HIV is a high-cost category with an increasing number of competitors, even as the number of generics grows as well. To help stakeholders absorb datapoints and perceptions from all directions and synthesize those insights into a tangible strategy for HIV, Zitter Insights surveys a leading panel of pharmacy and therapeutics (P&T) decision makers at payers and integrated delivery networks. The Managed Care Biologics and Injectables Index combines deep payer insights with the industry standard in market access information to produce quarterly reports and insights summaries on leading biologic brands.
Among P&T members who said that HIV has an above-average cost burden for their organization, the top strategy by covered lives was seeking portfolio contracts with manufacturers over the past 12 months (see chart below). Other strategies included implementing or evaluating copay accumulators and deferring more costs to members through copay or coinsurance increases. Multiple respondents said they had deferred costs by placing recent brand launches on the highest formulary tier. Some respondents had not implemented any cost-saving initiatives within the past 12 months.
P&T members said ViiV Healthcare’s Triumeq (abacavir/dolutegravir/lamivudine) is the top therapy by covered lives with which payers currently are engaged in a preferential utilization rebate-based contract. Gilead Sciences, Inc.’s Truvada (emtricitabine/tenofovir disoproxil fumarate) is the top treatment with which payers anticipate they will engage in contracting within the next 12 months, as generic competitors prepare to launch.
In April 2019, the FDA approved ViiV’s Dovato (dolutegravir/lamivudine) to treat HIV-1 infection in adults with no antiretroviral treatment history and no known resistance to the drug’s components. P&T members from surveyed payers covering 28% of total lives say they anticipate covering the therapy without prior authorization six months from now. They say clinical differentiation is the most influential factor in their anticipated management of Dovato (see chart below).
In July 2020, ViiV resubmitted a New Drug Application to the FDA for Cabenuva (cabotegravir/rilpivirine) to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to the drug’s components. Dosing would be once monthly via intramuscular injection by a health care professional. P&T member respondents say the most likely management strategy is to manage the drug at parity with certain HIV drugs, with Gilead’s Atripla (efavirenz/emtricitabine/tenofovir disoproxil) cited as a top drug for that tactic.
Nearly half of responding physicians said Dovato’s side effect profile is the most influential factor in prescribing the tablet, followed by its once-daily dosing regimen. When those respondents were asked about their anticipated actions if Cabenuva is approved, more than two-thirds said they were likely to prescribe it for patients who have had a history of adherence issues. The top factors they cited for their anticipated prescribing were route of administration and dosing regimen.
Message: “Potential advantages of cabotegravir include its administration schedule: given monthly by health care provider, which is theorized to improve adherence since doctor will know if patient receives it or not, but data is needed to confirm this hypothesis. However it requires two gluteal injections every month.”
Payer Thoughts: “It will be really interesting to see what utilization of this product is like. I think the company will fare better if they have a more patient-friendly formulation (one injection instead of two, subcutaneous instead of intramuscular). Until then, I don’t see a broad population of HIV patients utilizing this product instead of an oral therapy. Even though survey responders favored the product, this was a selected population that chose to enroll in the study and use an intramuscular injection in the first place.”
Generic Truvada Will Impact PrEP Coverage
A generic version of Gilead Sciences, Inc.’s Truvada (emtricitabine/tenofovir disoproxil fumarate) coming onto the market in 2020 will affect how payers cover pre-exposure prophylaxis (PrEP), but it will not significantly change how payers cover HIV drugs.
New Generic HIV Drugs Have Limited Impact
Though several new generics for HIV/AIDS are on deck for the U.S., they likely won’t create significant disruptions to the market due to the complexity of HIV/AIDS treatment and the current use of combination therapies.