MMIT Reality Check on HIV (1Q2023)

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 12% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 53% of the lives under commercial policies are covered with utilization management restrictions. Almost 96% 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 80% require multiple steps. Around 10% of payer-controlled pharmacy benefit covered lives require prior authorization, with 52% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Approves Sunlenca

In December 2022, the FDA approved Gilead Sciences, Inc.’s Sunlenca (lenacapavir) for the treatment, in combination with other antiretroviral(s), of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The agency gave the first-in-class capsid inhibitor priority review, fast track and breakthrough therapy designations. Two initiation dosing regimens are available: The first is 927 mg subcutaneous injection via two 1.5 mL injections and two 300 mg tablets on day one, two tablets on day two and then a 927 mg injection every six months, while the second is two tablets on days one and two, one tablet on day eight, a 927 mg injection on day 15 and then a 927 mg injection every six months. The drug’s wholesale acquisition cost for the first year is $42,250 and then $39,000 in subsequent years.

FDA Approves New Method of Administration for Trogarzo

In October 2022, the FDA approved a new method of administration for Theratechnologies Inc.’s Trogarzo (ibalizumab-uiyk) as a 30-second intravenous push every two weeks to treat, in combination with other antiretrovirals, HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant infection failing their current ARV regimen. The agency first approved the CD-4 directed post-attachment HIV-1 inhibitor on March 6, 2018, for administration as a 15-minute intravenous infusion every two weeks. Both routes of administration require a single intravenous loading dose of 2,000 mg and then 800 mg maintenance doses. Drugs.com lists the price of one 200 mg/1.33 mL (150 mg/mL) vial of intravenous solution as more than $2,827.

FDA Expands Cabenuva Label

In March 2022, the FDA expanded the label of ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine) to make the oral lead-in with ViiV’s Vocabria (cabotegravir) and Johnson & Johnson unit Janssen Therapeutics’ Edurant (rilpivirine) tablets optional for the treatment of HIV-1 infection in adults to replace a current antiretroviral regimen in people who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine. The agency initially approved the agent on Jan. 21, 2021. Recommended monthly dosing is injections of 400 mg of cabotegravir and 600 mg of rilpivirine; every-two-months dosing is 600 mg of cabotegravir and 900 mg of rilpivirine. The cost per dose is around $6,000.

Key Findings:

Market Events Drive Changes

In December 2022, the FDA approved Gilead Sciences, Inc.’s Sunlenca (lenacapavir) for the treatment, in combination with other antiretroviral(s), of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. In March 2022, the agency expanded the label of ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine) to make the oral lead-in with ViiV’s Vocabria (cabotegravir) and Johnson & Johnson unit Janssen Therapeutics’ Edurant (rilpivirine) tablets optional for the treatment of HIV-1 infection in adults to replace a current antiretroviral regimen in people who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine.

Competitive Market Landscape

Contracting is prevalent for drugs in the same HIV grouping, with most activity focused on tiering preference. With patent expirations, generics are expected to come to market for single agents.

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. Antiretrovirals is a protected class for Medicare with no prior authorization or step therapy allowed. 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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