ABSTRACT

Health Technology Assessment (HTA) supports public policies on technology management in several countries. In Brazil, the institutionalization of HTA began in 2000 at the Ministry of Health, and had the participation of the National Regulatory Agency for Private Health Insurance (ANS). However, the public and the private systems have taken different paths. Different HTA processes can generate rework, inefficiency and increase inequities between the public and the private sectors. The objective of this research was to identify the duality between those two sectors regarding the current models of HTA implemented in the country. A scoping review of the literature was carried out from 2000 to 2019, in the Medline, Scopus, Web of Science and Lilacs databases. ANS documents were also analyzed, relating to the HTA process in private health insurance sector. The literature review found a shortage of articles on the topic, while the document analysis allowed to draw a timeline with the main milestones related to the Agency’s HTA process. It was concluded that the national coordination of an HTA model is desired, aiming at increasing the transparency of the institutions, the greater credibility of their decisions, greater efficiency of the process, and providing greater equity.

KEYWORDS
Technology assessment, biomedical; Public policy; Supplemental health; Unified Health System

Introduction

The Brazilian health system was defined by the Federal Constitution of 1988 as unified and universal¹1 Brasil. Constituição, 1988. Constituição da República Federativa do Brasil. Brasília, DF: Senado Federal; 1988.. Despite the constitutional option for a model inspired by national health systems of universal and public access, there previously existed a significant private sector in the Country²2 Santos IS, Ugá MAD, Porto SM. O mix público-privado no Sistema de Saúde Brasileiro: financiamento, oferta e utilização de serviços de saúde. Ciênc. Saúde Colet. [internet]. 2008 [acesso 2015 jan 28]; 13(5):1431-1440. Disponível em: http://www.scielo.br/pdf/csc/v13n5/09.pdf.
http://www.scielo.br/pdf/csc/v13n5/09.pd... . That sector, comprised by a large extent of private hospital service providers and by private health plans and insurance, remained constitutionally free to act in a supplementary way to SUS¹1 Brasil. Constituição, 1988. Constituição da República Federativa do Brasil. Brasília, DF: Senado Federal; 1988..

The old system legacy, added to political and economic factors, favored the configuration of a health system characterized by a complex relationship between the public and private sectors. That relation will impact the access to health services, the structure of care networks, the sector financing, and in the implementation of public policies²2 Santos IS, Ugá MAD, Porto SM. O mix público-privado no Sistema de Saúde Brasileiro: financiamento, oferta e utilização de serviços de saúde. Ciênc. Saúde Colet. [internet]. 2008 [acesso 2015 jan 28]; 13(5):1431-1440. Disponível em: http://www.scielo.br/pdf/csc/v13n5/09.pdf.
http://www.scielo.br/pdf/csc/v13n5/09.pd... .

Private health plans and insurance stand out within the private sector, the reason why, in June 2019, both added covered more than twenty percent of the Brazilian population³3 Brasil. Agência Nacional de Saúde Suplementar. Caderno de Informação da Saúde Suplementar: Beneficiários, Operadoras e Planos. Rio de Janeiro: Agência Nacional de Saúde Suplementar; 2019.. So as to regulate the sector, the National Regulatory Agency for Private Health Insurance (ANS), an authority at the Ministry of Health (MS), was created by law in 2000 with the purpose of regulating, standardizing and supervising the activities of the private health plan companies⁴4 Brasil. Lei nº 9.961, de 28 de janeiro de 2000. Cria a Agência Nacional de Saúde Suplementar - ANS e dá outras providências. Diário Oficial da União [internet]. 29 Jan 2000. [acesso em 2021 jan 19]. Disponível em: http://www.planalto.gov.br/ccivil_03/leis/l9961.htm.
http://www.planalto.gov.br/ccivil_03/lei... .

Among ANS’ legal competencies, ensuring adequate and quality care coverage for health plan users is one of them. That understanding called⁴4 Brasil. Lei nº 9.961, de 28 de janeiro de 2000. Cria a Agência Nacional de Saúde Suplementar - ANS e dá outras providências. Diário Oficial da União [internet]. 29 Jan 2000. [acesso em 2021 jan 19]. Disponível em: http://www.planalto.gov.br/ccivil_03/leis/l9961.htm.
http://www.planalto.gov.br/ccivil_03/lei... the Agency’s obligation to periodically prepare and update a list of mandatory minimum coverage medical procedures by the health plan companies in the country.

It is precisely over the process of the ‘list of procedure’ periodic updating that technologies are incorporated or excluded in the supplementary health sector. Although not defining criteria or methodology for the ANS to comply with that obligation, HTA has been applied as a tool to assist in the decision-making, as disclosed by the Agency⁵5 Brasil. Agência Nacional de Saúde Suplementar. Nota Técnica no 26/2013/ GRRAS/DIPRO/ANS, de 20 de fevereiros de 2013. Atualização da Nota GGRAS/DIPRO nº 98, de 2011, que trata dos critérios para revisão do Rol de procedimentos e eventos em saúde - ANS-2013-2014. Diário Oficial da União [interent]. 21 Fev 2013. [acesso em 2021 jan 25]. Disponível em: http://www.ans.gov.br/images/stories/Plano_de_saude_e_Operadoras/Area_do_consumidor/nota_priorizacao.pdf.
http://www.ans.gov.br/images/stories/Pla... .

Since its inception, HTA has supported public policies in the field of technology management throughout several countries. According to the International Society for Pharmacoeconomics and Outcomes Research (Ispor), HTA is

That definition emphasizes HTA political orientation, which, unlike health-related researches, aims to produce and communicate broad information on scientific evidence that provides support for policy formulation⁷7 Battista RN, Hodge MJ. The evolving paradigm of health technology assessment: reflections for the millennium. CMAJ. 1999; 160(10):1464-1467.. It allows managers and policymakers to ground their decisions more safely and effectively, seeking to achieve the best value for the patient and society, in the light of benefits, risks and costs⁸8 Velasco Garrido M, World Health Organization, European Observatory on Health Systems and Policies, organizadores. Health technology assessment and health policymaking in Europe: current status, challenges, and potential. Copenhagen: World Health Organization on behalf of the European Observatory on Health Systems and Policies; 2008. 181 p. (Observatory studies series). [acesso em 2021 jan 20]. Disponível em: https://www.euro.who.int/__data/assets/pdf_file/0003/90426/E91922.pdf.
https://www.euro.who.int/__data/assets/p... .

