Health Technology Assessment and private health insurance in Brazil: a scoping review and document analysis

Lisbôa, Raquel; Caetano, Rosângela

doi:10.1590/0103-1104202012723I

Raquel Lisbôa raquelmedlisboa@gmail.com

Universidade do Estado do Rio de Janeiro (Uerj), Instituto de Medicina Social (IMS) – Rio de Janeiro (RJ), Brasil.

https://orcid.org/0000-0002-0159-0044

Rosângela Caetano

Universidade do Estado do Rio de Janeiro (Uerj), Instituto de Medicina Social (IMS) – Rio de Janeiro (RJ), Brasil.

https://orcid.org/0000-0003-1480-2453

raquelmedlisboa@gmail.com

Collaborators

Lisbôa R (0000-0002-0159-0044)^* * Orcid (Open Researcher and Contributor ID). worked on data conception, planning, collection, analysis, and interpretation; content preparation; text preparation and writing; and approval of the text final version. Caetano R (0000-0003-1480-2453)^* * Orcid (Open Researcher and Contributor ID). worked on the study conception and planning; text preparation and writing; text critical revision; and approval of the text final version.

Conflict of interests: non-existent

Database	Final date^* * Searches were carried out from September 30 to 31/10/2019.	Search strategy^ Strategies were defined with the help of a professional librarian from the Library of the National School of Public Health Sergio Arouca (Ensp) at the Oswaldo Cruz Foundation (Fiocruz).	Result
Medline (via Pubmed)	31/10/2019	((((((((((health technology assessment[Title/Abstract]) OR health technology assessment[MeSH Terms]) OR health assessment[Title/Abstract]) OR health assessment[MeSH Terms]) OR Technology Assessment, Biomedical[Title/Abstract]) OR Technology Assessment, Biomedical[MeSH Terms]))) OR (insurance health[Title/Abstract]) AND ((Brasil OR Brazil)) Filters: Humans, from 2000 - 2019	286
Lilacs (via BVS)	31/10/2019	tw:(ti:("Avaliação de tecnologias em saúde" OR "Avaliação de tecnologias biomédicas" OR "Tecnologia em saúde" OR "Incorporação de tecnologias" OR "tecnologia biomedica") AND ("saúde suplementar" OR "agencia nacional de suplementar" OR "seguros privados de saúde" OR "Sistema único de saúde" OR sus)) AND ( db:("LILACS") AND year_cluster:("2000" OR "2001" OR "2002" OR "2003" OR "2004" OR "2005" OR "2006" OR "2007" OR "2008" OR "2009" OR "2010" OR "2011" OR "2012" OR "2013" OR "2014" OR "2015" OR "2016" OR "2017" OR "2018" OR "2019"))	45
Web of Science	31/10/2019	TI= ("health technology assessment" OR "health assessment" OR "Technology Assessment, Biomedical") AND TS=("health insurance Insurance" OR "health private" OR "health insurance" OR SUS OR "Unified health system" OR Brasil^* * Searches were carried out from September 30 to 31/10/2019. OR Brazil^* * Searches were carried out from September 30 to 31/10/2019. )	90
Scopus	31/10/2019	(TITLE ("health technology assessment" OR "health assessment" OR "Technology Assessment,Biomedical" ) AND TITLE-ABS-KEY ("health insurance Insurance" OR "health private" OR "health insurance" OR SUS OR "Unified health system" OR brasil^* * Searches were carried out from September 30 to 31/10/2019. OR brazil^* * Searches were carried out from September 30 to 31/10/2019. ))	178
Total	31/10/2019		599

