OBJECTIVES:

To evaluate Brazil’s maturity in adopting innovative agreements for ATPM

METHODS: Analysis of normative acts and government technical documents, and statements by health managers at public events.

RESULTS: Advanced therapies in Brazil face access barriers, with the cheapest one costing around US$300 thousand. Conitec, the health technology assessment (HTA) body, denied the incorporation of Luxturna in 2021, arguing for its high financial impact and uncertainties on its long-term efficacy and effectiveness. In this scenario, we argue that innovative agreements can address this kind of access barriers for ATMP in Brazil by supplying the therapy while conditioning the incorporation to its real-life performance.

This thesis is supported by previous local experiences in negotiations of risk-sharing agreements (RSA) for rare disease therapies, which provided a normative basis, such as the nursinersena’s risk-sharing Ordinance. Even though the agreement did not work out, the Ordinance is wide enough to be applied in future cases. Furthermore, the Brazilian new law on bids encourages innovative agreements as it makes it possible for public administration to (i) request the industry for innovative solutions and (ii) establish variable payment fees according to the service’s performance.

In addition to legal framework, an analysis of the number of events and the discourse promoted by public managers suggests that the topic has gained space and supporters in policy arenas. More recently, this political interest of authorities in this area is being reversed in the second attempt to implement agreements of this type, now for alemtuzumab, which reinforces Brazil’s maturity in adopting these agreements also for ATPM.

CONCLUSIONS: Considering the current legal framework and discussions propelled by government stakeholders, this paper defends that the discussion around the guarantee of access to advanced therapies is pervaded by innovative agreements, which have increasingly gained the attention and affinity of public officials.