Brasília – The Drug Market Regulation Chamber (CMED) is advancing discussions on new pricing methodologies for advanced therapies, as current regulations fail to adequately address these high-cost and complex treatments. During a recent workshop, regulators highlighted that such products are currently treated as “omitted cases,” leading to slower, less transparent decisions and increased regulatory uncertainty.

Authorities signal a shift away from traditional external reference pricing, which is seen as insufficient for these therapies, and are evaluating alternative models such as value-based pricing, performance-based payments, installment schemes, and risk-sharing agreements. A specific resolution is under development and expected to go to public consultation in the coming months, aiming to improve predictability while balancing innovation, access, and system sustainability.

Source: Futuro da Saúde