Brasília – Advanced therapies are gaining prominence globally as promising solutions for rare diseases, cancers and conditions with limited therapeutic options. According to Futuro da Saúde, the high cost, regulatory and infrastructure demands, limited long-term safety data and complex manufacturing processes pose serious challenges to their adoption in Brazil, raising urgent questions about how to price these therapies in a way that balances innovation, access and sustainability.

The article notes that the national pricing regulator CMED has opened — between February and March 2025 — a public consultation to receive contributions on how to define prices for Advanced Therapy Products (ATPs), since the current norm from 2004 does not cover these new technologies and treats them as “omitted cases.” Meanwhile, only a handful of these therapies are registered in Brazil, far behind regulatory agencies in the United States and Europe. Experts warn that without a modernized pricing framework and alternative financing or reimbursement models — for example based on value or outcomes — Brazil risks limiting access to these transformative treatments and compromising the sustainability of the public and private health systems.

Source: Futuro da Saúde