
rate should be used to discount cost and effects to present value
7. Non-health effects and costs associated with gaining or providing access to health
interventions that don't accrue to the health budget should be identified where relevant
to the decision problem. All costs and effects should be disaggregated, either by sector
of the economy or to whom they accrue
8. The cost and effects of the intervention on sub-populations within the decision problem
should be explored and the implications appropriately characterised
24
ibid
25
ibid
26
see list of Reference Case for Economic Evaluation on the GEAR and IPSOR websites
http://www.gear4health.com/gear/health-economic-evaluation-guidelines and
https://www.ispor.org/PEguidelines/index.asp
31
9. The uncertainty associated with an economic evaluation should be appropriately
characterised
10. The impact of implementing the intervention on the health budget and on other
constraints should be identified clearly and separately
11. An economic evaluation should explore the equity implications of implementing the
intervention
vi. Retrieving available evidence

The evidence used in HTA is often scattered across different sources or exists in
different formats; this is particularly the case in LMICs. Evidence is best identified
through systematic literature reviews and grey literature reviews.
Literature reviews
A literature search will help you collate information about a particular health
technology. Below are some of the most commonly used databases for literature
reviews:
• PubMed
• WebMD
• Google Scholar
• Web of Science
• Scopus
• WHO/UN websites
• Jstor
To conduct a literature review, you will need to apply predetermined inclusion and
exclusion criteria to the literature search, critically appraising the relevant literature
and the extraction and synthesis of data from evidence base to formulate answers to
key questions27. The purpose of these methods is to minimise the possibility of
biasing the results in favour of or against particular technologies.
27
Ibid.
32
Literature search: inclusion and exclusion criteria
Exclusion criteria
To narrow your literature search, you will need to exclude some factors:
• Replace general search terms with more specific search terms (for example,
search for “low back pain” instead of “back pain”).
• Add additional terms to your search.
• Use filters to restrict your results by publication date (for example “published after
2005”), by species, disease, article type, etc.
Inclusion criteria:
To broaden your search, you will need to include relevant factors for the literature
you’re searching for:
• Remove unnecessary or overly specific terms from the search box.

• Try using alternative terms to describe the concepts you are searching.
28
Source: Adapted from PubMed Help
A useful way of defining the key questions for use in a literature review and to inform
the choice of inclusion criteria in the literature search, is the PICO format (sometimes
PICOTS):
Population: e.g., condition, disease severity/stage, comorbidities, risk factors,

demographics
Intervention: e.g., technology type, regimen/dosage/frequency,

technique/method of administration
Comparator: e.g., placebo, usual/standard care, active control
Outcomes: e.g., morbidity, mortality, quality of life, adverse events
Example of a PICO in a literature search
You can convert your question to a search strategy by identifying terms that
you would want to include in your search, like:
Population/Problem: Women over 40 with heart failure from dilated

cardiomyopathy
28
https://www.ncbi.nlm.nih.gov/books/NBK3827/#pubmedhelp.PubMed_Quick_Start
33
Intervention: Adding anticoagulation with warfarin to standard heart failure
therapy
Comparator: Compared with standard therapy alone
Outcomes: QALY gained
A systematic literature review collects, critically evaluates and integrates the

evidence presented in multiple research studies or papers for a given question; using
search and analytical methods that are clearly defined from the beginning.
Systematic reviews aim to minimize bias by using explicit and systematic methods.
The Cochrane Handbook for Systematic Reviews of Interventions can assist

technical staff by describing the process of developing and maintaining a systematic
literature review (for more information, see http://training.cochrane.org/handbook).
Grey literature research
The grey literature is a widespread but complex set of sources of information. It is

defined as ‘that which is produced at all levels of government, academics, business
and industry in print and electronic formats, but which is not controlled by
commercial publishers, i.e., where publishing is not the primary activity of the
producing body’29.
Grey literature is not formally published in academic books or journals and includes
reports, theses, conference proceedings, newspapers, fact sheets, websites, and
policy documents30. Grey literature encompasses different types of information, of
varying quality. Grey literature does not necessarily mean that the information hasn’t
been reviewed or fact-checked. However, the review process is typically not
externally conducted. For some type of evidence (i.e. clinical studies, etc.), it is
advisable to refer to peer reviewed literature. You may want to include some grey
literature in evidence syntheses for at least three reasons: grey literature can reduce
the impact of publication bias (when conducted alongside peer reviewed literature); it
can provide useful contextual information on how, why, and for whom complex public
health interventions are effective; and finally, to help identify what interventions exist,
the full range of evaluations that have been conducted, and where further
29
Godin et al., (2015). Applying systematic review search methods to the grey literature: a case study
examining guidelines for school-based breakfast programs in Canada.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4619264/pdf/13643_2015_Article_125.pdf
30
ibid
34
intervention development and evaluation is needed31.Grey literature of possible
relevance for HTA is found in sources such as32:
• Health and economic statistical reports

• Regulatory documents and government monographs
• Coverage policies of health authorities and insurance plans
• Drug and biologics compendia
• Health professional association reports and guidelines
• Industry (e.g., life sciences company) reports
• Market research reports for particular health care sectors/industries
• Policy and research institute studies
• Reports of special expert panels and commissions
• Conference proceedings, memoranda and working papers
• Technical specifications and standards
Real World Evidence

Increasingly, the term Real World Evidence (RWE) has been used to characterise
evidence that is generated outside of clinical trials or research setting. RWE is a
subset of grey literature as defined above. It makes use of electronic medical
records, claims and billing data, product and disease registries and data gathered
through personal services and health applications to gain information about patterns
of use for specific interventions, and sometimes linking it to health outcomes.33 The
increase in RWE has been important in recent years, as routine data collection
systems now generate large data sets on a number of issues.
RWE can be used as a sole source of information or be complementary to other type
of scientific evidence produced. For instance, RWE can help integrate clinical
research and more diverse data sources from implementation on the ground; and
can shed light on how factors in the clinical setting, provider or patient behaviour can
influence patient treatment outcomes. However, the use of RWE is still in its early
days and the quality and provenance of data is not often well understood by
researchers and end-users of this data (e.g. policy makers)34. Several groups are
31
Adams et al. (2016). Searching and synthesising ‘grey literature’ and ‘grey information’ in public
health: critical reflections on three case studies.
https://systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-016-0337-y
32
33
Sherman, R. E., Anderson, S. A., Dal Pan, G. J., Gray, G. W., Gross, T., Hunter, N. L., ... & Shuren,
J. (2016). Real-world evidence—what is it and what can it tell us. N Engl J Med, 375(23), 2293-2297.
34
ibid
35
working on developing appropriate methods for assessing the data provenance and
quality, and perhaps in the future even analytical approaches to draw causal
interference. Caution should apply when using this data.
vii. Identifying gaps in the evidence

Conducting a systematic literature review or grey literature review makes it easier to
identify gaps in existing evidence35. There are likely to be studies in your country that
have not been comprehensively reviewed.
Once gaps in evidence have been identified, it may be possible to:
Conduct primary research in order to fill them (even if only in part)
Adapt evidence from existing resources (for example from similar research done in
neighbouring countries)
Use the evidence in its entirety from another source
Assessing data gaps
Regardless of the chosen approach, in a first instance, it is important for you to

assess whether the existing data at your disposal can be used for conducting
primary research or adapting results from other countries.
Interviews with key stakeholders, a review of the health information systems, and
literature review can help locate where the information might be in your country. A
data gap analysis can then be conducted to plan for future data collection to meet
those requirements.
An analysis of data for HTA in India identified many sources of information of all
kinds: the health management information system, national family health survey,
clinical trials, national sample survey office, national disease control programs.
Further details are available here.
Conducting primary research
Primary research is research that generates or uses original data, as distinct from
secondary research, which summarises or adapts other people’s research. You will
need to assess your own needs in terms of primary research, perhaps, with the
support of partner universities. Ideally, primary research should be conducted to
generate locally relevant data that accounts for local peculiarities with up to date
35
Ibid.
36
information. However, this research is typically costly and might not generate timely
results.
University collaboration can bring research skills you may not have to conduct
primary research to fill gaps you have identified. Through such collaboration you may
also be able to tap literature search skills, get access to skills in adapting existing
research, or just get advice on methods. Using local capacity for research, besides
its direct usefulness, is also a way of building local research capacity and
demonstrating a demand for applied research skills.
One useful online tool is the Guide to Economic Analysis and Research (GEAR),
which informs researchers on methods of data collection and analysis in economic
evaluations. Most of this tool is devoted to answering commonly encountered
problems for researchers in LMICs, such as lack of costing or clinical data. A section
in the online tool also allows researchers to ask questions to GEAR experts and
discuss their problem on an open forum.
Guide to Economic Analysis and Research (GEAR) Online Resource
The Guide to Economic Analysis and Research (GEAR) online tool is a useful
resource for technical staff and researchers. GEAR provides useful definitions
and mind-maps for researchers facing questions, such as:
• What type of modelling should I do?

• What health outcome should I use?
• How may I overcome data limitations in conducting economic evaluation for my
country?
• What is the best way of presenting my research results?
GEAR provides ways of solving methodological difficulties in the conduct and

use of economic evaluations.
36
Source: GEAR
Adapting existing studies
In many LMICs, evidence is not available, relevant, or it might be of poor quality, or

incomplete. Studies that have been done in the past may have become outdated or
may have never been quality assessed or reviewed professionally as, for example,
when they are published in a reputable journal.
36
GEAR http://www.gear4health.com/about
37
Technical staff in ministries of health can try to keep abreast of the evidence
available in other settings, ideally from a neighbouring country of similar income level
and presenting common health system challenges, or elsewhere, often in high
income countries, where they have less in common with your country, or
international evidence in global studies that claim to be more or less generalisable in
all settings. It may sometimes be possible to use results from other research settings
directly, if the background is sufficiently similar to that in your country and it is not
going to be possible to do any primary research.
Transferring economic evaluations through adaptation has been proposed as an

alternative to the time-consuming and expensive new primary studies; it can perhaps
save resources in LMICs while encouraging the use of evidence-informed decision-
making37. If you are considering adapting the results from foreign hta studies, two
resources are available to help:
• Goeree et al. (2011) reviews several transferability tools developed for hta. They
include summaries of the types of checklists and assessment tools, including the
Welte’s decision chart and the Boulenger tool.
• EUNetHTA has also developed a short guide38 for countries to assess whether
existing hta studies can be adapted and transferred to different contexts. Their
Toolkit aims to help HTA agencies assess:
(1) The relevance of the report: is the policy and/or research question posed
sufficiently similar to warrant adaptation of this report?
(2) Reliability: is the quality of the report adequate?
(3) Transferability: what are the main issues to consider when using research done in
settings other than your own?
The table below shows examples of questions to ask when considering adapting
results from economic evaluations.
Example: Considering the adaptation of evidence on

economic evaluation
• How generalisable and relevant are the results, and validity of the data
and model to the relevant jurisdictions and populations?
• Are there any differences in the following factors?

Perspective, preferences, relative costs, indirect costs, discount rate,
37
Goeree, R., et al., Transferability of health technology assessments and economic evaluations: a
systematic review of approaches for assessment and application. ClinicoEconomics and Outcomes
Research, 2011. 3: p. 89–104.
38
EUNetHTA HTA Adaptation Toolkit & Glossary. See https://www.eunethta.eu/eunethta-hta-
adaptation-toolkit/
38
technological context, personnel characteristics, epidemiological context
(including genetic variants), factors which influence incidence and
prevalence, demographic context, life expectancy, reproduction, pre-
and post-intervention care, integration of technology in health care
system, incentives
a. If differences exist, how likely is it that each factor would impact

on the results? In which direction? Of what magnitude?
b. Taken together, how would they impact on the results and what
is the magnitude of the effect?
c. Given the differences, are the conclusions likely to be sensitive

to a change in the target setting? Are you able to quantify this to
any degree?
o Does the economic evaluation violate your national/regional guidelines
for health economic evaluation?
39
Source: EUNetHTA
If the differences between countries are known and measurable, there might be
scope for adapting the results from one context to another using specific methods. A
review conducted by Pichon et al. (2012) found that information regarding the
technology, safety, efficacy and effectiveness were often directly transferable from
one setting to another but that results in terms of budget impact, costs and
organisational issues usually require adaptation40.
Use of foreign research results of any kind usually requires changing the currency in
which ICERs and other monetary variables are calibrated (e.g. use of Purchasing
Power Parities (PPPs).
Transfer evidence from other context
A last option is to directly apply evidence from other settings to your own country.
This approach often involves transforming the results using exchange rates or
PPPs41.
39
EUNetHTA HTA Adaptation Toolkit & Glossary
40
Pichon-Riviere, A., Augustovski, F., García Martí, S., et al. Transferability of health technology
assessment reports in Latin America: an exploratory survey of researchers and decision makers.
International Journal of Technology Assessment in Health Care 2012; 28(2):180-6.
41
Goeree, R., et al., Transferability of health technology assessments and economic evaluations: a
systematic review of approaches for assessment and application. ClinicoEconomics and Outcomes
Research, 2011. 3: p. 89–104.
39
The suitability of this approach can be appraised from the list of questions listed
above. However, it is unlikely that results from a hta study from another country are
generalisable and will apply directly to your country.
A review conducted in Vietnam, India and Bangladesh indicated that policy-makers

in these three countries judged it inappropriate to use information from other settings
without adaptation. According to the technical staff who were interviewed, direct
information from other contexts was not suitable mainly because of differences in
costs and clinical practice42. Merely converting unit costs in PPPs will not adjust
appropriately for differences in costs between countries, as PPPs are generalised
ways of equalising the purchasing power of currencies. They enable one to compare
service cost differentials only internationally.
If you feel nonetheless that there is no alternative to un-adapted transfers of results,

the Disease Control Priorities (DCP)43 might help to contextualise and understand
what the global evidence suggests for particular interventions or health technologies
with its caveats. The purpose of DCP is to provide a comprehensive review of cost-
effective interventions in a variety of settings. A third edition of DCP was published in
December 2017. It comes in nine volumes. The first eight cover packages of related
interventions while the ninth provides an overview with main findings and
conclusions about health priorities. The main eight volumes cover surgery,
reproductive health (including maternal and child health), cancer, mental and
neurological disease, cardiovascular and respiratory disease, infectious disease,
injury and environmental health, childhood and adolescent diseases. Information on
DCP can be found on the DCP website.
42
Teerawattananon, Y., Tantivess, S., Yamabhai, I., Tritasavit, N., Walker, D. G., Cohen, J. T., &
Neumann, P. J. (2016). The influence of cost-per-DALY information in health prioritisation and
desirable features for a registry: a survey of health policy experts in Vietnam, India and Bangladesh.
Health research policy and systems, 14(1), 86.
43
Jamison, D. T., Alwan, A., Mock, C. N., Nugent, R., Watkins, D., Adeyi, O., ... & Binagwaho, A.
(2017). Universal health coverage and intersectoral action for health: key messages from Disease
Control Priorities. The Lancet. 391(10125):1108-1120
40
Building Block 3
A transparent and consistent
process of HTA
41
i. Introduction
This block introduces:
• Description of the various stages of the HTA process from topic selection to
analysis and appraisal of evidence
• Need for a process and methods guide
• Making recommendations
• The benefits and requirements of monitoring and evaluation
ii. The steps of HTA

There is no single ‘correct’ approach to designing and operating an HTA framework.
Decision-makers must design priority-setting processes that suit local settings,
political contexts and decision problems. However, a ‘five-step’ process developed
by PRICELESS allows policy-makers to plan for a typical cycle of priority setting.
Figure: A ‘five-step process’ of priority-setting
Source: Siegfried, Wilkinson & Hofman (2017)44
Transparent HTA arrangements are always desirable because transparency creates

trust and acceptance among stakeholders, such as patients and the medical
industry45. A published guide to the decision-making process is helpful. A methods
guide, containing detailed principles and guidelines for the conduct of economic
evaluations (covering steps 1-4 from the figure above), defines the information needs
of decision makers and guides manufacturers and others into ways of presenting
their technologies to meet those needs. Some countries include timelines to the
44
Siegfried, N., Wilkinson, T., & Hofman, K. (2017). Where from and where to for health technology
assessment in South Africa? A legal and policy landscape analysis. South African Health Review,
2017(1), 42-48.
45
Wild et al. (2017). Guidance for the development of a National HTA-strategy. Health Policy and
Technology, Vol. 6(3). https://www.sciencedirect.com/science/article/pii/S2211883717300461
42
process to avoid creating undue delays in bringing technologies to market.
Transparency also helps manufacturers, policy-makers, the medical profession and
the general public to understand the process and the expected time frame over
which decisions are made.
Making both the process and the methods guides available on-line is good practice.
As an example, NICE provides a defined set of steps with timelines (in terms of
weeks). The entire process from topic definition to the end of the appraisal is 43
weeks for NICE. This timeline can be found online.
iii. Topic selection for HTA

The number of existing or new technologies to assess in the health sector is
overwhelming, and HTA agencies can struggle to keep up with all new
technologies46, so we do not advise evaluating all existing technologies, The
PRICELESS step one, ‘Topic selection’, is plainly critically important.
At the beginning, it is unlikely that you will be able to look at newly approved drugs or
technologies in a systematic way. Topic choices may be motivated by specific
upcoming policy decisions or particular health problems, or they could be identified
through consultations with key stakeholders like politicians, leading clinicians and
senior health service managers in the public and private sectors.
For example, a country with scarce resources for HTA may start with a major, under-
addressed burden of disease and examine prevention and treatment alternatives; or
with a costly device that has powerful political support but which, if funded, is likely to
divert public funding from higher value uses47. In the early days, it is also useful to
seek out ‘low-hanging fruit’ to demonstrate the usefulness of HTA and to get some
results quickly. In such cases, it is key to select are topics for which there is already
credible evidence and the necessary analysis is mainly of the literature. Following
this, a routine can be established to sustain further work.
46
Sorenson et al. (2008). Ensuring Value for Money in Health Care: The role of health technology
assessment in the European Union.
http://www.euro.who.int/__data/assets/pdf_file/0011/98291/E91271.pdf
47
Glassman and Chalkidou (2012). Priority-Setting in Health Building institutions for smarter public
spending.
https://www.cgdev.org/sites/default/files/1426240_file_priority_setting_global_health_FINAL_0.pdf
43
Country example: Topic selection in Thailand
The process begins with an opportunity for stakeholders of the UHC scheme
to propose topics for assessment to a Working Group; this happens twice a
year in January and July.
Stakeholders include policymakers, physicians, academics, civil groups,

patient groups, the healthcare industry and the general public and each group
can propose up to three topics at a time.
The Working Group (comprised of physicians, academics, civil groups, and

patient groups), will select the assessment topics based on:
1) The number of people affected by the disease or problem;

2) The severity of the disease or problem;
3) The effectiveness of health technologies;
4) Differences in practice;
5) Economic impact on households;
6) Fairness, and social and ethical issues.
48
Source: HiTAP (2016)
There are various mechanisms for selecting topics and setting priorities. In some
countries, the topic agendas of review bodies are set by national authorities - usually
the health minister or department of health49. Other countries, like Germany and the
UK, have established processes for topics to be submitted by a wide range of
stakeholders including manufacturers.
The range of assessment topics varies between countries, with some HTA agencies
prioritising health technologies while others focusing on specific disease areas.
iv. Analysis
The main step after selecting a topic is the systematic evaluation of the relevant
evidence, which is further broken down in two different stages:
• A literature review of the intervention’s effectiveness
48
HiTAP (2016). Priority-setting for Universal Health Coverage, HITAP & iDSI
http://www.idsihealth.org/wp-content/uploads/2016/02/Priority-Setting-for-UHC.pdf
49
Sorenson et al. (2008). Ensuring Value for Money in Health Care: The role of health technology
assessment in the European Union.
http://www.euro.who.int/__data/assets/pdf_file/0011/98291/E91271.pdf
44
• An economic evaluation summarising the relationship between costs and
effects. This can include a budget impact assessment of the likely costs of
implementing the intervention.
This step also involves reviewing and assessing the quality of the evidence
submitted (usually the strengths, weaknesses, uncertainty and gaps of the
evidence). The evidence can be submitted from the manufacturer or be collected as
a result of a study conducted by the HTA unit or other organisations. In other words,
you will seek to understand the validity of the evidence collected. Validity refers to
how well a study measures what it is intended to measure50.
Tools such as Grading of Recommendations, Assessment, Development and

Evaluations (GRADE) or the Critical Appraisal Skills Program (CASP) can help
ensure that the evidence collected is of an adequate quality and relevance. CASP
specifically developed an approach to assess the risk of bias and study quality for a
range of evidence, including systematic reviews, as well as individual studies
(randomised-control trials, cohort studies etc.) User-friendly checklists have also
been developed to support application of those tools.
At this stage, the process and methods guide should provide details on the type of
evidence that is acceptable, methods for retrieving this evidence (e.g. Cochrane
handbook51), methods for assessing the quality of the studies, and methods for
determining who will be involved in this step (see building block ‘making HTA
inclusive’).
At the end of the analysis, a report synthesising evidence is produced and used in
the appraisal phase.
v. Appraisal
Appraisal is the structured consideration of the evidence, in order to inform
recommendations such as whether to include or exclude a particular drug from
public funding.
The appraisal process is often led by a committee that represents the views of a
wide range of stakeholders. The committee appraising the evidence should be
independent, so that the decisions made are impartial and serve the general public
interest. Any conflict of interest (personal, financial or professional) should be
declared (see the building block ‘making HTA inclusive’). A review of HTA analysis
50
51
Higgins, J. and Green, S. (2011). Cochrane Handbook for Systematic Reviews of Interventions.
The Cochrane Collaboration http://handbook-5-1.cochrane.org/
45
and appraisal in 9 countries found that appraisal committees were varied in size
(between 9-39 members) and composition. In the Netherlands, the appraisal
committee is composed of 9 members from the medical sector (experts in medical
ethics, HTA, practitioners) and one representative of patients. This is a more
restrictive representation compared to other bodies, such as NICE in the UK, where,
for instance, representatives of pharmaceutical and medical device industries,
academia and patient and carer organisations are represented in the Technology
Appraisal Committee.52
A methods guide will describe the composition of the committee (e.g. which
categories of stakeholder should be involved and how individuals will be selected)
and contain a policy on statement on conflicts of interest. Information on the style of
chairing and the mode of deliberation should also be detailed in the process guide.
A draft appraisal report for consideration is usually produced once the appraisal
process is over.
vi. Decision-making
Recommendations are usually drafted by a technical secretariat before being
submitted to the relevant decision-making bodies. Different decision-makers might
set up parallel mechanisms: for example, health insurers may have parallel,
independent decision-making processes on coverage. This is common in LMICs,
where several coverage mechanisms (with separate funding streams) might co-exist
in the same space. Who is involved at this stage depends on the characteristics of
your HTA system, and of the objective of the HTA recommendation. It is worth noting
that in the UK, the recommendations in go to the NICE Board, who is the decision-
maker, and whose decisions are legally binding.
The recommendations should reflect local values and principles. Each will be based
on the appraisal reports, but can include other ‘non-technical’ considerations.
Individual and collective beliefs, values, needs and aspirations might influence the
recommendation. Methods such as Multiple-criteria decision analysis can be used to
account for multiple and sometimes conflicting concerns53. Whether and how much
such considerations should affect the final recommendation are decisions that need
to be made by local stakeholders and are factors that lie outside HTA.
52
http://eprints.hta.lbg.ac.at/1036/1/DSD_72.pdf
53
See Thokala, P., Devlin, N., Marsh, K., Baltussen, R., Boysen, M., Kalo, Z., ... & Ijzerman, M.
(2016). Multiple criteria decision analysis for health care decision making—an introduction: report 1 of
the ISPOR MCDA Emerging Good Practices Task Force. Value in health, 19(1), 1-13.
46
Country example: Poland HTA Process
• Poland has an independent HTA agency known as the Agenja Oceny

Technologii Medycznych i Taryfikacji (the Agency for Health Technology
Assessment and Tariffs or AOTMiT). It has a wide scope of activity,
including drug and non-drug economic evaluations and the assessment
of all public health programs.
• Assessment of the evidence is done using an HTA methodological

guideline (last updated in 2016).
• Appraisal of evidence is undertaken by the Transparency Council. The

Council is an advisory committee of 20 members appointed by Minister
of Health. It is described as ‘advisory and independent’. The TC gives
advice on a technology in the form of a ‘position’.
• From the appraisal, a statement and recommendation is issued by the

President of the AOTMiT, which contains: information on the financing;
rationale for the recommendation; objective of the recommendation (e.g.
its intended use); a brief note on the health problem; a description of the
technology characteristics; a budget impact analysis; and
recommendations for foreign HTA institutions.
Source: Lipska et al. (2017)54
Cost-Effectiveness Thresholds
In some countries, making the HTA recommendation might involve the use of a
Cost-Effectiveness Threshold (CET), usually expressed in the form of X$55 per QALY
gained (or DALY averted). A CET is used to inform the decision to introduce or
exclude a drug, intervention or medical technology from coverage. In essence,
interventions across disease states can be ranked according to their cost-
effectiveness, and if their Incremental Cost-Effectiveness Ratio (see the building
54
Lipska, I. et al. (2017). A Decade of Health Technology Assessment in Poland. International Journal
of Technology Assessment in Health Care, Vol. 33(3)
https://www.cambridge.org/core/journals/international-journal-of-technology-assessment-in-health-
care/article/decade-of-health-technology-assessment-in-
poland/3274C7B577DAE6C88ABEF62AFECEA728
55
Or local currency
47
block on HTA evidence) is below the set CET, they are considered ‘good value for
money’56.
There is no international consensus over what a CET should represent, how it

should be calculated, how equity concerns can be embedded, and what sort of
evidence is needed for its calculation CETs57. CETs are sometimes based on
aspirational values (i.e. set independently of affordability), budget constraints or
GDP. The WHO-CHOICE models used a GDP based threshold (1-3x GDP), but this
method has recently been discarded by technical staff working at the WHO. One of
the concerns about this approach is that GDP-based CETs are set ‘too high’, and as
a result, interventions that are not affordable are covered and will exhaust the
available funding. On the other hand, setting a threshold too low would mean that
cost-effective interventions are not covered, resulting in unnecessary loss of life and
quality of life58. If you are involved in designing or modifying a CET, a useful rule of
thumb for judging whether your CET is set at roughly the right level is to consult with
colleagues about the current pressures on the system. If you judge that more
technologies are being introduced for ever more subgroups of patients, then your
CET is probably too high.
The general principle to keep in mind is known as ‘opportunity costs’. This states that
you ought not to recommend further technologies at the expense of others whenever
their cost per QALY (or averted DALY) is higher – unless there are powerful reasons
for wanting to sacrifice some health for some people.
The following list of studies might help you understand the challenges associated
with the development and use of a CET:
Bertram, M. Y., Lauer, J. A., De Joncheere, K., Edejer, T., Hutubessy, R., Kieny, M.
P., & Hill, S. R. (2016). Cost–effectiveness thresholds: pros and cons. Bulletin of the
World Health Organization, 94(12), 925.
Bilinski, A., Neumann, P., Cohen, J., Thorat, T., McDaniel, K., & Salomon, J. A.
(2017). When cost-effective interventions are unaffordable: Integrating cost-
56
Culyer, A. J. (2016). Cost-effectiveness thresholds in health care: a bookshelf guide to their
meaning and use. Health Economics, Policy and Law, 11(4), 415-432.
57
Ochalek, J., Lomas, J. and Claxton, K. (2015).Cost per DALY averted thresholds for low- and
middle-income countries: evidence from cross country data. Centre for Health Economics.
https://www.york.ac.uk/media/che/documents/papers/researchpapers/CHERP122_cost_DALY_LMIC
_threshold.pdf
58
Culyer, A. J. (2016). Cost-effectiveness thresholds in health care: a bookshelf guide to their
meaning and use. Health Economics, Policy and Law, 11(4), 415-432.
48
effectiveness and budget impact in priority setting for global health programs. PLoS
medicine, 14(10), e1002397.
Culyer, A. J. (2016). Cost-effectiveness thresholds in health care: a bookshelf guide

to their meaning and use. Health Economics, Policy and Law, 11(4), 415-432.
Ochalek, J., Claxton, K., Revill, P., Sculpher, M., & Rollinger, A. (2016). Supporting
the development of an essential health package: principles and initial assessment for
Malawi. CHE Research Paper, 136.
Revill, P., Walker, S., Madan, J., Ciaranello, A., Mwase, T., Gibb, D. M., ... &
Sculpher, M. J. (2014). Using cost-effectiveness thresholds to determine value for
money in low-and middle-income country health care systems: Are current
international norms fit for purpose? (No. 098cherp).
Revill, P., Ochalek, J., Lomas, J., Nakamura, R., Woods, B., Rollinger, A., ... &
Claxton, K. (2015). Cost effectiveness thresholds: guiding health care spending for
population health improvement.
Country example: Ireland’s Cost-effectiveness Thresholds
• Ireland uses an explicit CET that is broadly based on historical

estimates and judgement.
• The cost-effectiveness of all new medicines is evaluated by the National

