Brazil National Health System coverage of and access to HIV drugs

Brazil’s National Health System (SUS) currently provides coverage for 22 drugs that are distributed free of charge to more than 300,000 HIV-infected patients in the country, according to a new report from health care advisory firm Decision Resources.

Covered drugs are provided free of charge to eligible patients under the Strategic Program for Pharmaceutical Assistance (CESAF), managed at state and municipal levels. Drugs not covered by the SUS, such as the fixed-dose combinations (FDCs) Gilead Sciences’ (Nasdaq: GILD) Truvada (emtricitabine/tenofovir disoproxil fumarate), GlaxoSmithKline’s Kivexa (lamivudine and abacavir sulfate) and GlaxoSmithKline’s Triovir, must be paid for out-of-pocket or accessed via judicial action. Surveyed physicians indicate that less than 10% of patients receiving a nucleotide reverse transcriptase inhibitor (NRTI) receive treatment with FDC-NRTI.

The special report, titled HIV in Brazil: Physician & Payer Perspectives on the Market Access Hurdles and Levers that Impact this Dynamic Market, finds that access to antiretroviral (ARV) therapies is strictly defined by government-issued guidelines, known as the Clinical Protocol and Therapeutic Guidelines (PCDTs). The Ministry of Health, through the PCDTs, restricts the use of new, premium-priced therapies to third-line therapy, following proven failure of less costly therapies.

Government has used compulsory licensing threat to contain costs