Brazil’s government is investing heavily in the local manufacture of antiretroviral (ARV) drugs, hindering the market entry of new therapies, says new research.

Brazil’s National Health System (SUS) currently provides coverage for 22 drugs distributed free to over 300,000 people with HIV, says the study, from Decision Resources. 

Covered medicines are provided free to eligible patients under the Strategic Program for Pharmaceutical Assistance (CESAF), managed at state and municipal levels. Drugs not covered by the SUS, including fixed-dose combinations (FDCs) - Gilead’s Truvada (emtricitabine and tenofovir disproxil fumarate),plus  Kivexa (abacavir and lamivudine) and Triovir (abacavir, lamivudine and zidovudine), both from GlaxoSmithKline - must be paid for out of pocket or accessed via judicial action.

Physicians surveyed for the study indicate that fewer than 10% of patients in Brazil receiving a nucleotide reverse transcriptase inhibitor (NRTI) are treated with an FDC-NRTI, says DR.

Access to ARVs in Brazil is strictly defined by government-issued Clinical Protocol and Therapeutic Guidelines (PCDTs), through which the Ministry of Health restricts the use of new, premium-priced treatments to third-line therapy, following proven failure of less-expensive treatments. 

Moreover, although providing access to several ARV brands, Brazil has historically threatened compulsory licensing to contain the costs of purchasing HIV drugs, which it considers to be in the public interest. Also, in the past six years, it has excluded certain HIV therapies from patent protection - Gilead/United Medical’s Viread (tenofovir disoproxil fumarate) and AbbVie’s Kaletra (lopinavir and ritonavir) - and has granted a compulsory license for Merck & Co’s Stocrin (efavirenz).

“The Brazilian government has established Product Development Partnerships [PDPs] with domestic and foreign manufacturers to locally produce and supply the SUS with a single-tablet regimen [STR], an FDC and important new third-line ARVs such as Merck & Co’s Isentress [raltegravir],” comments DR analyst Dr Denise Ferreira.

“Payers believe that from the moment the ARVs from these PDPs become available, the recommendation from the PCDT may change to accommodate use of these drugs in early lines of therapy,” she adds.

The report also finds that the STR market in Brazil is unexploited, and that STRs Atripla (efavirenz, emtricitabine and tenofovir) Eviplera (emtricitabine, rilpivirine and tenofovir), both from Gilead, are not yet approved in this market.  Payers indicate that STRs combining novel agents, or agents currently not covered by the SUS, may see future reimbursement, pending demonstration of cost-effectiveness compared with currently-funded ARVs, it adds.