CVS is opting against covering a twice-yearly injectable HIV prevention drug, drawing criticism from advocates who are emphasizing that the medication is only effective if it is accessible.
The drug, which uses Gilead’s lenacapavir and is marketed under the brand name Yeztugo, was approved by the Food and Drug Administration (FDA) in June as a new form of PrEP. The approval of the twice-a-year injection came more than three years after the FDA’s approval of a separate injectable, cabotegravir, which ViiV Healthcare offers under the name Apretude and is administered every other month.
PrEP is among the prevention medications endorsed by the US Preventive Services Task Force (USPSTF), an influential advisory body responsible for making recommendations regarding which screening tests or preventive medications should be covered under the Affordable Care Act. Services must be covered when they are given an “A” or “B” rating by the USPSTF, and PrEP received an “A” grade.
In rejecting coverage of Yeztugo, a CVS spokesperson told Gay City News that the “the USPSTF has not added Yeztugo to its list of recommended PrEP therapies” and that the drug “has not been added to our commercial template formularies, nor our ACA formularies.”
“As is typical with new-to-market products, we undergo a careful review of clinical, financial, and regulatory considerations, under the guidance of our external Pharmacy and Therapeutics (P&T) Committee of independent medical experts,” the spokesperson said.
CVS went on to say it supports “the intent of USPSTF guidelines for delivering life-saving preventive therapies, and we believe that easy access to PrEP medications is critical for Americans who may be exposed to HIV.”
“Our formularies cover several PrEP options, both injectable and oral,” CVS added. “However, it is inappropriate for branded pharmaceutical manufacturers to try to manipulate pre-existing guidelines with clinically similar products that are priced far higher than what’s already on the market. In increasingly crowded therapy classes of highly effective options, a generics-first policy remains the best approach for affordability and, by extension, patient outcomes.”
Carl Schmid, who serves as the executive director of the HIV+Hepatitis Policy Institute, believes CVS is violating the ACA’s requirement to cover USPSTF-endorsed preventative services, which include PrEP.
“The entire world is excited by this drug and its potential contribution to preventing and eventually ending HIV,” Schmid said in a written statement. “However, a drug will only work if people can access it and right now CVS Health, which owns the largest pharmacy benefit manager in the country, is shamefully blocking people from taking it, unlike other payers. We urge CVS, which has been committed to ending HIV in the past, to reconsider their decision immediately. Additionally, we call on federal and state regulators to ensure that plans are in compliance with the federal government’s PrEP coverage guidance and the many state laws that require coverage of all PrEP drugs.”
As of now, however, the USPSTF recommendations only encompass three existing kinds of PrEP — the Truvada, Descovy, and Apretude — but not Yeztugo, according to Reuters. Still, Gilead told Reuters it is “extremely pleased” with its progress in negotiations with payers to cover the drug, and Gilead says it is on track to be covered by 90% of insurers by June 2026.
Pharmacy benefit managers such as CVS negotiate discounts with drug manufacturers on behalf of health plans. Gilead said in August that state-run Medicaid plans in New York already cover it, according to Reuters.