Author	Year	Title	Origin of study	Main results
Lima, Brito, Andrade (³⁷37 Lima SGG, Brito C, Andrade CJC. Health technology assessment in Brazil - an international perspective. Ciênc. Saúde Colet. [internet]. 2019 [acesso em 2018 ago 3]; 24(5):1709-1722. Disponível em: https://www.scopus.com/inward/record.uri?eid=2-s2.0-85067498997&doi=10.1590%2f1413-81232018245.17582017&partnerID=40&md5=660bd6171d6614046449e4d6e8571944. https://www.scopus.com/inward/record.uri... )	2019	O processo de incorporação de tecnologias em saúde no Brasil em uma perspectiva internacional (The process of incorporating health technology in Brazil from an international perspective)	Brazil	The authors reported that, despite the progress, the incorporation of health technologies in Brazil should keep on pursuing continuous improvement.
Pericleous, Amin, Goeree (⁴⁰40 Pericleous L, Amin M, Goeree R. The value and consequences of using public health technology assessments for private payer decision-making in Canada: one size does not fit all. J. Med. Econ. 2019; 22(5):478-487.)	2019	The value and consequences of using public health technology assessments for private payer decision-making in Canada: one size does not fit all	Canada	The literature review identified few studies meeting the inclusion criteria. The panelists concluded that, despite some similarities, there were substantial differences between the two systems. Most value parameters for the public sector were not applicable to the private one, needing adjustments or revision for their applicability to private payer systems.
Ali, Ichihara, Lopes, et al. (³⁸38 Ali MS, Ichihara MY, Lopes LC, et al. Administrative Data Linkage in Brazil: Potentials for Health Technology Assessment. Front Pharmacol. 2019; 10(984):1-20.)	2019	Administrative Data Linkage in Brazil: Potentials for Health Technology Assessment	Brazil	The study emphasized the availability of high-quality data for the adoption in research and policy formulation. This would allow large-scale observational studies to assess the clinical, economic and social impacts of health technologies and social policies, provided the support by specific legislation.
Silva e Elias (³⁹39 Silva HP, Elias FTS. Incorporação de tecnologias nos sistemas de saúde do Canadá e do Brasil: perspectivas para avanços nos processos de avaliação. Cad. Saúde Pública [internet]. 2019 [acesso em 2019 dez]; 35(supl2):1-14. Disponível em: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0102-311X2019000805007&tlng=pt. http://www.scielo.br/scielo.php?script=s... )	2019	Incorporação de tecnologias nos sistemas de saúde do Canadá e do Brasil: perspectivas para avanços nos processos de avaliação (Incorporation of technology in health systems in Canada and Brazil: perspectives for progress in assessment processes)	Canada and Brazil	The results revealed that both health systems carry weaknesses, although the Brazilian case exhibited a set of factors such as insufficient resources, impact of judicial decisions, strong dependence on technologies coming from abroad and incipient regional processes and planning in HTA field, which rendered the scenario more complex.
Pichon-Riviere, Soto, Augustovski, et al. (⁴¹41 Pichon-Riviere A, Soto N, Augustovski F, et al. Stakeholder involvement in the health technology assessment process in Latin America. Int. j. technol. assess. health care. 2018; 34(3):248-253.)	2018	Stakeholder involvement in the health technology assessment process in Latin America	Latin America	The forum participants concluded that the legitimacy of HTA and decision-making processes was identified as one of the main reasons for promoting stakeholder involvement; but certain basic conditions should be met, among them transparency in the HTA process and a clear link between HTA and decision-making.
Pichon-Riviere, Soto, Augustovski, et al. (⁴⁴44 Pichon-Riviere A, Soto NC, Augustovski FA, et al. Evaluación de tecnologías sanitarias para la toma de decisiones en Latinoamérica: principios de buenas prácticas. Rev. panam. salud pública. [internet]. 2017 [acesso em 2019 dez 18]; 41:1-8. Disponível em: http://iris.paho.org/xmlui/handle/123456789/34364. http://iris.paho.org/xmlui/handle/123456... )	2018	Health technology assessment for decision making in Latin America: Good practice principles	Latin America	The forum participants identified the principles of good practice to be strengthened by different countries in relation to HTA: transparency in reporting, involvement of relevant stakeholders in the process, mechanisms for appealing decisions, clear priority definition processes and a clear link between HTA results and decision-making.
