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Health Technology Assessment in Ecuador
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EXCLUSIVE EDITION FOR THE
ISPOR SANTIAGO CONFERENCE!!
Health Policy Series

Featuring nine articles of the News Across Latin America health policy series on HTA in Latin America
Editor-in-Chief Commentaries
Argentina: Current Status of Health Technology Assessment in Argentina
Brazil: A Perspective on Health Technology Assessment Activities in Brazil
Chile: Health Technology Assessment in Chile: Reflections on a Slow Process
Ecuador: Health Technology Assessment in Ecuador
Mexico: Ten Years of Pharmacoeconomics in Mexico
Paraguay: Considerations on Health Financing and Expenditures, and the
Decision-making Process to Incorporate Health Technologies in Paraguay
Peru: Implementing Health Technology Assessment in Peru: A Gradual Process

Trinidad & Tobago: Current Status of Health Development Challenges and
Strategies for the Decision-Making Process for Health Technology Incorporation
in Trinidad & Tobago
Uruguay: The Use of Health Technology Assessment in Military Health Care:

Experiences in Uruguay
Announcing the ISPOR HTA Training—Latin America
SPECIAL RELEASE: First ISPOR Latin America Consortium Science Policy Brief
Publishing & Editorial Office
News Across Latin America
ISSN 2330-9342
Led by:
ISPOR Latin America Consortium Publications Committee
“News Across Latin America” Newsletter Editorial Board
Website (English): http://www.ispor.org/consortiums/LatinAmerica/Newsletter.asp
Published quaterly by:

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Fax: 609.586.4982;
Website (English): http://www.ispor.org/consortiums/LatinAmerica.asp
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Website (Portuguese): http://www.ispor.org/consortiums/LatinAmerica_port.asp
Direct advertising, photocopy permission and reprint requests go to the

Managing Editor
email: laconsortiumpublications@ispor.org
©2015 International Society for Pharmacoeconomics and Outcomes Research

All rights reserved under International and Pan-American Copyright Conventions.
While “News Across Latin America” is designed to provide accurate information

regarding the subject matter covered, the views, opinions, and recommendations
expressed are those of the authors, Editor-in-Chief, Editorial Board, etc., and not of
the International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
and the Latin America Consortium.
Table of Contents
EDITORIAL BOARD
COMMENTARY FROM THE EDITORS
1 Outgoing 2012-2015 Editor-in-Chief Commentary

Manuel Antonio Espinoza, MD, MSc, PhD
2 Incoming 2015-2018 Editor-in-Chief Commentary

Yajaira Bastardo, PhD
COUNTRY-BASED HEALTH POLICY ARTICLES
3 Argentina: Current Status of Health Technology Assessment in Argentina

Lautaro Renati, MA
5 Brazil: A Perspective on Health Technology Assessment Activities in Brazil
Martine Bellanger, PhD; Paulo Picon, MD, PhD; and Louisa T. Stuwe, MPA, MPH
7 Chile: Health Technology Assessment in Chile: Reflections on a Slow Process
Manuel Antonio Espinoza, MD, MSc, PhD & Rony Lenz Alcayaga, MA
9 Ecuador: Health Technology Assessment in Ecuador
Ruth Jimbo Sotomayor, MD; Xavier Sánchez, MD; and Luciana Armijos, MD
11 Mexico: 10 Years of Pharmacoeconomics in Mexico
Rosa María Galindo-Suárez, MHE & Fabiola Melchor-Martínez
15 Paraguay: Considerations on Health Financing and Expenditures, and the Decision-making
Process to Incorporate Health Technologies in Paraguay
Ruben Gaete, MS
19 Peru: Implementing Health Technology Assessment in Peru: A Gradual Process

Enrique Longaray Chau, MD, MSc
21 Trinidad & Tobago: Current Status of Health, Development Challenges and Strategies in the
Decision-Making Process for Health Technology Incorporation in Trinidad & Tobago
Sameer Dhingra, B.Pharm, M.Pharm, PhD, RPh & Sandeep Maharaj, BSc Pharmacy, MBA, RPh
25 Uruguay: The Use of Health Technology Assessment in Military Health Care:

Experiences in Uruguay
Gabriela Navarro, PharmD; Francisco E. Estevez-Carrizo MD; Alberto Galasso, MD; and Carlos Peppe, MD
ANNOUNCEMENTS FROM THE ISPOR LATIN AMERICA CONSORTIUM
29 ISPOR HTA Training—Latin America
30 ISPOR Latin America Consortium Science Policy Brief: Budget Impact Analysis: New Norms (Spanish)
J. Jaime Caro, MDCM, FRCPC, FACP; Rafael Alfonso, MD, MSc, PhD; and Diego Guarín Garcia, MD, MPH, MA
Editorial Board | News across Latin America
2013-2015 EDITOR-IN-CHIEF
Manuel Antonio Espinoza, MD, MSc, PhD
Professor, Department of Public Health & Coordinator, HTA Unit, Center for Clinical Research
Catholic University of Chile, Santiago, Chile and Honorary Visiting Fellow, Centre for Health Economics
University of York, York, UK
2015-2018 EDITOR-IN-CHIEF
Yajaira Bastardo, PhD
Professor & Chair of Pharmacoeconomics and Pharmacy Administration
Central University of Venezuela, Caracas, Venezuela
2015-2018 CO-EDITORS
Iris Contreras,MD, MSc
Chief of Health Education and Research Coordination, Department of Internal Medicine, Hospital General de Zona
No. 1-A"Dr. Rodolfo Antonio de Mucha Macias", Mexican Institute of Social Security, Mexico City, Mexico
Alessandra Caroline Domingos De Fig ueiredo, MSc

Pharmacoeconomics Analyst, GlaxoSmithKline, Brazil, Rio de Janeiro, Brazil
F r a n c i s c o E. E s t e v e z—C a r r i z o , M D
President, Health Technology Evaluation Committee, National Board of Health of the Armed Forces (D.N.S.FF.AA.)
and Professor of Clinical Pharmacology, Center for Biomedical Sciences, University of Montevideo,
Montevideo, Uruguay
Márcio Machado, PhD

Pharmacoeconomics Manager, GlaxoSmithKline Brazil, Rio de Janeiro, Brazil
Aurelio Mejía Mejía, MSc

Deputy Director, Health Technology Assessment, Health Technology Assessment Institute (IETS)
Bogotá, Colombia
J o a q u í n F. M o u l d - Q u e v e d o , P h D , M S c , M B A
Global Health Economics & Outcomes Research Project Leader – Specialty Care, Global Market Access Team
Bayer Pharma AG, Berlin, Germany
Editorial Office
DIRECTOR, LATIN AMERICA DEVELOPMENT MANAGING EDITOR
Jerusha Harvey Mary Helen R. Pombo, MSc
Latin America Development, ISPOR Latin America Development, ISPOR
Lawrenceville New Jersey, United States Lawrenceville New Jersey, United States
2012-2015 E d i t o r - i n - C h i e f | Policy Series Commentary
Past Reflections
Dear friends:
The development of health technology assessment (HTA) in Latin America and the
Caribbean (LAC) has experienced significant growth during the last few years. While
Manuel Antonio countries like Mexico, Colombia, and Brazil have implemented formal institutions for
Espinoza, MD, MSc HTA, others have made significant efforts to introduce formal processes to support
PhD Professor, Dept decisions regarding coverage of health care interventions. As a consequence of this
of Public Health & progress, the number of professionals trained to support the HTA process has
Coordinator, HTA Unit, increased in countries of the LAC region.
Center for Clinical Research
Catholic University of Chile “News Across Latin America” was launched in 2012 as an initiative of the ISPOR Latin
Santiago, Chile and Honorary American Consortium for the regional consortium, chapter, and wider ISPOR
Visiting Fellow, Centre membership. It is published in three languages simultaneously: Spanish, Portuguese
for Health Economics,
and English. The main objective is to serve as a communication platform to
University of York, York
United Kingdom inform readership of recent advancements in research, training, and policies
across the countries of our region.
In the first stage, one of the objectives was to produce a set of articles able to
account for and share the recent developments in HTA in the LAC region. This
led to inclusion of the health policy section, primarily focused on the HTA
processes that various countries were implementing.
After two years, eight articles were published, gathered, and presented in this
special edition of “News Across Latin America” along with a special preview of
an upcoming policy focused on Brazil.
On behalf of the Editorial Board, I thank all authors who received our invitation
and submitted articles to our editorial review process. The contributions they
have made, now presented in this single exclusive conference edition, are a
priceless source of information on the state of HTA in the LAC region.
Finally, the articles presented in this edition do not only have value in terms of the
information produced, but also reflect the achievement of long term collaboration
between researchers across the region. The immense work of articulating and
coordinating this editorial initiative has been possible thanks to the platform provided
by ISPOR. As 2012-2015 Editor-in-Chief, I would also like to take the opportunity to
thank all Co-editors and staff of “News Across Latin America” and extend the invitation
to our colleagues in LAC to continue their participation in initiatives that serve to
broaden and deepen international understandings of applications of HEOR in practice.
Sincerely,
Manuel Espinoza, MD, MSc, PhD

2012-2015 Editor-in-Chief
News Across Latin America
1 | News Across Latin America Health Policy Series SPECIAL EDITION

2015– 2018 E d i t o r - i n - C h i e f | Policy Series Commentary
Future Directions
Dear readers:
This is an exciting, momentous time in the history of ISPOR. Our organization is
Yajaira Bastardo, PhD proud to be celebrating a 20-year history that is shaping the future of health
Professor & Chair of economics and outcomes research, and we celebrate ISPOR is the leading
Pharmaceocnomics and global professional society in pharmacoeconomics and outcomes research.
Pharmacy Administration
Central University of In a few days, we will be holding the 5th ISPOR Latin America Conference in
Venezuela, Caracas Santiago, Chile. For this occasion, “News Across Latin America”, the ISPOR
Venezuela Latin America Consortium newsletter, offers a Special Edition featuring
nine articles of its Health Policy Series on developments in pharmacoeconomics
and health technology assessment in Latin America.
I am thrilled to become the new Editor-in-chief of “News Across Latin America”

in this exciting moment for ISPOR. My role with the Latin America
Consortium newsletter is to help capture this excitement, the opportunities, and
the challenges to raise health economics and outcomes research scientific
standards. Under my term, a few more articles will be incorporated into this
valuable health policy series on developments in pharmacoeconomics and health
technology assessment in Latin America; some to cover additional countries in
the region and one multinational article that will offer a broad perspective on
these developments in Latin America. Then, a new health policy series will be
initiated on one of several issues of interest to the global challenge of
providing efficient and effective health care for our people.
We are confident that “News Across Latin America” will be expanding its
coverage in areas of interest for the membership of the ISPOR Latin America
Consortium. Our editorial board is comprised of an outstanding team of
experts eager to make a significant contribution to the development of
our disciplines in the region. Finally, I would like to invite professionals
from across the region interested in pharmacoeconomics and outcomes
research to join our editorial work.
We also welcome readers to view the articles presented in other regional

languages: Spanish and Portuguese, which are available on the “News Across
Latin America” webpage.
Kind regards,
Yajaira Bastard, PhD

