FAIR PRICING COALITION WELCOMES APPROVAL OF TWO-MONTH HIV PREVENTION SHOT; DENOUNCES VIIV HEALTHCARE'S EXORBITANT, UNSUSTAINABLE PRICING

WASHINGTON DC, DECEMBER 23, 2021 – The Fair Pricing Coalition (FPC) today welcomed U.S. Food and Drug Administration approval on December 20, 2021, of Apretude (cabotegravir extended-release injectable suspension) the first injectable, long-acting HIV Pre-Exposure Prophylaxis (PrEP) medication, an important new prevention option for people vulnerable to acquiring HIV.

 

At the same time the FPC, a group of activists directly advocating with the pharmaceutical industry for more reasonable HIV and hepatitis drug prices, expressed frustration that ViiV Healthcare established a wholesale acquisition cost for Apretude of $22,200 annually, 25% above the established cost of its active ingredient, cabotegravir, in another already overpriced ViiV product, Cabenuva, despite strong oppositional input from the FPC. Cabenuva is a combination monthly injection to treat HIV in persons who are already living with the virus.

 

“Cabotegravir in Cabenuva is priced at $2,970 per equivalent dose,” noted Paul Arons, a physician and member of the FPC, “What possible justification could there be for inflating the price further to $3,700 per dose, especially since much of the research on Apretude for PrEP was taxpayer funded through the U.S. government, and there is no cold chain shipping requirement for Apretude as there is for Cabenuva?”

 

Moreover, there is now a generic equivalent for Apretude’s competitor, Truvada, the once-daily PrEP pill, which sells for less than $30 per month. Ten people could be provided generic Truvada for a year for the same price as one dose of Apretude. Additional office and provider charges involved in administering an injectable are not included in the price announced by ViiV.

 

The FPC is also anxious to receive answers to the following questions:
 

  • Will Medicaid, Medicare and private insurance cover such an exorbitant option when there is a cost-effective alternative?

  • Will ViiV be donating hundreds of thousands of PrEP doses for those who cannot afford Apretude, as Gilead has done with Truvada and Descovy through the Department of Health and Human Service’s Ready, Set, PrEP program?

  • Will ViiV’s Patient Assistance Program cover PrEP treatments for individuals who do not have health insurance coverage?

  • Will ViiV reduce the annual price of Cabenuva if the FDA approves administration at two-month intervals as with Apretude, and as promised when they announced their original per ml. monthly pricing?


“We are way past the point in thinking that cost isn’t an important factor in ensuring equitable access to novel HIV prevention and treatment modalities,” added Tim Horn, a co-chair of the FPC. “We all want to see Apretude made widely available, particularly for people vulnerable to HIV who need an alternative to daily oral medications to maximize adherence. Should this price end up preventing or delaying coverage by public or commercial payors, or resulting in exorbitant out-of-pocket costs for any individuals, it will be a real shame.”

 

“At this unsustainable price,” long-time FPC member Lynda Dee concluded, “Apretude will never even make a dent in reaching the estimated 1.2 million US population in need of PrEP services or the US National HIV/AIDS Strategy goal of 95% fewer new HIV cases by 2030. This will no doubt adversely affect the at-risk population in the Southern US who need HIV prevention options the most.”