Banta (⁴²42 Banta HD. Perspective: Some Conclusions from My Life in Health Technology Assessment. Int. j. technol. assess. health care. 2018; 34(2):131-133.)	2018	Perspective: Some Conclusions from My Life in Health Technology Assessment	International	The author revealed his concerns regarding the narrowness of cost-effectiveness view and little emphasis on ethical, cultural and organizational HTA issues. He also manifested concern about the HTA organisms' independence, and the influence of the health industry.
Oortwijn, Determann, Schiffers, et al. (⁴⁵45 Oortwijn W, Determann D, Schiffers K, et al. Towards Integrated Health Technology Assessment for Improving Decision Making in Selected Countries. Value Health. 2017; 20(8):1121-1130.)	2017	Towards Integrated Health Technology Assessment for Improving Decision Making in Selected Countries	International	The study identified that monitoring and evaluation of the HTA process were not created in all the countries of the study. He concluded that HTA process implementation is time-consuming and that more transparent and robust processes were needed, among them greater consultation with stakeholders.
Lessa e Ferraz (³⁶36 Lessa F, Ferraz MB. Health technology assessment: The process in Brazil. Rev. panam. salud pública. [internet]. 2017 [acesso em 2018 ago 3]; 41(25):1-7. Disponível em: http://iris.paho.org/xmlui/handle/123456789/33901. http://iris.paho.org/xmlui/handle/123456... )	2017	Health technology assessment: The process in Brazil	Brazil	The study described the opinions of decision makers involved in HTA process in Brazil in 2011. The interviewees indicated that HTA process should be improved to meet their expectations and that the legislation issued that year on the subject beheld some of those concerns, such as the continued acceptance of submissions for assessment of new incorporations, the 180-day deadline for decision-making, and the broadening of the committee to absorb a greater representation of stakeholders.
Lessa, Caccavo, Curtis, et al. (⁴⁸48 Lessa F, Caccavo F, Curtis S, et al. Strengthening and implementing health technology assessment and the decision-making process in the Region of the Americas. Rev. panam. salud pública. [internet]. 2017 [acesso em 2019 dez 18]; 41:1-10. Disponível em: http://iris.paho.org/xmlui/handle/123456789/34574. http://iris.paho.org/xmlui/handle/123456... )	2017	Fortalecer e implementar a avaliação de tecnologias em saúde e o processo decisório na Região das Américas (The strengthening and implementing of health technology assessment and the decision-making process in Americas)	Americas	The study concluded that although some countries in the Region have created formal HTA units, there still existed a weak link between HTA process and decision-making.
Rosselli, Quirland-Lazo, Csanádi, et al. (⁴³43 Rosselli D, Quirland-Lazo C, Csanádi M, et al. HTA Implementation in Latin American Countries: Comparison of Current and Preferred Status. Value in health reg issues. 2017; 14:20-27.)	2017	HTA Implementation in Latin American Countries: Comparison of Current and Preferred Status.	Latin America	The authors acknowledged that HTA played a growing important role within Latin American countries, although each country would still need to record its current deployment status and to identify components for improvement. Duplication of effort could be reduced if international collaboration were integrated into HTA national implementation.
Novaes e Soárez (³⁵35 Novaes HMD, Soárez PC. Health technology assessment (HTA) organizations: Dimensions of the institutional and political framework. Cad. Saúde Pública [internet]. 2016 [acesso em 2018 ago 3]; 32(2):1-14. Disponível em: https://www.scopus.com/inward/record.uri?eid=2-s2.0-84994608064&doi=10.1590%2f0102-311X00022315&partnerID=40&md5=93d074a934eca065e211a8c35d025d8d. https://www.scopus.com/inward/record.uri... )	2016	Organizações de avaliação de tecnologias em saúde (ATS): Dimensões do arcabouço institucional e político (Health Technology Assessment (HTA) Organisms: Dimensions of the political and institutional framework)	Brazil	The study concluded that technical and political strengthening of HTA process of institutionalization within the national context could add to scientific, technological and innovation policies, effectively impacting on health policies.
Guimarães (²⁰20 Guimarães R. Incorporação tecnológica no SUS: o problema e seus desafios. Ciênc. Saúde Colet. [internet]. 2014 [acesso em 2017 set 24]; 19(12):4899-4908. Disponível em: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1413-81232014001204899&lng=en&tlng=en. http://www.scielo.br/scielo.php?script=s... )	2014	Incorporação tecnológica no SUS: o problema e seus desafios (Technological incorporation in SUS: the problem and its challenges)	Brazil	The author drawn HTA genealogy and its timeline in Brazil. He discussed the relevance and impact of Law No. 12,401/2011, which regulated integrality in SUS and proposed challenges for deepening HTA actions in Brazil. He also discussed the entry and role of supplementary health under this theme.
