Multiple generic formulations of tenofovir disoproxil fumarate/emtricitabine—the equivalent of Truvada—are now available in the United States for HIV treatment and prevention, leading to a dramatic drop in the price of pre-exposure prophylaxis (PrEP).
The Food and Drug Administration approved Gilead Sciences’ Truvada for HIV treatment in 2004 and for prevention in 2012. But the coformulation of tenofovir disoproxil fumarate (TDF) and emtricitabine was protected by patents, and the brand-name cost has been around $1,600 to $1,800 per month.
Under pressure from advocates and the U.S. government, Gilead reached an agreement with Teva Pharmaceuticals to allow the Israeli company exclusive rights to sell a generic version of Truvada in the United States a year before the patent on emtricitabine was set to expire. Teva’s generic product hit the U.S. market in October 2020, but at about $1,455 a month, it undercut the cost of brand-name Truvada by only a couple of hundred dollars.
“Historically, when there’s only one generic manufacturer in the field, the price difference is a minuscule 10% to 15%,” Tim Horn, the director of medication access and pricing at NASTAD told POZ. “The real savings for all purchasers and payers won’t begin until there’s robust generic competition.”
That time has now arrived. Teva’s six-month window of exclusivity expired in March, and at least eight additional generic TDF/emtricitabine products—made by companies including Aurobindo, Cipla and Mylan—are currently available. Generic drugs are tested for pharmacological equivalence, and they are as safe and effective as their brand-name counterparts.
As expected, the increased competition has led to a steep decline in prices. According to drug price comparison sites, such as GoodRx.com and RxSaver.com, generic Truvada can be purchased for as little as $69 per month with discount coupons.
Advocates have argued that cost is one of the barriers to wider use of PrEP. Now that prices have fallen, more people should have access to the HIV prevention pill. But that doesn’t necessarily mean the price will be lower for everyone.
Many people in the United States don’t pay full price for brand-name Truvada because it is covered by commercial insurance, Medicaid or Medicare. Thanks to a recommendation by the U.S. Preventive Services Task Force, private insurers are now required to cover PrEP without cost sharing, though people still may have to pay for the associated lab tests. Gilead offers a patient assistance program for low-income people without insurance and a co-pay card to cover out-of-pocket costs for those with private insurance. In addition, some state and local programs provide PrEP for free.
Given the complexities of the American drug pricing and insurance system, some individuals may find that they actually end up paying less for brand-name Truvada than they do for the new generic equivalents. But the lower-cost alternatives will relieve pressure on Medicaid, Medicare and state and local PrEP assistance programs.
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