UnitedHealthcare spurns Gilead's newer PrEP drug Descovy as Truvada generic looms: report

UnitedHealthcare has a history of limiting HIV drug costs, including offering cash incentives to patients who opt for low-priced regimens. Now, in a potentially major blow to HIV giant Gilead Sciences, the insurer has set its eyes on one of the California drugmaker’s new therapies.

Gilead’s new HIV PrEP option, Descovy, will no longer be covered by UnitedHealthcare starting next month, as the company’s old stalwart Truvada is slated to go generic, MedCity News reported, citing a notice the insurance supplier sent to its plan members.

Those who still wish to get Descovy as a PrEP med will have to seek prior authorization, a process through which the insurer will review whether the drug is indeed necessary for a patient. By contrast, generic Truvada will be offered at no out-of-pocket cost once it becomes available on Sept. 30, according to MedCity.

The decision, from such a big insurer as UnitedHealthcare, could be a blow to Gilead’s booming PrEP business, which the Big Biotech’s been busy securing by switching existing Truvada takers to Descovy ahead of the generic entry.

The FDA approved Descovy to prevent HIV last October. The drug, which combines a different version of tenofovir with emtricitabine, boasts a better kidney and bone toxicity profile than Truvada does, though studies showed no efficacy difference between the two drugs.

That better safety profile is Descovy’s main selling point, and Gilead has priced the two drugs with the same $1,758-per-month list tag. But SVB Leerink analyst Geoffrey Porges, calling the two products’ differences “modest,” previously noted that winning payer coverage for Descovy in PrEP could be challenging and warned that patients might transition back to Truvada upon generic arrival.

RELATED: Gilead's Descovy not worth the higher price over forthcoming Truvada generics: study

So far, the newer therapy has attracted new patients as Gilead planned. In the first half of 2020, Descovy sales in the U.S. jumped 46% year-over-year to $700 million, driven by increased use in PrEP. Meanwhile, Truvada’s U.S. sales dropped 38% to $753 million during the same period. The company has converted 43% of PrEP takers to Descovy, Gilead Chief Commercial Officer Johanna Mercier said on a conference call last month. Both Truvada and Descovy can also be paired with another drug in the HIV treatment setting.

Now UnitedHealthcare’s decision to favor low-cost generic Truvada could blunt Descovy’s growth trajectory. Through a patent deal with Gilead, Teva is set to launch its copycat in the U.S. on Sept. 30.

RELATED: GSK's ViiV, touting superior long-acting data, can challenge Gilead in HIV prevention: analyst

This is not the first time Gilead has felt the burn from a new policy by UnitedHealthcare. In 2018, the insurer rolled out the My ScriptRewards program, which offered patients up to $500 in prepaid debit cards to use toward other medical expenses if they choose a recommended lower-cost HIV regimen, which they could get at a pharmacy for no out-of-pocket cost. Select HIV antivirals by GlaxoSmithKline and Merck & Co. were the first medications included in that cost-savings program, whereas Gilead’s offerings were left out.

Generic Truvada and a Descovy rejection from UnitedHealthcare are not the only problems Gilead’s PrEP business could be facing. GSK recently showed its long-acting injectable cabotegravir, given every two months, cut HIV acquisition by 66% over daily oral Truvada in a phase 3 trial. The British pharma, through its HIV-focused subsidiary ViiV Healthcare, plans to file for FDA approval in early 2021.