Novaes e Elias (³⁴34 Novaes HMD, Elias FTS. Uso da avaliação de tecnologias em saúde em processos de análise para incorporação de tecnologias no Sistema Único de Saúde no Ministério da Saúde. Cad. Saúde Pública [internet]. 2013 [acesso em 2018 ago 3]; 29(supl1):S7-16. Disponível em: https://www.scopus.com/inward/record.uri?eid=2-s2.0-84887136937&doi=10.1590%2f0102-311X00008413&partnerID=40&md5=5e7ca7ed84a768a19caff3ff504e9323. https://www.scopus.com/inward/record.uri... )	2013	Uso da avaliação de tecnologias em saúde em processos de análise para incorporação de tecnologias no Sistema Único de Saúde no Ministério da Saúde (Use of health technology assessment under scrutiny for the incorporation of technology in the Unified Health System at the Ministry of Health)	Brazil	The study recognized a methodological and political learning process as for HTA adoption ongoing in that period, showing the need to deepen the analysis of its impact onto SUS.
Oortwijn, Broos, Vondeling, et al. (⁴⁶46 Oortwijn W, Broos P, Vondeling H, et al. Mapping of Health Technology Assessment in Selected Countries. Int. j. technol. assess. health care. 2013; 29(4):424-434.)	2013	Mapping of health technology assessment in selected countries	International	The study concluded that HTA mapping in a country could be carried out by focusing on the level of institutionalization and stages of the process, i.e., identification, priority definitions, assessment, appraisal, reporting, dissemination, and implementation in policies and practices. He also acknowledged that although HTA most developed in industrialized countries, there was a growing community in middle-income countries applying HTA.
Kuchenbecker e Polanczyk (³³33 Kuchenbecker R, Polanczyk CA. Institutionalizing Health Technology Assessment in Brazil: Challenges Ahead. Value in health reg issues (Online). [internet]. 2012 [acesso em 2018 ago 3]; 1(2):257-261. Disponível em: https://www.scopus.com/inward/record.uri?eid=2-s2.0-84870893629&doi=10.1016%2fj.vhri.2012.09.009&partnerID=40&md5=01c3a44281b4326ec87a752a238cddc0. https://www.scopus.com/inward/record.uri... )	2012	Institutionalizing Health Technology Assessment in Brazil: Challenges Ahead	Brazil	The authors concluded that the creation of a national HTA body was an important step not only in terms of HTA development in the country but also in relation to the consolidation of universal access to health care granted by the Brazilian Federal Constitution since SUS creation in 1988.
Silva, Petramale, Elias (¹²12 Silva HP, Petramale CA, Elias FTS. Avanços e desafios da Política Nacional de Gestão de Tecnologias em Saúde. Rev. saúde pública. 2012; 46(supl)1:83-90.)	2012	Avanços e desafios da Política Nacional de Gestão de Tecnologias em Saúde (Advances and challenges of the National Policy on Health Technology Management)	Brazil	The study acknowledged that despite the progresses achieved, Brazil still exhibited a limited tradition in the evidence use for decision-making in health care. It also stressed the constitutional challenge of consolidating a universal health system, bearing comprehensive and equitable care in a context of scarce resources and decentralized decision-making processes.
Ferraz, Soárez, Zucchi (³²32 Ferraz MB, Soárez PC, Zucchi P. Health technology assessment in Brazil: what do healthcare system players think about it? São Paulo med. j. [internet]. 2011 [acesso em 2018 ago 3]; 129(4):198-205. Disponível em: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-31802011000400002&lng=en&tlng=en. http://www.scielo.br/scielo.php?script=s... )	2011	Avaliação de tecnologias em saúde no Brasil: O que os atores do sistema de saúde pensam a respeito? (Health Technology Assessment in Brazil: What do the actors of the health system think about it?)	Brazil	The results showed that most respondents considered the HTA process of that period incomplete and unable to meet the needs of the health system. The study also identified a trend towards the development of a decentralized and regionalized process applying separated assessments and decisions as for the public and the private systems.
Silva (³¹31 Silva MT. Evaluación de tecnologías sanitarias: la experiencia em el ministerio de salud de Brasil. Rev. peru. med. exp. salud publica. 2011; 28(3):548-551.)	2011	Evaluación De Tecnologías Sanitarias: La Experiencia en el Ministerio de Salud de Brasil (Health Technology Assessment: the experience in the ministry of health of Brazil)	Brazil	The author considered that challenges persisted towards the achievement of a more effective HTA structure in Brazil, such as the creation of a governmental institution administratively agiler, among other attributes.
