In May, Democratic lawmakers asked Gilead Sciences to justify the high price of its HIV pre-exposure prophylaxis (PrEP) drug Truvada (FTC/tenofovir disoproxil fumarate) during a hearing of the House Committee on Oversight and Reform.
The controversy surrounding Truvada in the United States isn't just about the drug's price tag -- it's about public health. HIV doctors and activists point out that when prices drop, so do the number of new HIV infections.
For the past several years, doctors in the United States have watched enviously as other countries have approved generic versions of PrEP made by Mylan, Teva, and other generic drug companies. These cheaper generics have made it easier for governments to support large PrEP scale-up programs.
In Australia, for example, a 2016 PrEP scale-up program led to a 25% drop in new HIV infections among men who have sex with men (MSM) in the state of New South Wales. In Australia, PrEP costs as little as $8 per month. But even at higher prices, PrEP can be cost-effective, with a January 2018 paper concluding that PrEP in the United Kingdom is cost-effective for MSM at high risk for HIV, even at a price of nearly $500 per month.
In the United States, it's a different story, with an abstract presented at the 2019 National HIV Prevention Conference finding that PrEP is not cost-effective at its current price of $1,600 to $2,000 per month.
Truvada is expensive in the United States because it is still protected by a brand-name patent, but it will be going generic in 2021, while another Gilead product similar to Truvada, Descovy, is currently under review for Food and Drug Administration approval for PrEP. According to an analysis of PrEP availability worldwide conducted by the nonprofit AVAC, generic versions of Truvada for prevention are available in at least 26 countries, most of them in Europe, where individual governments have held various interpretations of Europe's regulations surrounding the patent exclusivity of brand-name products.
According to AVAC, as of April 2019, 44 countries have approved PrEP and 11 countries are on the cusp of approving the drug. While some countries have approved Gilead's Truvada, others have approved generic versions made by companies like Mylan, Teva, and Sandoz.
Public health is all about cost savings, and governments have limited budgets for HIV prevention, explained Ioannis Hodges-Mameletzis, of the Department of HIV/AIDS at the World Health Organization (WHO).
"You can either buy a generic or you can buy a brand-name product," said Hodges-Mameletzis, who helped create the WHO's PrEP guidance. With generics, he said, "you can scale up PrEP, you can think about contraception, you can hire more nurses and peer navigators."
With PrEP prices stirring controversy in the United States, here's a look at what generic PrEP costs in several European countries, according to Hodges-Mameletzis:
Ireland: Generic PrEP (sold by Mylan and Teva) is available for approximately $60 per month in retail pharmacies.
Sweden: PrEP is available for approximately $20 per month and is covered by the Swedish health system.
Germany: PrEP is available in various forms: Ratiopharm/Teva sells a bottle of 30 PrEP tablets for $80, while Hexal/Sandoz sells a blister pack of 28 pills for $32. A third version, sold by TAD Pharma, sells as 35 pills for $67.
Poland: Generic PrEP (sold by Mylan) is available for approximately $35 per month in retail pharmacies.
Austria: Generic PrEP (sold by Sandoz) is available for approximately $67 per month, but only in select pharmacies in Vienna.
Switzerland: Generic PrEP is available for approximately $130 per month, but it is only available in select pharmacies.
Italy: PrEP is available, but without a specific indication, for about $75 per month (sold by DOC Pharma and Teva).
Belgium: Although PrEP (Truvada) costs about $480 per month, Belgium's national reimbursement policy means individuals pay less than $15 per month.