It is glaring that health systems, in general, have been facing restrictions that challenge their sustainability, mainly because of rising costs and limited resources. In part, those challenges are due to the aging process and the epidemiological transition, which greatly increased spending on medical care. In addition, the accelerated process of technological innovation and the high and growing impact of new technologies on health spending have been blamed as the main reasons for the prominent concern on HTA⁹9 Goodman CS. HTA 101: Introduction to Health Technology Assessment. Bethesda, MD: National Library of Medicine; 2014..

In recent decades, HTA has become a mandatory theme in the organization of health systems in various parts of the world. To some extent, also the countries with national systems, financed and administered by the State, as those of a more liberal orientation and predominance of private assistance adopt HTA to support their decisions concerning the incorporation, payment, reimbursement or financing of new technologies in the system¹⁰10 Neumann PJ. Lessons for Health Technology Assessment: It Is Not Only about the Evidence. Value Health [internet]. 2009 [acesso em 2019 dez 2]; 12:S45-8. Disponível em: https://linkinghub.elsevier.com/retrieve/pii/S1098301510600617.
https://linkinghub.elsevier.com/retrieve... .

Following this trend, the theme has been discussed in Brazil since the mid-1980s¹¹11 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... , particularly among academics. However, HTA institutional actions were only initiated in the 2000s, following the creation of the Department of Science and Technology (Decit) at the Ministry of Health (MS)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..

After the publication of the National Policy of Science, Technology and Innovation in Health in 2004, HTA became officially considered an instrument to contribute to the improvement of the State’s regulatory capacity¹³13 Brasil. Ministério da Saúde, Secretaria de Ciência e Tecnologia e Insumos Estratégicos, Departamento de Ciência e Tecnologia. Política nacional de ciência, tecnologia e inovação em saúde. Brasília, DF: Ministério da Saúde; 2008.. As from that Policy, a committee was organized with the purpose of structuring the flow for the demands of incorporation, exclusion or alteration of new technologies in SUS, originating the Commission for the Incorporation of Technologies (Citec) at the MS in 2006¹⁴14 Brasil. Ministério da Saúde, Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Ciência e Tecnologia. Política Nacional de Gestão de Tecnologias em Saúde. Brasília, DF: Ministério da Saúde; 2010.. In addition, another committee was created to outline the National Policy for The Management of Health Technologies (PNGTS), published in 2009.

The PNGTS covers the principles and general guidelines regarding the actions of all actors involved in the institutionalization of health technology assessment and management in Brazil¹⁴14 Brasil. Ministério da Saúde, Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Ciência e Tecnologia. Política Nacional de Gestão de Tecnologias em Saúde. Brasília, DF: Ministério da Saúde; 2010.. In addition to tracing HTA guidelines for the public system, it carries out as part of its objectives to guide supplementary health managers in the incorporation of technologies to the sector¹⁴14 Brasil. Ministério da Saúde, Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Ciência e Tecnologia. Política Nacional de Gestão de Tecnologias em Saúde. Brasília, DF: Ministério da Saúde; 2010..

It is possible to note, based on documents and information issued by MS, that ANS has been part of the discussion forums on HTA policies and actions in the country since its inception¹⁵15 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.. In addition, the Agency participated and still participates in the collegiate bodies responsible for the analysis and recommendations concerning the Unified Health System (SUS) incorporation of technologies. The participation lasted since the Commission for Incorporation of Technologies at the Ministry of Health (Citec) inception until its replacement by the National Commission for Incorporation of Technologies in SUS (Conitec), created by Law in 2011¹⁶16 Brasil. Ministério da Saúde. Portaria nº 2.587, de 30 de outubro de 2008. Dispõe sobre a Comissão de Incorporação de Tecnologias do Ministério da Saúde e vincula sua gestão à Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Diário Oficial da União. 31 Out 2008.^,1717 Brasil. Lei nº 12.401, de 28 de abril de 2011. Altera a Lei nº 8.080, de 19 de setembro de 1990, para dispor sobre a assistência terapêutica e a incorporação de tecnologia em saúde no âmbito do Sistema Único de Saúde - SUS. Diário Oficial da União. 29 Abr 2011..

Despite ANS participation in the actions of the Ministry of Health regarding the implementation of that policy in the country, it is noted that the use of HTA as a decision-making tool in the process of incorporating, changing and excluding technologies took different paths in the SUS and in the supplementary health sector.

Several national scientific publications have addressed the theme HTA in the SUS, most of which describe its trajectory until the creation and implementation of Conitec or by examining the evaluation processes and recommendations of that Commission¹⁸18 Yuba TY, Novaes HMD, Soárez PC. Challenges to decision-making processes in the national HTA agency in Brazil: operational procedures, evidence use and recommendations. Health Res Policy Syst. 2018; 16(40):1-9.

19 Caetano R, Silva RM, Pedro ÉM, et al. Incorporação de novos medicamentos pela Comissão Nacional de Incorporação de Tecnologias do SUS, 2012 a junho de 2016. Ciênc. Saúde Colet. [internet]. 2017 [acesso em 2017 set 23]; 22(8):2513-2525. Disponível em: http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1413-81232017000802513.
http://www.scielosp.org/scielo.php?scrip... ^-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... . However, concerning HTA performance in supplementary health, scientific productions are scarce and often addressed to the assessment of specific technologies²¹21 Nita ME, Eliaschewitz FG, Ribeiro E, et al. Custo-efetividade e impacto orçamentário da saxagliptina como terapia adicional à metformina para o tratamento do diabetes mellitus tipo 2 no sistema de saúde suplementar do Brasil. AMB rev. Assoc. Med. Bras. [internet]. 2012 [acesso em 2019 dez 2]; 58(3):294-301. Disponível em: https://linkinghub.elsevier.com/retrieve/pii/S0104423012705122.
https://linkinghub.elsevier.com/retrieve... ^,2222 Pepe RSC, Bolzachini SN, Gomes MT, et al. Cost-Effectiveness and Cost-Utility Analyses of Dabigatran Compared with Warfarin in Patients with Nonvalvular Atrial Fibrillation and Risk Factors for Stroke and Systemic Embolism within Brazilian Private and Public Health Care Systems Perspectives. Value in health reg issues (Online). [internet]. 2015 [acesso em 2019 dez 2]; 8:36-42. Disponível em: https://linkinghub.elsevier.com/retrieve/pii/S2212109915000084.
https://linkinghub.elsevier.com/retrieve... . The literature review did not find studies mapping knowledge on the theme.

Therefore, this study aimed to map HTA implementation in Brazil since the year 2000 – year when Decit/MS and ANS were created –, exploring its performance in the field of supplementary health and identifying the duality between public and private sectors. A deeper knowledge of the process and its challenges may help the formulation of future public policies addressed to incorporate health technologies in the country more efficiently and equitably.

