Generic Truvada now available
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A long-awaited generic version of Truvada, used for both HIV treatment and PrEP, went on the market Friday, October 2. But the wholesale cost of the new pill from Teva Pharmaceuticals — about $1,455 — is only a couple hundred dollars less than the brand-name product from Gilead Sciences.
What's more, given the complexities of the American drug pricing and insurance system, some people may find that they have trouble getting coverage for either the generic or the brand-name pills, or they may end up actually paying less for the original product.
"This is a historic day in HIV prevention," said Montica Levy, biomedical HIV prevention coordinator at the San Francisco Department of Public Health's City Clinic. "The change to generic will hopefully eventually usher in an era of easier access to affordable PrEP, but in the short-term, the change could cause confusion for patients and could paradoxically increase their costs and therefore cause patients to stop PrEP."
To that end, the DPH has issued a fact sheet answering frequently asked questions and encouraging PrEP users to seek assistance if they encounter any roadblocks rather than discontinuing PrEP.
"Depending on your insurance situation, you may be charged for your PrEP medication when you go to the pharmacy," the fact sheet reads. "Upon your next visit to the pharmacy to pick up your PrEP, if you face ANY challenges, or if you are charged more than you've been charged in the past, please contact your PrEP provider immediately!"
Most insurance plans operating in California are required by state regulations to start covering PrEP medication and the associated tests and medical services without cost sharing by January 1, 2021, according to the fact sheet. People who are uninsured or have Medi-Cal should not see any changes in PrEP cost.
Price may fall next spring
The federal Food and Drug Administration approved Truvada (tenofovir disoproxil fumarate/emtricitabine) for HIV treatment in 2004 and for PrEP in 2012. Although the TDF component is already off patent, the patent for emtricitabine is not set to expire until next September.
Last year, Gilead announced agreement with Teva to give the Israeli company exclusive rights to sell a generic version of Truvada in the United States a year ahead of schedule. These rights will last for six months, after which other companies may join the market. Generic versions of the combo pill are already available in other countries, sold under names such as Tenof-EM, Tavin-EM, and Ricovir.
While the arrival of generics can lead to dramatic price reductions thanks to increased competition, this does not necessarily happen when only a single generic version is available.
According to Teva, generic Truvada is expected to be available at a wholesale acquisition cost of $48.51 per tablet, which works out to about $1,455 for a 30-day supply. Brand-name Truvada typically sells for around $1,600 to $1,800 per month. Generic versions of TDF/emtricitabine cost about $25 a month in other countries.
Many people do not pay full price for brand-name Truvada because it is covered by commercial insurance, Medicaid, or Medicare. 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.
Teva is also offering a co-pay card for generic Truvada that will cover $600 worth of out-of-pocket costs for a month's supply. This is the same annual amount as Gilead's co-pay card, though Gilead now sets the benefit at $7,200 per year with no monthly limit, after some people had trouble negotiating insurance deductibles and out-of-pocket maximums.
Generic version is effective
Teva's generic version is as safe and effective as brand-name Truvada.
"A generic medicine is the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken and should be used," although the pills may look different, according to the DPH fact sheet.
People taking either version of Truvada for PrEP must be tested before starting to ensure that they do not already have HIV, and they should receive regular tests for HIV, sexually transmitted infections, and kidney function while using it.
Generic Truvada comes with the same safety concerns, namely decreased kidney function and bone loss. However, studies have shown that Truvada is a safe PrEP option for most people. The drugs in Truvada are also active against hepatitis B, but it is not approved for this indication. People should be tested for hepatitis B before starting Truvada and closely monitored after stopping, as this can lead to liver disease flare-ups.
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