This document provides a comparative survey of health technology assessment (HTA) in Brazil, China, and India. It finds that Brazil has established the most advanced centralized HTA framework, including a national HTA commission called CONITEC that advises the Ministry of Health. China has begun emphasizing HTA but lacks a unified system, while HTA in India is limited. The study identifies lessons from Brazil's experience that may transfer to emerging countries, like China, seeking to implement HTA.
HTAi 2015 - Mapping the stakeholder’s opinion of prioritisation criteria for ...
Apresentação Louisa Stuwe - HTAi 2015 - 08 junho.
1. COMPARATIVE LITERATURE SURVEY OF
HEALTH TECHNOLOGY ASSESSMENT IN
BRAZIL, CHINA AND INDIA
POTENTIAL TRANSFERABLE LESSONS FROM BRAZIL
TO EMERGING COUNTRIES
Stuwe LT1, Bellanger MM2, Picon PD3, Chen Y45, Wie Y5, Chi X5, Mathew J6
1Pierre-and-Marie-Curie University, Paris, France, 2EHESP French School of
Public Health, Rennes, France, 3Federal University of Rio Grande do Sul,
Porto Alegre - RS, Brazil, 4Key Lab of Health Technology Assessment
(Ministry of Health), China 5Fudan University, China, 6Advanced Pediatrics
Centre Post Graduate Institute of Medical Education and Research
(PGIMER) Chandigarh, India
Contact e-mail:
louisa.stuwe@gmail.com
3. Background
• Health ministers of BRICS States, a political alliance comprising Brazil,
China, India, Russia and South Africa, have started to strengthen
collaboration in their shared objective to implement Universal Health
Coverage (UHC) (Rao et al. 2014)
• HTA is considered an important tool for priority-setting and guiding
reimbursement decisions (Busse et al. 2002)
• The key role of HTA has been underlined in the progressive attainment of
UHC, since it enables the efficient and equitable allocation of healthcare
and other resources (Chalkidou et al., 2013).
• Emerging countries often face similar challenges in introducing Health
Technology Assessment (HTA) frameworks
• Such a reality highlights the potential to share insights and strategies
• Network of researchers available in Brazil, China and India which allowed
to use these countries for a comparative assessment
4. Study objectives
Primary objective:
– To compare Brazil, China and India according to their level of
HTA influence in decision-making regarding public medicines
list management.
Secondary objectives:
– To provide an overview of the influence of HTA in decision-
making related to public medicines lists in Brazil, China and
India.
– To identify transferable lessons learned from one country to
another in terms of HTA processes and implementation.
.
5. Methodology
1) Published literature survey
• A systematic literature search for published articles for the time-period
2005 - early 2015
– In English in international databases: PubMed (MEDLINE), ScienceDirect, and
EBSCO-host databases (Academic Search Premier, CINAHL Plus with Full Text)
– In local languages (Portuguese, Chinese and English) in national databases
• Search equation : (<country> AND [“health technology assessment”])
AND ([medicine] OR [pharmaceutical] OR [drug] OR [vaccine] OR [“health
technology”])
• Results entered into PRISMA flow diagram
6. Methodology
2) Grey literature survey
• Scope (Schöpfel 2010): “manifold document types
produced on all levels of government, academics,
business and industry in print and electronic formats that
are protected by intellectual property rights, of sufficient
quality to be collected and preserved by library holdings
or institutional repositories, but not controlled by
commercial publishers”
• Grey literature search in local languages (Portuguese,
Chinese and English), according to selected grey
literature categories (cf. next slide)
7. Methodology : Grey literature sources
Grey literature category Subcategory
Central Government and agencies :
Ministry of Health, HTA agency/
commission, National Medicines
Agency
HTA and medicines evaluation policy / HTA regulations, ordinances, decrees / HTA
reports for medicines / Medicines incorporation decisions / HTA policy documents
and reports / HTA doctrine / HTA methodology / Clinical guidelines /
National medicines list / Bilateral or multilateral HTA statements/ MoU / Statements
during interviews, public hearings
State or municipal government :
Local secretaries of health
Regulations, ordinances / HTA reports / Medicines incorporation decisions / HTA
methodology / Clinical guidelines / State or municipal medicines lists / Statements