Material and methods

The study was designed on two complementary methods. The first comprised a scoping review of the literature, while the other consisted of an analysis of ANS public documents related to the process of evaluating technologies in the supplementary health sector.

The choice to use the scoping review rests on the fact that it is useful for

They represent a form of knowledge synthesis, which incorporates several study designs to systematize evidence with the aim to inform practices, programs and policies and to provide guidance for future research priorities²⁴24 Arksey H, O'Malley L. Scoping studies: towards a methodological framework. Int. j. soc. res. methodol. [internet]. 2005 [acesso em 2019 dez 2]; 8(1):19-32. Disponível em: http://www.tandfonline.com/doi/abs/10.1080/1364557032000119616.
http://www.tandfonline.com/doi/abs/10.10... . Essentially, they differ from systematic reviews for answering broader research questions, accepting different study designs and for not systematically performing the assessment of the study quality²⁴24 Arksey H, O'Malley L. Scoping studies: towards a methodological framework. Int. j. soc. res. methodol. [internet]. 2005 [acesso em 2019 dez 2]; 8(1):19-32. Disponível em: http://www.tandfonline.com/doi/abs/10.1080/1364557032000119616.
http://www.tandfonline.com/doi/abs/10.10... .

Its design and carrying out was based on the methodological proposal of Joanna Briggs Institute (JBI), which includes the following phases: definition of the research question; identification of relevant studies; selection of studies; data mapping; and grouping, synthesis and reporting of results²⁵25 Peters MDJ, Godfrey C, McInerney P, et al. Scoping Reviews. In: Aromataris E, Munn Z, editores. Joanna Briggs Institute Reviewer's Manual. [internet] Adelaide: The Joanna Briggs Institute; 2017. [acesso em 2020 jan 28]. Disponível em: https://reviewersmanual.joannabriggs.org/..

The research-based question was defined by means of the PCC strategy, a mnemonic for Population, Concept and Context²⁵25 Peters MDJ, Godfrey C, McInerney P, et al. Scoping Reviews. In: Aromataris E, Munn Z, editores. Joanna Briggs Institute Reviewer's Manual. [internet] Adelaide: The Joanna Briggs Institute; 2017. [acesso em 2020 jan 28]. Disponível em: https://reviewersmanual.joannabriggs.org/., where P is the supplementary health; C is HTA implementation; and C is the Brazilian health system. As result, the main question defined for the search and selection of studies was: ‘How did HTA policies implementation occur in the Brazilian supplementary health sector?’.

Additionally, aiming to expand the searches and to make their results more responsive to, due to their narrowness as for the Brazilian supplementary health, it was also asked: ‘How did HTA policies implementation occur within SUS scope?’ or ‘How did HTA policies implementation occur within the private health insurance scope when the international literature is concerned?’.

The bibliographic search, outlined with the help of a librarian, was carried out by means of databases Medline (via PubMed), Lilacs (via VHL), Web of Science, and Scopus. The search period lasted from January/2000 to October/2019. It is important to note that the year 2000 was chosen as the initial milestone for being the year of creation of also the Decit/MS as the ANS, which represented HTA institutionalization bodies within SUS and in supplementary health, respectively.

The following English descriptors were chosen following the MeSH (Medical Subject Headings), a dictionary of terms controlled by the U.S. National Library of Medicine to index articles in PubMed, or their synonyms: Technology Assessment, Biomedical; Insurance, Health; and related free terms, combined with Brazil/Brazil^**Orcid (Open Researcher and Contributor ID)., ‘SUS’ and ‘Unified Health System’, adding the use of the Boolean operators AND, OR and NOT. In Portuguese, the research adopted the Descriptors in Health Sciences (DeCS) or their synonyms, being used: Avaliação de Tecnologias em Saúde; Saúde Suplementar; Agência Nacional de Saúde Suplementar; and Sistema Único de Saúde.

The search strategies applied for each database are described in table 1, as are their respective results.

In a way to complement, a search for cross references was carried out for all the relevant texts identified so to minimize any losses.

The selection of studies was performed by one of the researchers, who relied on the appraisal of and discussion with the second author whenever a doubt appeared. It was carried out in two phases, first sequentially examining titles and abstracts, and then reading the full text as to apply the inclusion and exclusion criteria.

According to the inclusion criteria, studies of any design were accepted addressing the theme related to HTA policies in Brazil that involved ANS, the supplementary health sector or private health insurance or SUS. Only studies in English, Spanish or Portuguese were selected.

Studies on the assessment of specific technologies were excluded, as were those addressing only methodological issues or economic evaluations, and those that did not refer to HTA in the Brazilian context or in the supplementary health or in private health insurance.

The selected studies were organized in an electronic form created in Excel software spreadsheet®, which was also used to retrieve the relevant data. The following information was extracted: author, year of publication, title, origin of the study, objectives, methodology, results and main findings.

The origin of each study in the description of results was classified as ‘national’ whenever referring only to the Brazilian context, and as ‘international’ whenever exclusively covering the private insurance sector of other countries or whenever dealing with HTA assessment in other realities, provided that Brazil was among them.

Results were reported descriptively, employing tables to summarize the study data. The analysis of main findings was later matched up with data retrieved from the national and international literature on the HTA policies’ implementation.

The second methodological path undertaken concerned the search, synthesis and descriptive analysis of the public documents available on ANS website. Documents analyzed included the process of preparation, updating and periodic reviewing of the list of mandatory coverage procedures, since it is the process of incorporation, alteration or exclusion of the sector technologies.

Therefore, the following documents were selected: the two laws governing the sector, the Normative Resolution (RN) and that from the collegiate board, as well as reports and technical notes on the subject.

Aiming to complement the document analysis, the information available in minutes of meetings and presentations of technical groups linked to ANS list of procedures was included, as was that one released by the Permanent Healthcare Regulation Committee (Cosaúde), created by the Agency to address issues concerning care regulation²⁶26 Brasil. Agência Nacional de Saúde Suplementar. Instrução Normativa no 44, de 13 de fevereiro de 2014. Institui o Comitê Permanente de Regulação da Atenção à Saúde no Âmbito da ANS. Diário Oficial da União. 14 Fev 2014. [acesso em 2021 jan 19]. Disponível em: https://www.ans.gov.br/component/legislacao/?view=legislacao&task=TextoLei&format=raw&id=MjY2OA==.
https://www.ans.gov.br/component/legisla... .

The results of the analysis were reported descriptively, aiming to draw an evolutionary line depicting the process of updating and periodic reviewing of the list of procedures over time. It started at the inception of the sector regulatory framework, Law No. 9656 of 1998²⁷27 Brasil. Lei nº 9.656, de 03 de junho de 1998. Dispõe sobre os planos e seguros privados de assistência à saúde. Diário Oficial da União. 4 Jun 1998. [acesso em 2021 jan 19]. Disponível em: http://www.planalto.gov.br/ccivil_03/leis/l9656.htm.
http://www.planalto.gov.br/ccivil_03/lei... , and included the last normative published on the subject until December 2019.

All documents employed in the document analysis are available for public and free access on ANS website. Therefore, the research exempted the Ethics Committee appraisal, since it applied only the literature secondary data and free internet sites.

Results

Scoping review

The search in electronic databases returned 599 records. After removal of duplicates, 519 records remained for title screening, after which 427 records were excluded, leaving 92 papers to be submitted to the abstract screening. Then, the full text of 28 papers was evaluated, 26 of which remained for the final data set. The assessed cross-references were not eligible for inclusion. It is also worth mentioning that no reference was identified in languages other than those defined in the review inclusion criteria (picture 1).

Although the searches in the databases included references from the year 2000, the selected studies were all published within the period 2004–2019, among which more than 90% were published as from 2009 (N=24). The latest years concentrated a larger number of studies, as: 2017 (N=4), 2018 (N=3), and 2019 (N=4) (table 2).

None of the 26 selected studies addressed exclusively the HTA implementation in the supplementary health. Brazil was the origin of most studies (N=15), among which predominated those whose main objective was to present, describe or inform on HTA trajectory in SUS (N=9). ANS participation in HTA implementation process over the country or the reference to the private sector in that process were addressed in less than half of the studies (N=12).

The national studies were mainly dedicated to reporting on actions coordinated by the MS concerning HTA implementation in the public sector. Many of them depicted a timeline including the main milestones in the trajectory, such as the creation of Decit, Citec and Conitec organizational structures, as well as the publication of national policies that aimed to guide the process throughout the Country¹¹11 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... ^,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.^,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.^,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... ^,2828 Krauss-Silva L. Avaliação tecnológica em saúde: questões metodológicas e operacionais. Cad. Saúde Pública. 2004; 20(supl)2:S199-207.

29 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.

30 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.

31 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.

32 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...

33 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...

34 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...

35 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...

36 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... ^-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... .

Among the national studies, Guimarães’ work²⁰20 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... stood out due to addressing HTA in supplementary health more consistently. The author raises specific questions on the private sector, such as the use of new technologies incorporation as a competitive differential between companies operating private health plans. He also mentions some divergences and convergences between different HTA processes in the two sectors²⁰20 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... .

Banta and Almeida¹¹11 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... emphasized the need to integrate ANS into HTA implementation process in Brazil. They reinforced the importance of encouraging HTA use by private health plans, reporting that ANS created, in 2005, a task force for technology management in the supplementary health sector, establishing an organizational structure exclusively to that end¹¹11 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... .

Also as per the Brazilian literature, Ali 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. presented a discussion about HTA and its evolution in Brazil, and described some secondary data sources available in the country potentially able to generate evidence on HTA and political decisions³⁸38 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.. Silva and Elias³⁹39 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... compared how HTA systems are organized in Brazil and Canada, noting that both are characterized by a wide coverage of the activity scope and by the concentration of activities in national agencies or bodies, despite both carrying out some health system fragmentation, which hinders the coordination of public policies due to the overlap of competencies and the competition between the different entities of the federation³⁹39 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... .

All international studies, except for that of Pericleous and collaborators’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. published in 2019, evaluated, comparatively and to some extent, HTA experiences in different countries, including Brazil⁴¹41 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.

42 Banta HD. Perspective: Some Conclusions from My Life in Health Technology Assessment. Int. j. technol. assess. health care. 2018; 34(2):131-133.

43 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.

44 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...

45 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.

46 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.

47 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.

48 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... ^-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... . The differences among Latin American countries prevailed, among which Brazil stood out for fast developing HTA programs considered effective⁴⁶46 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.. In general, those studies involved only the Brazilian public system, that is, also HTA applied to supplementary health as the private insurance sector were not the object of analysis.

Pericleous’s study⁴⁰40 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. aimed to examine, by means of literature review and panel of experts, HTA applicability to the public sector as for decision-making of private payers in Canada. Thus, it was similar, at least in part, to the object of this research with regard to the identification of divergences and convergences between HTA application in the public and private sectors. The authors also found scarce publications on the subject in Canada and in the United States. Additionally, the panel of experts concluded that, despite some similarities, there were substantial differences between the two systems, such as demographic issues, health status and other beneficiaries’ characteristics that did not favor the adoption of the same kind of assessment for both.

Document analysis

The legal and infra-legal framework that grants ANS the responsibility for the incorporation, alteration and exclusion of technologies as for the supplementary health sector was examined with the objective of extracting information able to identify HTA implementation and use in the Agency’s decision-making process.

Law No. 9,656 of 1998, the legal framework that regulated the private health insurance and plan sector²⁷27 Brasil. Lei nº 9.656, de 03 de junho de 1998. Dispõe sobre os planos e seguros privados de assistência à saúde. Diário Oficial da União. 4 Jun 1998. [acesso em 2021 jan 19]. Disponível em: http://www.planalto.gov.br/ccivil_03/leis/l9656.htm.
http://www.planalto.gov.br/ccivil_03/lei... , and Law No. 9,961 of 2000⁴4 Brasil. Lei nº 9.961, de 28 de janeiro de 2000. Cria a Agência Nacional de Saúde Suplementar - ANS e dá outras providências. Diário Oficial da União [internet]. 29 Jan 2000. [acesso em 2021 jan 19]. Disponível em: http://www.planalto.gov.br/ccivil_03/leis/l9961.htm.
http://www.planalto.gov.br/ccivil_03/lei... , which created ANS, were analyzed. In addition, all Collegiate Board Resolutions (RDC) and Normative Resolutions (RN) related to the process of preparation and periodic updating of the Agency’s list of procedures were examined and summarized in table 3, as was the complementary material made available to assist society in public consultations by means its Technical Notes.

Based on the analysis of those documents, it was possible to draw a timeline containing the main regulatory and operational frameworks related to the complex process of periodic review of the Regulatory Agency’s list of procedures (picture 2).

The first version of the list was created by Private Health Insurance and Plans Council Resolution No. 10 – Consu 10 of 1998 – as part of the deliberations of Law No. 9,656 of 1998 and even before ANS creation. The records related to the methodology adopted in its elaboration were not found on the Agency’s website. However, due to the remarkable similarity between the list and the table of procedures of the Brazilian Medical Association (AMB) at the time, it is plausible to assume that the table influenced that construction.