Centre for Pharmacoeconomics in collaboration with the Health Service
Executive, the public body responsible for delivering state-funded
healthcare in Ireland.
• The Irish Pharmaceutical Healthcare Association and the Executive

have an agreement that explicitly states that the CET to be used in the
HTA process is €45,000/QALY.
• This value is also confirmed on the National Centre’s website. However,

its recommendations are not mandatory and can be overruled by the
health minister or the Executive.
59
Source: Thokala, P. et al. (2018)
59
Thokala, P., Ochalek, J., Leech, A.A. et al. (2018). Cost-Effectiveness Thresholds: the Past, the
Present and the Future. PharmacoEconomics. https://link.springer.com/article/10.1007%2Fs40273-
017-0606-1
49
vii. Monitoring and Evaluation
Finally, depending on your resources and plans, it is good practice to monitor the
impact of HTA decisions. Monitoring and Evaluation can help provide evidence on
the value of HTA and inform policy-makers and other stakeholders on the value of
HTA in decision-making. Monitoring and Evaluation can also inform changes in the
medium term (2-3 years), for instance if new competing and better technologies have
appeared in the meantime.
At the most simple level, monitoring seeks to address the following questions:
• How do the observed outcomes align with your initial hypotheses/predicted

impacts?
• Do we observe changes in health technology utilisation after the decision?
• Which patients receive it? And in what setting?
Those questions will need to be addressed by ‘real life’ data and information. This
information can be gained from administrative data, procurement data, registries and
electronic medical records (depending on the detail available in your health
information infrastructure). Surveys and clinical audits can also be used to
investigate the impact of the HTA decision at the level of provision of care, but those
require specific data collection and are more costly60.
Very few countries engage thoroughly in monitoring the uptake of HTA decisions,
although this activity can be included in the methods and process guide. In the UK,
uptake of new medicines are monitored using the innovation scorecard, a tool that
currently covers 104 medicines for acute coronary syndrome, diabetes, multiple
sclerosis and stroke.
In a first instance, you should survey the availability of such data in your country and
try to estimate your needs in terms of data collection.
Challenges to creating monitoring mechanisms
• Monitoring requires observational data that can be provided by any

stakeholder, but must be critically appraised.
• When monitoring involves partnership between stakeholders (including

patients and providers), a clear governance structure needs to be in
place with documents agreeing the purpose, conduct, reporting,
60
Frønsdal, K. et al. (2010). Health technology assessment to optimize health technology utilization:
Using implementation initiatives and monitoring processes. International Journal of Technology
Assessment in Health Care, Vol. 26(3)
50
intended actions from the monitoring activity and the sharing of risks.
• Barriers can include lack of routine data collection systems and health
information systems, a lack of patient participation, competing demands
on clinicians, alteration of patient pathways, quality, and costs of
monitoring activities.
• You will need to consider who will pay for good-quality monitoring
studies as health organisations usually have limited budgets for this
type of study.
Source: Frønsdal, K. et al. (2010)61
More comprehensive impact evaluations can also be conducted, often by

independent academic institutions. Guthrie et al. (2015) worked on a review of the
impact of the studies from the National Institute for Health Research (NIHR) Health
Technology Assessment (HTA) program in the United-Kingdom62. Impacts in the
following area were recorded: National Health Service and patients, UK policy,
academic and research system, industry and the economic, and international. The
review shows impact on patient outcomes, mainly through the implementation of
guidelines.
61
Frønsdal, K. et al. (2010). Health technology assessment to optimize health technology utilization:
Using implementation initiatives and monitoring processes. International Journal of Technology
Assessment in Health Care, Vol. 26(3) https://www.cambridge.org/core/services/aop-cambridge-
core/content/view/80E6482BE29E809A2BB3E4FDCCF1A31E/S0266462310000309a.pdf/health_tech
nology_assessment_to_optimize_health_technology_utilization_using_implementation_initiatives_and
_monitoring_processes.pdf
62
Guthrie, S., Bienkowska-Gibbs, T., Manville, C., Pollitt, A., Kirtley, A., & Wooding, S. (2015). The
impact of the National Institute for Health Research Health Technology Assessment program, 2003–
13: a multimethod evaluation.
51
Building Block 4
Building capacity to support HTA
52
i. Introduction
This building block focuses on:
• The types of capacity and skills that are essential in HTA

• How to plan to build the capacity that is needed
• Getting the right mix of expert individuals working on HTA
• How to find help for training, funding and capacity building at the regional and global
level.
ii. Building capacity

Capacity building is not only about providing people with the technical skills for
conducting economic evaluation. On HTA specifically, you should be thinking about
the following types of capacity:
• People and organisations that generate HTA evidence (i.e. supply side; usually
researchers)
• People that use HTA evidence to make or inform high-level decisions (i.e. demand
side; e.g. policymakers; e.g. technical officers working for them to
commission/interpret/appraise evidence).
• Professionals, who need to understand the reasons why resources are available for
some purposes but not others, and whose own professional practice should be
informed by the best clinical evidence
• Knowledge brokers, who are a special category of actors facilitating the transfer of
knowledge and engagement between the producers of HTA evidence and the end-
users (e.g. the media who facilitate understanding of priority setting agencies such as
HITAP by the public and health professionals, and educationally influential members
of the medical and managerial professions, who can lead by example).
All capacity-building activities ultimately involve empowering individuals63. To some

extent, building technical capacity is straightforward; it involves the development of
essential skills and knowledge through the training of individual researchers64.
However, infrastructure and resources, such as data availability and management,
expertise in related fields, a set of procedural guidelines will be required to ensure
63
Li, R. et al. (2017). Evidence-informed capacity building for setting health priorities in low- and
middle-income countries: A framework and recommendations for further research.
https://www.ncbi.nlm.nih.gov/pubmed/28721199
64
Tantivess, S. et al. (2017). Health Technology Assessment capacity development in low and
middle-income countries: Experiences from the international units of HITAP and NICE.
53
quality of the capacity building process65. Moreover, capacity building is not only
about training individuals with the right skills (i.e. technical capacity); how this
capacity will work within institutions and how it is connected to other parts of the
healthcare system (including decision-making) is as important.
The United Nations Development Program Individual, Node, Network and Enabling
Environment (INNE) Model is one way in which thinking about capacity can be
organised66. This model emphasizes the need to build local relevant technical
capacity for specific skills (as discussed below), as well as building the nodes,
networks and enabling environment to ensure that those skills are best put to use.
The table below outlines the distinct characteristics and approaches to capacity
building for those four elements:
Individual, Node, Network and Enabling Environment (INNE) Model
Enabling Environment - Requires institutionalising priority-setting agencies

at local, national and regional levels, ensuring that appropriate structures,
processes and incentives are in place.
Stakeholders: Healthcare system, media, civil society, industry, judicial

system, political environment, economic environment, global health and
development community
Network – Global funders and development partners help shape priority-

setting either directly through their purchasing or provision of specific
interventions, delivery platforms, research investment and technical
assistance; or indirectly through their role as setters of global standards and
norms, for example with the iDSI Reference Case.
Stakeholders: funders and development partners like the WHO and World
Bank, global and regional networks and associations for priority-setting
including the iDSI, academic networks
Node and Individual – There needs to be political commitment among policy

leaders to move towards UHC, using HTA to help achieve that aim. There
also need to be continuing engagement of patients and the public, whose
understanding of the process and decisions of HTA are important for the
65
Tantivess, S. et al. (2017). Health Technology Assessment capacity development in low and
middle-income countries: Experiences from the international units of HITAP and NICE.
66
54
success of the strategy.
Stakeholders: consumers of evidence such as government, healthcare

professionals, health service managers, payers/insurers, courts and the
judiciary, patients and the public. Knowledge brokers such as priority-setting
institutions, media and journals. Producers of evidence such as academia
institutions, researchers and research managers. Influencers such as
industry organisations, patient organisations and NGOs.
67
Source: Li et al. (2017)
There is a wide range of stakeholder groups to be targeted at country, regional and

global levels for capacity building. Some of these groups operate across INNE
levels. For example, NICE and HITAP can be considered as ‘Nodes’ that have
significant functions across the ‘Network’ of academic, clinical and policy
institutions; they can be thought of as knowledge brokers whose core function is to
support the translation of evidence into policy in priority-setting, through linking
researchers and decision-makers.
iii. Human resources

Human resources are one of the most important aspects of capacity-building. Due to
the multidisciplinary nature of HTA, you will need to ensure your HTA organisation
has the right mix of expert skills.
Developing skills in the following fields is nearly always needed68:
• Clinical epidemiology
• Evidence-based medicine
• Clinical trials
• Health services research
• Literature review and meta-analysis
• Cost-effectiveness analysis and other economic evaluation methods
• Consensus conferences
• Technology management
• Decision-making
• Policy making and analysis
• Priority-setting
• Analysis of legal, social and ethical aspects
67
68
EUnetHTA Work Package 8 (2008). EUnetHTA Handbook on Health Technology Assessment
Capacity Building. http://www.inahta.org/wp-
content/themes/inahta/img/eunethta_wp8_hb_hta_capacity_building1.pdf
55
Capacity building can be delivered through interactive short workshops and training
sessions. Some of its non-clinical elements can be introduced in undergraduate and
graduate teaching for the health professions.
These skills will be carried out by a range of different people. An international survey
on HTA with results from Europe (73.1%), North America (19.5%), South America
(2.4%), Asia (2.4%) and Australasia (2.4%) found that the majority of HTA
organisations had “Clinical specialists” (71.1%) in their organisations, followed by
“Economists” (68.4%) and “Information specialists” in third place (65.8%)69.
Information specialists are a significant part of the HTA team, as they can assist the
entire HTA process, especially when planning searches on various databases or
systematic literature reviews.
HTA organisations also employed dentists, pharmacists, physiotherapists, lawyers,

chemists, nutritionists and engineers (mainly biomedical engineers) 70. In addition,
support from administrative staff (e.g. human resources and communications
managers) will be needed.
The amount of human resources you will need is dependent on the legal mandate
and budget given to the HTA program and the size of planned HTA activities. The
Center for Drug Evaluation/Health Technology Assessment, the Malaysian Health
Technology Assessment Section and HITAP respectively have 25, 31 and 55 full
time employees (research and admin)71.
iv. Training and recruitment

Currently, there are relatively few experts working in HTA compared to the number of
new and existing technologies to be evaluated72. You can conduct a capacity gap
analysis to understand the lack of current human capacity, the gaps in training and
recruitment that exist, to define a strategy for filling the gaps, and to assess the
investments and resources necessary to fill this gap (see building block ‘setting the
69
70
Ibid
71
HITAP (2016). Policy Brief and Working Paper: Conducive Factors to the Development of Health
Technology Assessment in Asia. http://www.idsihealth.org/wp-content/uploads/2016/02/CONDUCIVE-
FACTORS-TO-THE-DEVELOPMENT_resize.pdf
72
56
scene’). A capacity gap analysis could also help identify other potential constraints
(e.g. on hiring) that can be best addressed from the beginning73.
The 2015 WHO survey of HTA found that fewer than half the participating countries
had an HTA academic or training program. However, half stated they had staff
training sessions or external courses, seminars or workshops74. It is best to link up
with universities in your country to identify the types of training and curriculum they
offer in the specialties listed above, as well as identify number of undergraduate and
graduate students in training.
You do not need to rely solely on individuals trained specifically in HTA. Short
training courses in HTA methods for health economists and clinical epidemiologists
are early candidates for ‘low hanging fruit’. Specialised online training (for
professionals already working on health policy but with no experience of HTA) are
available if short courses are not available in your country. There are several
Masters degree programmes specialised on HTA in the world. It will not normally be
necessary to start training HTA experts at the doctoral level until the HTA program is
fully established.
If no training is available in your country and initially it is not possible to introduce

any, it might be possible to send staff to attend HTA courses in other countries. The
table below shows a list of regional/global training programs.
73
74
57
Examples of regional and Global Training Programs specialised in HTA
Short courses
• ISPOR HTA short training (4 days) – 2 or 3 trainings are organised each year ($600
for students)
• Health Technology Assessment: choosing which treatments get funded by the