Amorim, Ferreira Júnior, Faria, et al. (³⁰30 Amorim FF, Júnior PNF, Faria ER, et al. Avaliação de Tecnologias em Saúde: Contexto Histórico e Perspectivas. Com. Ciências Saúde. 2010; 21(4):343-348.)	2011	Avaliação de tecnologias em saúde: contexto histórico e perspectivas (Health Technology Assessment: historical context and perspectives)	Brazil	The study stood out for improvements incorporated by the Ministry of Health in HTA process, including the creation of Rebrats and the promulgation of Law No. 12,401/2011, which regulated the incorporation of new technologies within SUS scope.
Oortwijn, Mathijssen, Banta (⁴⁷47 Oortwijn W, Mathijssen J, Banta D. The role of health technology assessment on pharmaceutical reimbursement in selected middle-income countries. Health Policy. 2010; 95(2-3):174-184.)	2010	The role of health technology assessment on pharmaceutical reimbursement in selected middle-income countries	International	The study concluded that increased spending on health care and access to modern technologies strongly boosted HTA in the world. However, HTA developed under unequal pace in middle-income countries provided many of them took advantage of the organizational and methodological experiences of previously created HTA bodies.
Ministério da Saúde (¹⁵15 Brasil. Ministério da Saúde, Secretaria de Ciência, Tecnologia e Insumos Estratégicos, Departamento de Ciência e Tecnologia. Consolidação da área de avaliação de tecnologias em saúde no Brasil. Rev Saúde Publica. 2010; 44(2):381-383.)	2010	Consolidação da área de avaliação de tecnologias em saúde no Brasil (Consolidation of the health technology assessment field in Brazil)	Brazil	The technical report accounted for Rebrats actions of strengthening, approval of the National Policy for Management of Health Technologies, and holding of the HTAi Congress in Rio de Janeiro-Brazil in 2011.
Banta e Almeida (¹¹11 Banta D, Almeida RT. The development of health technology assessment in Brazil. Int. j. technol. assess. health care. [internet]. 2009 [acesso em 2017 set 23]; 25(S1):255-9. Disponível em: http://www.journals.cambridge.org/abstract_S0266462309090722. http://www.journals.cambridge.org/abstra... )	2009	The development of health technology assessment in Brazil	Brazil	The authors acknowledged the need for additional policy changes so to maximize the HTA development impact. They considered desirable that the Brazilian Ministry of Health carried on the development of a HTA national agency.
Banta (⁴⁹49 Banta D. Health Technology Assessment in Latin America and the Caribbean. Int J Technol Assess Health Care [internet]. 2009 [acesso em 2019 dez 20]; 25(S1):253-254. Disponível em: https://www.cambridge.org/core/product/identifier/S0266462309090710/type/journal_article. https://www.cambridge.org/core/product/i... )	2009	Health Technology Assessment in Latin America and the Caribbean	Latin America	The study identified a number of countries under the process of HTA active implementation, such as Brazil, Mexico, Chile and Argentina. Other countries, such as Costa Rica, Colombia, Cuba, Peru, Panama, Paraguay, Trinidad and Tobago and Uruguay, seemed to be following this trend and some others seemed likely to move in that direction in subsequent years.
Ministério da Saúde (²⁹29 Brasil. Ministério da Saúde, Departamento de Ciência e Tecnologia. Avaliação de Tecnologias em Saúde: institucionalização das ações no Ministério da Saúde. Rev Saúde Pública. 2006; 40(4):743-747.)	2006	Avaliação de Tecnologias em Saúde: institucionalização das ações no Ministério da Saúde (Health Technology Assessment: institutionalization of actions within the Ministry of Health)	Brazil	The technical report listed a set of actions implemented by the Ministry of Health: the formal adoption of the Health Technology Assessment; Rebrats and the human resources' training; the Permanent Working Group on Health Technology Assessment (GT-HTA); the technical-operational guidelines; methodological guidelines for studies on HTA and international cooperation, providing the entry of Decit in Inatha.
Krauss-Silva (²⁸28 Krauss-Silva L. Avaliação tecnológica em saúde: questões metodológicas e operacionais. Cad. Saúde Pública. 2004; 20(supl)2:S199-207.)	2004	Avaliação tecnológica em saúde: questões metodológicas e operacionais (Health Technology Assessment: methodological and operational issues)	Brazil	The study took in account operational difficulties for the conception and use of technological assessment, for which Brazil depends on data adequacy and availability and on the training of researchers and decision makers.

