Pharmacists consider going to court against new rule for health plan coverage – 09/12/2023 – Market

At a time when the health insurance sector is going through a crisis with unprecedented operational losses, the pharmaceutical industry is evaluating an offensive in court to question a new rule from the ANS (National Supplementary Health Agency).

Released by the regulatory body last week, the measure determines that products classified by Anvisa as advanced therapy must undergo technical analysis and social participation stages, such as hearings and public consultations, before being included in the list of mandatory coverage guaranteed by health care operators. health insurance.

Entities representing large drug manufacturers are considering going to court against the determination. According to the industry, the rule creates a new obstacle for the category that covers biological products obtained from human cells and tissues subjected to a manufacturing process.

Recombinant nucleic acids, DNA or RNA molecules manipulated in the laboratory to combine parts of genetic material from different sources, also fall into the category.

“We are seriously thinking about taking legal action, on behalf of our members who have these products”, says Nelson Mussolini, president of Sindusfarma, a union that brings together large pharmaceutical companies.

In the view of Renato Porto, president of Interfarma, another industry entity, there was a lack of debate with all links in the sector before the measure was approved. He states that this is yet another obstacle to patient access to treatment.

“We were surprised by this decision. We are carrying out a technical-regulatory assessment of this scenario and, at the same time, a legal assessment to see if we are going to take it to court”, says Porto.

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.

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.

In a note to Sheet, the pharmaceutical company states that it has been following the discussion. According to the company, this is a broad topic that concerns the entire healthcare ecosystem.

According to the ANS technical note, the products in question are not common medicines, but a “chain of gene production and manipulation, involving steps that, according to health regulations, need to be established and registered for proper use”.

Also according to the document, “even when carrying out the entire process in a standardized way and within specifications, there is ultimately a risk that the product to be dispensed and applied does not meet the necessary characteristics established as clinical criteria for the product’s effectiveness” .

Contacted by the report, the ANS states that its decision “was intended to protect the consumer, as it makes the study of therapy through the evaluation of health technologies essential and prioritizes social participation”, says the body in a statement.

Among the points of the analysis to define the new rules, the agency also says that the need to create specific regulations on the subject and the preparation characteristics of some of these products suggest that they are not comparable to medicines previously registered with Anvisa, both due to the complexity of its production and its cost.

Cassio Ide Alves, medical superintendent at Abramge (an association that brings together health plan companies), states that the issue of financial sustainability is, in fact, one of the pillars in the evaluation of health technologies, alongside effectiveness and safety, but this product category requires attention.

“We are talking about gene therapy. If there are any complications in the population in terms of genetic inheritance, who is responsible?”, says Alves.

In a statement released on the subject, FenaSaúde (sector federation) says it sees scientific rigor in the new rules established by the ANS for the coverage of advanced therapy treatments.

“These therapies are complex and innovative in nature. Therefore, a careful approval process guarantees greater safety for the health of patients”, says the executive director of FenaSaúde, Vera Valente, in a statement.