The Brazilian Supplementary Health Agency approves rules regarding coverage of advanced therapies

September 5, 2023

The ANS (Brazilian Supplementary Health Agency), at its Board Meeting which took place this Monday (September 4), debated the rules regarding coverage of advanced therapies. The Agency is against the inclusion of these therapies in the list of ANS-covered procedures without the individual approval of the therapy in accordance with the procedure for updating the list.

In February 2023, the Agency had published a technical note claiming that advanced therapies already approved by the Brazilian Food and Drug Agency (ANVISA) were not comparable to other types of drugs for purposes of inclusion in the coverage list. Their grounding was that different rules would have to be set before these technologies were incorporated in the list of covered products, given that they are highly complex to produce, costly, and require continuous monitoring by ANVISA. Based on this understanding, the ANS argues that specific and stricter regulations are necessary, observing the peculiarities of these new therapeutic options.

According to the Agency, advanced therapies must be treated as a special category of medication, the coverage of which, whether for ambulatory or hospital use, must always undergo the ANS list update process, in accordance with Normative Resolution #555/2022. This process takes place by analyzing a proposal to update the Agency’s list, as well as the later approval or disapproval of the proposal by the ANS Collegiate Board. Furthermore, this inclusion may take place when the technology is incorporated into the Brazilian Public Healthcare System (SUS), which makes mandatory the inclusion of the therapy into the Agency’s list within 60 days.

This understanding aligns with the interests of healthcare providers, who still lack a defined strategy to support the financial impact which will be created by including advanced therapies in the coverage list. On the other hand, this perspective does not consider the interests of patients, who see these new therapeutic options as their last hope for a cure or a guarantee of quality of life.