HIV drug Yeztugo not covered by CVS Health plans

CVS Health, one of the nation’s largest pharmacy benefit manager companies that play a lead role in deciding which drugs are covered by health insurance plans, has initially decided not to approve coverage for the new HIV prevention drug Yeztugo

Developed and manufactured by the pharmaceutical company Gilead Sciences, Yeztugo was approved for use in June of this year by the U.S. Food and Drug Administration as an HIV prevention or PrEP medication that needs to be taken just twice a year by injection.

HIV prevention advocates hailed the new drug as a major breakthrough in the years long effort to curtail and end the HIV/AIDS epidemic by enabling far more people at risk for HIV infection to adhere to a prevention drug regimen that needed to be taken once every six months rather than daily pills or through bi-monthly injections.

But the same advocates warned that the benefits of Yeztugo, which tests showed is greater than 99 percent effective in preventing HIV infection, could not be realized if the cost of the drug is not covered by health insurance plans or other coverage programs.

At the time the FDA approved its drug, Gilead Sciences announced that the yearly retail price for Yeztugo without insurance coverage would be $26,218.

According to reports by Reuters and Bloomberg news publications, a CVS Health spokesperson disclosed on Aug. 21 that the company “for now” would not add Yeztugo to its commercial coverage plans.

“As is typical with new-to-market products, we undergo a careful review of clinical, financial, and regulatory considerations,” Bloomberg News quoted CVS spokesperson David Whitrap as saying. Bloomberg reports that Whitman added that Yeztugo hasn’t been added to CVS Caremark’s commercial drug plans or U.S. Affordable Care Act plans.

“The entire world is excited by this drug and its potential contribution to preventing and eventually ending HIV,” said Carl Schmid, executive director of the D.C.-based HIV + Hepatitis Policy Institute. “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,” Schmid said in a statement.

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

Gilead Sciences, meanwhile, has said it is “extremely pleased” with the progress it is making with other health insurance companies and  “payers” to arrange for coverage of Yeztugo, according to Reuters. “[T]he company said it is on track to secure 75 percent of U.S. insurer coverage of Yeztugo by year-end, and 90 percent coverage by June 2026,”  Reuters reports.