The ANS creation law in 2000 defines, in its article 4, the Agency capacity, including the obligation to elaborate the list of procedures and health events⁴4 Brasil. Lei nº 9.961, de 28 de janeiro de 2000. Cria a Agência Nacional de Saúde Suplementar - ANS e dá outras providências. Diário Oficial da União [internet]. 29 Jan 2000. [acesso em 2021 jan 19]. Disponível em: http://www.planalto.gov.br/ccivil_03/leis/l9961.htm.
http://www.planalto.gov.br/ccivil_03/lei... . To this end, the regulator created a discussion forum, attended by several agents of the sector, to discuss the list updating and improvement⁵⁰50 Brasil. Agência Nacional de Saúde Suplementar. Nota Técnica n.º 16 /Assessoria Especial/DIPRO/2004, de 18 de agosto de 2004. Análise técnica da Classificação Brasileira Hierarquizada de Procedimentos Médicos - CBHPM. [acesso em 2021 jan 19]. Disponível em: http://ans.gov.br/images/stories/Legislacao/consultas_publicas/cp_19_exposicao_de_motivos.pdf.
http://ans.gov.br/images/stories/Legisla... . In the same year, two Collegiate Board Resolutions (RDC No. 21 and RDC No. 41) were published revising the original list (table 2).

During the period 2000–2008, the initial list suffered six revisions. Among them, only those issued in 2004 and 2007 were preceded by public consultation. As from 2008, all RN modifying the list were systematically preceded by public consultation⁵¹51 Brasil. Agência Nacional de Saúde Suplementar. Espaço do Consumidor: o que é o Rol de Procedimentos e Evento em Saúde [internet]. Brasília, DF: Agência Nacional de Saúde Suplementar; 2018. [acesso em 2018 maio 7]. Disponível em: http://www.ans.gov.br/index.php/planos-de-saude-e-operadoras/espaco-do-consumidor/737-rol-de-procedimentos.
http://www.ans.gov.br/index.php/planos-d... (table 3).

Consu No. 10 was revoked in 2008 and a new version of the list was published (RN No. 167), bringing a series of changes and innovations, such as the introduction of clinical and use guidelines for some specific procedures. Those guidelines linked the mandatory coverage to the compliance with requirements grounded on evidence-based medicine, i.e., procedures with clinical or use guidelines would only be covered by health plan companies when these requirements were fulfilled⁵²52 Brasil. Agência Nacional de Saúde Suplementar. Entra em vigor a nova cobertura obrigatória dos planos de saúde [internet]. Brasília, DF: Agência Nacional de Saúde Suplementar; 2010. [acesso em 2018 ago 13]. Disponível em: >http://www.ans.gov.br/aans/noticias-ans/consumidor/419-entra-em-vigor-a-nova-cobertura-obrigatoria-dos-planos-de-saude?highlight=WyJyZGMi%E2%80%A6.
http://www.ans.gov.br/aans/noticias-ans/... .

As from June 2010, the list revisions became regular, being carried out every two years⁵²52 Brasil. Agência Nacional de Saúde Suplementar. Entra em vigor a nova cobertura obrigatória dos planos de saúde [internet]. Brasília, DF: Agência Nacional de Saúde Suplementar; 2010. [acesso em 2018 ago 13]. Disponível em: >http://www.ans.gov.br/aans/noticias-ans/consumidor/419-entra-em-vigor-a-nova-cobertura-obrigatoria-dos-planos-de-saude?highlight=WyJyZGMi%E2%80%A6.
http://www.ans.gov.br/aans/noticias-ans/... . Additionally, a technical advisory group was created, and composed of the main agents working in the sector, i.e., consumer protection entities, health plan companies, medical professionals and ANS technicians, whose technical discussions preceded the public consultation and were made available on the ANS website⁵²52 Brasil. Agência Nacional de Saúde Suplementar. Entra em vigor a nova cobertura obrigatória dos planos de saúde [internet]. Brasília, DF: Agência Nacional de Saúde Suplementar; 2010. [acesso em 2018 ago 13]. Disponível em: >http://www.ans.gov.br/aans/noticias-ans/consumidor/419-entra-em-vigor-a-nova-cobertura-obrigatoria-dos-planos-de-saude?highlight=WyJyZGMi%E2%80%A6.
http://www.ans.gov.br/aans/noticias-ans/... .

In 2013, a technical note was published by the Agency containing the criteria for including new procedures in the mandatory coverage⁵5 Brasil. Agência Nacional de Saúde Suplementar. Nota Técnica no 26/2013/ GRRAS/DIPRO/ANS, de 20 de fevereiros de 2013. Atualização da Nota GGRAS/DIPRO nº 98, de 2011, que trata dos critérios para revisão do Rol de procedimentos e eventos em saúde - ANS-2013-2014. Diário Oficial da União [interent]. 21 Fev 2013. [acesso em 2021 jan 25]. Disponível em: http://www.ans.gov.br/images/stories/Plano_de_saude_e_Operadoras/Area_do_consumidor/nota_priorizacao.pdf.
http://www.ans.gov.br/images/stories/Pla... . Among those criteria, stood out the HTA use, the Evidence-Based Medicine, and the need for economic evaluations. Furthermore, the document refers to Conitec’s decisions as one of the key factors in the Agency’s decisions⁵5 Brasil. Agência Nacional de Saúde Suplementar. Nota Técnica no 26/2013/ GRRAS/DIPRO/ANS, de 20 de fevereiros de 2013. Atualização da Nota GGRAS/DIPRO nº 98, de 2011, que trata dos critérios para revisão do Rol de procedimentos e eventos em saúde - ANS-2013-2014. Diário Oficial da União [interent]. 21 Fev 2013. [acesso em 2021 jan 25]. Disponível em: http://www.ans.gov.br/images/stories/Plano_de_saude_e_Operadoras/Area_do_consumidor/nota_priorizacao.pdf.
http://www.ans.gov.br/images/stories/Pla... .

It is important to note that, since the publication of Technical Note No. 26, in February 2013⁵5 Brasil. Agência Nacional de Saúde Suplementar. Nota Técnica no 26/2013/ GRRAS/DIPRO/ANS, de 20 de fevereiros de 2013. Atualização da Nota GGRAS/DIPRO nº 98, de 2011, que trata dos critérios para revisão do Rol de procedimentos e eventos em saúde - ANS-2013-2014. Diário Oficial da União [interent]. 21 Fev 2013. [acesso em 2021 jan 25]. Disponível em: http://www.ans.gov.br/images/stories/Plano_de_saude_e_Operadoras/Area_do_consumidor/nota_priorizacao.pdf.
http://www.ans.gov.br/images/stories/Pla... , ANS started to use HTA explicitly in its public material as a justification for its decisions regarding the incorporation, alteration or exclusion of new technologies for mandatory coverage in the sector.

