Since 1996, the Brazilian government has distributed HIV antiretrovirals (ARVs) free of charge to infected individuals in need of treatment through the National Program of STDs, AIDS and Viral Hepatitis of the Ministry of Health (MoH). This program serves over 300,000 patients regularly and currently includes 21 HIV ARVs. During the past six years, the Brazilian government has proposed bills excluding HIV therapies from patent protection or granted compulsory licenses to certain ARVs (e.g., Merck Sharp & Dohme’s Stocrin [efavirenz] and Gilead/United Medical’s Viread [tenofovir]), while providing certain other brands with coverage by SUS (National Health System) (e.g., Janssen’s Intelence [etravirine] and Abbvie’s Kaletra [lopinavir/ritonavir]) and recommending the inclusion of new agents (e.g., GlaxoSmithKline’s Celsentri [maraviroc], recommended by CONITEC for SUS coverage in October 2012, subject to conditions including late-line use and a price ceiling). Understanding what drives/restricts brand performance in the competitive HIV space in Brazil is crucial for the design of a successful market access strategy in this evolving market. This report explores dynamics that affect sales of current and emerging ARV therapies used for the management of HIV infections in Brazil. This report:
- Assesses the impact of the National Program of STDs, AIDS and Viral Hepatitis of the MoH on patient access to new HIV ARV treatments, alongside the increasing availability of generic versions of key HIV ARVs, such as Bristol-Myers Squibb’s Sustiva (efavirenz) and Gilead’s Viread (tenofovir).
- Examines the market opportunity for single-tablet regimens (STRs), such as Gilead/Bristol-Myers Squibb’s Atripla (efavirenz/emtricitabine/tenofovir) and Janssen/Gilead’s Eviplera (rilpivirine/emtricitabine/tenofovir). These regimens are widely prescribed in the EU5 but have not launched in Brazil where generic versions of the individual components combined in the single pill are widely available.
- Explores the opportunity in Brazil for several novel premium-priced treatment options poised to launch in the United States and Europe, and probe the potential impact of these emerging brands on current brands. Emerging agents in this report include integrase inhibitors and integrase-inhibitor-based STRs, such as Gilead’s Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir) and ViiV’s 572-Trii (dolutegravir/abacavir/lamivudine).
Understanding how the current market access landscape will evolve in the next two to three years if new ARVs and STRs launch in Brazil will be essential for positioning novel treatments and expanding/protecting the penetration of current brands.
Questions Answered in This Report:
Current treatment trends and impact of generics:
What is the diagnosis and referral pattern for newly diagnosed HIV patients? Are there government efforts in place around the diagnosis and prevention of HIV? What is the government’s position on “treatment as prevention,” such as pre-exposure prophylaxis (PrEP)? Which currently available ARVs do Brazilian physicians prescribe most?
How does treatment and access to treatment vary between mono-infected HIV patients and HCV/HIV co-infected patients? What does an analysis of these prescribing patterns reveal about the impact of payer policies on access and uptake of key branded ARVs versus generic formulations? In an increasingly generic market, what are physician and payer perceptions of the role of the novel, premium-priced STRs in the treatment of AIDS in Brazil?
Understand the access and reimbursement environment for ARVs in Brazil:
Which ARVs are included in the RENAME, as part of the CESAF (Strategic Program for Pharmaceutical Assistance), and covered under the National Program of STDs, AIDS and Viral Hepatitis? How do the real limitations of state budgets impact supply and access? To what extent does regional autonomy to deviate from the RENAME impact access to off-formulary agents? What procedures must patients and providing institutions follow in order to receive drugs listed, and not listed, in the drug formularies? How do payers expect access to high-cost brands to evolve in the next three years? Are government initiatives under way to expand access? What can manufacturers do to influence and expand access? Will physicians be able to switch patients currently receiving multi-pill regimens utilizing a mix of generic and branded ARVs to the STRs if they reach the Brazilian market? In what circumstances, and what which patients will qualify?
Market Access challenges and outlook for emerging therapies:
What are physician’s perceptions of emerging ARV therapies? Which current therapies do they think are most at risk of losing market share to emerging treatment options? How will physicians prescribe emerging treatments? What budgetary constraints do prescribers and payers face, and how might these evolve in the next few years? What is the main path for inclusion of new products in the government coverage for HIV treatments? Does a drug need to be part of the AIDS package or may be an isolated inclusion? What attributes must an emerging therapy offer to secure optimal pricing, favorable HTA review from CONITEC, and inclusion in the CESAF? Will the new STRs have a chance of incorporation in the National Program of AIDS? Are Brazilian payers likely to issue compulsory licenses for the emerging STRs? What are payers’ expectations around the price of novel therapies in order to avoid the threat of compulsory licensing agreements?
This Special Report–Market Access covers the prescribing and coverage environment for ARV therapies in Brazil and compares attitudes of physicians and payers to assess how the HIV market access landscape will evolve in the next two to three years as the treatment armamentarium for HIV expands and generics of ARVs increase their penetration. We draw upon insights from 40 surveyed prescribers (infectious disease specialists and internal medicine physicians) and interviews with 3 payers who have influence at a national or regional level:
- Pharmacist responsible for programming and distribution of ARVs in one of the most important reference hospitals for HIV treatment in Brazil
- Special advisor to the MoH for the STD/AIDS program
- Head of pharmacy from a reference center in the STD/AIDS program.