FDA approves the first once-a-month injections to treat HIV. They will cost $4000 each.

A doctor giving a patient an injection
Photo: Shutterstock

Last week, the FDA approved a monthly injection to treat HIV which could be used as a replacement for daily pills, called Cabenuva from Viiv Healthcare, a subsidiary of GlaxoSmithKline.

But it’s the price tag of the shots that is getting the most attention; they’ll cost $5,940 for the first month’s treatment and $3,960 for each month’s dose after that.

Related: Pharma company triples the price for HIV drug after FDA says it can’t be used to treat coronavirus

Describing Cabenuva as “the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults,” Viiv Healthcare announced that the FDA approved the monthly treatment for HIV, which comes in the form of two shots per month, one for the drug rilpivirine and the other for cabotegravir, which is already produced by Viiv Healthcare.

“Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” said Lynn Baxter of Viiv in a press release. “Cabenuva reduces the treatment dosing days from 365 days to 12 days per year. At ViiV Healthcare, we are dedicated to ensuring no one living with HIV is left behind, and adding this first-of-its-kind regimen to our industry-leading portfolio of innovative medicines reinforces our mission.”

“A long-acting, injectable form of HIV medicine is truly a medical breakthrough that will make the lives of people living with HIV easier and better,” said Jesse Milan Jr. of AIDS United in a statement. “That cannot be stated enough.”

But the Washington Post is reporting that Viiv Healthcare isn’t going to be making anyone’s lives easier out of a sense of charity, with patients expected to shell out nearly $50,000 for the first year’s treatments. This is even more expensive than the average cost of current antiretroviral treatments, which was between $36,000 and $48,000 for a year’s supply in 2018, according to the AIDS research organization amfAR.

Viiv Healthcare said that they expect private insurers and state Medicaid programs as well as Medicare to cover the cost. But Milan said that it’s not clear that that will be the case and that people who need the medication will have to battle their insurer or their state’s Medicaid program to get them to pay for the injections.

The company said that there is evidence that the injections are effective if used once every two months and is currently seeking approval for that treatment regimen. They are also exploring the use of the treatment as a form of pre-exposure prophylaxis, or PrEP.

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