São Paulo – A São Paulo court rejects a request from Sindusfarma to suspend the National Supplementary Health Agency’s rule that all advanced therapies must undergo formal Health Technology Assessment before being considered for mandatory coverage in private health plans. The decision endorses ANS’s position that these products demand differentiated evaluation due to their complexity, cost and clinical risks.

ANS argues that gene therapies, cell therapies and other high-cost biologics require structured evidence review to assess safety, therapeutic benefit and cost-effectiveness. Sindusfarma maintains that therapies already approved by the regulatory authority should be automatically covered and indicates it will appeal the ruling, potentially taking the case to the Supreme Federal Court.

Source: Futuro da Saúde