STJ: plan must pay for ‘off-label’ medicine for cancer – 09/12/2023 – Health

Health plans may be required to pay for medications prescribed by doctors for illnesses that are not specified in their respective leaflets, according to a judgment concluded on June 12 by the 4th Panel of the STJ (Superior Court of Justice).

Known by the English term “off-label”, the practice is a frequent subject of lawsuits filed by hospitalized people (hospital or home) and by cancer patients who take medication at home, according to lawyers specializing in supplementary health consulted by Sheet.

According to the collegiate’s judgment, if the medicine is registered with Anvisa (National Health Surveillance Agency), the operator’s refusal to treat is abusive. This applies to the “off-label” indication, made by the doctor, and also to treatments considered experimental.

Applied specifically to res judicata, the determination can influence decisions on processes in which the same right is sought. But this does not automatically affect ongoing actions or future processes.

To generate this type of cascade effect, the STJ would need to have analyzed the issue as a Repetitive Appeal (when the court defines that a thesis must be applied to identical processes), which did not happen, explains lawyer Franco Mauro Russo Brugioni.

“Of course, it sets an important precedent, as it is a decision by one of the highest bodies of the Judiciary”, says Brugioni.

He also reinforces that it is only through legal action that there is a chance of obtaining the right to pay for “off-label” medication.

The decision is aimed at treatments carried out in the hospital, but there are two exceptions: antineoplastic drugs, which are chemotherapy drugs regularly used in the treatment of cancer and which can be taken at home, and home care authorized by the ANS (National Agency of Health), according to lawyer Bruno Tasso.

It is therefore not possible to apply the decision to other cases of medications prescribed outside the specifications of the leaflet, such as Ozempic. The drug indicated for diabetes has become very popular for weight loss in a short time.

At the origin of the case, a health plan beneficiary filed a lawsuit against the operator to claim the cost of the medication Rituximab. It is an antineoplastic drug indicated in the leaflet for some types of lymphoma and rheumatoid arthritis.

In the patient’s case, however, the medication was administered during hospitalization to treat complications resulting from an autoimmune disease.

When denying coverage, the plan operator SAID that the drug would not be included in the ANS list of health procedures and events.

The rapporteur at the STJ of the appeal presented by the operator, Minister Raul Araújo, highlighted, however, that the court had already admitted the possibility of coverage in the event of there being no therapeutic substitute, under certain conditions.

In the report, the minister highlights, however, that coverage outside the ANS list, which serves as a basic reference, must be analyzed on a case-by-case basis.

“In this scenario, it is concluded that both the jurisprudence of the STJ and the new wording of the Health Plans Law allow the coverage, in an exceptional manner, of procedures or medicines not included in the ANS list, as long as they are supported by technical criteria, whose The need must be analyzed case by case”, concluded Raul Araújo.

Thamy de Souza Ribeiro, a lawyer at the firm that represented the patient, states that it is the practice of most healthcare providers to deny procedures in which the indication on the leaflet does not necessarily correspond to the intended treatment. It turns out that, as in the case of the case in question, the doctor should dictate the procedure or circumstances for using the medicine, not the operator”, says Ribeiro.

She also states that the client’s doctor identified several scientific studies that showed the effectiveness of the medication prescribed for the treatment of lupus. “We also remember that the patient arrived at the hospital in an emergency condition, with great risk of death. We understand that the refusal, in addition to being illegal, is cruel.”

The main representative of the country’s health operators, FenaSaúde said that it did not participate in the process and, therefore, does not have technical details to analyze the case.

ANS stated that it would not comment on the decision.

Alex Sabino collaborated