In 2014, the Agency created the Cosaúde with the purpose of addressing issues of care regulation, including the mandatory coverage²⁶26 Brasil. Agência Nacional de Saúde Suplementar. Instrução Normativa no 44, de 13 de fevereiro de 2014. Institui o Comitê Permanente de Regulação da Atenção à Saúde no Âmbito da ANS. Diário Oficial da União. 14 Fev 2014. [acesso em 2021 jan 19]. Disponível em: https://www.ans.gov.br/component/legislacao/?view=legislacao&task=TextoLei&format=raw&id=MjY2OA==.
https://www.ans.gov.br/component/legisla... . As a standing committee, it granted greater stability to its members composition, which includes more than thirty institutions working in the supplementary health sector. Since Cosaúde creation, the minutes and meeting presentations became available on the ANS website systematically, easing public access to information related to the list periodic reviewing process⁵³53 Brasil. Agência Nacional de Saúde Suplementar. COSAÚDE: Comitê Permanente de Regulação da Atenção à Saúde [internet]. Brasília, DF: Agência Nacional de Saúde Suplementar; 2018. [acesso em 2019 maio 22]. Disponível em: http://www.ans.gov.br/participacao-da-sociedade/comites-e-comissoes/comite-permanente-de-regulacao-da-atencao-a-saude-cosaude/atas-das-reunioes-do-cosaude.
http://www.ans.gov.br/participacao-da-so... .

As from 2015, became available on ANS website documents containing more information on the list of procedures so to assist society in the involvement of public consultations. Besides, post-public consultation reports were publicized informing the reasons for also the society demands accepted as for those not accepted by the Agency⁵⁴54 Brasil. Agência Nacional de Saúde Suplementar. Consultas Públicas encerradas [internet]. Brasília, DF: Agência Nacional de Saúde Suplementar; 2020. [acesso em 2020 jan 5]. Disponível em: http://www.ans.gov.br/participacao-da-sociedade/consultas-e-participacoes-publicas/consultas-publicas-encerradas.
http://www.ans.gov.br/participacao-da-so... .

Still in 2015, ANS organized the entry flow of demands for changes to the list by means of an electronic form that required technical information about the technology claimed by the plaintiff. The form was only provided for requests coming from Cosaúde members⁵⁵55 Brasil. Agência Nacional de Saúde Suplementar. Consulta Pública 59: RN do Rol de Procedimentos e Eventos em Saúde [internet]. Brasília, DF: Agência Nacional de Saúde Suplementar; 2015. [acesso em 2020 jan 5]. Disponível em: http://www.ans.gov.br/images/stories/Particitacao_da_sociedade/consultas_publicas/cp59/cp_59_nota172.pdf.
http://www.ans.gov.br/images/stories/Par... .

In 2017, the disclosure of another technical note was added⁵⁶56 Brasil. Agência Nacional de Saúde Suplementar. Nota Técnica nº 19/2018, de 5 de fevereiro de 2018. Impacto Regulatório da normatização do processo de atualização do Rol de Procedimentos e Eventos em Saúde. [acesso em 2021 jan 20]. Disponível em: http://www.ans.gov.br/images/stories/Particitacao_da_sociedade/consultas_publicas/cp69/cp69_notatecnica19-2018.pdf.
http://www.ans.gov.br/images/stories/Par... containing, for the first time, a Regulatory Impact Analysis (AIR) as for the new resolution to be published with the list updating. That technical note also included a Budget Impact Analysis (AIO) regarding the proposal for new incorporation of technologies in the sector⁵⁶56 Brasil. Agência Nacional de Saúde Suplementar. Nota Técnica nº 19/2018, de 5 de fevereiro de 2018. Impacto Regulatório da normatização do processo de atualização do Rol de Procedimentos e Eventos em Saúde. [acesso em 2021 jan 20]. Disponível em: http://www.ans.gov.br/images/stories/Particitacao_da_sociedade/consultas_publicas/cp69/cp69_notatecnica19-2018.pdf.
http://www.ans.gov.br/images/stories/Par... .

Finally, in 2018, ANS developed a norm to regulate the process itself concerning the list of procedures periodic updating, RN No. 439. The norm defined procedures and flows necessary for the list periodic updating. Among others, stood out the standardization of the entry flow and processing of demands for changing the list, as well as the clear definition of the deliberative instances and the broader participation of society⁵⁷57 Brasil. Agência Nacional de Saúde Suplementar. Nota Técnica nº 18/2018, de 16 de março de 2018. Processo de normatização da atualização periódica do Rol de Procedimentos e Eventos em Saúde. [acesso em 2021 jan 20]. Disponível em: http://www.ans.gov.br/images/stories/Particitacao_da_sociedade/consultas_publicas/cp69/cp69_notatecnica18-2018.pdf.
http://www.ans.gov.br/images/stories/Par... .

Discussion

The review showed the scarcity of works on HTA implementation and use in Brazilian supplementary health. Also at the international level, the theme is still poorly explored, as indicated by Pericleous and collaborators⁴⁰40 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.. Most of the selected studies focused on evaluating HTA implementation in SUS. Only two studies²⁰20 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... ^,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. addressed critically and explicitly the differences between technology assessments in public and private sectors.

In spite of few exceptions¹¹11 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... ^,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... , studies addressing HTA in supplementary health referred to the sector vaguely and superficially or barely referred to ANS as one of the organisms linked to the Ministry of Health that participated in technical groups and other discussion forums on the subject.

The document analysis revealed an evolution in terms of the organization of the list periodic reviewing process, especially with regard to the participation of society, what generated a greater number of public consultations and institutional transparency, making available a larger number of documents of public access.

Although more robust, ANS list’ process of periodic reviewing, up to the study period, still holds weak relation to the guidelines and directions followed by Conitec concerning the process of evaluating technologies for SUS, thus confirming the dichotomy between the two models. The adoption of an application form for inquiries, the request for the plaintiff technical and scientific opinion, and the carrying out of ANS public consultations are the main similarities between the two processes.

On the other hand, the non-disclosure of HTA reports, the lack of economic assessment, and, particularly, the criteria lack of precision as to the Agency’s advising are some of the differences between ANS process and Conitec’.

