CVS Health Refuses to Cover Cost of Twice-a-Year Injectable PrEP
The pharmacy benefit manager has refused to cover the $28,000-a-year treatment, blocking patients from receiving it at no cost.
CVS Health, which runs the nation’s largest pharmacy benefit manager, will not cover Gilead Sciences’ FDA-approved HIV prevention drug Yeztugo, also known as lenacapavir, an injectable form of PrEP shown to be nearly 100% effective at preventing HIV transmission.
CVS spokesman David Whitrap told Reuters the decision was based on “clinical, financial, and regulatory factors,” citing the drug’s high price as a major concern.
Whitrap added that CVS will also exclude Yeztugo from its Affordable Care Act formularies, noting that its ACA preventive program follows recommendations from the U.S. Department of Health and Human Services.
The U.S. Preventive Services Task Force, which guides HHS policy and was upheld as constitutional by the Supreme Court earlier this summer, currently recommends only three older PrEP drugs: daily oral Truvada (also available as a generic), daily oral Descovy, and Apretude, a bimonthly injectable from ViiV Healthcare.
Some HIV advocates worry that HHS Secretary Robert F. Kennedy Jr. — known for questioning modern medicine and whose personal beliefs about HIV transmission are not based in science, and border on the bizarre — could replace members of the 16-member task force with ideologically aligned appointees.
Such an overhaul could lead to flawed preventive care guidelines across multiple diseases, higher out-of-pocket costs for patients, and even a rise in new HIV infections.
Mitchell Warren, executive director of the HIV/AIDS nonprofit AVAC, called CVS’s refusal to cover injectable PrEP “a grave disappointment and frankly a missed opportunity.”
“It does reflect a price that is too high and a U.S. pharmaceutical pricing structure that is frankly not sustainable,” Warren said.
Patient advocates had hoped Yeztugo, given twice a year by injection, would not only help prevent the spread of HIV but also reduce reliance on daily oral PrEP, lowering the risk of noncompliance that can undermine effectiveness. They believed the drug could further “bend the curve” and accelerate progress toward ending the HIV epidemic by cutting new infections each year.
HIV infects an estimated 1.3 million people annually and has caused more than 42 million deaths since the virus first emerged.
A source familiar with the matter told Reuters that Gilead is still negotiating with CVS over Yeztugo, which carries a U.S. list price of more than $28,000 a year.
Gilead said it is “extremely pleased” with progress in its conversations with payers, most of whom continue to cover HIV prevention products with no cost-sharing or coverage barriers. The company said it is on track to secure 75% of U.S. insurer coverage of Yeztugo by year’s end, and 90% coverage by June 2026.
Pharmacy benefit managers, or PBMs, serve as middlemen between drug companies and consumers, negotiating discounts with manufacturers on behalf of employers and health plans. The three largest PBMs — CVS Caremark, UnitedHealth Group’s OptumRx, and Cigna’s Express Scripts — control about 70% of U.S. specialty drug prescriptions.
Optum said it will review Yeztugo for coverage in the coming weeks, while Express Scripts did not respond to requests for comment from news wire services.
Government programs, including the Veterans Administration and Medicare, have already added Yeztugo to their coverage lists. Gilead said earlier this month that Medicaid programs in states such as California and New York are also covering the drug.
Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, blasted CVS Health’s refusal to cover Yeztugo as a “clear violation” of the Affordable Care Act, which requires preventive treatments, including PrEP, to be offered to patients at no additional cost.
“The entire world is excited by this drug and its potential contribution to preventing and eventually ending HIV,” Schmid said in a statement. “However, a drug will only work if people can access it, and right now CVS Health, which owns the nation’s largest pharmacy benefit manager, is shamefully blocking people from taking it.”
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