2015-2018 Editor-in-Chief
SPECIAL EDITION News Across Latin America Health Policy Series | 2

Argentina | Health Policy
Current Status of
Health Technology Assessment
in Argentina
In 1991, health economics became officially institutionalized in Argentina with the founding of the
Health Economics Association. The fundamental purpose of this association was to generate a scientific
Lautaro Renati, MA -academic field dedicated to the reflection on, research, and training of human resources in the area of
Health Economics health economics, especially to improve efficiency and equity in the Argentinian health care system.
Professor, Department of Throughout the first years of the new millennium during a period of increasing variability in clinical
Medicine, FASTA University practice, new equipment, and pharmacological therapy developments in the country (especially in the
Pharmacoeconomics area of biotechnology), it became essential to explore the tools that health technology assessment
Postgraduate Courses (HTA) offers to consider the economic, financial, and clinical impact of these new scenarios –
Coordinator, National particularly given the uncertainty surrounding the effect of certain diagnostic and therapeutic interven-
University of Cordoba & tions. Political agendas from that moment onward began to acknowledge the need to work with
National University of Mar entities that would effectively address studies on therapeutic development through the use of HTA.
del Plata; and Head
Benefits Audit Department The first milestone came with the “Decree 1343/2013”, issued on 4 October 2007, which amended the
National Institute of Social organizational chart of the Ministry of Health. It also created the Health Economics Directorate and
Services for Retirees and assigned to this entity, among its primary responsibilities, the task of "assessing the national and
Pensioners, Buenos Aries provincial health care system's services delivery performance by conducting cost-benefit analysis with-
Argentina in the sector that would allow for a reallocation of resources at the political level”. Also during that
same year, the ISPOR Argentina chapter was founded.
The first health economics congress for Latin America and the Caribbean was organized by
the HTA Directorate in March 2009. Issues associated with HTA were incorporated in the
agenda and the participants included representatives of Brazil, Paraguay, Cuba, Chile, Uruguay,
Costa Rica, Argentina, and PAHO/WHO.
Along the same line of work, the Ministry of Health authorities declared the “Resolution 458/2009” on
14 October 2009 whereby the Coordinating Unit for Evaluation and Implementation of
Health Technology (UCEETS) was created. The objective of this entity is to guarantee access to
quality, equitable, and efficient health care services for citizens and advocate for the
periodization of these topics within health care policies. HTA as a key tool for guiding rational decision
making, based on scientific methods, provides many answers to questions posed by the various
health care stakeholders, making it useful for not only health professionals, but also public authorities,
insurers, administrators, payers, and the population at large.
UCEETS integrates several actors from the health care sector, such as payers and implementers,
including: (1) the National Administration of Drugs, Food and Medical Technology (ANMAT);
(2) the National Administration of Laboratories and Health Institutes (ANLIS); (3) the Health Care
Services Superintendence; (4) the National Institute of Social Services for Retirees and Pensioners
(INSSJP); (5) the National Single Central Institute for the Coordination of Implants and Ablation
(INCUCAI); (6) the National Directorate of Health Regulation and Health Services Quality; (7) the
Directorate of Health Services Quality; (8) the National Committee of Health, Science, and Technology
(SACYT);(9) the National Hospital "Dr. Alejandro Posadas"; and (10) the National Pediatric Hospital
SAMIC" Professor Dr. Juan P. Garrahan".
The objectives established for UCEETS are the following: (1) develop a strategic annual plan of
inclusion, needs, and prioritization of technologies requiring assessment; (2) identify and evaluate new
or previously established technologies that require evaluation; (3) establish and manage an
accreditation system for the national implementers of health technology assessment; (4) generate HTA
products, particularly Clinical Practice Guides and Technical Reports on technology considered a
priority for UCEETS; (5) encourage research and development of HTA for priority areas of health care,
especially when using economic evaluation methodology adapted to the local context; and (6) develop
projects that promote international cooperation in the elaboration and dissemination of HTA products.

Argentina | Health Policy
Between 2012 and 2013, UCEETS produced numerous reports related to the regulation of
gluten-free foods, the cost-effectiveness of the conjugated pneumococcal vaccine, bosentan
for pulmonary fibrosis in children, bevacizumab in metastatic colon cancer, etc.
There is also another institutional body of excellence dedicated to HTA in the country, the
Institute of Clinical and Health Care Effectiveness (IECS), which was designated as a
Collaborating Centre of Health Technology Assessment by PAHO/WHO in 2013. The IECS is a
source of knowledge not only for Argentina, but for many countries in the region as well, such as
Bolivia, Mexico, Panama, Peru, etc. Both UCEETS and IECS are members of the International
Network of Agencies for Health Technology Assessment (INHATA).
Recently, the ISALUD University, an academic entity that has always been at the forefront
of issues related to health economics, opened its Health Technology Assessment Centre (CETSA),
composed of highly qualified professionals.
By disposition of the “Decree 4632/2012” dated 8 August 2012, the National Administration
of Drugs, Food and Medical Technology (ANMAT) created the "Health Technology
Assessment Programme". The essential competency of this new program is the technological
evaluation of products. Its tasks are to: (1) provide requested consultations; (2) generate
evaluation reports and/or recommendations on the application of technologies; (3) collect
scientific evidence to explore opportunities and convenient usages; and (4) provide accurate
and updated data in the subject area of competence. This goal should be achieved through
the use of agile and reliable data collection tools, storage and dissemination related to health
technology assessment, and applied research and statistical developments.
The Federal Network of Health Technology Assessment (RedARETS) was created in 2012.
RedARETS has direct intervention in the cooperation between provinces in order to support
the efficient application of consensus generated in health care decision making.
Finally, it is important to mention that in 2012, Argentina modified its reimbursement
system, specifically as it relates to low-incidence and high-cost treatments for its social
insurance agents when the Single Reimbursement System (SUR) was created. In this system,
the implementation of a Guardianship System of Emerging Health Care Technologies is
under consideration. It would include 46 "guarded pairs", the pathology with the corresponding
therapy. These thematic pairs vary from paroxysmal nocturnal hemoglobinuria to various
cancer types. The regulation priorities focus on patient safety and setting maximum fixed
values for the reimbursement of pharmaceuticals.
It is clear there has been significant development in the creation of qualified institutional bodies
to produce economic evaluations. However, that the country still does not have an "Argentinian
Quality Adjusted Life Year" value, which is necessary measure to estimate costs based on robust
methodological tools and generating a national QALY should therefore be considered in the near
future. Some of these tools could include the construction of a federal epidemiological map to
measure the actual disease burden of each region and province, the discussion of thresholds, etc.
A national QALY would allow for scientifically informed health care coverage policies, which would
help in determining cost-effective innovations, supported by clear rules of coverage, safety,
clinical variability, and efficient health care resources management.
Published in Volume 2 Issue 2, August/September 2014 edition of “News Across Latin America”.
Brazil | Health Policy
A Perspective on Health Technology

Assessment Activities in Brazil
The authors would like to thank Carisi A. Polanczyk, MD, ScD and Ricardo Kuchenbecker, MD,
ScD, Institute of Health Technology Assessment (IATS/CNPq), Hospital de Clinicas de Porto
Alegre and Graduate Studies in Epidemiology, Federal University of Rio Grande do Sul, Porto
Alegre, Brazil, for their helpful comments on a previous version of this article.
Martine Bellanger
PhD, Professor of Health In Brazil, visible Health Technology Assessment (HTA) processes have been in place since
Economics, Pierre-and- 2000 (1). This was carried out by the Secretariat of Health care provision (SAS, Secretaria de
Marie-Curie University Atenção à Saúde) of the Brazilian Ministry of Health (MS, Ministério da Saúde) and followed
(UPMC) and EHESP French by the Department of Science and Technology (DECIT, Departamento de Ciência e
School of Public Health Tecnologia) under the auspices of the Secretariat of Science, Technology and Strategic
University Sorbonne Paris Inputs (SCTIE, Secretaria de Ciência, Tecnologia e Insumos Estratégicos). A decade later, Law
Cité , Paris, France 12.401 of December 2011 established an institutional framework for HTA and National
Clinical Guidelines via the creation of the National Committee for Incorporation of
Technologies (CONITEC, Comissão Nacional de Incorporação de Tecnologias) in the Unified
Health System (SUS, Sistema Único de Saúde). As part of SCTIE, CONITEC succeeds the
former Commission for Incorporation of Technologies (CITEC, Comissão de Incorporação de
Tecnologias) established in 2006 and supports a more rational decision-making process at
both clinical and policy levels (1) in line with priorities identified by the Ministry of Health.
Current HTA Framework in Brazil
CONITEC consists of an Executive Secretariat and 13 members. Of the latter, 7 members
Paulo Picon, MD emanate from different secretariats of the Ministry of Health, representing the
PhD, Professor, Dept. same composition as CITEC. However, six other members are now part of CONITEC: the
of Internal Medicine & National Council of Municipal Health Secretaries (CONASEMS, Conselho Nacional de
Chief, Clinical Research Secretarias Municipais de Saúde), the National Council of State Health Secretaries
Unit Hospital de Clínicas (CONASS, Conselho Nacional de Secretários de Saúde), the National Health Council
Federal University of Rio (CNS, Conselho Nacional de Saúde) the National Agency of Supplementary Health
Grande do Sul (UFRGS) (ANS, Agência Nacional de Saúde Suplementar), the National Health Surveillance
Porto Alegre, Brazil Agency (ANVISA, Agência Nacional de Vigilância Sanitária) and the Federal Council of
Medicine (CFM, Conselho Federal de Medicina).
This composition reflects the complex multifaceted governance structure of the Brazilian
public-funded national health care system which provides universal access to all Brazilian
citizens to free health care at primary, secondary, and tertiary levels. Decision-making
processes involve social control of public policies by means of the CNS, 27 State Councils,
more than 5000 Municipality Councils, in addition to the Tripartite Committee at the
federal level and the bipartite committees in each of the states.
Louisa T. Stuwe
MPA, MPH The mission of CONITEC is to make recommendations on the incorporation, alteration or
PhD Candidate, Pierre-and- exclusion of health technologies in the National Medicines List (RENAME, Relação nacional
Marie-Curie University de medicamentos essenciais) and the National list of Health Actions and Services (RENASES,
(UPMC) and EHESP French Relação nacional de ações e serviços de saúde), as well as for the update of Clinical Practice
School of Public Health, Guidelines and Therapeutic Directives (PCDT, Protocolos Clínicos e Diretrizes Terapêuticas).
University Sorbonne Paris These recommendations are made in line with social, health, and management needs of the
Cité and Program Officer SUS through using an evidence-based approach. (2) With the introduction of CONITEC,
French Ministry of Health all requests for coverage of technologies need to present scientific evidence
Paris, France regarding efficacy and safety, in the form of systematic reviews or technical-scientific
advice, as well as health economic evaluation and budget-impact studies.(2)
On average, CONITEC convenes during two-day sessions on a monthly basis. The full list
of recommendations is regularly updated on the website of CONITEC.