University of Sheffield (4 weeks, 3 hours per week, free – upgrade possible)
• Adelaide HTA short course – online and on-campus short covering HTA methods
and how to link HTA to policy (online + 4 day on-campus training, $969-$1,800
AUD for members of LMICs).
Degrees
• Master Of Science Program In Health Technology Assessment by Mahidol

University with funding available from iDSI.
• Masters of Science in Economic Evaluation For Health Technology Assessment by

the University of York (2 years)
• Post-graduate taught HTA course at the University of Glasgow – several options

(MSc/PgDip/PgCert) covering different aspects of HTA including methods, health
economics, decision-analytic modelling, global health and HTA (online distance
learning + optional training on campus).
NB: those courses are known to our staff members. However, this is not an
exhaustive list and in no way constitutes a recommendation list from iDSI
An alternative to attendance of formal training is to find support from regional and

international networks to conduct case study projects for economic evaluation. Case
study projects will help individuals gain experience with the production or use of HTA
evidence. For instance, iDSI works closely with academic groups and technical staff
at the Ministries of Health or other health agencies on completing ‘proof of concept
projects’.
Finding support
You can identify regional support for capacity building by identifying big players who
can help with funding, HTA advice or short training courses. Some HTA
organisations, such as HITAP and the iDSI have a specific international branch for
helping develop HTA internationally. iDSI is conducting training programs focused on
specific skills or type of methods; and has run such training in many countries,
including India, Vietnam, Indonesia or South Africa.
58
You can connect with regional and global initiatives, or even other countries for peer
support and learning. For example, South Africa and China both have organisations
that can support neighbouring countries in evidence-based decision making; Priority
Cost Effective Lessons for System Strengthening (PRICELESSA) in SA and the
China National Health and Development Research Center have become focal points
for academic institutions and government-aligned think tanks75.
iDSI
iDSI is a partnership between government institutes, universities and think

tanks. The initiative was launched in November 2013 by the Global Health and
Development Group at Imperial College London, Health Intervention and
Technology Assessment Program (HITAP), the Center for Global
Development (CGD), Priority Cost Effective Lessons for Systems
Strengthening South Africa (PRICELESS SA), and the China National
Development and Reform Commission (CHNDRC).
iDSI offers a unique combination of skills and expertise on priority setting in

health, ranging from the production of cutting edge research and cost-
effectiveness tools to policy support and technical assistance. iDSI relies on
national institutions and staff, and strongly invests in building local capacity to
conduct priority setting exercises (for instance, cost effectiveness analyses)
and develop appropriate policies; creating building blocks in countries for
future priority setting functions. It currently works in a number of countries in
the Asia Pacific region, as well as in Sub-Saharan Africa. For instance,
through Imperial College London, iDSI has worked with the Ministry of Health
of Ghana to find cost-effective ways to manage hypertension. Through HITAP,
iDSI has also worked with the Government of Bhutan on an economic
evaluation of Pneumococcal vaccine or looking at the social costs of tobacco
and alcohol in Sri Lanka.
More information on iDSI’s work portfolio can be found here.
75
59
Building Block 5
Ensuring political commitment
for HTA
60
i. Introduction
This building block will:

• Provide information on why you need political support
• Suggest how to get this support
• Give ideas about how to promote HTA through conferences and awareness-raising
workshops
• Help you to formalise support through legislation
• Understand the long-term financial commitments to support HTA
• Discuss the timeframe over which HTA processes are established
ii. Who should support HTA?

There are several political stakeholders who should support HTA, including policy-
makers, high-level bureaucrats/administrators, senior clinicians and external
partners. Political will (in its broadest sense), leadership and legislation are all
needed to drive the development of HTA76.
HTA can contribute to a wide range of decisions, some of them outside the health
sector. This means that formalised support from high-level civil servants and
administrators can help mitigate opposition, even from within the MoH or other arms
of the government (e.g. Ministry of Finance).
If higher levels of bureaucracy are committed to using HTA, a top-down approach

can be used, whereby high-level bureaucrats implement adequate provisions (e.g.
political initiatives and resources) to include HTA. Formalised support could take the
form of a policy document stating support for HTA. A bottom-up approach is also
possible, by preparing technical staff in Ministries of Health to establish HTA, first
focusing on a well-defined decision space and then expanding to new areas of
decision-making. The demand for HTA could also arise from clinicians and other
medical professionals as their clinical curriculum might help raise awareness on
evidence-based medicine and HTA.
76
61
External support accounts for a high level of healthcare expenditure in many
LMICs77. Partners providing this support can exert a great deal of influence on
spending decisions for their own programs; and can also support technical staff in
ministries in setting up HTA. In addition, there might be initiatives to support HTA at
the global level. In 2014, a resolution at the World Health Organisation (WHO) urged
member states to develop capacities to support HTA78. The resolution acknowledges
that HTA can inform policies to reduce waste from inappropriate investments in
health technologies. Several analytical documents have been produced as a result of
this resolution (e.g. global mapping survey)79.
iii. Raising awareness

Initially, it is important to raise awareness of the benefits and value of the use of
HTA, compared to alternative decision-making frames. Events and meetings with
key technical staff or high level policy-makers within the Ministry of Health can be
organised to raise the profile of HTA. International conferences and workshops such
as those organised by HTAsiaLink, HTAi or the Priorities Conference are examples
of such events. Participation to such events can be costly (due to high registration
fees), although some conferences waive fees for young researchers from LMICs
(e.g. HTAsiaLink).
The timing of these events and meetings is important. The situational analysis
conducted to ‘set the scene’ (see the building block ‘setting the scene’) will help you
identify windows of opportunities (e.g. development of a new health benefits
package, large budget deficits).
Using HTA in a pilot or ‘proof of concept’ decision can also help raise awareness. A
flagship project could demonstrate the feasibility of producing locally relevant
evidence (with local data), and the value of using HTA within a small and self-
contained decision-space.
77
Hernandez-Villafuerte, K. et al. (). International Decision Support Initiative: Mapping of Priority-
Setting in Health for 17 Low and Middle Countries Across Asia, Latin America and Africa.
78
Resolution WHA60.29
79
World Health Organization. (2015). Global Survey on Health Technology Assessment by National
Authorities. Main findings.
62
iv. Legislative framework
Once the HTA process is set up and operational, establishing a legislative framework
can help ensure that HTA decisions are taken into account by relevant authorities.
Although it is not essential to legislate for HTA - Thailand has an effective HTA
process without legislation – it can help sustain the long-term and successful use of
HTA80. Novaes and Soárez (2016) argue that the extent to which an HTA
organization will be able to cause change within healthcare systems depends on the
policy and regulatory characteristics within which it operates – if regulatory or
professional bodies do not use the products from the agencies or do not
accept/implement the conclusions of HTA reports, the overall impact of HTA will be
limited81.
Legislation help strengthen legitimacy of HTA principles such as participation,

transparency and the systematic application of the HTA process82. Legislation can
also cover several aspects of the HTA process, including the broad objectives, scope
and principles for conducting HTA.
80
81
Novaes and Soárez (2016). Health technology assessment (HTA) organizations: dimensions of the
institutional and political framework. http://www.scielo.br/pdf/csp/v32s2/1678-4464-csp-32-s2-
e0002231pdf
82
63
Lessons from the legislative process to support HTA in Lithuania
To ensure commitment to HTA, decisions can be supported by regulatory or

legislative provisions. The first stage in establishing a political framework to legislate
for HTA includes one or more of the following conditions:
• The Ministry of Health expresses a political wish to introduce HTA; or

• Regulations for mandatory HTA have already been passed ahead of major
healthcare investment decisions but HTA has not yet begun; or
• Initiatives have already set up HTA structures, like an HTA committee, for the
introduction of HTA.
Steps necessary to reach the objective:
• Minister of health approves the HTA strategy as a priority;

• A list of upcoming choices by decision-makers on intervention programs or
technologies is collected as basis for prioritisation. Major stakeholders are involved
in the topic list, and in decisions on the HTA work program;
• This prioritisation tool is used for deciding an annual HTA work program: criteria
such as technologies with high cost/ high volume/ high uncertainty or low-cost
interventions with the potential for the improvement of health of many citizens are
applied;
• Rules of governance to secure independence and transparency of HTA are defined
and agreed.
83
Source: Wild et al. (2017)
Legislation can be useful by providing a clear mandate to HTA institutions and in

some cases, sufficient authority to enforce decisions. For example, Taiwan,
Indonesia and South Korea have used legislation to appoint their HTA body and
define the scope of the work. As a result, in those countries, HTA is recognised in
the decision-making process, supported by high-level policy and directly linked with
public health resource allocation. This, in turn, promotes the need for more and
better HTA84. In 2013, a revision to the National Health Insurance Act Implementing
Rules and regulations in the Philippines stipulated that only services deemed cost-
effective through HTA would be covered85. In addition, in 2017, the lower house
83
Technology Vol 6(3). https://www.sciencedirect.com/science/article/pii/S2211883717300461
84
85
PhilHealth (2013). Implementing Rules and Regulations of Republic Act 7875 as Amended
Otherwise Known as the National Health Insurance Act of 2013.
https://www.philhealth.gov.ph/about_us/irr_nhia2013.pdf
64
approved a bill granting the right to health to its citizens, which emphasizes the value
of HTA and has led to the creation of the Health Technology Assessment Council86.
In the UK, legislation has been adopted with regards to decisions taken by NICE:
once a health technology has been approved, the NHS must make it available within
three months, unless specified.
On the other hand, it is worth noting that some aspects of the legislative and
regulatory environment can hinder the implementation of HTA decisions. In some
countries in Latin America and in South Africa, HTA decisions are often challenged
with the right to health by patients requiring access to health technologies that have
been ruled out in the HTA process87. Political commitment is essential to support
HTA decisions, in courts or in the media.
v. Committing resources
The long-term and sustainable commitment of resources is important for the
institutionalisation of HTA. This includes financial and human resources (the
development of human resources for HTA is discussed further in the building block
‘Building capacity to support HTA’).
A 2015 WHO survey on HTA found 77 countries cited lack of funding for the HTA
process as a major barrier to HTA, along with a lack of information (59 countries)
and a lack of knowledge of HTA methods (58 countries)88.
A stable long-term commitment to funding HTA activities, and ensuring mechanisms

against political interference, are essential for the continuing development and
implementation of HTA89. In some countries, applications of health technology are
subject to a fee (either review or registration fee). However, we advise that HTA
systems do not rely too heavily on such fees to sustain their activities; and that
separate funding streams are made available from public sources in order to
maintain the independence and quality of the HTA process. This is done by The
National Evidence-based Healthcare Collaborating Agency in South Korea, the
Center for Drug Evaluation/ Health Technology Assessment, and the Malaysian
86
https://www.idsihealth.org/blog/towards-hta-in-the-philippines-idsi-welcomes-passage-of-new-
congress-uhc-bill/
87
Dittrich, R., Cubillos, L., Gostin, L., Chalkidou, K., & Li, R. (2016). The international right to health:
what does it mean in legal practice and how can it affect priority setting for universal health
coverage?. Health Systems & Reform, 2(1), 23-31.
88
89
65
Health Technology Assessment Section, all of which receive annual budgets to
support their research activities from the government.90
In South Africa, budget to support HTA work was inscribed in the National Budget in
2018 and in the Mid-Term Expenditure Framework for the three financial years
spanning from 2018-2021.
Process for funding HTA
Objective: To establish structures for timely, efficient and good-quality provision

of HTA through financing and organisation
Strategic activities necessary to reach the objective:
• An earmarked budget for HTA activities is ensured and funding for existing trained
HTA staff (e.g. in international projects) is safeguarded;
• A task force or HTA coordinator is appointed to enforce and monitor HTA activities.
These tasks are clearly defined (e.g. criteria for prioritisation, governance principles
securing independence, co-ordination of methodology standards, set-up of internet
platform for public access to HTA reports, policies to include stakeholders, conflict
of interest management etc.)
• For promoting the concept of HTA and for increasing visibility of HTA, pilot projects
are conducted.
• Eventually external funding (for example research grants) is applied for, to foster
independence.
91
Source: Wild et al. (2017)
We provide examples of costing of HTA institutions below. However, it is not

possible to give indications as to what the resource requirement would be in your
country. The level of resources depends on a wide range of considerations, including
the scope of the activities. However, from the examples below, the cost estimates of
HTA processes show that they are ‘marginal’ compared to the overall amount of
funding in the healthcare sector.
It is worth noting that Guthrie et al. (2015) have shown that in the case of NICE and
the National Health Research Institute, those costs are largely offset by gains in the
health system from implementation of HTA decisions.
90
91
66
Looking at a sample of 10 hta studies, they find that if 12% of the potential net
benefit were realised in one year, it would then cover the costs of the entire HTA
programme from 1993 to 201292.
92
Guthrie, S., Bienkowska-Gibbs, T., Manville, C., Pollitt, A., Kirtley, A., & Wooding, S. (2015). The
impact of the National Institute for Health Research Health Technology Assessment program, 2003–
13: a multimethod evaluation. Health Technology Assessment. 19(67):1-291.
67
Review of funding sources and budgets of HTA agencies across several
countries
Source: Glassman, A., & Chalkidou, K. (2012) 93
93
Glassman, A., & Chalkidou, K. (2012). Priority-setting in health: building institutions for smarter
public spending. Washington, DC: Center for Global Development.
68
vi. Be patient
Sustainable HTA processes for priority setting are typically not built overnight.
However, there is no ‘typical’ or reference timeframe for HTA institutionalisation.
While some countries have managed to set up institutions quickly, links into
implementation, decision- and policy-making are more challenging. In many cases,
several attempts are necessary. For instance, HITAP was only established after
three attempts: the Technological Assessment and Social Security in Thailand (or
TASSIT), the Institute of Medical Research and Technology Assessment (IMRTA)
and the Setting Priorities using Information on Cost-Effectiveness (SPICE). Those
attempts were unsuccessful for different reasons; including lack of capacity and
expertise, limited support and long-time commitment, as well as poor integration to
decision-making and implementation94.
In China, the Vice Minister of Health advocated for the use of HTA in policy making
in a speech in 1999. This was the first public political commitment in the country and
the first important milestone in the HTA institutionalisation process95. However, an
HTA division was set up at the China National Health and Development Research
Center only years later in 2008, and the scope of its work was limited in its initial
mandate. In the last decade, the number of htas have significantly increased.
However, integration of HTA into policy-making is relatively recent. In 2016, the
National Health and Family Planning Commission issued policies to strengthen the
use of HTA for policy-making. HTA evidence is now also used to decide on inclusion
of drugs into the national drug reimbursement policy in the national health insurance
schemes. All in all, it took 20 years between the Vice Minister of Health’s speech and
a more coherent and systematic inclusion of HTA in decision-making processes. A
timeline of main milestones can be found on iDSI's evolution of HTA in China
timeline. On the other hand, in 2011, the National Committee for Health Technology
Incorporation, or CONITEC, was set up in Brazil through a decree. The link between
CONITEC’s work and policy-making was relatively well defined and CONITEC’s
decisions were quickly implemented under the National Health System (SUS). A
review showed that between 2011 and 2014, more than 100 technologies were
incorporated in the SUS based on CONITEC recommendations.
Contextual elements (out of the scope of the institutionalisation process) can also
have significant consequences on the success or timeframe; e.g., political
94
Culyer, A., Podhisita, C., & Santatiwongchai, B. (2017). A star in the east: History of HITAP.
F1000Research, 6.
95
Chen, Y., He, Y., Chi, X., Wei, Y., & Shi, L. (2018). Development of health technology assessment
in China: New challenges. Bioscience trends, 12(2), 102-108.
69
commitment, capacity for investment, degree of maturity of the decision-making
processes, structure of the national health insurance or system96.
96
Kuchenbecker, R., & Polanczyk, C. A. (2012). Institutionalizing health technology assessment in
Brazil: challenges ahead. Value in health regional issues, 1(2), 257-261.
70
Building Block 6
Making HTA an inclusive process
71
i. Introduction
This block covers:
• The importance of inclusivity in your HTA procedures

• Identifying and including relevant stakeholders, such as patient groups and
industry
• The need for and role of public consultation or participation
• Communications internally and externally to stakeholders of all kinds
• The design and establishment of an appeal process.
HTA is more than a technical exercise; it should be a deliberative process involving

relevant stakeholders. This poses important questions: who should participate? Do
all participants get equal representation and influence in the process? At which stage
should they participate? And how do they participate? You should think through
these questions carefully when defining a mode of engagement with other
stakeholders.
The answers to these questions will often be specific to your country, the scope of
your HTA process, and the challenges you perceive. However, failure to consider
those points can be detrimental to the quality of the HTA process and undermine its
legitimacy.
ii. Identifying relevant stakeholders

In the building block ‘setting the scene’, we discussed how it is necessary to identify
the relevant stakeholders to include in the HTA process through a stakeholder
analysis. It is also possible to identify stakeholders through an open registration. For
instance, in India, the Medical Technology Assessment Board has an open online
registration system on which stakeholders can register their interest.
Stakeholders might represent one or several interests/parties (see illustration from

Singapore), and have immediate goals that might differ from long-term ones.
72
HTA stakeholder groups (representation for Singapore)
Source: NIHA (2013)97
Patient/interest groups
HTA can run into challenging or conflicting social and ethical values to be weighed
alongside technical information and evidence. HTA decisions also frequently apply
across a wide population98. The general public therefore needs to understand the
implications of policy and the decision-making process: how specific decisions are
made and whether they are an efficient and ethical use of public money99.
Taking into account the perspective of patients and care-givers can provide a unique
insight into the experience of a particular disease or condition, such as explaining the
advantages and disadvantages of a therapy that may not be presented in published
97
NIHA (2013). Engaging Stakeholders in Health Technology Assessment for Health Policy.
http://www.gai.nus.edu.sg/niha/wp-content/uploads/2013/07/NIHA_Forum_2013_White_Paper.pdf
98
Whitty (2013). An International Survey of the Public Engagement Practices of Health Technology
Assessment Organizations. https://www.sciencedirect.com/science/article/pii/S1098301512041411
99
Li et al. (2017). Evidence-informed capacity building for setting health priorities in low- and middle-
income countries: A framework and recommendations for further research.
73
literature100. In Taiwan, a process for patient and caregiver testimony is put in place
for each technology appraisal (albeit limited to 300 characters), which is then
considered by the appraisal committee101.
Moreover, involvement of patient groups could help strengthen the trust and
legitimacy of the process. Some studies have highlighted other positive impacts of
patient engagement, such as improving the responsiveness of decisions to patient
needs, patient education and health literacy, and managing patient expectations102.
However, this should be carefully managed. Creating a formal mechanism for
appointing representatives of patient groups can help ensuring the representation of
different patient subgroups.
CONITEC’s public consultation process
Patient and public consultations play an important role at the Brazilian HTA
body, CONITEC. Each technology appraisal’s initial conclusions are
submitted to a 20-day public consultation period over which individuals (from
all groups) are invited to comment on the decisions using two forms:
• Technical and scientific (for professionals, industry and citizens)
• Opinion or experience (for patients, caregivers and professionals)
Upcoming public consultations are now announced through social networks,
website and e-mail list. Lay and summary versions of the initial
recommendations are provided for the purpose of enhancing the public’s
knowledge on the process and recommendation.
Since 2012, 220 public consultations have taken place, over which more than
30 thousand contributions were received from stakeholders across the board:
ranging from patients, caregivers to health professionals. In 2015 alone,
13,619 feedback was received. A review of the process showed that the
contributions from the public have influenced/swayed the decision103.
In addition, stakeholders are asked to put forward information on their
100
Haslam (2016). The NICE Citizens Council and the role of social value judgements.
http://www.idsihealth.org/wp-content/uploads/2016/05/Citizens-Council-and-Board.pdf
101
Facey, K. M., Hansen, H. P., & Single, A. N. (Eds.). (2017). Patient involvement in health
technology assessment. Springer: Singapore.
102
Souliotis, K. (2016). Public and patient involvement in health policy: a continuously growing
field. Health Expectations, 19(6), 1171-1172.
103
http://press.ispor.org/LatinAmerica/2017/09/involving-public-and-patients-in-the-process-of-
evaluation-of-health-technologies-in-brazil/
74
experience in some specific cases where the information is judged incomplete
(e.g. fingolimod for treatment of multiple sclerosis and budesonide 200
µg/formoterol 6 µg in aerosol suspension for the treatment of asthma).
Source: adapted from Silva (2017)104
Medical Professionals
Medical professionals are the end users of many of the applications of HTA in policy-
making. For instance, the practice of care is directly influenced by coverage
decisions or standard treatment guidelines. Without this link to the practice of care,
the HTA process would add little value, if any. Medical professionals can also bring
in new perspectives on patient care that might be considered in the HTA process (for
instance at the evidence submission phase).
As a result, the role of medical professionals varies between countries; they can be
supportive of HTA efforts, or equally impede or ignore HTA recommendations.
Opposition from medical professionals or associations can be very powerful. For
instance, in the United-States, influential segments of the medical community were
opposed to the research findings from the Agency for Health-care Policy and
Research, the predecessor to the Agency for Healthcare Research and Quality. This
led to serious impairments in the activities of the agencies and eventually to its
dismissal105. Some authors have highlighted the need to incorporate training to raise
clinicians’ awareness around the value of health economics and HTA, financial
responsibility, guidelines and evidence-based medicine106 .
Industry
Industry - such as pharmaceutical companies and medical device manufacturers -