Norm	Term	Theme	Public Consultation (CP)	CP Support Material
Consu No. 10/1998	04/11/1998 to 11/05/2000	Provides for list of procedures preparation	NR	---
RDC No. 21/2000	12/05/2000 to 25/06/2002	Provides for dental list of procedures elaboration	NR	---
RDC No. 41/2000	14/12/2000 to 06/05/2001	Modifies list of procedures	NR	---
RDC No. 67/2001	07/05/2001 to 28/09/2004	Updates list of procedures	NR	---
RN No. 9/2002	26/06/2002 to 05/07/2007	Updates dental list of procedures	NR	---
RN No. 82/2004	29/09/2004 to 01/04/2008	Provides for the list of procedures and its ratings as for segmentation (MH, AMB, OD, with or without OBS)	CP No. 19	NT No. 16/2004
RN No. 154/2007	06/07/2007 to 06/06/2010	Updates dental list of procedures	CP No. 25	Without NT
RN No. 167/2008	02/04/2008 to 06/06/2010	Updates list of procedures and revokes Consu No. 10	CP No. 27	Without NT
RN No. 211/2010	07/06/2010 to 31/12/2011	Updates list of procedures	CP No. 31	Without NT
RN No. 262/2011	01/01/2012 to 01/01/2014	Updates list of procedures	CP No. 40	Without NT
RN No. 338/2013	02/01/2014 to 01/01/2016	Updates list of procedures	CP No. 53	NT No. 192/ 2013
RN No. 387/2015	02/01/2016 to 01/01/2018	Updates list of procedures	CP No. 59	NT No. 26/2013
RN No. 428/2017	02/01/2018 Effective to date	Updates list of procedures	CP No. 61	NT No. 178/ 2017 and List of procedures Reviewing Report / 2017
RN No. 439/2018	03/12/2018 Effective until publication of this research	Provides for periodic update of the list of procedures process	CP No. 69	NT No. 18 e 19 / 2018

[1] raquelmedlisboa@gmail.com

Brasil

Brasil

Health Technology Assessment and private health insurance in Brazil: a scoping review and document analysis

ABSTRACT