In parallel, DECIT has continued to be involved in health research, HTA studies, training
dissemination and management of the Brazilian Network for Health Technology Assessment
(REBRATS, Rede Brasileira de Avaliação de Tecnologias em Saúde). The creation and influence of the
Institute for Health Technology Assessment (IATS, Instituto de Avaliação de Tecnologia em Saúde), a
National Institute of Science and Technology, promoted by the National Council for Scientific and
Technological Development (CNPq, Conselho Nacional de Desenvolvimento Científico e Tecnológico),
composed of several national institutions and research groups, has been beneficial to a variety
of health care facilities and decision makers.
IATS supports the development of health care strategies, by evaluating the incorporation of economic,
ethical and public health consequences of new technologies by public and private health care providers
in Brazil. Last but not least, the Brazilian Chapter of the International Society For Pharmacoeconomics
and Outcomes Research (ISPOR) has claimed to act as an educational resource in Brazil, by translating
Health Economics and Outcomes Research (HEOR) concepts into Brazilian Portuguese and by
encouraging the adoption of Consolidated Health Economic Evaluation Reporting Standards (CHEERS
Checklist) (3) into the recently published pharmacoeconomic guidelines by the Ministry of Health (4).
Two year assessment of CONITEC’s activity (2012-2013)
We analyzed publicly available CONITEC recommendations on the incorporation of pharmaceutical

drugs and vaccines for 2012 and 2013. Medical devices, diagnostics and procedures were excluded
from the study since they only represented a fourth of CONITEC reports for the given period. One third
of all requests emanated from a department pertaining to the MS and 56 percent from pharmaceutical
manufacturers. For the latter, only one fourth received a positive response for drug incorporation,
while this was the case for the large majority of MS claims, as shown in Figure 1.
Figure 1. Breakdown of CONITEC recommendations per claimant request in percent, between 2012 and 2013
Most drugs and vaccines that obtained a positive recommendation were later included
in RENAME. This may suggest a clear alignment between CONITEC’s work agenda
and evidence-based public health priorities, further illuminating how HTA sustains
rational decision making within the Brazilian SUS.
Almost half of drugs and vaccines that obtained a positive recommendation belonged
to the class of antineoplastic and immune modulating agents, followed by anti-infective
for systemic use and respiratory drugs. This could be linked to the fact that over the
same period, the Brazilian government placed strong focus on access to oncology
treatments, which is illustrated by a national policy for the prevention and control of
cancer in 2013, published by means of an Ordinance in May of 2013.
There were several reasons for rejecting a drug for incorporation. Among them appeared
to be the lack of further results related to its safety and efficacy, counter-evidence
identified by means of a systematic literature review, and the existence of a
therapeutic alternative available in the SUS with lower cost of treatment. CONITEC
also frequently cross-referenced HTA conducted by other agencies, such as the
National Institute for Health and Clinical Excellence (NICE) in the United Kingdom,
the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Australian
Pharmaceutical Benefits Advisory Committee (PBAC), as a justification for rejecting a drug.
Perspectives on HTA development in Brazil
Kuchenbecker and Polanczyk (2012) highlighted that “the SUS has been incorporating
new interventions and technologies in a context of chronic underinvestment” which
has led to right-to-health litigations for “high-cost medications that sometimes
have unproven and/or even debatable benefits. In this context, “HTA will certainly
contribute toward better decision making in Brazil, by enhancing its transparency
and accountability.”(5) Indeed, the introduction of CONITEC represents a step
towards more transparency and societal participation in the process of HTA. This
is proven not only by the consistent online availability of CONITEC reports, but
also the existence and effective use of the public consultation procedure, meaning
that the civil society’s perspective is considered in CONITEC’s recommendations.
However, the role of civil society in other appraisal committees, such as in Germany,
Australia, Sweden, Scotland and England, still seem to be stronger.
As of today, CONITEC, as its name indicates, is still a Committee, following priorities

identified by the government, and by 7 out of 13 members composed of MS
representatives. CONITEC is not yet an independent agency, at the example of the
French National Authority for Health (HAS, Haute Autorité de Santé).
Another important issue to take into consideration is that the HTA trend in Brazil
should not only be measured at the national level. Indeed, important initiatives
have emerged at the state level, such as the HTA Network of the São Paulo state.
Last but not least, HTA processes are embedded in the complex governance
structure of the SUS. This raises the question whether political and economic
dimensions do not outweigh technical and scientific contributions gained in the HTA
process, through networks and initiatives, such as REBRATS or IATS. Their potential
benefit would be much more important if the decentralization process of the SUS
would had been more effective since its creation 25 years ago.
7 |5 |News Across
News Latin
Across America
Latin Health
America Policy
Health Series
Policy SeriesSPECIAL EDITION
SPECIAL EDITION
Conclusion
HTA implementation in Brazil has been a stepwise and concerted process, involving
a wide range of actors and continuously building on societal consensus. A strong
network between several universities and the Ministry of Health has been established
in the creation of national guidelines for high-cost medicines as well as in the IATS
initiative. The Brazilian experience shows that a unified HTA commission can be
created in a federal State despite various regional contexts and an important
number of administrative entities.
With the creation of CONITEC, the relationship or the link between HTA and
evidence-based policy has become stronger. A larger question that is valid both for
Brazil and for other emerging countries is to know whether the use of HTA has
led to improved access to quality medicines for the patients, which is the goal that
HTA should ultimately serve. A comprehensive national database would be
helpful to better estimate such impact
References
(1) Picon PD, Beltrame A, Banta D. National guidelines for high-cost drugs in Brazil:
achievements and constraints of an innovative national evidence-based public health
policy. Int J Technol Assess Health Care. 2013 Apr;29(02):198–206.
(2) Laranjeira F de O, Petramale CA. A avaliação econômica em saúde na tomada de
decisão: a experiência da CONITEC. BIS Bol Inst Saúde Impresso. 2012;14(2):165–70.
(3) Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consol-
idated Health Economic Evaluation Reporting Standards (CHEERS)—Explanation and Elab-
oration: A Report of the ISPOR Health Economic Evaluation Publication Guidelines Good
Reporting Practices Task Force. Value Health. 2013 Mar;16(2):231–50.
(4) Brasil. Ministério da Saúde. Secretaria de Ciência, Tecnologia e Insumos Estratégicos.
Departamento de Ciência e Tecnologia. Diretrizes metodológicas : Diretriz de Avaliação
Econômica / Ministério da Saúde, Secretaria de Ciência, Tecnologia e Insumos Estraté-
gicos, Departamento de Ciência e Tecnologia. – 2. ed. – Brasília: Ministério da Saúde,
2014. 132 p. : il.
(5) Kuchenbecker R, Polanczyk CA. Institutionalizing Health Technology Assessment in
Brazil: Challenges Ahead. Value Health Reg Issues. 2012 Dec;1(2):257–61.
Upcoming publication in “News Across Latin America”.

Chile | Health Policy
Health Technology Assessment in Chile:

Reflections on a Slow Process
Efforts to formalize a Health Technology Assessment (HTA) process in Chile date

Manuel Antonio back to the year 1997, with the creation of the Health Technology Assessment Unit
Espinoza, MD, MSc in the Chilean Ministry of Health. This unit was formed with the aim of aiding the
PhD Professor, Dept decision-making process by preparing synthesis reports on evidence concerning
of Public Health & health intervention effectiveness and safety. Nonetheless, these reports did
Coordinator, HTA Unit not always respond to health authority needs and in practice, the reports did not
Center for Clinical Research necessarily lead to the proper development of institutional mechanisms for
Catholic University of Chile implementing an HTA process as we understand one today. This unit was in operation
Santiago Chile and Honorary until 2008, when the unit´s last two reports were published.
Visiting Fellow, Centre for
Health Economics, University
of York, York, UK In Chile, evidence-based decision-making processes concerning health technology
coverage are still in development under the auspices of the latest health reform,
which began its implementation in 2005. One element of the reform was the
creation of an explicit guarantee system for a set of health issues. This forced
not only prioritization of diseases and health problems, but it also forced the definition
of a set of health services guaranteed by law, regardless of whether the patient
possesses public or private insurance. As a result, clinical practice guidelines were
generated based on information concerning the efficacy, effectiveness, and safety of
interventions. However, the guaranteed set of services is only defined upon
completion of an assessment on the feasibility of financing those services. Although
the clinical guidelines generation process benefits from sufficient legitimacy due
to the participation of academic experts and scientific societies, the decision on financial
coverage still does not comparatively have a systematic, clear, and transparent process.
Rony Lenz Alcayaga
MA, Professor, School of
Along with the Ministry of Health, various sectors of Chilean society have made
Public Health, University of
Chile and Head Consultant efforts to advance developments in the decision-making process. In Chile, evidence-
Lenz Consulting, Santiago based medicine is undoubtedly the fastest growing field in HTA. Its development
Chile can be seen in the consolidation of research groups in this area in several universities
in Chile, as well as the creation of post-graduate training programs in the field. At
present, Chile can now count on qualified local professionals to take on HTA in the
field of intervention efficacy and safety evaluations.
Development of certain aspects of HTA economics has been more limited. In 2007, the
founding of the ISPOR Chile Chapter has played a significant role in maintaining a flow of
activities, which has allowed for the continuous training of professionals in areas such as
economic evaluations, HTA, and health economics, in general. However, the ISPOR Chile
Chapter is not the only institution actively engaged in this arena. Universities have also
made significant efforts. The Catholic University of Chile established an economic
evaluation degree program in 2010 and the Universities of Chile and the Andes
have also been developing extension courses on this subject. In addition to those
previously mentioned, other institutions have integrated the subject area into their
post-graduate programs and at the same time have produced relevant research, as
is the case of Universidad de La Frontera, Universidad Mayor and Universidad Católica
del Norte. Finally, recognition must be given to the efforts of the pharmaceutical industry
in promoting continuous training and discussion of these matters by organizing seminars
and extension courses with the participation of well-regarded international experts.