also needs to be engaged in HTA. This can be done in a number of ways. For
example, in South Korea, there is an opportunity for industry to participate in the
HTA process through preliminary consultations, an open period for industry and
other professional organisations to respond and comment during deliberation and a
post-deliberation appeal process107.
104
https://htai.org/wp-content/uploads/2018/02/Patient_involvement_in_Brazil.pdf
105
O'Donnell, J. C., Pham, S. V., Pashos, C. L., Miller, D. W., & Smith, M. D. (2009). Health
technology assessment: lessons learned from around the world—an overview. Value in health,
12(s2).
106
Jain, V. (2016). Time to take health economics seriously—medical education in the United
Kingdom. Perspectives on medical education, 5(1), 45-47.
107
75
Industry can also be engaged by having representatives as part of committees. For
example in the UK, NICE has a Technology Appraisal Committee which is made up
of clinicians, lay members, statisticians, commissioners, health economists and
representatives from industry. This committee then interacts with four main
stakeholder groups: invited experts, manufacturers, independent academic groups
and NICE itself108 .
Media organisations and journalists
Incorporating media organisations and journalists in the HTA discussion can be a

way of informing public understanding, encouraging positive public debate and
improving policymaking through holding decision-makers accountable to the general
public109. The media are a powerful tool for directing the public’s attention towards
specific problems and issues in the health care sector. Issues not mentioned in the
media are on average more likely to be ignored or receive very little attention, even
from policy makers110.
Journalists should be encouraged to report on stories linked to health priority-setting

and to government decision-making institutions in an objective and impartial
manner111. However, media coverage needs to be appropriately managed and can
sometimes be detrimental to public health objectives. While scientific journals publish
press releases for the media, those are often misunderstood and tend to overstate
the findings112 . The coverage, misunderstanding and uncritical acceptance of the
Wakefield’s 1990 Lancet paper on the link between autism and combined
vaccination for measles, mumps, and rubella shows that media coverage might fail
to report health stories, with aggravated consequences on population health113. An
important role for any agency thus becomes ensuring that well-written briefing notes
are available, especially on controversial recommendations or decisions.
108
Ibid.
109
Li et al. (2017). Evidence-informed capacity building for setting health priorities in low- and middle-
income countries: A framework and recommendations for further research.
110
Institute of Medicine (US). Committee on Assuring the Health of the Public in the 21st Century.
(2003). The Future of the Public's Health in the 21st Century. National Academy Press.
111
Ibid.
112
Institute of Medicine (US). Committee on Assuring the Health of the Public in the 21st Century.
(2003). The Future of the Public's Health in the 21st Century. National Academy Press.
113
Coombes, R. (2009). Health journalism: two clicks away from Britney Spears?. BMJ.338.
76
iii. Modalities of engagement of stakeholders
Once stakeholders have been identified, they can be involved in the HTA process.
Participation of stakeholders in public policy is still emerging in most LMICs and
there are no guidelines as to who should be engaged in the HTA process, when and
for what purpose114 .
There are different levels and methods of stakeholder engagement115:
1. Information-gathering: collecting information about attitudes, opinions and

preferences that will improve understanding of the decision problem and lead
to more informed decision making.
2. Consultation: obtaining feedback from stakeholders about specific
documents or findings that have been made available to them.
3. Participation: involving stakeholders actively at all stages to ensure their
concerns are understood and considered, and to give them influence over
decisions
Information-gathering represents a low level of engagement; it is a one-way

movement of information from stakeholder to assessor and the stakeholder has no
option of affecting the way HTA is carried out116. This can include evidence
submissions, which often comes from industry but sometimes comes from patient
representative groups - for example, to gather patient experiences of a medicine
under consideration117.
Consultation and participation also result in information-gathering and represent a

higher level of stakeholder engagement.
114
Alderman, K. B., Hipgrave, D., & Jimenez-Soto, E. (2013). Public engagement in health priority
setting in low-and middle-income countries: current trends and considerations for policy. PLoS
medicine, 10(8), e1001495.
115
Health Information and Quality Authority (2014). Guidelines for Stakeholder Engagement in Health
Technology Assessment in Ireland. https://www.hiqa.ie/system/files/HTA-Guidelines-Stakeholder-
Engagement.pdf
116
Engagement.pdf
117
HTAi (2014). Completing a Patient Group Submission Template: Guidance for Patient
Organisations.
https://www.htai.org/fileadmin/HTAi_Files/ISG/PatientInvolvement/v2_files/Resource/PCISG-
Resource-GuidanceandChecklist-Dec14.pdf
77
Stakeholder engagement
consultation vs participation
Consultation
• A form of open-engagement.
• Formal and structured process in which stakeholders can comment on and
contribute to decisions that may directly affect them.
• Commonly seen in the form of a public consultation, in which a draft document
is made available and the general public/specific stakeholders are invited to
provide feedback within a given time period.
• Benefits:
o It is possible to include a large number of stakeholders, including the
general public.
• Limitations:
o In a consultative-only process, stakeholders can only input when allowed
and are not involved at each stage of the process. This can lead to a lack
of transparency and less understanding of the goals/objectives of an HTA.
o Limited scope for stakeholder input.
o If the collection of feedback is at a late stage in the project there is a
potential for delay in the identification of mistakes or shortcomings in the
project scope and methodology. This could have consequences for the
timely and efficient delivery of the HTA.
o If the consultation period is too short, stakeholders may have limited
opportunity to give useful feedback, defeating the purpose of the exercise.
• Public consultation:
o Public involvement is defined as “the involvement of lay people in strategy
decision about health services and policy at the local and national
level”118. Public involvement can help improve the quality of the decisions
taken during the HTA process, by ensuring that the decisions account for
the views and preferences of the end-users (patients and front-line
providers) and can also lead to better accountability of decisions.
Participation
• A form of closed engagement.
• It is a process in which stakeholders can have input into how the HTA is
118
Souliotis, K. (2016). Public and patient involvement in health policy: a continuously growing
field. Health Expectations, 19(6), 1171-1172.
78
carried out in terms of the process, the agenda, and the main considerations.
• Gives stakeholders an opportunity to actively assist in the development of
information and advice that informs a decision, rather than being part of a
committee that actually makes a decision.
• Commonly seen in the form of expert panels.
• Benefits:
o Involves stakeholders more deeply.
o Results are more transparent for participants.
o It can facilitate a more nuanced and in-depth analysis; and may lead to a
better understanding of complex issues.
• Limitations:
o Resource-intensive for both the assessor and the stakeholders.
o Usually requires stakeholder commitment for the duration of the project
and providing substantial input when necessary.
o Ensuring that the mix of stakeholders is sufficiently broad to represent
multiple perspectives can be challenging.
119
Source: Health Information and Quality Authority (2014)
You will need to choose whether to use consultation or participation. Your choice will
likely depend on the type and the topic of a specific HTA. Consider the following
factors120:
• What is the purpose of the HTA?

• What is the need for input from specific stakeholders?
• How much ownership of the process do the stakeholders need?
• How sensitive is the topic?
• How complex is the HTA?
• What is the timeframe of the HTA?
Modalities of engagement can be arranged depending on those characteristics, in

other words, topic by topic. However, you may also want to define one modality of
engagement that applies across all HTA activities for the entire program.
119
Engagement.pdf
120
Ibid
79
The way in which stakeholders are involved in the HTA process will be different for
different groups and different countries. You do not need to involve all identified
stakeholders; and should exercise caution when choosing the form of stakeholder
engagement. It is possible to engage stakeholders throughout the entire HTA
process, from evidence generation to decision-making (see building block ‘A
transparent and consistent process of HTA’ for details on the steps).
iv. Challenges of stakeholder engagement

Successful application of HTA decisions can challenge different stakeholders, from
technical staff at the Ministry of Health to front-line health providers. Having a top-
down approach to HTA decisions can generate disruptions and jeopardise the
implementation process. Having a clear, transparent and inclusive HTA process
creates trust and acceptance among stakeholders121 , but also presents its own
challenges. For instance, in a study conducted in Uganda, participation to meetings
relating to the health strategy was highly correlated to poverty, age and wealth
level122. More concerning, evidence from Latin America has shown that the Industry,
in particular pharmaceutical companies, might play an indirect role by lobbying
against HTA through patient groups123. This represents an important challenge for
ensuring the independence of the decisions.
Challenges in stakeholder engagement
Stakeholder engagement takes time and resources

