The FDA Has Approved Generic PrEP—but Access May Remain Difficult

This article from Vice.com does an excellent job of detailing the complicated issues related to the recent FDA approval of generic Truvada for PrEP.

ORIGINAL POST: https://www.vice.com/en_us/article/the-fda-has-approved-generic-prepbut-access-may-remain-difficult

Experts cited complicated factors, like patient and doctor awareness and the unique way the US HIV medication market functions, as reasons not to get your hopes up.

On June 9th, soon after headlines announcing the US Food and Drug Administration’s approval of a generic version of the HIV medication Truvada began appearing online, Rochelle Walensky started getting emails. Walensky, an infectious disease physician at Massachusetts General Hospital who serves on the FDA’s guidelines committee for treating HIV/AIDS in adults and adolescents, said that at one point, she got nearly a dozen messages in the space of an hour, all with the same question: “What does this mean?”

It’s something many are asking, including seasoned HIV treatment and prevention experts. While Truvada is commonly used to treat HIV infection, it is also the only drug approved by the FDA to prevent HIV in uninfected high-risk people (as pre-exposure prophylaxis, or “PrEP”). Yet despite great promise, PrEP uptake has been disappointingly slow among gay and bisexual men, and some blame Truvada’s cost, averaging over $1,700 per month of treatment in 2015. It’s widely assumed that generic drugs are cheaper than brand-name drugs—wouldn’t it be good for patient access, then, if a generic alternative to Truvada were available?

That’s the conclusion many arrived at with Friday’s news; the HIV/AIDS publication Poz stressed its potential “major implications” on cost for patients and insurance companies (while acknowledging what’s still unknown), while Attitude, a UK-based LGBTQ magazine, hailed it as a “landmark move.” But the answer, say Walensky and other experts, is complicated. And ultimately, they say, the FDA’s recent approval of generic Truvada in the US may not change drug costs or patient access at all.

Ambiguity about the availability and impact of generic Truvada stems from the fact that FDA approvals for generic drugs do not stipulate when the generic version will be brought to market. Tim Horn of the Treatment Action Group, an HIV, tuberculosis, and hepatitis C advocacy organization, said the approval did two things. First, it certified that the generic drug will contain the same amount of active ingredients as the brand-name drug. Second, it affirms that the FDA is satisfied with the terms of a legal settlement that was reached between Gilead, the manufacturer of Truvada, and Teva, the prospective manufacturer of a generic version, with regard to the patents protecting Truvada from generic competition.

Truvada is a combination of two HIV antiretroviral drugs, emtricitabine and tenofovir. Gilead and Teva’s legal settlement, Horn said, may involve an agreement by Teva to delay bringing its generic competitor to market until after Gilead’s patent on emtricitabine expires in 2021. (Their tenofovir patent expires much sooner, in December 2017.)

Because the agreement between Gilead and Truvada is confidential, its details are unknown. However, Horn has reason to be suspicious: Teva and Gilead have likely engaged in a similar agreement before. In 2015, Teva’s generic version of another antiretroviral, Viread, was approved by the FDA. However, the generic version of the drug is not yet available, and Horn said it likely won’t be until December 2017, the date of the drug’s patent expiration. (Horn notes this date was agreed upon by the companies in another patent challenge settlement.)

 

The Federal Trade Commission views pay-for-delay settlements as anti-competitive and has been prosecuting such cases since 2000. The FTC did not respond to a request for comment on either of Teva and Gilead’s agreements. A spokesperson from Teva wrote in an email that the company has “a settlement that controls our entry for which the terms are confidential,” while a Gilead representative wrote that “a generic version of Truvada will not be immediately available.”

Walensky cautions that the availability of a generic form of a drug is not a guarantee of reduced cost. “Competition in the generic market [is what] makes it cheaper,” she said. In the case of HIV medications, competition among generics does exist—just not in the US. Worldwide, many pharmaceutical companies make generic antiretroviral drugs to treat HIV/AIDS, which are used in developing countries in association with the American foreign aid program, PEPFAR (the President’s Emergency Plan for AIDS Relief). And though those generic drugs are not available to HIV-infected people in America while their brand-name counterparts are still under patent, they may eventually enter the market when those patents expire.

In the early years of HIV drug development, drugs often became obsolete quickly, only to be replaced by newer, less-toxic formulations before their patents could expire. But the latest generation of HIV drugs have demonstrated more staying power, with more durable antiretroviral effects and more agreeable side effect profiles. As a result, said Walensky, multiple anti-HIV workhorses will become candidates for replacement by generic alternatives over the next few years. (She added that newer and incrementally better brand-name drugs will also likely emerge.) But the entry of a single generic drug before that critical mass occurs is unlikely to quickly do much to change the cost of the drug.

When generic drugs do become commercially available, an additional concern for HIV patient advocates is the possibility that patient assistance programs could be eliminated—like Gilead’s, which covers either the insurance co-pay for the drug or some or all of its cost for patients below a certain income.

Some health policy experts say such programs ultimately keep America’s broken drug-pricing system broken, shifting the cost of drugs from individual patients to taxpayers and insurers, because insurance companies administering both private and Obamacare-funded plans end up paying the high drug costs. However, many argue they are critical to meeting the needs of low-income patients. Horn said there have been cases of drug manufacturers ending patient assistance programs for brand-name drugs when generic versions entered the market, citing the anti-HIV drug Epzicom, a product of ViiV Healthcare. Shortly after a generic version of the drug became available in mid-2016, the company discontinued support of their Patient Savings Card program offering eligible patients savings on the medication. (It still offers the medication at no cost to very-low-income patients who qualify.)

A Gilead spokesperson wrote in an email that there are no planned changes to its co-pay or medication assistance programs at this time.

Ultimately, the availability of Truvada’s generic form specifically may not be the most important issue at hand. Walensky said that in early 2018, new generic medications for HIV treatment are likely to enter the market, which could decrease the cost of some regimens by about $7,000 annually. And studiesunderway to find alternative drugs to Truvada for HIV PrEP may result in new treatment options as early as 2019 (though these, too, will likely be brand-name drugs).

David Wohl, an infectious disease doctor who leads the North Carolina AIDS Training and Education Center, said that Truvada’s cost is just one of the many barriers to PrEP access patients experience. The drug’s high cost is often paid for either by insurance or by Gilead’s patient-assistance program, he said. The cost of clinic visits, blood work and HIV tests PrEP patients usually undergo every three months represent their own challenge. “The financial obstacle to PrEP isn’t so much the medication as the associated costs,” he said.

An even bigger problem is a lack of physician and patient knowledge about PrEP, and its acceptability within the communities that need it, Wohl said. He thinks addressing those issues will likely have a greater positive effect on PrEP uptake than finding a generic alternative to Truvada—”but every little bit helps.”