Generic PrEP is here — but don’t get excited yet

Teva’s rollout of generic tenofovir is a small step in the right direction


Canada will finally see some generic drugs to prevent HIV transmission — but not in the way, or at the price, anyone hoped for.

A deal between the drug’s creator, Gilead Sciences, and the Israeli pharmaceutical giant Teva has opened up the sale of a generic version of the pre-exposure prophylaxis (PrEP) drug in Canada. But the generics are still priced at over $400 a month, and more competition in the generics market will be needed to make them widely affordable.

Studies have found that Gilead’s drug tenofovir-emtricitabine, sold as Truvada, is as safe as daily aspirin and as effective as wearing condoms at protecting people from contracting HIV. Unfortunately, Truvada costs more than $900 a month in Canada, and has so far only been subsidized in Quebec. The only way for most people to get Truvada has been through some private insurance plans, or by importing it quasi-legally from overseas.

Enter generics. PrEP advocates hope generic Truvada will dramatically drop prices, giving many more people access to HIV prevention, and convincing provinces to subsidize the drugs or cover them completely.

But here’s where it gets complicated. Truvada is made up of two components, tenofovir and emtricitabine. Gilead’s patent on tenofovir ended in July 2017, but its grasp on emtricitabine continues until 2021. The only way generics companies can sell the product is by either convincing a court that Gilead has already got its money’s worth and should no longer hold the patent, or by striking a deal with Gilead. A deal is likely the worse option for buyers of the drug, since Gilead might insist that the generic be priced high or delayed.

Meanwhile, generics companies have been circling, securing the government approval they will need to sell the drug once the patents fall.

Health Canada records show that Canadian generics company Apotex got its notice of compliance here in May. In June, Teva Pharmaceuticals received approval from the American FDA to produce the generic drug, followed by a notice of compliance from Health Canada on July 26.

Immediately after receiving the notice of compliance, Teva rolled out the drugs for sale to pharmacies in Canada. Toronto pharmacist and PrEP advocate Michael Fanous confirms that pharmacies can buy the Teva drugs in Canada for over $400 a month, but says prices vary from place to place.

Teva would only tell Xtra that the company has made a “settlement that controls our entry for which the terms are confidential.”

 

At the same time, in an earnings call on July 26, Gilead told investors they expected generic Truvada not to hit the shelves in the United States until 2021 — the year the emtricitabine patent expires.

So what does that tell us? It seems Teva has likely reached a deal with Gilead allowing sale of generic PrEP in Canada but not in the United States. The next steps are likely in the hands of Apotex, the Canadian company that also has a notice of compliance to produce generic tenofovir-emtricitabine in Canada.

Apotex has a reputation as a patent buster, having wrested the right to make Viagra and Lipitor from Pfizer. If Teva has struck a deal with Gilead, it is probably up to Apotex to make the next move by challenging Gilead’s patent in court. Other generics companies could also step in as well, negotiating with Gilead or going to court themselves.

Apotex also declined to comment on its strategy in Canada, only saying the company “is currently assessing the potential launch of this product in Canada.”

Even when prices do drop, the battle to make PrEP accessible in Canada will not be over. In some provinces, the generic will need to be designated “interchangeable” with Truvada before it can be prescribed, and provincial drug plans will have to get on board to cover the costs for those who cannot afford it.

It’s about time that happened, says Fanous, the pharmacist.

“Let’s aim for the ideal situation, where people get it on formulary, reimbursed by the government, seen every three months by their doctor for testing,” he says. “Let’s not make any more loopholes or backdoors to access. We can end the epidemic with proper prevention strategies if the government is interested.”

Teva’s release of generic PrEP in Canada is only a small first step on the way to that dream.

Niko Bell

Niko Bell is a writer, editor and translator from Vancouver. He writes about sexual health, science, food and language.

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Sexual Health, Health, Opinion, HIV/AIDS

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