The Trump administration’s campaign to curtail new HIV infections is off to a slow start. The most effective intervention’s high price is to blame.
Earlier this year, the president pledged to lower the transmission rate of the AIDS-causing HIV by 90% by 2030. A worthy goal. Not only will narrowing the pipeline of new infections reduce human suffering, it will save the government a ton of money.
The federal government spent $21 billion last year treating people with HIV. Most went for the three-drug cocktail that turns the once fatal infection into a manageable chronic condition. There are about 1.25 million Americans living with HIV, with slightly over half receiving drug therapy.
The Centers for Disease Control and Prevention estimates another 1.2 million people are at high risk of HIV exposure. The main conduits for transmission are exposure to an HIV carrier through unprotected sex or sharing intravenous needles.
Underfunded public health interventions like encouraging condom use have had a limited impact on preventing HIV’s spread. Over 37,000 new cases were diagnosed last year, a rate of transmission that has edged down only slightly over the past seven years.
Public health officials now believe the best approach for preventing new infections is a once-a-day pill approved by the Food and Drug Administration in 2012. Truvada, the pre-exposure prophylaxis, or PrEP, pill manufactured by Gilead Sciences, is over 90% effective.
However, it now costs roughly $20,000 a year, more than double what Gilead charged when it came on the market. In Canada, where a generic version is available, it’s roughly a sixth that price.
Its high price is indefensible. Gilead didn’t conduct any of the clinical trials that led to Truvada’s approval as PrEP. Those were financed by the National Institutes of Health and the Bill and Melinda Gates Foundation.
Indeed, the CDC developed the concept of using PrEP, and applied for a patent in 2007, which wasn’t granted until 2015. Last month, the administration sued Gilead for failing to pay royalties on sales of a drug that reached $2.6 billion last year.
Gilead CEO Daniel O’Day defended Truvada’s high price earlier this year with the industry’s shopworn argument that future innovation depends on it. “We have to be sure that Americans get our medicines at a price that allows us to invest in research,” he told a congressional committee.
A few months later, Gilead received FDA approval for some of the fruits of that “innovation”—a second PrEP pill called Descovy, which contains a minor variation in one of the two drugs in the Truvada pill. It gives Gilead something to market when Truvada comes off patent next year.
The public health consequences of Gilead’s high prices and patent gaming have been dire. Some insurers are balking at covering the drug. Most cash-strapped Medicaid programs, even with discounts, are not incentivizing their managed-care organizations to reach out to the populations who would benefit most from PrEP.
Last week, the Trump administration rolled out a new program negotiated with Gilead to provide free Truvada for the uninsured. AIDS activist groups say this just puts a government gloss on the existing patient-assistance program run by Gilead, which has been ineffective at expanding use.
The president in his budget asked for an additional $291 million for outreach and education, a move that has bipartisan support. But a successful campaign would bust insurer and Medicaid budgets because of PrEP’s price.
If the government really wants to put a major dent in HIV transmission, it should use its patent to negotiate a fair price with Gilead, buy it in bulk and distribute it free to all who need it.