How Will the Availability of Generic Antiretrovirals Impact the Uptake of Branded Single-Tablet Regimens in the United States?

The availability of once-daily single-tablet regimens (STRs) with high efficacy and good safety profiles has transformed HIV into a manageable chronic illness for most patients. However, the need for expensive, daily, lifelong antiretroviral (ARV) therapy can place a considerable cost burden on insurance providers. As a result, the eminent availability of generic versions of components in heavily prescribed regimens may force prescribing physicians to “break up” STRs and shift prescriptions to multi-tablet regimens (MTRs) that incorporate generics.

This U.S. Physician & Payer Forum report explores dynamics that impact uptake of current and emerging ARV agents used for the management of HIV infections. In particular, this report assesses what impact, if any, payer-imposed cost-containment measures will have on physician uptake of branded STRs and other premium-priced ARV agents. In addition to the treatment of HIV infections, this report delves into physician use of Gilead’s Truvada (emtricitabine/tenofovir disoproxil fumarate [TDF]) as pre-exposure prophylaxis (PrEP) for the prevention of HIV infection. Truvada is currently the only FDA-approved ARV agent for use as PrEP. Our findings are based on survey responses from U.S. infectious disease (ID) specialists and U.S. managed care organization (MCO) pharmacy directors/medical directors (PDs/MDs).

Questions Answered in This Report:

  • Companies should be aware of evolving prescribing trends and formulary access considerations for current brands: What are the most prescribed ARV drugs/regimens for the treatment of newly diagnosed and previously diagnosed HIV patients? What are key drivers and constraints for key ARV brands? How are different ARV brands positioned in commercial and Medicaid MCO insurance plans? What formulary/prescribing restrictions are typically associated with popular ARV brands? To what extent are physicians prescribing Gilead’s Truvada for PrEP, and how do they anticipate their prescribing to change in the near future?

  • The impact of generic ARVs on prescribing of STRs is critical to understanding the future of HIV treatment: How will the availability of generic ARVs impact physician prescribing of STRs? What formulary positioning changes to STRs will MCOs implement once generic ARVs are available? How will prescribing physicians respond to payer-implemented mandates for generic prescribing?

  • Learn about formulary access and uptake of emerging therapies in the United States: What current ARV drugs/regimens do ID specialists see as the greatest competitors to key emerging drugs/regimens? Based on available clinical data, how do physicians anticipate prescribing two emerging STRs: Gilead’s TAF-Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [TAF]) and Janssen’s darunavir-containing STR (darunavir/cobicistat/emtricitabine/TAF)? For emerging therapies, which improvements in drug attributes do physicians consider important differentiators from current therapies? How receptive are MCOs to TAF-Stribild, Janssen’s darunavir-based STR, and Merck’s emerging NNRTI doravirine? How do MCOs anticipate positioning these emerging therapies in their commercial and/or Medicaid MCO plans’ formularies?


The Decision Resources U.S. Physician & Payer Forum report “Breaking Up Is Hard to Do: How Will the Availability of Generic Antiretrovirals Impact the Uptake of Branded Single-Tablet Regimens in the United States?” contains insights from a survey of 102 physicians (ID specialists) and 30 MCO PDs/MDs regarding the dynamics that affect prescribing practices and formulary coverage of treatments for HIV infections in the United States. We explore the factors that shape current and future treatment patterns as well as reimbursement trends in the HIV space. Additionally, this report reveals physicians’ and MCO payers’ perceptions of mainstay and select branded HIV drugs/regimens as well as select emerging therapies that are projected to launch in the United States over the next few years.

Markets covered: United States.

Primary research: Online survey of 102 ID specialists and 30 MCO PDs and MDs.

Author(s): Maria Ascano, Ph.D.