Chile | Health Policy
One of the most important milestones in recent years for the development of HTA in
Chile was the formation of the National Health Technology Assessment Council in
the Chilean Ministry of Health. This council is different from the previous national
HTA Unit in terms of its structure and objectives. The National HTA Council consists
of 16 members representing the various entities that make up the health authority
and 2 advisers to carry out technical tasks as required by its members. The Council's
main objective is to formulate a proposal for standardizing the implementation of
an HTA model in Chile based on the review of normative considerations, international
experiences, and an assessment of the country's internal capabilities; the proposal
would be strictly adjusted according to scientific and technical considerations. There
is hope that the work of the Council will have a positive impact not only on the
health authority, but also for the various stakeholders who should feel part of this process.
The implementation of a systematic, transparent, and socially legitimate decision-making

process on health technology coverage ought to be a goal for society as a whole,
extending to various political sectors and social movements. In other words, the
institutionalization of an HTA process is not, nor should it be, considered a policy
bound to one sector, but as an area of public policy, where debates should focus on
scope and process definition and implementation. We believe this argument
resonates beyond the borders of Chile and is applicable to all countries of the region
that are still in the incipient stages of HTA development.
Finally, we acknowledge the work of the National HTA Council as a fundamental actor of HTA
development in Chile. However, it is far from being the only one. It is necessary for the
country to have other social sectors taking part in public dialogue concerning the proposal
being drawn up by the Council. Therefore, we consider it essential to invite scientific and
health professional societies, leading health authorities, and institutes relating to public
health, as well as the private sector, to actively contribute to the discussion in order to
obtain a result that, although imperfect, has the societal support a health policy requires.
Published in Volume 1 Issue 4, September/October 2013 edition of “News Across Latin America”.
Ecuador | Health Policy

in Ecuador
Over the past five decades, technological innovation has produced truly remarkable advances
in health technology worldwide (1). On the other hand, growth of public expenses and
particularly, health technology expenses have made Health Technology Assessments (HTA)
Luciana Armijos, MD play an important role in decision making in health technology in several countries (2).
Master in biomedical
research, Health Intelligence In Ecuador, HTA is a process that began in late 2012 as a tool to aid health technology related
Directorate, Ministry of Public decision-making within the Ministry of Public Health from Ecuador (MPH), which is the
Health of Ecuador , Quito governing body of the sector. The Health Intelligence Bureau is responsible for the
Ecuador development of the HTA process; and work under the General Coordination of Strategic
Development in Health (GCSDH), which is vested with advisory enabling capacity, according
to the Organic Statute of Organizational Management for Processes from the MPH.
Together with the Department of Health Economics, the GCSDH generates information based
on the best scientific evidence available regarding the use of health technologies.
Since the beginning of HTA applications in the country, reports generated on this subject
have been used as input for making informed decisions on the inclusion or exclusion of
Xavier Sánchez, MD technologies for the Basic Tables or Set of Benefits, the purchase of technologies outside
Health Technology Assessment the Set of Benefits, and any other decision that involves allocating public resources within the
Specialist, Catholic University of scope of work designated to the MPH and National Health System of Ecuador.
Ecuador & Ministry of Public
Health of Ecuador, Quito The HTA process in the MPH include four components: (1) generation of HTA reports; (2)
Ecuador distribution of information related to HTA; (3) training on issues related to HTA for key
players in the process; and (4) monitoring the impact of the reports in decision making.
Most HTA reports developed by the GCSDH are rapid responses, resulting from requests
made on demand by authorities from the MPH in issues related mostly to the domains of
efficacy, safety and economic considerations. In 2014, 82 rapid response reports were
generated; 53% referring to medications; 7% to diagnostic tests; 6% to medical procedures;
5% to health programs; 1% to devices; and 18% to other technologies.
Ruth Jimbo Sotomayor
MD, Health Technology Considering that medication have been the type of technologies most frequently evaluated,
Assessment Specialist, Catholic at the end of 2014 a prioritization process of health technologies was proposed that
University of Ecuador & Ministry would use the multi-criteria decision analysis method (MCDA) (3). This method supports
of Public Health of Ecuador decision makers who face the assessment of health alternatives, for which multiple
Quito, Ecuador explicit criteria are taken into account during the selection period. The selected criteria
for the development of the prioritization matrix included: the impact of illness;
intervention context; the type of technology benefit; and cost and quality of the
available scientific evidence related to the relevant technology. From the prioritization
process, rapid, short, and complete HTA reports of HTA were developed based on
the technologies defined as high priority during 2015.
In regard to the distribution of information related to HTA, the MPH publishes quarterly
HTA newsletters aimed towards key players in the process. The connection among actors
involved in HTA is important; training and distribution processes in HTA allow decision
makers, applicants, patients, and thematic experts to properly connect and gives
them the opportunity to create agreements, legitimize, and consolidate the process.
Since late 2014, a mechanism for evaluating the impact of HTA report on decision making in
our country was proposed. It aims to collect information on the usefulness of the process in
health care decisions.

Ecuador | Health Policy
With the report from the 67th World Health Assembly from the World Health Organization (WHO) (4),
governments were urged to use interventions and health technology evaluation in support of universal health
coverage. Ecuador acknowledges the importance of HTA to achieve better decisions for universal coverage.
The significance of participating in HTA international networks lies in the opportunity it provides to
exchange experiences and improve analytical capabilities in working with HTA issues. Ecuador actively
participates in several networks, such as the Health Technology Assessment Network in the
Americas (RedETSA) and Andean Network of Health Technology Assessment (RAETS) since 2013;
and since 2014 in the HTA component of the International Cooperation project on Information
Generation for the Improvement of the Efficiency in the Management of High Financial Impact
Medications, financed by the Inter-American Development Bank (IDB), which participates currently
with Colombia, Mexico, and Ecuador with the purpose of achieving a regional HTA direction.
Ecuador is in a critical moment vis-a-vis the development of HTA thanks to the institutional support
provided by MPH, an entity that see the process as an invaluable tool for decision making.
Given that the country is at an early phase of HTA development, several institutions, particularly in academia,
have expressed their interest in generating HTA centers as if the case of the City of Knowledge, Yachay.
They could be involved directly in supporting the National Health Authority to respond to HTA requests.
As with most countries where the application of HTA arose for decision making, in Ecuador there
are some clearly identified barriers that limit the development process—among them, limited technical
capacity for the development of HTA reports, increased need for a prioritization of technologies and
the existence of insufficient data on local health problems.
Finally, several recommendations were proposed to further develop HTA in Ecuador—among them,
consolidating a work team with analytical capabilities related to the field of HTA, achieving an
adequate interaction with all players involved in the HTA process, and working with a regional HTA
vision. All of this would help to better enable decision making in the field of health in the country to be
based on the best available scientific evidence.
References
(1) Goodman CS. Introduction to Health Technology Assessment. 2014.

(2)Ortún-Rubio V, Pinto-Prades JL, Puig-Junoy J. La economía de la salud y su aplicación a la evaluación.
Atención Primaria [Internet]. 2001 Jan;27(1):62–4.[The health economy and its application to the evalua-
tion. Primary Care]
(3)Thokala P, Duenas A. Multiple criteria decision analysis for health technology assessment. Value Health
[Internet]. 2012 Dec [cited 2015 Jan 30];15(8):1172–81.
(4) Consejo Ejecutivo de la OMS. Evaluación de las intervenciones y las tecnologías sanitarias en apoyo de la
cobertura sanitaria universal [Internet]. 2014 p. 1–8. [Executive Board of WHO. Evaluation of health interven-
tions and technologies in support of the universal health coverage]
(5) 67.ª Asamblea Mundial de la Salud, Evaluación de las intervenciones y las tecnologías sanitarias en apoyo
de la cobertura sanitaria universal, WHA67.23. 2014 [67th World Assembly of Health, Evaluation of health
interventions and technologies in support of the universal health coverage]
Published in Volume 3 Issue 1, February/March 2015 edition of “News Across Latin America”.
Mexico | Health Policy
Ten Years of Pharmacoeconomics

in Mexico
Over the course of these last 10 years, the General Health Council has positioned itself as the
main health technology assessor given that it is this collegiate body's sole responsibility to
constantly maintain and update the Basic Formulary Medications List and Healthcare Supplies
Rosa María Galindo- Catalog (Cuadro Básico y Catálogo de Insumos del Sector Salud - CByCISS). This document
Suárez, MHE groups, characterizes, and encodes the drugs, medical supplies, instruments, medical
Deputy Director General equipment, and diagnostics used by National Health System’s public institutions to
of Prioritization, General provide health services to the population. The Basic Formulary Medications List applies to the
Health Council, Ministry first level of care and the Healthcare Supplies Catalog applies to the second and third levels.
of Health of Mexico,
Mexico City, Mexico The fundamental aim of this list is to assist in optimizing public resources directed at address-
ing health problems in the country, by means of using technologies tested for safety,
therapeutic effectiveness, and efficiency. Additionally, the supplies list is a reference tool
that serves to notify and assist, which aims to achieve updating health professionals.
All of the foregoing is based on the Internal Regulations of the CByCISS Inter-Institutional
Commission, whose legislation aims to regulate the manner in which the CByCISS is drawn up,
updated, and published, in order to assist in improving the quality, safety, and efficiency of
Fabiola Melchor- health care offered by public institutions of the National Health System. It establishes
Martínez, Director of the ethical principles and commitments of the CByCISS Inter-Institutional Commission
Catastrophic Expenses aimed to achieve efficient, transparent processes based on scientific evidence.
Prioritization & Cross-
Sector Management, This year marks precisely the 10th anniversary of the General Health Council’s update to
General Health Council its regulations, requiring the inclusion of a pharmacoeconomics study. This factor triggered
Ministry of Health of the development and strengthening of health technology assessment, as a national priority.
Mexico, Mexico City,
Mexico The first signs of the importance of this new requirement were, among others, the creation
of pharmacoeconomics management departments by several pharmaceutical companies,
the establishment of the ISPOR Mexico Chapter (August 2006) with no less than 15 members,
and 4 new consultancy firms in the country.
Following the modification of the regulation, the General Health Council published its
Guidelines for Conducting Economic Evaluation Studies in the year 2008 and its Guidelines
for Evaluating Healthcare Supplies in the year 2011, as well as a new regulation which
further strengthened the specific requirements pharmacoeconomics studies should contain.
In principle, this new regulation and the Guidelines for Evaluating Healthcare Supplies meant
a structural change to evaluating supplies, as specific criteria were established such as
defining a 1PIB per capita threshold. This change clearly meant a growth in employment
creation given the opening of new positions within the industry, consultancy firms and
government and a clear need for training human resources.
Companies that started off with a single pharmacoeconomics manager, now have a
department with at least 4 positions. Likewise, the ISPOR Mexico Chapter currently has
grown more than 70 active members and has organized and carried out two training
seminars during this time period. The growth of the number of people who are
dedicated to this matter is more than obvious, although it is still insufficient given the
large number of submissions presented to the General Health Council.

Mexico | Health Policy
A total of 118 requests were received during the period between September 2011 and May 2013, which solely
concerned medication. Of these, only 89 were evaluated since the remaining did not meet basic requirements.
Of the total requests evaluated, 47% were approved to be included in the CByCISS. It is important to mention that 29 of
these were requests for modifications, in other words, the inclusion of new indications, new dosage forms or the
submission of drugs already listed, and 13 were requests for new inclusions (Figure 1).
Figure 1. Number of approved requests
Modifications
New Inclusions
It should be noted that 7 of the 13 requests for the inclusion of drugs correspond to the endocrinology
and metabolism and oncology therapeutic groups (Table 1). The foregoing reflects the positive correlation
between public health problems that affect our population and the current list of health care priorities made
by health authorities.
Table 1. New Inclusions of Drugs by Therapeutic Group
Therapeutic Group Name 2013 Thus, in recent years, pharmacoeconomics

has been the most important factor,
Endocrinology & Metabolism 3 although not the only one, in the
Communicable & Parasitic Diseases 1 decision-making process to include the
CByCISS. However, although the General
Hematology 2
Health Council has been the leader
Pneumology 1 of the entire technology assessment
Oncology 4 movement by giving economic evaluation
studies a leading role, it has not
Rheumatology 2
neglected the importance of clinical
13 information. Alternative oncology or orphan
drugs may not have been cost-effective
alternatives, per se; however, they
are alternatives, which cover latent health needs. Therefore, in this way the Council is currently starting to evaluate
new methodologies, which consider each variable (clinical, social, and environmental) to keep promoting and
strengthening the decision-making process for innovative drugs with the ultimate objective of patient access.
Published in Volume 1 Issue 5, November/December 2013 edition of “News Across Latin America”.
Paraguay | Health Policy
Considerations on Health Financing and Expenditures,

