VALUE FRAMEWORK FOR HEALTH TECHNOLOGY ASSESSMENT IN BRAZIL'S SUPPLEMENTARY HEALTH SYSTEM: IDENTIFYING THE KEY DRIVERS OF DECISION-MAKING (2021-2025)
Author(s)
Erika Resende, Master1, Ligiane Alves de Oliveira Silva, Master1, Helaine Capucho, PhD1, Aline Santos, Master1, Rafael Raimondi Coelho, Master1, Renato Porto, Bachelor's1, Danilo Moreira Simoes, MBA2, Mauricio Franca, Jr., MBA3, Rafael Miranda Magno Freixo, MBA2.
1Interfarma – Associação da Indústria Farmacêutica de Pesquisa, São Paulo, Brazil, 2L.E.K. Consulting, Boston, MA, USA, 3L.E.K. Consulting, Sao Paulo, Brazil.
1Interfarma – Associação da Indústria Farmacêutica de Pesquisa, São Paulo, Brazil, 2L.E.K. Consulting, Boston, MA, USA, 3L.E.K. Consulting, Sao Paulo, Brazil.
OBJECTIVES: Health Technology Assessment (HTA) in Brazil's supplementary health system remains a recent and evolving discipline, currently governed by RN nº 555/2022 after successive reforms to the mandatory coverage list (Rol). With these rules still maturing, this study analyzed ANS coverage decisions on medicines to identify their key drivers.
METHODS: All 81 medicine submissions from 2021 to 2025 were collected from official sources and assessed across the dimensions in the agency's HTA manual, with the final incorporation decision as the outcome. As ANS issues no global certainty rating, evidence certainty was reconstructed from its outcome-level assessments and the final decision reports documenting each acceptance or rejection; dossiers were reviewed to cross-check the economic judgement. A classification tree (CART) was fitted by recursive binary partitioning to rank the drivers of incorporation.
RESULTS: 54 of 81 medicines (67%) were incorporated. The tree discriminated incorporated from non-incorporated medicines (accuracy 83%; AUC 0.87), revealing a clear hierarchy. Evidence certainty was dominant, yet rated high in only 2 submissions, moderate in 34, and low in 45. Where certainty was high or moderate (n=36), incorporation was near-universal: 100% for disruptive benefit, and for incremental benefit declining as system-wide budget impact grew (100% under savings, 92% at R$0-30M, 73% above R$30M). Among the 45 low-certainty submissions, almost half were incorporated (49%), the decision turning on economics: 93% under savings, but 32% at R$0-30M and 25% above R$30M. Dossiers showed the agency reconstructed proponents' budget-impact models, often excluding downstream clinical costs, and applied this scoping inconsistently across comparable submissions.
CONCLUSIONS: Incorporation followed a predictable logic, but budget impact became decisive precisely where clinical certainty was considered weakest by ANS’ assessment, the most common scenario. There, access hinged on an economic analysis that was both simplified and inconsistently applied, leaving genuinely uncertain technologies on a fragile basis for decision.
METHODS: All 81 medicine submissions from 2021 to 2025 were collected from official sources and assessed across the dimensions in the agency's HTA manual, with the final incorporation decision as the outcome. As ANS issues no global certainty rating, evidence certainty was reconstructed from its outcome-level assessments and the final decision reports documenting each acceptance or rejection; dossiers were reviewed to cross-check the economic judgement. A classification tree (CART) was fitted by recursive binary partitioning to rank the drivers of incorporation.
RESULTS: 54 of 81 medicines (67%) were incorporated. The tree discriminated incorporated from non-incorporated medicines (accuracy 83%; AUC 0.87), revealing a clear hierarchy. Evidence certainty was dominant, yet rated high in only 2 submissions, moderate in 34, and low in 45. Where certainty was high or moderate (n=36), incorporation was near-universal: 100% for disruptive benefit, and for incremental benefit declining as system-wide budget impact grew (100% under savings, 92% at R$0-30M, 73% above R$30M). Among the 45 low-certainty submissions, almost half were incorporated (49%), the decision turning on economics: 93% under savings, but 32% at R$0-30M and 25% above R$30M. Dossiers showed the agency reconstructed proponents' budget-impact models, often excluding downstream clinical costs, and applied this scoping inconsistently across comparable submissions.
CONCLUSIONS: Incorporation followed a predictable logic, but budget impact became decisive precisely where clinical certainty was considered weakest by ANS’ assessment, the most common scenario. There, access hinged on an economic analysis that was both simplified and inconsistently applied, leaving genuinely uncertain technologies on a fragile basis for decision.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA383
Topic
Health Technology Assessment
Topic Subcategory
Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas