Health technology assessment in Brazil – an international perspective

Lima, Sandra Gonçalves Gomes; Brito, Cláudia de; Andrade, Carlos José Coelho de

doi:10.1590/1413-81232018245.17582017

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ARTICLE • Ciênc. saúde colet. 24 (5) • May 2019 • https://doi.org/10.1590/1413-81232018245.17582017 copy

Health technology assessment in Brazil – an international perspective

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Given the financial impact of the adoption of new health technologies in health systems, choosing what technology should be introduced and when poses a major challenge for health managers. The health technology assessment (HTA) process should therefore be underpinned by transparent and objective criteria. The objective of this study was to analyze HTA processes in Brazil, overseen by the National Commission for the Incorporation of Health Technology (CONITEC), and to compare these processes with those in countries considered to be at the forefront of this field: Australia, Canada, and the United Kingdom. The following categories were used for the comparative analysis: program structure, definition and selection of topics, evidence review, use of HTA in decision making, program products and dissemination, and transparency. The findings show that there are more similarities than differences between these countries’ processes and the CONITEC processes. The main differences identified were: composition of committees, entitlement to appeal, program evaluation, and timeframes for the implementation of recommendations/decisions. Despite making major strides in recent years, Brazil should continue to promote continuous improvement of its HTA process.

Health investment; Technological development; Health technology assessment; Unified Health System

Domain	Component
I. Program structure	(1) Program purpose
	(2) Governance and organization
	(3) Scope
	(4) Key factors analyzed
	(5) Stakeholder involvement
	(6) Target audience
II. Definition and Selection of Topics	(1) Topic definition
	(2) Topic refinement
	(3) Topic selection
III. Evidence Synthesis	(1) Entities conducting reviews
	(2) Review methods
IV. Use of HTA in Decision-making (Incorporation)	(1) Decision making bodies
	(2) Decision making process and criteria (incorporation)
	(3) Appeal process
V. Program Products and Dissemination	(1) HTA products
	(2) Implementation
	(3) Timeframe for implementing guidance after its publication
	(4) HTA program evaluation
VI. Transparency	(1) Public documents

Program Structure

Component	Australia (MSAC)	Canada (CADTH)	UK (NICE)	Brazil (CONITEC)
Program purpose	Advisory role in relation to evidence and policy	Advisory role only in relation to evidence	Advisory role in relation to evidence and policy	Advisory role in relation to evidence and policy
Governance and organization	Government agency	Independent, nonprofit agency	Government agency	Government commission
Governance and organization	Medical Services Advisory Committee, Protocol Advisory Sub-Committee, Evaluation Sub-committee	Drug Policy Advisory Committee, Canadian Drug Expert Committee, COMPUS Expert Review Committee, in addition to specialist panels for specific projects	Four technology assessment standing committees	SE/CONITEC, Plenary, Technical Sub-Commission for the Assessment of CPTG, Technical Sub-Commission for Updating the RENAME and FTN; and Technical Sub-Commission for Updating RENASES
Scope	Products (including vaccines), diagnostic tests (including pathology), medical devices, surgically implanted prostheses, medical procedures and services, surgical interventions, and public health interventions. Pharmaceuticals: responsibility of the PBAC Prostheses: responsibility of the PLAC	Pharmaceuticals, medical devices, medical procedures and health system used in health maintenance, treatment, and promotion	Pharmaceutical products, medical devices, diagnostic techniques, surgical procedures, treatment technologies, and health promotion activities	Pharmaceuticals, products and procedures (vaccines, in vitro diagnostic products, equipment, technical procedures, organizational, information, and educational, and support systems, care programs and protocols)
Key factors analyzed	Safety, clinical effectiveness, and cost-effectiveness	Efficacy, effectiveness, cost-effectiveness, and impact on service	Clinical effectiveness and cost-effectiveness	Efficacy, accuracy, effectiveness, safety, cost-effectiveness, and budgetary impact
Stakeholder involvement	The MSAC sub-committees include clinical specialists and consumer representatives. Topic definition and selection: open to all applicants for public funding Research protocol: work with applicant/industry and input from the public Evidence review: applicants can give their opinion MSAC pre-assessment report: applicants can give their opinion (public consultation)	Topic definition: open to the public, topics refined with the proponent Evidence review: information requested from manufacturers, authors of reports, and other specialist Implementation: Knowledge Transfer Program centered on relaying the research to decision makers	Stakeholders are involved in every stage of the HTA process Consultants invited to present statements and participate in the HTA process (including, for example, national patient groups, industry, health professionals, and Department of Health) Commentator organizations are also invited to participate in the HTA process	Topic definition: not restrictions on the type of applicant Plenary of CONITEC includes representatives of the CFM, CNS, CONASS, CONASEMS, ANS, ANVISA, as well as the Ministry of Health CONITEC may invite external specialists to assist, collaborate in meetings, or provide technical inputs and/or sign technical cooperation agreements Stakeholders can provide input during the public consultation process and/or public hearing Applicants may appeal against decisions/recommendations published in the official gazette
Target audience	Australia’s Department of Health and Aging, health professionals, hospitals, and consumers	Territorial, provincial, and federal health ministries, including drug plans, regional health authorities, and hospitals and clinics	NHS, doctors, patients and carers (England and Wales)	SUS, health professionals, and industry

