MMIT Reality Check on HIV

Payer Coverage:

A review of market access for HIV treatments shows that under the pharmacy benefit, about 11% of the lives under commercial formularies are covered with utilization management restrictions. Around 14% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 48% of the lives under commercial policies are covered with utilization management restrictions. Almost 95% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.

For about 96% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 84% require multiple steps. Around 10% of payer-controlled pharmacy benefit covered lives require prior authorization, with 57% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Expands Cabenuva Label

In February 2022, the FDA expanded the label of ViiV Healthcare’s Cabenuva (cabotegravir/rilpivirine) to include every-two-months dosing for the treatment of HIV-1 in virologically suppressed adults on a stable regimen, with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine. The agency first approved the drug on Jan. 21, 2021. Following oral one-month lead-in dosing with the tablet Vocabria (cabotegravir) with Johnson & Johnson unit Janssen Therapeutics’ tablet Edurant (rilpivirine), the new schedule is Cabenuva 600 mg/900 mg on the last day of the oral lead-in, followed by dosing at month two, month three and then every two months. The cost per dose is around $6,000.

FDA Expands Label of Biktarvy

In October 2021, the FDA expanded the label of Gilead Sciences, Inc.’s Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg) as a lower-dose tablet for the treatment of HIV in pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy. The agency first approved the drug on Feb. 7, 2018. Dosing is one tablet daily. The list price is $3,394.00 per month.

HHS Issues New Guidance on PrEP-Related Services

In guidance issued on July 19, 2021, HHS and the Labor and Treasury departments told health insurers that not only must they cover pre-exposure prophylaxis (PrEP) drugs that prevent HIV with no cost-sharing, they must do the same for services associated with PrEP. That includes provider visits, HIV testing, pregnancy testing and other laboratory tests, the guidance states. Because PrEP received an “A” recommendation from the U.S. Preventive Services Task Force in 2019, starting in January 2021 almost all private health plans were required to cover such therapies at no cost to members. Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, said the group is “pleased that the federal government has issued this long-awaited guidance to insurers that will reduce barriers to PrEP and help prevent further HIV infections while advancing efforts to end HIV in the United States.”

Key Findings:

Market Events Drive Changes

In February 2022, the FDA expanded the label of ViiV Healthcare’s Cabenuva (cabotegravir/rilpivirine) to include every-two-months dosing for the treatment of HIV-1 in virologically suppressed adults on a stable regimen, with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine. In October 2021, the agency expanded the label of Gilead Sciences, Inc.’s Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg) as a lower-dose tablet for the treatment of HIV in pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy.

Competitive Market Landscape

Contracting is prevalent for drugs in the same HIV grouping, with most activity focused on tiering preference. The designation as a protected Medicare class ensures good coverage for branded agents and more rapid inclusions on formularies.

Pharmacy, Medical Benefit Implications

This disease area includes good pharmacy benefit coverage for most products. Quantity limits are commonplace, and prior authorizations usually ensure diagnosis. State carveouts are important in this class, which means that policy coverage shifts from health plans to a state-based focus.

Key Players in Market:

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