When the medicine comes through the courts: access to pembrolizumab in Brazil

The background

Pembrolizumab is one of the leading cancer immunotherapy drugs and has dozens of approved uses in Brazil. In the public health system, however, access is limited, and many patients turn to the courts. To help judges, a national technical unit, NAT-Jus, issues expert opinions on each request.

What we did

We analyzed every national expert opinion on pembrolizumab issued between January 2019 and March 2024: 1,288 cases.

What we found

• The vast majority of requests, 83%, were for uses already approved by Anvisa, Brazil's drug regulator.
• The most frequent cases were melanoma (41%), lung (16%) and kidney (11%).
• Among unfavorable opinions, the main reasons were missing test results in the case file and the drug being requested for the wrong indication.
• PD-L1, a test that helps determine whether immunotherapy is appropriate for several tumors, was reported in only 14% of cases.

What this means for you

Many of the denials are not about the drug itself but about incomplete paperwork. If you need to seek treatment this way, a detailed medical report, with the diagnosis, the tumor test results and a justification based on clinical studies, makes a difference.

What lies ahead

A September 2024 ruling by Brazil's Supreme Federal Court gave more weight to the recommendations of CONITEC, the committee that evaluates which drugs are added to the SUS, Brazil's public health system. Because CONITEC recommends pembrolizumab only for advanced melanoma, access through the courts is likely to become more restricted. It is an important debate about how to make sure medical advances reach the people who need them.

For information only. It does not replace an individual medical assessment or individual legal advice.