and the Decision-making Process to Incorporate
Health Technologies in Paraguay
Health Financing and Expenditure
Ruben Gaete, MS Health financing refers to the movement of resources from their funding sources to the financial agents in
President of the Paraguayan health. In Paraguay, the financial bodies are clustered into three subsectors that composing the health care
Health Economics Association
system. Each subsector has its own mechanisms and sources of funding.
and Coordinator of the
"Community System of The General Budget of the Nation finances the public sector via: (a) resources from the public treasury
Healthcare for Pregnant generated by fiscal income/taxes; (b) foreign loans; and (c) institutional resources collected from the
Women and Newborns"
payment of certain fees, donations, and other resources. In 2011, the budget of the Ministry of Public
Project, BID/JPO - Resource
Centre for Information and
Health and Social Welfare (MSPBS) depended on financing from treasury resources (88%), from foreign loans
Development, Asuncion (2%), and from institutional resources (10%). In 2002, the percentages were 77.7 %, 6.5% and 15.9%,
Paraguay respectively. The numbers indicate that the MSPBS financing dependent on the public treasury resources
has increased over the last decade. This has decreased the relative weight of foreign loans and institutional
resources, which is auspicious because it represents a decrease in out-of-pocket spending for the average
families. National universities (Health Departments) and Military and Police Health care, which are also
part the public health subsector, are financed primarily by tax revenues.
The Social Security Institute (IPS) is financed by: employer contribution (14%); by the workers monthly salaries (9%); and state
contribution (1.5 % ) of the salaries reported by employers. The 14% employer contribution includes a 1.5 % that the IPS collects and
transfers to the MSPBS to fund prevention programs and cover the expenditures of the National Programme of Vector Borne Diseases
(SENEPA). Some groups, such as teachers working in public and private sectors, are organized into different categories with special
contribution schemes. Financing for the IPS health expenses via the Sickness and Maternity Fund stems primarily from taxes collected
from the total amount of wages (9%). There are indicators that demonstrate a high evasion of the social insurance by employers, and
the state's failure to enforce compliance to the mandatory contribution is partly responsible for the significant state debt to the IPS.
The private sector is financed by the users’ payment and contributions of prepaid health schemes members.
Figure 1 illustrates the finance flow and health care system expenditure.
Sector Private
Public Social Security
Other Ministry of Employees Employers Donations
Finance: taxes, contribution contribution Employers Homes
Funds / Resources* and
foreign loans
Financing. Contributions
Fees (if they were)
Pocket expenditure
Direct payments
Bonuses
Bonuses
Ministry of National
Armed Social Non-profit
Buyers: Public Universities Private
Forces and Security Institutions
Financing Health and (Departments insurance
Police of Medicine) Institute (IPS)
Social
Agents Healthcare
Wellbeing
Hospitals, Specialized
Institutions, clinics and Hospitals, clinics and
MSPBS healthcare Hospitals, clinics and Hospitals, clinics, drugstores and private
public medical
centers other IPS practice profit and non-profit clinics
Suppliers centers of each
institution establishments
Poor population Military, police and Formal sector Population with Population
Users and/or people personnel from the workers and payment capacity without
withoute institutions and its beneficiaries insurance
coverage branches coverage
•Other Resources– complementary special resources that come primarily from cooperative agencies.

When observing the aggregate expenditure on health care, the importance of the diverse financing sources as a whole becomes clear.
The health expenditure numbers as a
percentage of the last years' GDP
Table 1: Health care and Public Health Aggregated Expenditure, Paraguay, 2009
(2000 to 2009) show that it has been
steadily dropping since 2000 (8.4%)
Subsectors and its main source of financing Participation Percentage GDP % to 2008 (6%), the year the lowest
numbers of the considered period
a. Public (mainly taxes) 25.4% 1.8% were recorded. From 2009 on,
spending increased to 7.1% of GDP;
b. Social Security (IPS) (contribution from wages) 17.5% 1.25% 57% of which were private expenses.
c. Private Sector (user payment) 57.1% 4.05% The national aggregated expenditure
was an estimated US$ 159 per
Total expenses in health 100.0% 7.1% capita that year (current values).
The amount almost doubled that
of Bolivia; however it was much
lower than that of Argentina, Brazil,
and Uruguay, whose per capita
expenditure levels are four times
higher than that of Paraguay.
Paraguay: Health Care Expenditure as a % of GDP, 2000-2009 The out-of-pocket expenditure in

Paraguay represents an 85% of
the private health expenditure. It
includes direct payments made
by families for health care and
medicines. A total of 58.6 % of the
out –of- pocket spending for families
was allocated toward purchasing
medicines. That amount of out-of-
pocket expenditure reveals a highly
segmented health care system due
to the fact that families have lower
effective protection from the state
regarding health care; thus, this
contributes to increased inequities
since, proportionally, the poorest
apply a higher portion of their
incomes for their health care needs.
The allocation of the national budget
to the health sector, as measured
by the MSPBS' budget allocation
has significantly increased in the last
years, growing 4 times. In the last
Source: Gaete, R. elaboration with data from the Global Health Observatory, WHO, and Satellite health accounts from Paraguay, MSPBS. 11 years, even though in relation to
the GDP, the public sector represents
only the 3%. The budget execution
capacity measured by the PE/PA
ratio was an average of 81% for the
2000 -2001 period. The lowest
execution level was observed in
the year 2000 reaching 72% and
the highest in the year 2010 when
it reached 90% as is shown in the
following table:
The relative value available in Table 4 provides information on the expenditures of Paraguay’s two principal health care
provider institutions established by the MSPBS and the IPS. The table reveals values related to the governing body activities, which entails
leading, coordinating and regulating the sector; public health activities constituted by the set of actions and services designed to protect
the population's health as a collective unit (promotion and prevention); and individual health care, which consists of health
care provision (inpatient and outpatient health services, diagnosis and other services).
In the 2005 - 2008 period, the public health sector channeled most of
Table 4 its expenditure (77.3 %) towards individual health activities, 13.8% to
Classification of Expenditures of the MSPBS and the IPS public health activities and, 8.9% to the governing body activities,
according to the Type of Services: 2005 - 2008 in %
respectively, on average. This expenditure composition remained
2005 2006 2007 2008 constant in the years 2005 and 2006, varying significantly in the years
2007 and 2008 in respect to the governing body and individual
MSPBS
health activities, while spending on public health remained constant.
Governing body 9% 9% 13% 5%
In a strict sense, public health is considered a public good: the fact that
Public Health 14% 14% 14% 14% resources to fund these activities increased to only the 13.8% of the
public budget reveals that the preventive and promotional
Individual Health 77% 77% 74% 81% expenditure orientation is still insufficient. There exists an important
Total 100% 100% 100% 100% opportunity to influence the order of the sectorial resource
allocation priority to improve allocative efficiency.
IPS
Allocative efficiency implies assigning resources following the declared
health policy priorities or the main goals that society would like
Public Health 14% 14% 14% 14% achieve collectively. International evidence suggests that health care
Individual Health 77% 77% 77% 77% systems based on primary assistance have better health outcomes are
more efficient, and achieve higher user satisfaction when compared to
Total 100% 100% 100% 100%
systems with weak orientation to primary care assistance.
MSPBS + IPS
It is in that sense that improving the allocative efficiency in a country,
such as Paraguay involves increasing the proportion of resources
PUBLIC SECTOR destined to primary care assistance, which implies the reorientation
of health care services to promotion and prevention.
Public Health 14% 14% 14% 14% Furthermore, in the context of resources allocation via the public
budget to improve allocative efficiency, the short-term perspective
Individual Health 77% 77% 75% 79%
must be exceeded. Whereas the annual budgets do not consider the
Total 100% 100% 100% 100% medium-term implications of current decisions, e.g., the recurring
future expenses associated to current investments. Another
alternative is to reduce the imbalance of resources allocation, e.g.,
health care establishments where there are 4 dentists but only one dental chair and no anesthesia; x-ray equipment but no radiologists;
or for example existing therapy equipment but no professional to use it.
Process of Decision Making for Health Technology Incorporation

Health technology plays an essential role in the pursuit of equity, quality, and efficiency of health care systems and entails an
increasing budgetary impact that could jeopardize its sustainability.
The establishment of an institutional framework for decision making on the incorporation health technologies in the health care
system aids in overcoming one of the principal obstacles identified in the World Health Report 2010 to accomplish universal
coverage: the inefficient use of resources.

A key tool to guide decision making in a rational and efficient manner, based on scientific methods, is health technology assessment,
as it is the nexus between scientific knowledge and the decision making process. In a broader approach that addresses the
distinct functions related to the health technologies regarding regulation, incorporation, and rational use, HTA should be applied.
In Paraguay, the current institutional mechanisms to control the inclusion of health technologies in the health care system
do not guarantee the incorporation and use of those that achieve improved health status. Even those technologies whose
effectiveness are doubtful or unknown find a place within the system. This is observable in the diverse scope of existing
technologies -from the simplest to the most complex- in both the private and public sectors.
While providing a broad approach to HTA in Paraguay is not issue of this article, the process of establishing the Essential Medicines
List (LME) in 2008 and the Essential Medical Supplies List (LIME) in 2012 may be mentioned as positive milestones in the use of HTA
for decision making in the medicines and supplies area. Both instruments constitute a reference framework for the acquisition,
distribution and use of the medicines and supplies in all the management and attention levels of the public sector, as well as
a tool for prioritized inputs manufacturing and for the health registry that regulates marketing and usage.
The methodology utilized for developing the LME consisted of 3 stages: (1) formation of a National Technical Committee integrated
by MSPBS technical division officials, national universities, and national institutes directly related to the medicines selection
activities; (2) dissemination of the proposed LME through the strategy of focus groups of prescriber clinicians of representative
health care regions and specialist clinicians by pharmacological groups; and (3) technical review of the medicines proposed to be
included or excluded from the development of the LME (a stage in which the national technical committee evaluated the suggested
recommendations in the dissemination process and made the necessary adjustments by identifying and applying the reference
information from the best available evidence). This is important for reviewing efficacy and safety aspects of the medicine given that
the selection is based on primary election indications for each health issue. The specialized information sources were consulted
on aspects related to the pharmacological characteristics of the medicines, to check the content of each selected medicine.
The criteria considered by the national technical committee for the selection of the medicines included in the LME are promoted
and applied by the WHO in the elaboration of the Model List of Essential Medicines and are presented below: (a) relevance
to the pattern of prevalent diseases; (b) demonstrated efficacy and safety; (c) evidence that the expected results are produced in
diverse environments; (d) adequate quality, including bioavailability, and stability; (e) favorable cost-benefit relation in terms of the
treatment total cost; (f) desirable pharmacokinetic properties and local production possibility; and (g) marketing as
individual compounds. The development of the LIME followed a similar process of the LME.
In a health care system like that of Paraguay, one where it is clear that the country has still large social inequities in health
(inequality), the process of health technology assessment must necessarily incorporate the equity dimension in order to assess all
impacts of a particular technology (including the impact on equity) for the HTA to contribute to a more efficient and fair system.
Therefore, developing a regulatory and operational institutional framework that comprehensively addresses the varied
functions related to the health technology regulation, incorporation and rational use, is a challenge for Paraguay. It is especially
necessary to strengthen the link between HTA and the decision making process of health technology incorporation in order to
contribute more effectively to achieve more efficient, equitable and quality health system.
1 The MSPBS has implemented free healthcare since 2008, which implies the removal of all healthcare provision charges (copayments) in all the
healthcare facilities that depend of this institution. The MSPBS still receives fees, however, these come from the registration of drugs in the National
Direction of Healthcare Surveillance, the registration of food in the National Institute of Food and Nutrition (INAN) or control of professions, instead
of healthcare services.
2 The IPS covers short-term (health care) and long-term (retirement and pension) benefits.
3 For the MSPBS budget, this contribution constitutes the funding through institutional resources.
4 Data from the Global Health Observatory, WHO
5 National Health Accounts. Paraguay 2002/2004. MSPBS, PAHO/WHO
6 PE: Executed Budget; PA: Allocated Budget
7 Calculus based on Satellite Health Accounts of Paraguay, Public Sector – 2007 (Exploratory Exercise). MSPBS. PAHO/WHO
Published in Volume 2 Issue 4, November/ December 2014 edition of “News Across Latin America”.
Peru | Health Policy
Implementing Health Technology Assessment