during interviews
Academia and university hospitals
HTA abstracts for congresses / Written expertise / HTA studies /
Methodology / Existence of HTA degree or specialization programmes / Academic
workshops / Statements during interviews, public hearings / HTA hospital networks
/ Specialized academic HTA centers
Doctors, healthcare professionals
Written expertise / HTA studies / Implementation of HTA / Statements during
interviews / public hearings / Participation rates in continued education or
specialization courses
Parliament
HTA legislation / Parliamentary debates on HTA / Statements during interviews /
Public hearings
Judiciary Judicial decisions / Right to health litigation / Public hearings
Private sector (consulting and
pharmaceutical industry)
HTA incorporation requests / Statements / News articles / HTA abstracts for
congresses / HTA powerpoint presentations for congresses
Civil society and patient
associations HTA incorporation requests / HTA-related Statements
International organizations
Communiqués related to participation in international HTA networks / International
or regional recommendations for HTA
Bilateral cooperation / International organizations (WHO, World Bank, EU, etc.)
8. Methodology
•Policy objectives of the HTA system, its legal status, and its relationships with the remainder
of the health system, with other public sector bodies and stakeholders
• The existence of an HTA commission (yes/no)
• Specific methodology used/ doctrine published by HTA commission (yes/no(NA)
• Policies, laws and regulation regarding HTA for medicines evaluation and list incorporation (yes/no)
• Policies, laws and regulation regarding clinical guidelines and implementation (yes/no)
• Existence of HTA networks (yes/no)
• Membership in international HTA networks (INATHA) (yes/no)
• Participation in international HTA congresses (ISPOR, HTAi) (yes/no
• International (bilateral, multilateral, academic) collaborations in the area of HTA (yes/no)
• Publications in HTA (yes/no/specify)
1) HTA Policy
implementation
level (adapted
from Hutton et al.)
• HTA Stakeholder mapping
•Government (Ministry of Health and HTA commission/ agency)
•Academia and university hospitals
•Doctors, hospitals, healthcare professionals
•Parliament
•Judiciary
•Private sector (consulting and pharmaceutical industry)
•Civil society and patient associations
•International organizations (e.g. Mercosur, PAHO/WHO)
2) Identification
and weight of
different
stakeholders in
HTA process
(adapted from
Varvasovszky et al.)
•Influence of HTA on policy and administrative decisions : effective dissemination of HTA reports
and recommendations, translation of recommendations into decisions, quality of HTA reports,
accessibility of HTA reports, timeliness
•Influence of HTA on administrative action
•Influence of HTA on delivery of health care and on the health status of patients: access to
medicines policy linked to HTA, changes to health care and/or health outcomes
3) Assessment
of influence of
HTA on
decision-making
(INAHTA)
10. Grey literature results (simplified overview)
Grey literature category Brazil China India
Central Government and agencies : Ministry of Health,
HTA agency/ commission, National Medicines Agency…
State or municipal government : Local secretaries of
health
Academia and university hospitals
Doctors, healthcare professionals
Parliament
Judiciary
Private sector (pharmaceutical industry, consulting,
insurance)
Civil society and patient associations
International organizations
11. HTA Policy implementation level (adapted from Hutton et al.)
Involvement in HTA activities (yes = 1, no = 0) Brazil China India
The existence of an HTA commission 1 0 0
Specific methodology used/ doctrine published by HTA
commission 0 0 0
Policies, laws and regulation regarding HTA for medicines
evaluation and list incorporation 1 0 0
Policies, laws and regulation regarding clinical guidelines and
implementation 1 0 0
Existence of HTA networks 1 1 1
Membership in international HTA networks (INATHA) 1 1 0
Participation in international HTA congresses (ISPOR, HTAi) 1 1 0
International (bilateral, multilateral, academic) collaborations in
the area of HTA 1 0 0
Publications in HTA 1 1 0
Sum of points / 9 8 4 1
Policy objectives of the HTA system, its legal status, and its relationships with the
remainder of the health system, with other public sector bodies and stakeholders
12. Identification and weight of different stakeholders in HTA
process (adapted from Varvasovszky et al.)
