CVS Health denies coverage for  breakthrough HIV drug, committing 'clear violation' of ACA

CVS Health has denied coverage for a new HIV prevention drug despite it being nearly 100 percent effective, citing in part the medication's high cost.

The nation's largest pharmacy benefit manager will not cover Gilead's Yeztugo, generic name lenacapavir (LEN), neither through its commercial plans nor the Affordable Care Act. CVS spokesperson David Whitrap told Reuters that the decision was based on "clinical, financial, and regulatory factors."

Gilead is still negotiating the price with CVS, other sources told the outlet, which currently sits at over $28,000 annually. Gilead said that it has not had issues with other pharmacy benefit managers, and that it is still on track to reach 75 percent U.S. insurer coverage by the end of the year and 90 percent coverage by June next year.

“CVS Health’s decision is a clear violation of the ACA’s requirement to cover USPSTF-recommended preventive services, including PrEP," Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, said in a statement. "The entire world is excited by this drug and its potential contribution to preventing and eventually ending HIV. 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."

Yeztugo was approved for prevention by the Food and Drug Administration in June after highly successful trials last September found that it nearly eliminated the spread of the virus among patients, showing a 96 percent relative risk reduction versus bHIV. The drug, given as an injection at clinics every six months, had already been approved for treatment of multidrug-resistant HIV.

Lenacapavir's trials, known as Purpose 1 and Purpose 2, examined the frequency at which patients contracted HIV without the use of PrEP. Purpose 1 took place in June and measured the effectiveness of lenacapavir among cisgender women in sub-Saharan Africa.

Purpose 2 included cisgender and transgender men, trans women, and nonbinary individuals who engage in sexual relations with partners assigned male at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the U.S. To compare effectiveness, 2,180 participants used lenacapavir and 1,087 participants used Truvada, another drug from Gilead approved for prevention. There were only two reported incidents of HIV in the lenacapavir test group versus nine in the Truvada group.

"We urge CVS, which has been committed to ending HIV in the past, to reconsider their decision immediately," Schmid continued. "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.”