in Peru: A Gradual Process
Even though it is true that in Peru efforts are being made to introduce health technology
assessment (HTA) as an essential tool for health care decision making, the fact is that after many
Enrique Longaray years the results are not very encouraging.
Chau, MD, MSc
Health Economist and The Ministry of Health is the entity that has made the most progress in the implementation of HTA.
Cardiologist, Department In 2010, the Ministry of Health established the Health Technology Assessment Unit and supported
of Cardiology Naval investing in staff training programs in health economic evaluations such as the one provided by the
Medical Center, Peruvian Institute for Clinical Effectiveness and Health (IECS). In addition, the Sectorial Committee on Health
Navy and Clinic, Jesús Technology Assessment in Health and High Cost Diseases was founded in 2011 to “promote and
del Norte, Lima, Peru conduct health care technology assessments to technically support decisions related to the
selection, integration and dissemination of technologies in the Ministry of Health and gradually, in
the Health Care System". This committee includes representatives of the General Directorate
of Medicines, Supplies, and Drugs (DIGEMID) and the National Institute of Health (INS). The
Health Technology Assessment Center is part of this committee and it is expected to become
the head of a network of HTA centers throughout the nation.
Among its various functions, a primary role of this Sectoral Committee is "to plan, organize, and
develop HTA activities to support coverage decisions and other health care-related decisions", but
it does not have the power to directly determine or recommend which technologies should be
covered by the Ministry of Health, much less for the general health care system. Ideally,
their recommendations should have a binding effect in order to enable the adoption and
implementation of its conclusions without further administrative burden.
In EsSALUD (the public social security agency where workers who contribute 9% of their salary
through their employers have the right to access services), the implementation of health technology
assessment processes has not yet been formally and effectively established. There have been
projects emanating from some of its authorities, but unfortunately, they have not been
successful. For example, in August 2013, there was a project to create a management body
for technological innovation in healthcare upon which a sub-management committee for
health technology assessment should have depended. However, no specific unit responsible
for performing HTA has been established in EsSALUD thus far. Currently, the Pharmacological
Committee has added to its duties the task of evaluating cost-effectiveness related issues. EsSALUD
urgently needs to have an HTA unit in place, given that the various health care technologies that
require assessment go well beyond the scope of drug evaluation alone; and extend to the rational
use of health care resources. According to 2012 data, the drugs requested by EsSalud exceeded
25% of those available in the National List of Essential Drugs, which is defined by the Ministry of
Health to be applied in all health care facilities throughout the nation (Ministry of Health,
regional governments, local governments, social security, health care services of the police
and armed forces of Peru, clinics, and others from the private sub-sector).
The ongoing work being carried out by institutions like the Pan American Health Care Organization
(PAHO- PERU) has made notable contributions to raising awareness and providing training on the
need to promote the development of HTA. From the Technical Meeting on Health Technology
Assessment and Management that was developed jointly with the Ministry of Health and EsSalud,
which culminated in a panel discussion entitled: "Implementing Proposals for Health Technology
Assessment and Economic Evaluations for Decision Making in Peru" last year in October, it can be
inferred that we are still currently in the early stage of the process in Peru.
The private sector has become increasingly more interested in health technology assessment and
economic evaluations, especially in the pharmaceutical industry and with private insurance
companies (health care providers), but there are still few institutions that have established some
form of management or positions dedicated exclusively to economic evaluations and HTA in general.

Peru | Health Policy
Interest in developing economic evaluations in Peru has existed for several years. The first
International Seminar on Health Economics took place in Lima as early as 1995. The seminar was
organized by the Peruvian Association for the Development of Health Care Economics and
sponsored by, among others, the Inter-American Network on Health Economics and Financing
(REDEFS) and the Economics Department of the National University of San Marcos (UNMSM).
The University of San Marcos, through its Economics Department, has been and remains one of
the greatest academic driving forces of health economics in Peru and is developing a Master’s
degree program in Health Economics since 2000. In addition, other universities have sporadically
developed seminars or certificate courses on health economics, pharmacoeconomics, or health
technology assessment. There is a labor market demand that is gradually growing at the public
level and that has grown even more greatly within the private sphere, as is the case for the
pharmaceutical industry and health care insurance companies.
The strong interest of many professionals involved in this field has led to the formation of several
associations, such as the Peruvian Society of Health Economics, founded in 2007. Moreover, in
January 2011 the regional chapter of ISPOR (International Society for Pharmacoeconomics and
Outcomes Research), ISPOR Peru, was established. It should be noted that the demand for
research on economic evaluations and health technology assessments has increased, but it is
primarily sought by the private sector. This demand is mainly seen in high-cost products, which are
generally those that face greater obstacles to inclusion on the National List of Essential drugs from
public institutions and private health care insurance companies. Usually, the public sector does not
directly require cost-effectiveness studies, but it is beginning to use them as evaluation criteria for
decision making. For example, although at the Police and Armed Forces institutions there is no
coherent and serious policy on the routine use of health technology assessment, the truth is that
other institutions have expressed interest; last year the National Police Hospital invited ISPOR Peru
to give a presentation on health technology assessment and its usefulness in decision making.
In our country, as elsewhere in Latin America, efforts are being made to improve access to health
services, however these efforts are not enough; we must ensure that everyone is able to access
quality services. When we affirm that access must be accompanied by equal quality for all,
we are talking about an essential issue, that of equity.
At this point, it is important to highlight that health technology assessment is not solely about
evaluating the economics of an intervention; rather it is a broader tool that primarily seeks to
identify interventions that are not effective or may be inefficient in order to avoid costs that
could be employed to serve more people with better technologies. Often, health care decisions
are not simple, much less so when a patient's health depends on how much we can spend;
but if we are a country with scarce resources, it is all the more reason, for us to learn to
use tools that allow us to make better decisions. The most important step to advance
the implementation of HTA in Peru is to sensitize the current governing authorities to
egularly enact these policies that may withstand the changes of government.
Published in Volume 2 Issue I, February/ March 2014 edition of “News Across Latin America”.
Trinidad & Tobago| Health Policy
Current Status of Health Development Challenges and

Startegies in the Decision-Making Process for Health
Technology Incorporation in Trinidad & Tobago
Sameer Dhingra Introduction
B.Pharm, M.Pharm
Trinidad & Tobago is a twin-island democratic republic located off the north coast of Venezuela in the
PhD, RPh, Lecturer
School of Pharmacy
Caribbean Sea. The country achieved independence from Britain in 1962, followed by Republican status
Faculty of Medical Sciences in 1976; however, it remains a member of the British Commonwealth. Its Constitution provides for the
University of the West Indies separation of powers of the three branches of government – the Executive, Legislative, and Judicial – and
St. Augustine, Trinidad & the country is organized into thirteen administrative areas. Tobago is administered separately by the
Tobago Tobago House of Assembly (THA).
The total population of the two islands is 1.33 million, with 4% living in Tobago. There is a male: female
ratio of 1:1, and an ethnic mix of East Indian 41%, African 40%, and other groups 19% (Chinese,
European, and Middle Eastern). The annual growth rate is estimated to decline from 0.5% in 1995-2000
to -0.11% for 2014; fertility rates have been declining since the 1970s. Life expectancy at birth was
estimated at 69.42 years for males, and 75.24 for females in 2014, which compares favourably
with the figures for more developed countries1.
Sandeep Maharaj
Health systems and services
MBA, RPh, Lecturer
School of Pharmacy
Faculty of Medical Sciences The Government of Trinidad &Tobago has made a policy decision to achieve developed nation status for
University of the West Indies the country by the year 2020 and has developed a strategic framework to bring this vision to fruition. A
St. Augustine, Trinidad & health sub-committee was established to develop a strategic framework for the sector. The mission state-
Tobago ment articulated by this sub-committee was “To create a nation of individuals, families and
communities empowered to achieve and sustain the highest standards of health and well-being through
the provision of efficient, effective, equitable and collaborative services that support good health”
The goals were developed to harmonize with the Health

Sector Reform Programme (HSRP), and the success of this
The following seven goals2 for health have been identified: harmonized approach will depend on a high degree of
intersectoral collaboration and commitment to continuity
 Improve the general health status of the population
by successive governments. While the Vision 2020
 Enhance the management of communicable and non-communicable diseases strategic framework for the health sector has been
developed, the MoH has yet to make it operational,
 Improve the performance of health care delivery systems through the development of a strategic health plan2.
 Improve the quality of health care services
In July 1996, the Government of Trinidad and Tobago
 Unify the delivery of health care services signed a loan agreement with the Inter-American
Development Bank (IADB) for the implementation of
 Develop/strengthen the health research system to facilitate evidence-based HSRP. The health reform programme was intended to
decision making, policy formulation, new learning, and development bring about fundamental changes through the
 Create a patient-centred health care environment strengthening of the leadership role of the Ministry of
Health, development of health systems, and
implementation of the Regional Health Authorities Act of
1994. The Act defined the Ministry’s role as being a
'purchaser' of health care services with Regional Health Authorities (RHAs) being the providers. However, implementation has been
slow and challenging, and the loan was extended to the end of 2006. At this time, the MoH has not yet been able to effectively assume
the leadership role and transform itself into an effective policy, planning, and regulatory organisation3.
Major challenges are present in the current health system, which does not have a health workforce that corresponds in quantity, competencies,
and quality to the current and projected health needs of the population, due to inadequate strategic human resource planning.