Stakeholder involved in HTA (yes = 1, no = 0) Brazil China India
Government (Ministry of Health and HTA commission/ agency) 1 0 0
Academia and university hospitals 1 1 1
Healthcare professionals
1 1 1
Judiciary
1 0 0
Parliament 1 0 0
Private sector (consulting and pharmaceutical industry) 1 1 1
Civil society and patient associations 1 0 0
International organizations (e.g. Mercosur, PAHO/WHO)
1 0 0
Sum of points / 8 8 3 3
13. Assessment of influence of HTA on decision-making (INAHTA)
Influence of HTA (yes = 1, no = 0) Brazil China India
Influence of HTA on policy and
administrative decisions
Effective dissemination of
HTA reports and
recommendations 1 0 0
Translation of
recommendations into
decisions 1 0 0
Quality of HTA reports 1 0 0
Accessibility of HTA
reports 1 0 0
Timeliness 1 0 0
Influence of HTA on administrative action
Influence of HTA on delivery of
health care and on the health
status of patients
Access to medicines
policy linked to HTA 1 0 0
Changes to health care
and/or health outcomes
0 0 0
Sum of points / 8 6 0 0
14. 0 1 2 3 4 5 6 7 8 9
Assessment of influence of HTA on
decision-making (INAHTA)
Identification and weight of different
stakeholders in HTA process (adapted
from Varvasovszky et al.)
HTA Policy implementation level (adapted
from Hutton et al.)
Comparison of countries according to HTA
implementation measurements
India China Brazil
15. Discussion : Added value
• No comparative study on HTA status between Brazil,
China and India so far conducted
• Same methodology applied to all three countries,
involvement of local researchers and languages
• Main finding is that Brazil has established a centralized
framework for HTA, whereas it is absent in the other
countries
• Advanced situation of Brazil, but progressive steps
taken in China and India
16. Discussion: Transferable HTA in Brazil to China and India
• The institutionalization of HTA by means of a national
commission that orients MoH health priority-setting and
decision-making regarding public medicines lists management
• More transparent processes represented by consistent online
publication of reports
• The effective use of public consultations
• Regional involvement of Brazil within Mercosur, RedETSA, etc…
17. Discussion : Limitations
• Limitations of the study
Interpretation bias using Brazil as a starting point
Time frame too short for an external assessment
Focus only on medicines and exclusion of medical devices and procedures
Difficulty in assessing grey literature, insufficient results for India may question the results
Comparability of the three countries is questionable
• Transferability of lessons learned
China, HTA might be used in future listing, pricing, and reimbursement of drugs (16),
which opens up the possibility to transfer the centralized Brazilian HTA model to China.
• Remaining challenges in Brazil not sufficiently underlined
Lack of transparency in the decision-making process
No cost-effectiveness threshold in the HTA process
Insufficient involvement of the public and of patients in the HTA process
Implementation of HTA via clinical guidelines
18. Conclusion
• Among the three countries, Brazil is most advanced in terms of HTA
implementation
• In China, the national plan for health-care reform has put special emphasis on
making appropriate, cost–effective and essential health care and technology
available to all people in the country: great potential of HTA to contribute to this
reform
• India takes into account HTAs done in other countries but there is no link
between HTA and the regulatory process and visible steps towards the
implementation of HTA.
• The Brazilian experience shows that HTA can provide information needed for
evidence-based policies, and offers lessons transferable to other emerging
countries.