• Recruiting and coordinating stakeholders for committees and meetings and
soliciting comments/response can significantly add to the timeline of the HTA
process.
• Stakeholders will need to be sensitised to the benefits and challenges of an
approach using HTA and trained on methods.
Even when the value of HTA is acknowledged, other background
121
Wild et al. (2017). Guidance for the development of a National HTA-strategy.
122
Kapiriri L, Norheim OF, Heggenhougen K (2003) Public participation in health planning and
priority setting at the district level in Uganda. Health Policy Plan 18: 205–213.
123
Dittrich, R., Cubillos, L., Gostin, L., Chalkidou, K., & Li, R. (2016). The international right to health:
what does it mean in legal practice and how can it affect priority setting for universal health
coverage?. Health Systems & Reform, 2(1), 23-31.
80
factors may impede the willingness of stakeholders to engage
• In Thailand, key barriers among policy actors included distrust, conflicting
philosophies, pre-existing loyalties to other organisations and concerns about
political pressure and acceptability124.
Stakeholders’ views are likely to clash

• Incorporating the perspectives of various groups can be difficult in the face of
different interests, perceptions and expectations. In healthcare, perspectives
are often in conflict, and decisions often involve making difficult choices that
will cause opposition from some groups. For instance, coverage decisions for
drugs - a common application of HTA decisions - will be a matter of life and
death for some patient groups. Medical providers or the industry are also
equally likely to oppose such decisions. A very important challenge is to
ensure the representation of those views, while ensuring that decisions are
impartial and objective.
Engagement can increase the risk of controversy

• An open and consultative process introduces risks such as popular outcry
and coordination of efforts across powerful lobbies and special interest
groups. Media coverage can be extremely powerful in influencing the public
opinion on a decision. For example in 2009, NICE in the UK rejected the use
of Sorafenib (Nexavar®) a liver cancer drug, in the National Health Service
and this decision provoked a strong negative reaction from parliamentarians,
patient organisations and the popular press125.
Managing conflicts of interest
Involving a range of stakeholders can create significant Conflicts of interest (COI),

which are impossible to avoid completely.
COI arise when the judgement of someone involved in the HTA process is potentially
compromised by financial or other concerns and can be managed in different ways.
For instance, a significant share of the evidence is produced by Industry. On the
other hand, the industry has its own objectives: to expand the sale of its products
and to foster the interests (financial and non-financial) of its constituencies (e.g.
shareholders, employees etc.). It is clear that those objectives can conflict with a
fundamental principle of any HTA system: the supremacy of public interest.
124
125
See http://news.bbc.co.uk/1/hi/health/8367614.stm
81
Instead of trying to avoid conflicts altogether, you should seek to manage them.
COIs should be clearly stated in any reports, specifying the principles underlying the
prevention of conflict of interest: impartiality, integrity, transparency and the
supremacy of public interest. Without the management of COIs, professionals and
the public would lose confidence in HTA126.
Country example: NICE policy on COIs
The Code of Practice applies to all those who work at NICE or who are
involved in the development of its guidance, to avoid public concern that
COI might prejudice the integrity or impartiality of NICE.
An example of the steps NICE takes to ensure transparency in regard to

COI:
• NICE committee members are advised to consider if they have an

interest in the subject under review that might influence their judgement
and objectivity in decision-making;
• Interaction with the commercial sector doesn’t automatically disqualify

an individual’s membership of a NICE committee, but should be
declared;
• However, committee chairs are recognised as being in a special

position, so should not have any financial, personal, non-personal or
family interests that could affect their judgement.
v. Communication
The results of HTA decisions need to be communicated to stakeholders and the
general public. Dissemination materials include publishing reports, policy briefs,
newsletters, articles, press releases, fact sheets and infographics. For medical
providers, dissemination of HTA decisions can be done through prescription
guidelines. In Sweden, publication of full technical reports is accompanied by the
publication of fact sheets, PowerPoint presentation and FAQ sheets covering
information not only on the technical aspects of the health technology, but also on
the process (analysis, appraisal and recommendation)127.
126
NICE Policy on Conflict of Interest. https://www.nice.org.uk/Media/Default/About/Who-we-
are/Policies-and-procedures/Code-of-practice-for-declaring-and-managing-conflicts-of-interest.pdf
127
Angelis, A., Lange, A., & Kanavos, P. (2018). Using health technology assessment to assess the
value of new medicines: results of a systematic review and expert consultation across eight European
countries. The European Journal of Health Economics, 19(1), 123-152.
82
The dissemination strategy should be adapted to the intended audience. At a
minimum, HTA decisions should be published online and freely accessible and
should include online registers and user-friendly versions for patients. In some
countries, a quarterly report (containing information on current, planned and
completed htas) can be published.
Effective communication may also require adapting the language of publications to

meet the needs of individuals with learning disabilities and/or non-native speakers128.
128
83
Example: HITAP’s Communication Strategy
Thailand’s Health Intervention and Technology Assessment Program (HITAP)

was created in 2007.
The goal of HITAP was to provide policymakers, health professionals, health

providers and the public with robust scientific evidence about the costs and
benefits of introducing of health products, procedures and programs.
HITAP has a dedicated communications teams working on presenting information

to suit each stakeholder group. The primary output from HITAP’s projects is a
research report with policy briefs for policymakers and others. The policy briefs
are short four-page briefings designed to inform policymakers and non-technical
readerships.
The communication team also publishes HITAP newsletters, which include

updates on HITAP work every three to four months. Hard copies of newsletters
and policy briefs are circulated to subscribers, and electronic versions are
uploaded to the website. The full range of communication products and target
audiences also includes press releases, fact sheets, infographics and, of course,
articles in technical and academic journals.
The communications strategy aims to have:
• Sincere dialogue with all parties, including general public, to pursue

understanding and collaboration
• Tailor-made information and messages to suit particular target groups
• A two-way stream of communication

ff
129
Source: Culyer et al. (2016)
vi. Appeal process

An important part of the HTA process is to have a means of appealing decisions as a
way of managing potential opposition of decisions. Giving the possibility to appeal an
HTA decisions can also reduce the risk of litigation or court cases against HTA
decisions.
Appeals usually occur after a decision has been made. It is important to allow any
stakeholder to file an appeal. Appeals are usually filed for the following reasons:
129
Culyer, A.J, Podhisita, C. and Santatiwongchai, B. (2016). A Star in the East: A Short History of
HITAP. https://f1000research.com/documents/6-487
84
• Formal errors in the evidence submitted
• Suspicions that the evidence has not been interpreted correctly
• If the health technology under consideration does not fall in the agreed scope
of the HTA process
An appeal is usually reviewed by an independent panel of experts, which then issues

a recommendation to the relevant institution. Following the review of the appeal, a
response should be published in the public domain, whether positive or negative. In
addition, renewal of registration also offers a possibility for individuals
(manufacturers, research groups, etc.) to resubmit evidence.
85
Citing the HTA Toolkit as a
source
When citing the HTA Toolkit please quote: HTA Toolkit v1, the International Decision
Support Initiative (iDSI): www.idsihealth.org/HTATOOLKIT
86

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The International Decision Support Initiative

Health Technology Assessment Toolkit

Mairi Jeffery Y-Ling Chi Madeleine Stewart

Toolkit contributors and reviewers (in alphabetical order)

Diana Beatriz Bayani Kalipso Chalkidou Francoise Cluzeau

Tony Culyer Samantha Diamond Laura Downey

Shalu Jain Mohamed Gad Sam Hollingworth

Karthik Balajee Laksham Phung Lam Toi Ryan Li

Rong Liu Nancy Njeru Anthony Kamau Njuguna

Timothy Panga Pempa Pempa Roman Perez-Velasco

Sonam Phuntsho Pilar Pinilla Dominguez Francis Ruiz

Khairol Sabtu Ambrish Singh Roza Sn

Introduction to the HTA Toolkit................................................................................ 6

Glossary of terms ...................................................................................................... 9

Building Block 1 - Setting the Scene for HTA ....................................................... 12

Building Block 2 - Compiling the best HTA evidence ......................................... 25

Building Block 3 - A transparent and consistent process of HTA ...................... 41

Building Block 4 - Building capacity to support HTA .......................................... 52

Building Block 5 - Ensuring political commitment for HTA ................................ 60

Building Block 6 - Making HTA an inclusive process .......................................... 71

Citing the HTA Toolkit as a source ........................................................................ 86

This is where building a sustainable and locally relevant Health Technology

ii. What is HTA?

Typically, the term ‘HTA’ refers to individual studies on a specific technology.

iii. Aims of the Toolkit

Cost-effectiveness threshold: the ceiling incremental cost-effectiveness ratio

Disability-adjusted life year: A measure of overall disease burden, expressed as

External/development partners: Terms widely used in the field of international

Health Technology Assessment: a systematic, transparent and multidisciplinary

Incremental cost-effectiveness ratio: a summary measure of the cost-

Industry (referring to ‘healthcare industry’): Private sector organisations, or groups

Institutionalisation: The embedding of certain rules and norms, and associated

Multiple-criteria decision analysis: a method for guiding decision-making by

Proof of concept: evidence which establishes that an idea, invention, process or

Quality-adjusted life-year: a measure of the state of health of a person or group in

Stakeholder: a person, group or organisation that has interest or concern in an

Systematic literature review (or systematic review): research that summarises

• understand how HTA can be used to inform policy-making in your country

ii. Having a plan

Categories of health technology

Biologics: e.g., vaccines, blood products, cellular and gene therapies

Medical and surgical procedures: e.g., acupuncture, psychotherapy, coronary angiography,

Organisational and managerial systems: e.g., medication adherence programs,

Source: Priority-setting for Universal Health Coverage

Country example: Ghana HTA pilot study

The Ghanaian Technical Working Group, supported by the International

It was seen as an opportunity to build on previous efforts to establish a

It highlighted the importance of HTA as a way of supporting UHC and having

iii. Situational analysis

Finding who is working on HTA in your country

A good starting point is to conduct a situational analysis to make an inventory of the

• Who is already working on HTA or similar types of evaluation?

These questions can be answered by organising an HTA awareness-raising event

Stakeholder analysis is the process of gathering information to determine whose

Examples of relevant questions to identify stakeholders

Politicians & politically appointed decision-makers:

• What and who dominates the discourse regarding UHC?

Policy and professional decision-makers (civil service/bureaucracy)

Health service managers