Trinidad & Tobago | Health Policy
There are vacancies in key management positions and a shortage of staff even for acting positions. Transfer of staff from the MoH
to the RHAs and resolution of industrial relations issues have been problematic. Pre-service and continuing education training
programmes have not been effectively adapted to meet training needs for the health workforce due to inadequate dialogue
among critical stakeholders in the health and education/academic sectors and professional bodies3.
Professional bodies operate within the framework of regulations; however, enforcement of these regulations is a concern. Dual
work practices, which allow many senior public service doctors to work in private as well as public practice, have resulted in the
limitation of their public sector work hours, to the detriment of those who cannot afford to pay to see doctors in private practice3.
In Trinidad and Tobago, the health budget has declined from 12% of the total budget in the early 1970s, to about 7% in 20033.
The public health system in Trinidad &Tobago comprises hospitals – tertiary level, district, and specialist (long-stay) – and a mix of
primary health care (PHC) facilities, with district health facilities at the hub of health and outreach centres. The private sector in-
volves practitioners, hospitals, maternity centres, pharmacies, biomedical laboratories and radiological diagnostic services. Though
the private sector remains highly unregulated, some publicly-funded health institutions are outsourcing some of their health and
ancillary services to private providers. Trinidad and Tobago also serves as a tertiary care referral centre for persons from other
CARICOM (Caribbean Community) countries. Nearly all health centres continue to offer traditional services2,3.
Current health sector development challenges in decision making
There is insufficient evidence-based planning and decision making for health technology incorporation in the health sector due to
the lack of an integrated health management information system. The system for drug utilisation is inadequate, the national drug
policy and formulary are outdated, and there is a lack of drug utilisation reviews. The laboratory system has been unable to
adequately meet service needs due to many factors, including limited financial resources, inadequate physical plant, insufficient
professional and technical leadership, outdated regulations, and poor dialogue with clinical services.
Areas identified and strategies involved for the process of decision making for health technology incorporation
The health sector development challenges identified are diverse, but the priority challenges are categorized by critical areas that
include: planning and policy development – the regulatory framework; health information systems, epidemiological surveillance,
data analysis, and the use of information for decision-making; human resources in the public and appropriate competencies; the
development of the health system and services; and the coordination, follow-up and networking at the local level for regional and
global commitments2,3.
Planning and policy development - the regulatory framework3

There is need to:
 Strengthen planning, policy, and regulatory capacities and to create a “planning culture.”
 Strengthen leadership and managerial capacities of the Ministry of Health and the Regional Health Authorities.
 Ensure evidence-based planning and decision-making in the health system.
 Strengthen national emergency preparedness and response legislation which would mandate actions.
 Strengthen the leadership role in providing policy direction on the issue of decentralization of environmental health services
and to promote collaboration and rationalization of responsibilities between health and the ministries of local government,
agriculture, labour, and public utilities, to better utilize resources to ensure a better provision of these services.
 Address the lack of cohesive national policies for waste management (solid and hazardous wastes cover several sectors), with
regulations and systems for implementation.
Health information systems and epidemiological surveillance3

There is need to:
 Develop and strengthen health information systems at the national and RHA levels.
 Develop standardized surveillance methods for public and private health facilities and adequate competencies in surveillance
and analysis to heighten surveillance required for both communicable and non-communicable diseases.
Trinidad & Tobago | Health Policy
Human resources in health3

There is need to:
 Develop a policy and plan for human resource development and management, which will address the widening human resource gap
in the public health sector.
 Ensure that the vertical services which remain the core responsibility of the Ministry of Health have enhanced human resources and
facilities.
Health systems and services development3
There is need to:
 Develop and implement a strategy to define and operationalize the Primary Health Care and Health Promotion model, ensuring
implementation of prevention interventions, including prevention of violence and substance abuse at all levels and in all sectors.
 Strengthen norms and standards, evidence-based practices, rules, and protocols relating to patient care and safety, and overall clinical
management at all levels of care.
 Develop and implement a strategic plan for the strengthening of medical laboratory services and ensure effective maintenance and
health technology assessment of the engineering functions of health facilities (plant, buildings, and equipment).
 Appropriately address and improve the quality of health care for pregnant women, including issues of low birth weight (LBW) babies,
reduction of exclusive breastfeeding, and iron deficiency anaemia.
 Address overweight and obesity among pre-schoolers, adolescents, and adults, as major public health problems, especially given the
profound implications of these conditions for the development of chronic, non-communicable, nutrition-related diseases.
 Promote universal access to prevention, care, treatment and support for HIV/AIDS and ensure accessible and comprehensive sexual
and reproductive health (SRH).
 Develop a social health insurance model that is equitable and sustainable.
 Address environmental health issues, including strengthening environmental risk management, including vector control, and ensuring
equitable and reliable access to potable water for the population.
Coordination and networking3

There is need to:
 Improve and/or establish adequate communication and coordination and operational relationships and mechanisms between the
Ministry of Health and agencies/institutions, such as UWI, the RHAs, development agencies, and other health development partners.
 Promote and strengthen involvement and partnership on HIV/AIDS between the public and private sectors, including observation of
the human rights of Persons Living With HIV/AIDS (PLWHA).
References and further reading

(1) http://www.indexmundi.com/trinidad_and_tobago/population_growth_rate.html
(2) Ministry of Health, Trinidad & Tobago. Final Report, Vision 2020 Sub-Committee on Health.
(3) PAHO/WHO Country cooperation strategy, Trinidad and Tobago, November 2006.
Published in Volume 3 Issue 2, May/June 2015 edition of News Across Latin America”.

Uruguay | Health Policy
The Use of Health Technology Assessment in

Military Health Care: Experiences in Uruguay
“In a world with unlimited resources, it would be unnecessary to have methods to determine the best way
to allocate those resources among alternative uses. But resources are limited……..” Frank Sloan 1
Francisco E. Estevez-
Carrizo, MD, MSc
Background
President, ISPOR Uruguay
Regional Chapter; President, Since January 2008, the Integrated National Health System (SNIS) covers both the public and private
Health Technology Evaluation subsectors in Uruguay. Under the same law, the National Health Insurance (SNS) was created
Committee National Board of and financed by FONASA, the National Health Fund, which collects contributions of SNIS users in the
Health of the Armed Forces form of a salary percentage deduction (between 4.5 and 6.0%) for this purpose. The National
(D.N.S.FF.AA.); and Professor Board of Health (JUNASA) manages this fund, and FONASA covers a set of benefits that
of Clinical Pharmacology, Institutions must offer to their members, including pharmaceuticals.
Center for Biomedical Scienc-
es, University of Montevideo
The National Therapeutic Formulary (FTN) Commission of the Ministry of Public Health generates
Montevideo, Uruguay
and reviews the FTN periodically. This is the essential list of medicines that each therapeutic formulary of
every public hospital or private health institution should include. According to the epidemiological
profile of the user population, FONASA provides funding to each health care institution; they also
include the per capita for this coverage.
The National Resources Fund (FNR) authorizes and funds high-cost medicines (e.g. biologics). The FNR is a
non-state based national institution with public institutional characteristics that provides financial
coverage for highly specialized medical procedures and high-cost pharmaceuticals for all residents in the
Alberto Galasso, MD country and SNIS users. FNR is financed with the contribution of diverse institutions: FONASA finances its
Advisor, Health Technology members, the Ministry of Economy and Finances pays the public hospital users and private health care
Assessment Committee (CETM), institutions for their beneficiaries that do not contribute to FONASA or other alike.
Health National Directorate of
the Armed Forces (D.N.D.FF.AA.) The National Health Directorate of the Armed Forces of the Oriental Republic of Uruguay (D.N.S.FF.AA.) is
and Professor of Clinical & not part of the SNIS or the FNR. Therefore, to offer them benefits consistent with international standards
Forensic Toxicology, School of
of quality and efficiency, the Health Technology Assessment Committee of the National Health
Medicine CLAEH, Punta del Este,
Directorate of the Armed Forces (CETM-D.N.S.FF.AA.) was created in August 2008. Its mission is to study
Uruguay, Montevideo, Uruguay
all the problems associated with health technologies in the broadest sense: the incorporation of new
technologies and the study of existing ones. Health technology is viewed as the set of medicines, devices
and medical or surgical procedures used in health care, as well as the organizational and supportive
systems within which such care is provided.
In this presentation, we will refer exclusively to high-cost pharmaceutical technology, which is a regular
concern for the work of this Committee. The objective of the CETM - D.N.S.FF.AA is to ensure that
Gabriela Navarro patients are cared for with optimal incremental cost-effectiveness treatment. This pharmacoeconomic
PharmD, Technical Director tool determines which medication will be available and how they should be used to guarantee user
Health Technology Assessment satisfaction, the rational use of resources, institutional sustainability and equity for the member
Committee (CETM), Health population of the health care system.
National Directorate of the
Armed Forces (D.N.D.FF.AA.) Organization
Montevideo, Uruguay
The CETM - D.N.S.FF.AA depends directly on the National Director of the D.N.S.FF.AA. and its members
should be free from any conflicts of interest. It is structured according to World Health Organization 2
(WHO) recommendations, with permanent, alternate and consultant members. The President must be a
Carlos Peppe, MD referring physician in the institution; the Vice-President, a medical pharmacologist; and the Secretary, a
(Former) Medical Director
pharmaceutical chemist. The first member must be an economist, the second member an engineer spe-
Committee (CETM), Health
cialized in hospital equipment, and all should demonstrate expertise in health technology assessment.
National Directorate of the The Commission is supported by two administrative staff members that have neither voice, nor vote.
Armed Forces (D.N.D.FF.AA.)
Montevideo, Uruguay The alternate members who have voice and vote are specialists appointed by the CETM – D.N.S.FF.AA.
that belong to the Armed Forces Central Hospital and are designated when knowledge in specific health
areas is required.

Operation
The permanent members of the CETM - D.N.S.FF.AA meet regularly to evaluate the applications received. They are sent via application
forms and there are two types of request forms: (a) a request to a specific treatment for a determined patient and (b) a request for the
addition of a medication to the D.N.S.FF.AA Therapeutic Formulary.
The applicant doctor must complete these forms with their own information, patient data, the requested medication, indication,
dosage, the patient's clinical condition, and other received treatments along with the scientific basis and pharmacoeconomic studies
leading to the request of the particular treatment.
In response to the requests, the Commission undertakes an objective and thorough analysis, based on the reviews of international
health technology assessment of incremental cost-effectiveness agencies. Besides the bibliographical evidence, the Commission
performs their own incremental cost-effectiveness evaluation for each high-cost pharmaceutical technology acquisition. The
evaluation is based on clinical evidence from studies designed according to GCP-ICH publications in peer-reviewed journals
taking into consideration local market conditions and the local health system.
Furthermore, the Commission additionally analyzes the economic feasibility and sustainability of pharmaceutical technologies over
time. In all required or appropriate cases, alternate or consultant members are consulted before making any decisions. These analyses
are performed for medicines that are not included in the institution's therapeutic formulary or covered by the National Resources Fund
(FNR). Criterion proposed by the WHO3 was applied to set the favorable and unfavorable incremental cost-effectiveness limits. The
adopted approach is: 1 GDP per capita is cost-effective; between 1 and 3 GDP per capita are discussed case by case depending on
prognostic factors; budget impact; etc., more than 3 GDP per capita is not cost- effective. This approach attempts to adapt the
acceptance or rejection thresholds of new technology to the prevailing economic situation in the country at the particular time in
which the economic analysis is conducted (the GDP per capita of Uruguay was around US$ 16,000 in 2013).
Economic Impact of Expenses in Medication That Was Not Included in the Therapeutic Form.
Chart 1 shows the relative variation in costs for medication not included in the D.N.S.FF.AA Formulary throughout 2005-2012, which
considers 100% of the expenses in 2008, the year of the creation of CETM. In the same chart, it is possible to note that since 2005
there has been a significant growth in annual expenses, which increased between 2006 and 2007, mainly due to the increment of high
-cost biotechnology derived medication in the local market.
Chart 1. Relative Variation of Expenses in

