Lenacapavir Sodium

“As of this time, Yeztugo has not been added to our commercial template formularies, nor our ACA formularies," a CVS Health spokesperson said. The owner of the U.S.' largest pharmacy benefit manager is declining to cover Gilead Sciences’ long-acting HIV prevention breakthrough, at least for now.CVS Health, the parent of PBM juggernaut CVS Caremark, won’t presently add Gilead’s twice-yearly pre-exposure prophylaxis (PrEP) drug Yeztugo to its commercial plans or Affordable Care Act (ACA) formularies, a company spokesperson confirmed to Fierce Pharma.Yeztugo, which leverages Gilead’s proven HIV-1 capsid inhibitor lenacapavir, scored its FDA approval back in June. The green light has been trumpeted as a breakthrough in HIV prevention that could significantly improve convenience and adherence rates compared to daily pills.“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,” a CVS Health spokesperson said of the decision in an emailed statement.“As of this time, Yeztugo has not been added to our commercial template formularies, nor our ACA formularies. Also of note, the [United States Preventative Services Taskforce] has not added Yeztugo to its list of recommended PrEP therapies,” he explained.On the ACA decision specifically, that program is informed by recommendations from the Department of Health and Human Services’ Preventive Services Task Force (USPSTF), the current PrEP guidelines of which revolve around three older drugs, according to Reuters, which first broke the news of CVS’ coverage verdict.CVS Health supports those USPSTF guidelines and believes in providing easy access to PrEP medications for people living in the U.S., the company’s spokesperson stressed.“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,” the spokesperson said.“In increasingly crowded therapy classes of highly effective options, a generics-first policy remains the best approach for affordability and, by extension, patient outcomes,” he continued.Yeztugo’s cost before discounts and rebates is roughly $28,000 for one year, according to multiple online sources. Despite the coverage rebuff, Gilead may still be negotiating with CVS on Yeztugo, Reuters wrote in its report, citing a person close to the matter.Mitchell Warren, executive director of the nonprofit AIDS Vaccine Advocacy Coalition, told Reuters that CVS' decision is “a grave disappointment and frankly a missed opportunity,” while admitting that it “does reflect a price that is too high and a U.S. pharmaceutical pricing structure that is frankly not sustainable.”Meanwhile, the outcry from the HIV+Hepatitis Policy Institute was even more fierce, with the organization's executive director, Carl Schmid, urging CVS to “reconsider their decision immediately.” “CVS Health’s decision is a clear violation of the ACA’s requirement to cover USPSTF-recommended preventive services, including PrEP,” he said in an emailed statement. He said that “the entire world is excited by [Yeztugo]” but cautioned that “a drug will only work if people can access it and right now, CVS Health ... is shamefully blocking people from taking it, unlike other payers.”Gilead, for its part, noted that it’s “extremely pleased” with how payer talks for Yeztugo are playing out so far. A spokesperson for the company said over email that Gilead is “well on our way to achieving 75% access for Yeztugo within six months of launch, and 90% within 12 months.”“Most payers continue to cover our HIV prevention products, including Descovy and Yeztugo with no cost sharing or medical management, and continue to follow the USPSTF Grade A recommendation for PrEP,” the spokesperson added.Analysts and doctors alike have predicted that uptake of Yeztugo will be sweeping and swift in the U.S. Back in June, an HIV physician told the team at Mizuho Securities that she expected a “majority” of her 125 PrEP-using patients to switch to Yeztugo over the next year, citing their desire for a less burdensome HIV prevention option.Yeztugo has been shown to be about 99% effective at preventing HIV and is dosed just once every six months. Oral PrEP options, on the other hand, must typically be taken daily, while comparable injectables are often administered every couple of months.Editor's note: This story has been updated with a statement from the HIV+Hepatitis Policy Institute.