Program Products, Dissemination and Transparency

Component	Australia (MSAC)	Canada (CADTH)	the UK (NICE)	Brazil (CONITEC)
HTA products	Technology Assessments; Public Summaries	Technology Reports; Technology Overviews; Health Technology Update Issues in Emerging Health Technologies; Emerging Drug List	Focused (single issue or technology); Large-scale (multiple technologies or diseases)	Report of Recommendations; CPTG; RENAME; FTN; RENASES
Implementation	HTA reports available on website (in English)	HTA reports available on website (in English); knowledge transfer specialist (KTS)	HTA reports available on website (in English); development of implementation tools; costing and audit support	Report of Recommendations and CPTG CONITEC available on website (in Portuguese)
Timeframe for implementing guidance after its publication	Information not identified	Information not identified	90 days	180 days
HTA Program Evaluation	Internal evaluation conducted in 2010	Internal and external evaluation conducted in 2010	Internal evaluation conducted in 2008	Information not identified
Public documents	Following information available on MSAC’s website: list of applications in progress, draft protocols, and final assessment reports, and public summary documents, and information on meetings (dates, agendas, minutes)	The HTA products provide a detailed, reproducible, and transparent description. All reports and other products are publicly accessible	HTA process documents and guidance is published on NICE’s website	CONITEC publishes the following information on its website: list of technology undergoing assessment, draft reports submitted to public consultations, inputs to public consultations, final assessment reports (with decisions and recommendations regarding incorporation), CPTG RENASES, RENAME, information on meetings (dates, agendas, minutes)

Definition and Selection of Topics and Evidence Synthesis

Component	Australia (MSAC)	Canada (CADTH)	the UK (NICE)	Brazil (CONITEC)
Topic definition	Open to the public	Open to the public	Open to the public	Open to the public (no restrictions identified)
Topic refinement	Works with nominating author to refine topic and develop search protocol	Works with nominating author to refine topic and develop search protocol; conducts preliminary literature assessment	Internal project group refines topic, develops search protocol, and conducts preliminary literature assessment	SE/CONITEC refines topic and conducts preliminary literature assessment. May be conducted by an external group at the request of CONITEC
Topic selection	Department of Health and Ageing determines whether proposed service for review is clinically relevant professional service	Topics approved and prioritized by Advisory Committees and Board of Directors based on six core criteria (disease burden, potential clinical impact, available alternatives, potential budget impact, potential economic impact, and available evidence)	UK Department of Health refers technologies for HTA based on prioritization criteria (disease load; impact on health resources; clinical and political importance; whether there Is there significant inappropriate variation in the use of the technology across the country; factors that potentially affect the timely determination of guidance or guidelines (timeframes); likelihood of the guidance having an impact on policy, quality of life, and reduction of access disparities)	Use of prioritization criteria by CONITEC to select topics for review was not identified.
Entities conducting reviews of evidence	External contractors	Combined internal project group and external contractor	Independent academic centers	Combined internal project group, with the possibility of external contractors
Evidence review methods	Systematic review (full systematic literature review and modeled economic evaluation)	Systematic review	Systematic review	Systematic review or PTC developed in accordance with the latest edition of the Ministry of Health’s Methodological Guidelines for the Elaboration of PTC / economic evaluation study (cost-effectiveness, cost-minimization, cost-utility, or cost-benefit) in the context of the SUS in accordance with the latest edition of the Ministry of Health’s Methodological Guidelines for Economic Evaluation of Health Technology Studies

Use of HTA in Decision-Making (Incorporation)

Component	Australia (MSAC)	Canada (CADTH)	the UK (NICE)	Brazil (CONITEC)
Decision Making Bodies	Australian Department of Health and Ageing	Federal, provincial, and territorial health ministries	NICE	Secretary of the SCTIE
Decision Making Process and Criteria (incorporation)	MSAC advises the Department of Health and Ageing with respect to strength of evidence and public coverage recommendations	CADTH advises regarding the strength of evidence supporting coverage of drugs and health care technologies	Appraisal Committee issues the final appraisal determination. NICE distributes the determination to NHS in England and Wales	CONITEC advises/makes r the Secretary of the SCTIE as to whether the technology should be incorporated into the SUS
Appeal process	No appeal process identified	No appeal process identified	15 business days for consultees to appeal	10 days starting from the date of publication in the official gazette

ABRASCO - Associação Brasileira de Saúde Coletiva Av. Brasil, 4036 - sala 700 Manguinhos, 21040-361 Rio de Janeiro RJ - Brazil, Tel.: +55 21 3882-9153 / 3882-9151 - Rio de Janeiro - RJ - Brazil
E-mail: cienciasaudecoletiva@fiocruz.br

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[1] Collaborators

SGG Lima: literature review; data collection, analysis, and interpretation; drafting of the content of the article; revision of the content of the article; approval of the final version to be submitted. C Brito and CJC Andrade: data analysis and interpretation; critical review of the content of the article; approval of the final version to be submitted.