Recently, the Pharmaceutical Products Industry Union (Sindusfarma) obtained an injunction from the Federal Regional Court (TRF) of the 3rd Region, in São Paulo, suspending the decision of the National Supplementary Health Agency (ANS) to adopt new rules for the evaluation of advanced therapies, from September 2023. The information was published exclusively by Portal Futuro da Saúde.
Exclusive: pharmaceutical industry obtains an injunction suspending ANS decision on advanced therapies
In the last quarter of last year, the ANS filed an appeal that suspended Law No. 14,307/2022, which requires that technologies evaluated and recommended by the National Commission for the Incorporation of Technologies into the Unified Health System (Conitec) and incorporated into the Unified Health System (SUS) must also be included in the ANS list within 60 days. Currently, six advanced therapies are registered with Anvisa, all of which are very expensive.
In that context, the ANS issued a technical note that changed the rules for advanced therapies, stating that they must undergo Health Technology Assessment (ATS) to be included (or not) in the list of health plan procedures. The argument used by the Agency was that these drugs are complex and innovative and, therefore, should undergo technical evaluation before the process of incorporation into the list of procedures, as well as through the process of social participation. For this reason, there was pressure from health plans for ANS to act.
In 2023, ABHH published a Technical note addressed to the CEO of ANS, Paulo Rebello Filho, where he clarified the importance of advanced therapies in onco-hematological treatment; in particular, patients with Acute Lymphoblastic Leukemia (ALL), Non-Hodgkin Lymphoma and Multiple Myeloma, and about the Association's efforts to make these technologies available in public and private health networks in Brazil. On the same note, the ABHH expressed concern that a separate regulatory process would further delay the effective use, especially, of CAR-T therapy, leading to a worsening of the patients' clinical condition. The Association's position was based on scientific criteria and the use of ABHH's own Consensus on Genetically Modified Cells.
In view of the injunction granted by the TRF of the 3rd Region to Sindusfarma in March of this year, ABHH is once again available to contribute to the country's regulatory agents, in an ethical, technical and scientific manner, allowing the use of advanced therapies and ensuring equity in safe access to these technologies by patients in the health systems.