• Further analyses should be conducted to test the transferability of these lessons
learned at the State level, starting by China, the second most advanced country
in terms of HTA development after Brazil.
20. References
• Busse R, Orvain J, Velasco M, Perleth M, Drummond M, Jørgensen T, et al. Best practice in
undertaking and reporting health technology assessments. Int J Technol Assess Health Care.
2002;18(02):361–422.
• Chalkidou K, Marten R, Cutler D, Culyer T, Smith R, Teerawattananon Y, et al. Health technology
assessment in universal health coverage. The Lancet. 2013 Dec;382(9910):e48–9.
• Hutton J, McGrath C, Frybourg J-M, Tremblay M, Bramley-Harker E, Henshall C. Framework for
describing and classifying decision-making systems using technology assessment to determine the
reimbursement of health technologies (fourth hurdle systems). Int J Technol Assess Health Care.
2006;22(01):10–8.
• INAHTA Conceptual Paper on the Influence of HTA 2014
• National Information Center on Health Services Research and Health Care Technology (NICHSR),
U.S: National Library of Medicine, HTA 101: VII. RETRIEVE EVIDENCE, Accessed May 1, 2015 at:
http://www.nlm.nih.gov/nichsr/hta101/ta10109.html#Heading1
• Rao KD, Petrosyan V, Araujo EC, McIntyre D. Progress towards universal health coverage in BRICS:
translating economic growth into better health. Bull World Health Organ. 2014 Jun 1;92(6):429–35.
• Schöpfel J. Towards a Prague Definition of Grey Literature. GL 12. Twelfth International Conference
on Grey Literature. Prague, Czech Republic. December 2010. Accessed May 29, 2015 at:
http://www.textrelease.com/images/GL12_Abstract_S1N1.pdf
• Varvasovszky Z, Brugha R. A stakeholder analysis. Health Policy Plan. 2000 Sep 1;15(3):338–45.
21. Results : HTA in Brazil
• Brazil established a health technology unit in 2003
• Institutionalization and new framework for HTA in the Brazilian healthcare
system with Law 12.401/2011 which resulted from a public hearing in 2011
• New national HTA commission operating from on January 1st 2012: Comissão
Nacional de Incorporação de Tecnologias no Sistema Único de Saúde
(CONITEC) = National Commission for the Incorporation of Technologies
• CONITEC’s mission : to advise the MoH in the incorporation and management
of new technologies
• CONITEC produces studies comparing technologies as well as guidelines for
clinical practice and lists of drugs to be reimbursed
• A link between HTA outcomes assembled and recommendations issued by
the national HTA commission and MoH health priority-setting and decision-
making regarding public medicines lists management
• More transparent processes represented by consistent online publication of
reports and the effective use of public consultations
22. Results : HTA in China
• Even though HTA can be traced back to early 1990s, no national HTA governing structure
and system in place
• HTA activities fragmented and inconsistent, not all regulations, reports and
methodology are available
• The national plan for health-care reform has put special emphasis on making
appropriate, cost–effective and essential health care and technology available to all
people in the country: great potential of HTA to contribute to this reform
• Some HTA or pharmacoeconomic evaluation centres at academic institutions:
• National Key Laboratory of Health Technology in Fudan (MOH)
• China National Health Development Research Center are the two specialized academic
HTA centers
• “Experiential decision making” preferred over evidence-based decision-making for
doctors, healthcare professionals and policy makers
Scattered HTA framework in various authorities, lack of consistency, no national body.
23. Results : HTA in India
• India takes into account HTAs done in other countries
• Actors: division of Healthcare Technology in the National Health
Systems Resource Centre (NHSRC), a technical support institution
under the Ministry of Health and Family Welfare and Healthcare
Technology Innovation Centre
• Training of professionals in health technology assessment, as part
of three fellowship programmes while two more programmes are
planned this year
No link between HTA and the regulatory process and visible
steps towards the implementation of HTA.