CRITICAL ASSESSMENT OF PRICING PATHWAYS AND REGULATORY CLASSIFICATION OF ATMPS APPROVED IN BRAZIL
Author(s)
Erika Resende, Master1, Helaine Capucho, PhD1, Rafael Raimondi Coelho, Master1, Ligiane Alves de Oliveira Silva, Master1, Aline Santos, Master1, Renato Porto, Bachelor's1, Renato Mantelli Picoli, PhD2, Alef Almeida, Master2, Aline Mauch dos Santos, Master2.
1Interfarma – Associação da Indústria Farmacêutica de Pesquisa, São Paulo, Brazil, 2Oracle Life Science, São Paulo, Brazil.
1Interfarma – Associação da Indústria Farmacêutica de Pesquisa, São Paulo, Brazil, 2Oracle Life Science, São Paulo, Brazil.
OBJECTIVES: In Brazil, pharmaceutical pricing is regulated by the Drug Market Regulation Chamber (CMED) under CMED Resolution No. 2/2004 and recently under Resolution No. 3/2025, which establish categories for determining prices. Cases that do not fall within the categories set forth in the resolution are classified as "Omitted Cases" and are analyzed on a case-by-case basis. This study aimed to characterize the pricing pathways and regulatory classification of Advanced therapy medicinal products (ATMP) approved in Brazil.
METHODS: A documentary review, based on CMED’ official pricing assessment reports of all 7 ATMPs approved in Brazil, was conducted. Following that, pricing classifications, rationale for price determination, and reference pricing approaches were identified and assessed.
RESULTS: Manufactures submitted 6 ATMPs pricing requests under Res 2/2004’ Category I (novel patented medicine in Brazil with proven clinical benefit added) and 1 under Category II (novel medicine that do not meet Cat I criteria). Despite that, all of them were assessed as "Omitted Cases", based on a similar rationale: ATMPs should be assessed case-by-case because of the specific features of each one, even that they were novel therapies in Brazil subject, then, to categories I e II pathways. Regarding pricing decisions, they were predominantly based on the lowest international price validated by CMED, regardless of whether manufacturers had submitted alternative international reference prices in their pricing dossiers.
CONCLUSIONS: Although ATMPs had been submitted to CMED into categories I e II, CMED priced them systematically as "omitted cases", in the sake of their “specific features”. This may suggest room for improvements on how CMED handles evidence for these new types of medicines, enabling the application of established pricing processes for innovative products like ATMPs. Treating them as “omitted cases” and employing specific frameworks for these medicines might increase uncertainty and disincentive the launch of ATMPs in Brazil.
METHODS: A documentary review, based on CMED’ official pricing assessment reports of all 7 ATMPs approved in Brazil, was conducted. Following that, pricing classifications, rationale for price determination, and reference pricing approaches were identified and assessed.
RESULTS: Manufactures submitted 6 ATMPs pricing requests under Res 2/2004’ Category I (novel patented medicine in Brazil with proven clinical benefit added) and 1 under Category II (novel medicine that do not meet Cat I criteria). Despite that, all of them were assessed as "Omitted Cases", based on a similar rationale: ATMPs should be assessed case-by-case because of the specific features of each one, even that they were novel therapies in Brazil subject, then, to categories I e II pathways. Regarding pricing decisions, they were predominantly based on the lowest international price validated by CMED, regardless of whether manufacturers had submitted alternative international reference prices in their pricing dossiers.
CONCLUSIONS: Although ATMPs had been submitted to CMED into categories I e II, CMED priced them systematically as "omitted cases", in the sake of their “specific features”. This may suggest room for improvements on how CMED handles evidence for these new types of medicines, enabling the application of established pricing processes for innovative products like ATMPs. Treating them as “omitted cases” and employing specific frameworks for these medicines might increase uncertainty and disincentive the launch of ATMPs in Brazil.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
PT32
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas