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Research & Reports

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The Approaching Cliff: How Will the Availability of Generic Antiretrovirals Impact the EU5 Prescribing and Reimbursement Landscape for Current and Emerging Brands in HIV?

This report explores the dynamics that affect sales of current and emerging antiretroviral (ARV) therapies used for the management of HIV infection. In particular, the report assesses the impact of the growing availability of generic versions of key HIV ARVs, such as Bristol-Myers Squibb’s Sustiva (efavirenz), amid the launch of new, premium-priced treatment options, including integrase inhibitors and integrase inhibitor-based single-tablet regimens (STRs), such as Gilead’s Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) and ViiV’s 572-Trii (dolutegravir/abacavir/lamivudine).

The availability of once-daily treatment options with high efficacy and good safety profiles has transformed HIV into a manageable, chronic illness for most patients. However, the requirement for expensive, daily ARV therapy places a considerable burden on the cost-constrained public health systems and prescription drug coverage programs in the EU5 markets. The expected launch in Europe of generic versions of commonly prescribed ARV drugs will lead to increasing use of generics. Importantly, the availability of generic versions of components of heavily prescribed regimens that combine multiple ARVs into a single pill may force EU5 physicians to shift prescriptions from STRs, such as Gilead/Bristol-Myers Squibb’s Atripla (efavirenz/emtricitabine/tenofovir), to multi-pill regimens combining generics (i.e., efavirenz) with branded fixed-dose combinations (FDCs), such as Gilead’s Truvada (emtricitabine/tenofovir disoproxil fumarate) or ViiV’s Kivexa (abacavir/lamivudine).

Questions Answered in This Report:

  • Current prescribing trends and impact of generics: Which currently available ARVs do European physicians prescribe most? What does an analysis of these prescribing patterns reveal about the impact of payer policies on reimbursement and uptake of key branded ARVs? How will this evolve over the next 2-3 years as the patent cliff arrives? What are physicians’ perceptions of the impact of emerging generics on current and future ARV prescribing decisions? Are European payers likely to mandate that physicians switch patients currently receiving STRs to multi-pill regimens utilizing generic ARVs?

  • Market access challenges and outlook for emerging therapies: What are physicians’ perceptions of emerging ARV therapies? Which current therapies do they think are most at risk of losing market share to emerging treatment options? To which patient populations will physicians prescribe emerging treatments? How might hospital and community funding mechanisms impact access to novel ARVs? What budgetary constraints do prescribers and payers face, and how might these evolve in the next few years? What attributes must an emerging therapy offer to secure favorable HTA review, optimal pricing and reimbursement, and maximal formulary inclusion?


Decision Resources’ European Physician & Payer Forum report “The Approaching Cliff: How Will the Availability of Generic Antiretrovirals Impact the EU5 Prescribing and Reimbursement Landscape for Current and Emerging Brands in HIV?” explores the many clinical and funding/budgetary/reimbursement factors that affect the use and sales of ARVs for the treatment of HIV infections. It draws insights from 270 surveyed ARV therapy prescribers in the EU5, and from 15 interviewed European payers, to explore how increasing availability of generic ARVs will affect sales of premium-priced branded agents, including coformulated FDCs and STRs, and examine levers and barriers that will promote or restrict market access for key emerging therapies. Interviewed payers, all of whom have influence at a national or regional level, include the following:

- France: A past member of the Transparency Commission (CT) who advises the High Authority for Health (HAS) on market access, pricing, and reimbursement. Hospital Pharmacy Directors.

- Germany: Key opinion leader with expertise in quality assurance, quality management, drug budget guidance, managed care, and disease management. Provides medical guidance to the Joint Federal Committee of Physicians, Dentists, Hospitals, and Health Insurance Funds (GBA) as a trained physician. A Pharmacy Director of a large university hospital.

- Italy: A regional hospital formulary (PTOR) member with responsibility for assessing new drugs for formulary inclusion, and a hospital formulary (PTO) co-chair with responsibility in the drug evaluation and tendering process. Regional payers and Chief Pharmacists.

- Spain: Consultant for the Ministry of Health, and hospital pharmacy committee member.  Hospital Pharmacy Director. Regional Formulary Committee member.

- United Kingdom: National Institute for Health and Care Excellence (NICE) Technology Appraisal committee member with responsibility for evaluating new drugs at national level, and hospital program director who sits on the local NHS commissioning board. Head pharmacist and formulary committee member. Local Authority Head of Medicines Management with responsibility for commissioning for drugs in primary and secondary care.