Brazil's National Health System Currently Provides Coverage for 22 Drugs that are Distributed Free of Charge to Over 300,000 HIV-Infected Patients
The Brazilian Government is Heavily Investing in the Local Manufacturing of ARVs, Hindering Market Entry of New Drugs, According to a New Report from Decision Resources
BURLINGTON, Mass., Dec. 23, 2013 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that 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. 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's Truvada, GlaxoSmithKline's Kivexa and GlaxoSmithKline's Triovir, must be paid for out-of-pocket or accessed via judicial action. Surveyed physicians indicate that less than 10 percent of patients receiving a nucleotide reverse transcriptase inhibitor (NRTI) receive treatment with FDC-NRTI.
The special report entitled 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. Moreover, while providing access to several ARV brands, the Brazilian government has historically threatened imposing compulsory licensing to contain the costs associated with the purchase of HIV drugs, which it considers to be of public interest. Moreover, in the past six years the government has excluded certain HIV therapies from patent protection (Gilead/United Medical's Viread and AbbVie's Kaletra), and has granted a compulsory license for Merck's Stocrin.
"The Brazilian government has established Productive 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's Isentress," said Decision Resources Analyst Denise Ferreira, Ph.D. "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."
The report also finds that the STR market is unexploited in Brazil, and that Gilead's Atripla and Gilead's Eviplera STRs 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.
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