Medication That Was Not Included in the
Therapeutic Form.
In 2008, the growth came to a halt. Given the

trend change, the CETM-D.N.S.FF.AA began
operating in August of that year to establish a
scientific methodology for authorizing
high-cost treatments.
From 2008 to 2010, the expenditure dropped

and reached, in constant dollars, 30.4% of the
accrued expenses in 2008. From 2010, the
expenses of medication not included in the
therapeutic formulary began to increase
gradually. This may be due to the
development of new treatments, particularly
biologics, in different therapeutic groups, to
restore the typical clinical efficacy loss from
these products.
Below, Chart 2 shows the percentage of the expenditure on medication not included in the therapeutic formulary by specialty
according to the total expense medication in the D.N.S.FF.AA for 2011 (a) and 2012 (b).
Five specialties (oncology, endocrinology, rheumatology, hemato-oncology and hepatology) claim almost 80% of the total budget
items intended for medication not included in the therapeutic formulary for both years.
Chart 2 - Percentage of Expenses in Medication not Included in the Therapeutic Form by Specialty. (a) Year 2011 and (b) Year 2012.
a) 30,00
25,00
20,00
15,00
%
10,00
5,00
0,00
Neuropediatrics
ÍA
Psychiatry RÍA
ÍA
ÍA
ÍA
ÍA
ÍA
ÍA
ÍA
ÍA
ÍA
Rheumatology
Endocrinology G
G
TR
TR
G
G
G
G
G
T
LO
LO
LO
LO
LO
O
LO
LO
IA
IA
IA
Hepatology OL
Hematology
O
O
O
TO
O
TO
U
D
Neurology ED
Infectology
OncologyECT
IN
C
IQ
R
Pediatrics PE
AT
A
A
N
U
U
P
R
Urology S
M
P
M
O
O
E
C
P
F
N
E
U
R
O
IN
H
H
E
U
D
R
E
N
N
E
b) 30,00
25,00
20,00
15,00
%
10,00
5,00
0,00
Neuropediatrics
ÍA
ÍA
ÍA
ÍA
ÍA
ÍA
ÍA
ÍA
ÍA
ÍA
ÍA
Rheumatology
Endocrinology
TR
G
G
TR
G
G
TR
LO
LO
LO
LO
LO
LO
LO
LO
IA
IA
IA
Hematology
Oncology RINO
TO
TO
O
O
O
TO
TO
U
D
D
R
R
IQ
C
E
Infectology
HepatologyPE
A
C
U
Pediatrics EU
N
S
M
FE
P
M
O
O
C
P
E
Neurology
U
N
E
Psychiatry
O
IN
H
E
U
D
E
N
N
E
Urology

Unsurprisingly, specialties such as oncology, rheumatology and hepatology have the greatest weight in the expenses of recent
years. For the first two aforementioned, a wide range of high-cost drugs that are marketed for terminal cancer or chronic rheu-
matic diseases, such as novel monoclonal antibodies and the tyrosine kinase inhibitors was developed. The D.N.S.FF.AA. has
the unique referral hospital for liver transplant in the country, therefore the expenses for hepatology are also predictable.
Regarding the expense distribution for medication not included in the therapeutic formulary, of the patients treated with this
medication in 2011, 53% required 85% of the total intended budget items, while in 2012, 49% of the patients required 86% of
the total budget items.
When comparing medication expenses not included in the Therapeutic Formulary to the total medicine expenses
of the D.N.S.FF.AA., the results show that in 2011, the expenses reached 10.5% of total medication expenses and in 2012,
it accounted for 13.3% of the total. These expenditures were accrued by 0.20% and 0.24% of the total number of users in
those years, respectively.
Conclusions
The public budget is overburdened by health expenditures throughout the developed world. Every dollar invested in
health will no longer be available to assign to other important state benefits. In addition, a significant amount of our
spending is allocated to the buying of medical technologies whose effectiveness and safety are far from justifying
the opportunity cost for the health care system.
The Health Technology Assessment Committee of the D.N.S.FF.AA optimized their medication expenditure since the beginning
of its management by basing their decisions on objective and scientifically supported criteria, thus becoming an essential tool
within the institution to streamline health care and make it sustainable over time.
As far as the demand for high-cost treatments not included in the national benefit plan is concerned, the D.N.S.FF.AA.
faces typical challenges with low incidence and high cost medication. They generate high economic impact that is gradually
growing. This is a global phenomenon and our country is not exempt due to its small market. On the contrary this
phenomenon may only intensify for us.
We must continue to improve communication with specialists working at CETM-D.N.S.FF.AA. in order to obtain a growing
support base for decision-making among physicians whose prescriptions have a high budget impact.
This approach is imperative due to the prosecution of medical acts, and the pressure from suppliers and patients exerted on
our colleagues is difficult to handle. The determined and scientifically based support of the institution through the
CETM- D.N.S.FF.AA., is the only defense that our physicians have to stop prescribing products of questionable or decisively
unfavorable cost-effectiveness.
References
1. Valuing Health Care. Cost, Benefits, and Effectiveness of Pharmaceuticals and Other Medical Technologies. Edited by Frank
A. Sloan. Duke University. Cambridge University Press. (1995).
2. WHO “Drug and Therapeutic Committees, a Practical Guide”, (2004)
WHO-CHOICE. Cost Effectiveness and Strategic Planning. Cost Effectiveness Thresholds. En: [http://www.who.int/choice/costs/
CER_thresholds/en/] found on 08/04/2014
Published in Volume 2 Issue 2, May/ June 2014 edition of “News Across Latin America”.
ISPOR Health Technology Assessment (HTA)
Training Program—COMING TO LATIN AMERICA IN 2016!
The ISPOR Health Technology Assessment (HTA) Training was developed by the ISPOR HTA Council, which
consists of the Chairs of the ISPOR HTA Roundtables in Europe and North America, the Chair of ISPOR’s
HTAnetAsia, and the Chair of HTAnetLatAm. The ISPOR HTA Training became a priority for the Council
based on input from ISPOR members and regional groups for support in knowledge building.
The ISPOR HTA Training Program is a 1–3½ day modular course intended for “users and doers” in
HTA, such as Ministries of Health and health insurance funds, evolving and established HTA agencies or
other government departments responsible for health care decision making. It is also designed for public
and private payers, industry, health plans, academia, and patient group representatives interested in learn-
ing how to conduct various aspects of HTA with an emphasis on clinical and economic evaluation. The pro-
gram is also intended to aid decision makers in understanding how to interpret data presented to them, as
well as what a good HTA process requires and how this can be tailored to different settings.
OBJECTIVES
By the end of the course, participants will be able to:
 Describe what a 'good' HTA process looks like and why this is important for health policy decisions
 Understand what evidence is, how evidence needs of patients, providers, payers and regulators may
differ; and how to identify and combine clinical research (i.e., meta-analysis and modeling)
 Recognize best practices in conduct and reporting of economic evaluation and be able to conduct a
trial- and modeling-based economic evaluation
 Be aware of other important factors in policy decision making, including societal value, patient perspec-
tives, ethical, legal, social and cultural implications of technology use and how these can be incorporated
into an HTA process
 Appreciate different issues related to the use and conduct of HTA as well as the importance of different
perspectives.
VISIT THE ISPOR WEBSITE

Find the following information at www.ispor.org >> Councils & Roundtables >> Health Technology
Assessment Council >> HTA Assessment of Value Training Program:
 Background Information
 HTA Training Program Outline
 Request Training Form
SPONOSORSHIP OPPORTUNITIES
Interested in sponsoring ISPOR’s upcoming Latin America HTA training in 2016? For information on
sponsorship opportunities, write to laconsortium@ispor.org
ELECTRONIC VERSION AVAILABLE ON THE ISPOR LATIN AMERICA CONSORTIUM WEBPAGE
COMING TO
LATIN AMERICA
IN 2016!!
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Health Technology Assessment in Ecuador

Article · July 2015

Ruth Jimbo Sotomayor Xavier Sánchez

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Maria Luciana Armijos

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Health Policy Series

Peru: Implementing Health Technology Assessment in Peru: A Gradual Process

Uruguay: The Use of Health Technology Assessment in Military Health Care:

Announcing the ISPOR HTA Training—Latin America

Published quaterly by:

Tel: 609.586.4981; Toll Free: 1.800.992.0643

Direct advertising, photocopy permission and reprint requests go to the

©2015 International Society for Pharmacoeconomics and Outcomes Research

While “News Across Latin America” is designed to provide accurate information

COMMENTARY FROM THE EDITORS

1 Outgoing 2012-2015 Editor-in-Chief Commentary

2 Incoming 2015-2018 Editor-in-Chief Commentary

COUNTRY-BASED HEALTH POLICY ARTICLES

3 Argentina: Current Status of Health Technology Assessment in Argentina

19 Peru: Implementing Health Technology Assessment in Peru: A Gradual Process

25 Uruguay: The Use of Health Technology Assessment in Military Health Care:

ANNOUNCEMENTS FROM THE ISPOR LATIN AMERICA CONSORTIUM

29 ISPOR HTA Training—Latin America

Alessandra Caroline Domingos De Fig ueiredo, MSc

Márcio Machado, PhD

Aurelio Mejía Mejía, MSc

Manuel Espinoza, MD, MSc, PhD

1 | News Across Latin America Health Policy Series SPECIAL EDITION

I am thrilled to become the new Editor-in-chief of “News Across Latin America”

We also welcome readers to view the articles presented in other regional

Yajaira Bastard, PhD

SPECIAL EDITION News Across Latin America Health Policy Series | 2

3 | News Across Latin America Health Policy Series SPECIAL EDITION

A Perspective on Health Technology

5 | News Across Latin America Health Policy Series SPECIAL EDITION

Two year assessment of CONITEC’s activity (2012-2013)

We analyzed publicly available CONITEC recommendations on the incorporation of pharmaceutical

Perspectives on HTA development in Brazil

As of today, CONITEC, as its name indicates, is still a Committee, following priorities

Upcoming publication in “News Across Latin America”.

Health Technology Assessment in Chile:

Efforts to formalize a Health Technology Assessment (HTA) process in Chile date

9 | News Across Latin America Health Policy Series SPECIAL EDITION

The implementation of a systematic, transparent, and socially legitimate decision-making

Health Technology Assessment

11 | News Across Latin America Health Policy Series SPECIAL EDITION

(1) Goodman CS. Introduction to Health Technology Assessment. 2014.

Ten Years of Pharmacoeconomics

13 | News Across Latin America Health Policy Series SPECIAL EDITION

Figure 1. Number of approved requests

Table 1. New Inclusions of Drugs by Therapeutic Group

Therapeutic Group Name 2013 Thus, in recent years, pharmacoeconomics

Considerations on Health Financing and Expenditures,

Fees (if they were)

15 | News Across Latin America Health Policy Series SPECIAL EDITION

Paraguay: Health Care Expenditure as a % of GDP, 2000-2009 The out-of-pocket expenditure in

Process of Decision Making for Health Technology Incorporation