Pharmacists ask the court to annul ANS rule on gene therapy – 12/22/2023 – Health

Pharmacists filed a lawsuit in the 10th Civil Court of São Paulo to annul an ANS (National Supplementary Health Agency) rule that determines that products classified as advanced therapy must undergo technical analysis and stages of social participation, such as hearings and public consultations, before being included in the list of mandatory health plan coverage.

The action, with a request for an injunction, came from Sindusfarma (Pharmaceutical Products Industry Union). Interfarma (Association of the Pharmaceutical Research Industry) requested to join as amicus curiae (interested entity), so that it can petition and provide support to the process.

According to pharmaceutical companies, the ANS standard has formal defects, such as the lack of regulatory impact analysis and there are conflicts with deliberations already made by Anvisa (National Health Surveillance Agency).

In general terms, the ANS understands that advanced therapies would not be included in the existing coverage rules in supplementary health because they would not fit into the concept of medicines in general.

In the action, the pharmaceutical companies ask that the rule be annulled and, consequently, that advanced therapy medicines be automatically included in the ANS list.

Advanced therapies are biological products obtained from human cells and tissues that have undergone a manufacturing process. Also included in the category are recombinant nucleic acids – DNA or RNA molecules manipulated in the laboratory to combine parts of genetic material from different sources.

The aim of these therapies is to regulate, repair, replace, add or delete a genetic sequence or modify the expression of a gene. Anvisa gave them a special classification.

For ANS, due to the complex and innovative nature of these treatments, only by submitting these products to the agency’s technical analysis and the screening of social participation can there be a safe, effective and sustainable incorporation, which takes into account the benefits, risks, uncertainties and high costs inherent to this type of product.

In a note, Sindusfarma argues that ANS did not widely discuss the issue and usurped the prerogative of another agency, Anvisa. “I wanted to redefine in a mere ‘technical note’ a concept adopted by all major international health regulatory agencies, which classify new biological technologies of advanced therapy as ‘medicine'”, he says.

Interfarma informs that, as amicus curiae, it will reinforce formal defects, the conflict of competence with Anvisa and impacts on society to bring greater robustness and credibility to the arguments.

The two entities joined the ANS with a request to open a regulatory process on advanced therapies so that everyone involved can be heard.

For Interfarma, the technical note as proposed by the ANS is a fragile instrument that does not have the necessary robustness and can create a very unstable scenario for patient access due to the denial of such treatments by health plans. health.

” Interfarma understands that the ANS decision is a barrier to patients’ access to advanced therapy medicines, as it excludes from the list of mandatory coverage of health plans, established by law, products registered with Anvisa in the “therapy medicine” category. advanced.”

In a note, ANS informed that it does not comment on legal actions before the decision becomes final.

Abramge (Brazilian Association of Health Plans) says that it is strange and regrets the commercial pressure from the international pharmaceutical industry for the automatic incorporation of advanced therapies in the coverage of health plans in Brazil, which goes against the grain of the process carried out around the world. , including in the headquarters countries of large manufacturers.

“It is essential to differentiate between the health registration of a technology and the incorporation of a technology into a care list. Obviously, scientific evidence on safety, efficacy and cost-effectiveness must be more robust due to the clinical, social and economic implications.”

Abramge recalls that in the United States, the FDA, the drug regulatory agency, is investigating what it called a “serious risk” of malignancies, such as hospitalizations and death generated by advanced therapies without robust evidence of safety and effectiveness.

“Once again, Brazil runs the risk of medicines and other technologies being tested on health plan beneficiaries, as the aim is to eliminate the need for any more in-depth study that proves clinical benefit, safety, efficacy and cost-effectiveness, that is, we can become a great experimental field for international laboratories.”

Fenasaúde (National Supplementary Health Federation), representing the main health plan operators in the country, says that it considers it essential for patient safety to maintain the rules established by the ANS for the coverage of advanced therapy treatments.

“Therapies of a complex and innovative nature require long-term monitoring, regardless of the presentation of promising initial results. Therefore, a careful approval procedure, as happens in all countries around the world, guarantees greater safety for the health of patients.”

For now, there are only five registrations in the advanced therapies category, which includes products for rare diseases or oncology treatment lines manufactured by Novartis, Janssen and Gilead. Many families have gone to court to obtain them.

One of them is Zolgensma, from Novartis, whose high cost – which can exceed R$8 million, according to operators – has been worrying executives in the health plan sector.

Also classified as an advanced therapy, Kymriah works by removing T cells from the patient’s blood to insert a new gene and target the body’s cancer cells, according to the manufacturer Novartis.