Brasília — The Supreme Court has ruled that private health plans in Brazil may be required to cover medical treatments or procedures not listed in the ANS’s mandatory list, but only if all of the following five conditions are met:

1 – The treatment must be prescribed by a qualified physician or dentist.

2 – There must be no formal refusal by ANS to include the procedure, nor an ongoing update process concerning that treatment.

3 – There must be no adequate and effective alternative treatment already included in the ANS list.

4 – The treatment must be supported by robust scientific evidence of efficacy and safety, such as randomized clinical trials, systematic reviews or meta-analyses.

5 – The drug or technology must be registered and approved by Anvisa.

The court emphasized that the ANS list remains the main reference, but with “mitigated taxativity,” meaning exceptions are possible under strict conditions. Judicial decisions must also comply with these criteria, taking into account prior requests to health plans and data from technical bodies such as NATJUS.

The ruling relates to Law 14.454/2022, which altered Law 9.656/1998 to make the list more open and flexible. While patient advocates warn that access to treatments may become more restrictive, health plan operators expect the decision will reduce litigation and generate cost savings estimated at around R$ 25 billion.

Source: O Estado de S.Paulo

Would you like a complete analysis on this? Contact us at pharmabrnews@gmail.com