Coming into force in 2019, the new rule RN No. 439 organizes the list periodic reviewing process, in which some changes tend to increase the congruence between the two processes. Of these changes, stand out the possibility that the society in general require modifications in the list, previously restricted to Cosaúde members; and the possibility that ANS request reports issued by public or private institutions specialized in HTA, similar to what happens in Conitec⁵⁸58 Brasil. Agência Nacional de Saúde Suplementar. Resolução Normativa nº 439, de 3 de dezembro de 2018. Dispõe sobre processo de atualização periódica do Rol de Procedimentos e Eventos em Saúde, no âmbito da Agência Nacional de Saúde Suplementar. Diário Oficial da União. 4 Dez 2018. [acesso em 2021 jan 20]. Disponível em: https://www.in.gov.br/materia/-/asset_publisher/Kujrw0TZC2Mb/content/id/54733061/do1-2018-12-12-resolucao-normativa-rn-n-439-de-3-de-dezembro-de-2018-54733018.
https://www.in.gov.br/materia/-/asset_pu... .

Some consideration on the possibility of congruence between HTA public and private processes can be made as from the literature scoping review. Thus, it was evinced in two selected studies²⁰20 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... ^,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. that one of HTA differences between private and public sectors relies on the incorporation of new technologies, modern and appealing, as a competitive tool among private companies working in the sector. Such difference sustains itself on the fact that companies provide for-profit service both for individuals and other companies; therefore, the client wish is essential⁴⁰40 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..

In that regard, Guimarães²⁰20 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... draws the attention to the change in the behavior of companies working in the Brazilian supplementary health sector concerning the incorporation of new technologies. The author questions that companies often applied uncritical incorporation of new technologies as a marketing tool so to increase their product sales²⁰20 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... . As from a given moment, the acknowledgement of exponential increase in care expenses questioned such behavior, causing HTA to take part in the speech of private companies’ managers as a way of reducing spending²⁰20 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... .

Concurrently, as from 2013, ANS disseminates, by means of a technical note, the use of HTA and economic evaluations as part of the criteria for incorporating new technologies in the sector⁵5 Brasil. Agência Nacional de Saúde Suplementar. Nota Técnica no 26/2013/ GRRAS/DIPRO/ANS, de 20 de fevereiros de 2013. Atualização da Nota GGRAS/DIPRO nº 98, de 2011, que trata dos critérios para revisão do Rol de procedimentos e eventos em saúde - ANS-2013-2014. Diário Oficial da União [interent]. 21 Fev 2013. [acesso em 2021 jan 25]. Disponível em: http://www.ans.gov.br/images/stories/Plano_de_saude_e_Operadoras/Area_do_consumidor/nota_priorizacao.pdf.
http://www.ans.gov.br/images/stories/Pla... . Following that logic, it is plausible to assume that health entrepreneurs themselves increased the pressure onto the Regulatory Agency so to strengthen HTA use in the sector adoption of new technologies for mandatory coverage.

As consequence of that inflection, health plan companies started to create their own HTA centers. The Cosaúde meeting minutes started to grant a more technical character to the discussions regarding the incorporation of new technologies in the sector⁵³53 Brasil. Agência Nacional de Saúde Suplementar. COSAÚDE: Comitê Permanente de Regulação da Atenção à Saúde [internet]. Brasília, DF: Agência Nacional de Saúde Suplementar; 2018. [acesso em 2019 maio 22]. Disponível em: http://www.ans.gov.br/participacao-da-sociedade/comites-e-comissoes/comite-permanente-de-regulacao-da-atencao-a-saude-cosaude/atas-das-reunioes-do-cosaude.
http://www.ans.gov.br/participacao-da-so... . Consonant with Guimarães’ postulate²⁰20 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... , those behavior changes as for the private sector can lead to a congruence between the supplementary health processes of technology incorporation and the SUS.

Comparing the findings of this study with the international literature³⁹39 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... ^,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.^,5959 Perry S, Thamer M. Health technology assessment: Decentralized and fragmented in the US compared to other countries. Health Policy [internet]. 1997 [acesso em 2020 jan 3]; 40(3):177-198. Disponível em: https://linkinghub.elsevier.com/retrieve/pii/S016885109700897X.
https://linkinghub.elsevier.com/retrieve... ^,6060 Banta D. The development of health technology assessment. Health Policy [internet]. 2003 [acesso em 2020 jan 5]; 63(2):121-132. Disponível em: https://linkinghub.elsevier.com/retrieve/pii/S0168851002000593.
https://linkinghub.elsevier.com/retrieve... , it is reasonable to consider the need to promote HTA coordination processes in a country. The comparison between the United States (USA) and other European countries, such as Sweden and England, was chosen by Banta⁶⁰60 Banta D. The development of health technology assessment. Health Policy [internet]. 2003 [acesso em 2020 jan 5]; 63(2):121-132. Disponível em: https://linkinghub.elsevier.com/retrieve/pii/S0168851002000593.
https://linkinghub.elsevier.com/retrieve... so to demonstrate discrepancies between countries not unified towards a national direction and the coordinated functioning of national health systems.

Banta⁶⁰60 Banta D. The development of health technology assessment. Health Policy [internet]. 2003 [acesso em 2020 jan 5]; 63(2):121-132. Disponível em: https://linkinghub.elsevier.com/retrieve/pii/S0168851002000593.
https://linkinghub.elsevier.com/retrieve... affirms that in the USA, without effective national process coordination, HTA activities are carried out by multiple organizations following various targets, often adopting different methods and without process transparency. The predominant object is probably cost containment, although other purposes are also mentioned by assessors, such as quality improvement or innovation⁶⁰60 Banta D. The development of health technology assessment. Health Policy [internet]. 2003 [acesso em 2020 jan 5]; 63(2):121-132. Disponível em: https://linkinghub.elsevier.com/retrieve/pii/S0168851002000593.
https://linkinghub.elsevier.com/retrieve... .

In 1997, Seymour Perry and Mae Thamer⁵⁹59 Perry S, Thamer M. Health technology assessment: Decentralized and fragmented in the US compared to other countries. Health Policy [internet]. 1997 [acesso em 2020 jan 3]; 40(3):177-198. Disponível em: https://linkinghub.elsevier.com/retrieve/pii/S016885109700897X.
https://linkinghub.elsevier.com/retrieve... described earlier the lack of coordination of various HTA instances in the USA, most of them private, i.e., medical centers, hospitals, health insurers, pharmaceutical industry and medical equipment. The authors argue that these private organizations priorities may not necessarily coincide with national priorities as for technology evaluation. Moreover, there is virtually no information exchange or coordination among those groups. Also, the proprietary nature of results among many organizations further limits the availability and usefulness of those evaluations⁵⁹59 Perry S, Thamer M. Health technology assessment: Decentralized and fragmented in the US compared to other countries. Health Policy [internet]. 1997 [acesso em 2020 jan 3]; 40(3):177-198. Disponível em: https://linkinghub.elsevier.com/retrieve/pii/S016885109700897X.
https://linkinghub.elsevier.com/retrieve... .

Regarding those countries carrying out coordinated HTA activity, they tend to implement national health systems and consider convenient and efficient to create HTA programs linked to and supported by the national government¹⁰10 Neumann PJ. Lessons for Health Technology Assessment: It Is Not Only about the Evidence. Value Health [internet]. 2009 [acesso em 2019 dez 2]; 12:S45-8. Disponível em: https://linkinghub.elsevier.com/retrieve/pii/S1098301510600617.
https://linkinghub.elsevier.com/retrieve... . In many cases, the acquisition and access to new technologies are under government control, particularly as for federal health programs⁵⁹59 Perry S, Thamer M. Health technology assessment: Decentralized and fragmented in the US compared to other countries. Health Policy [internet]. 1997 [acesso em 2020 jan 3]; 40(3):177-198. Disponível em: https://linkinghub.elsevier.com/retrieve/pii/S016885109700897X.
https://linkinghub.elsevier.com/retrieve... . Overall, they seem to exert important influence on their countries’ technology management policy.

In Brazil, the HTA system is consisted of a centralized governmental body, Conitec, which is responsible for advising the MS on evaluations and recommendations on SUS’ incorporation of technologies at the national level; of limited experiences on HTA very structures at the state level; and of various public and private organizations, such as teaching hospitals, research institutes, among others³⁹39 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... . Additionally, ANS operates in parallel, adopting HTA as a tool to exercise its legal obligation of updating the list of mandatory coverage procedures in the supplementary sector.

Thus, a fragmented HTA system arises, in which several organizations work at different levels, duplicating efforts and breaking completely the incorporation processes in public and private health sectors. In general, both sectors assess aspects such as effectiveness, safety and budgetary impact, besides promoting, to some extent, the participation of society. However, no comprehensive value-based assessments were identified as per each perspective.

Final considerations

The study aimed to trace HTA history in supplementary health, depicting HTA implementation milestones in SUS and identifying existing dualities between public and private sectors in this process.

HTA implementation throughout the country is part of a broader policy of incentives to science, technology and innovation, aiming to confer rationality to the process of technological incorporation. MS guided the actions towards such implementation, always relying on ANS participation. However, results obtained so far reveal that the Agency and the Conitec/MS work independently and without coordination, applying distinct methodologies to produce their reports and recommendations regarding the inclusion, exclusion or modification of technology use in supplementary health and in SUS.

The disconnection among those findings is noteworthy, as is the country option when defining the PNGTS with the general purpose of

Such Policy should guide all actors involved in the institutionalization of the appraisal and management of health technologies in Brazil.

Besides, the Brazilian Network of Health Technology Assessment (Rebrats) was created in 2008 implying the government cooperation with universities, teaching and research institutes, among others, of which ANS is part. The use of HTA national network of cooperation should also be aimed at reducing the discrepancies between the evaluations carried out for SUS and supplementary health¹⁵15 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..

As stated by Seymour Perry and Mae Thamer⁵⁹59 Perry S, Thamer M. Health technology assessment: Decentralized and fragmented in the US compared to other countries. Health Policy [internet]. 1997 [acesso em 2020 jan 3]; 40(3):177-198. Disponível em: https://linkinghub.elsevier.com/retrieve/pii/S016885109700897X.
https://linkinghub.elsevier.com/retrieve... , Banta⁶⁰60 Banta D. The development of health technology assessment. Health Policy [internet]. 2003 [acesso em 2020 jan 5]; 63(2):121-132. Disponível em: https://linkinghub.elsevier.com/retrieve/pii/S0168851002000593.
https://linkinghub.elsevier.com/retrieve... and by Silva and Elias³⁹39 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... , international experiences have suggested that coordinated and standardized HTA processes can bring gains to the evaluation efficiency, reducing redundancies and re-work, in addition to improving care supply to the population’s health needs. In this sense, as far as the national scope is concerned, both Conitec’ and ANS’ evaluations are funding by public resources; therefore, their products should revert in favor of the society, either the private health plan beneficiary or SUS’ user.

Actually, the evaluation of technologies must necessarily take into account various contextual elements from the public and supplementary sectors, such as economic and structural factors. Thus, different payers may face different priorities and decision-making processes. There are also important differences between the sectors concerning demographic terms, health status and other user characteristics. So, different approaches should be undertaken for assessment of the public sector and the private market⁴⁰40 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..

However, the same methodological guidance – standardized HTA reports – joined to greater participation of society, both within SUS and in supplementary health, can offer greater transparency to manager decisions. Increasing transparency of the decision-making process provides greater understanding by the society, allowing the citizen a more consciously demand, besides rendering greater credibility to the process.

Although Brazil has a unified health system, the private sector, especially supplementary health, is quite robust. As a consequence of the dichotomy between the public and private sectors, the implementation of public policies of national scope is hindered, as can be seen by the PNGTS. The national coordination of an HTA model that meets its specificities is desired, for the sake of increasing transparency of the accountable institutions, greater credibility of their decisions, greater efficiency of the process and, especially, to provide greater equity.

Regarding equity, HTA should function as strategy for the consolidation of that principle, favoring a more adequate distribution of resources within the health system, whatever the subsector involved. Equity can be analyzed as a balance between the population to be benefited due to their vulnerabilities and the health needs, regardless of its purchasing power. Better allocation of resources based on health needs provides more equitable supply and distribution of services in both sectors, since those who finance the system are the users themselves, both in the public sector, by means of taxes, and in supplementary health, by means of cash compensation.

Similarly, HTA use can avoid waste and generate greater efficiency in the provision of health services in both sectors, since their products, in addition to identifying the safest and most effective technologies, also inform under which conditions and for which groups of individuals their benefits will be more significant.

It is undeniable the important improvement of HTA implementation in the country since 2000, especially in SUS, which culminated with the Conitec’ creation in 2011. As for supplementary health, only in 2013 ANS published a technical note officially creating HTA as a decision-making tool. In 2018, the Agency published a norm defining the list reviewing process, more tuned with SUS patterns.

Neither the literature scoping review nor the document analysis could explicitly evidence the reasons for such discrepancies. However, it can be inferred that commercial, marketing and economic-financial issues involving especially private health plan companies could explain also the HTA late implementation in the supplementary health as part of the lack of transparency concerning HTA model implemented in ANS.

Few studies investigated the consequences of the lack of alignment between HTA policies in the public and private sectors. New studies under various approaches are essential to a broader understanding of the theme. Therefore, the strengthening of this process is expected due to being essential for the health system sustainability in Brazil.

References

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