Generic Truvada; why it is still not available on the US market?

In the US most patients who require PrEP (HIV Pre-Exposure Prophylaxis) get coverage for Truvada by their insurance companies. Patients with medicaid coverage have copays ranging from $3 – 25, however individuals with commercial insurance may have to pay up to $800 a month towards medication cost. This has proven to be a barrier for many patients seeking PrEP. Gilead Sciences who owns the patient for Truvada has generous co-pay cards that covers for these costs. This appear to work out for most who require Truvada but some insurance companies are now insisting that deductibles cannot be met with these co-pay cards putting this drug out of the reach of many patients. Generic Truvada may be a solution but it is still not available on the US market even though it has FDA approval

truvada_status_july2018

Status of generic Truvada globally – whilst medication is approved for use in the US and Canada it is only available in Canada.

In June 2017 the US Food and Drug Administration (FDA) approved generic Truvada production by Teva Pharmaceuticals. This announcement was greeted with excitement by HIV and AIDS advocates, it was clear most were seeing a $50 price tab for 30 day supply of Truvada. More than a year after the FDA announcement the much anticipated generic Truvada is still not available on the US market. The question that I keep asking myself is; what is holding things up? After a few checks it became clear what was holding back this generic medication. The patent on emtricitabine the other drug paired with Tenofovir in Truvada expires in November, 2020.

The drug Emtricitabine has a really long history going as far bask as 1995 when its sister drug Lamivudine (GlaxoSmithKline) was approved by the FDA. In 1997 GSK combined AZT with Lamivudine to develop Combivir the first fixed drug combination for HIV. This opened the door on a solution for a problem that many healthcare providers had been grappling with and continue to grapple with today; medication adherence. Today anecdotal  experience and research both suggest that reducing dosing complexity with fixed dose combinations improves adherence. The initial success of Combivir lead to  a rapid evolution of fixed dose HIV medications.

Abbott Laboratories followed with Kaletra and for many years these two drugs held the market. I still occasionally see a few patients still on Combivir and Kaletra for their ART (Antiretroviral Therapy) regimen. Tenofovir was approved by FDA in October 2001 but combined tablets were king and Gilead needed to get into the game quickly. The company thus developed a “me too” drug to attach to Tenofovir, and boom Emtricitabine was born in July 2003 apparently to get Gilead into the game with its first fixed dose combination. A year after FDA approval for Emtricitabine which only differs from Lamivudine by one side chain, Truvada was approved by the FDA in 2004.  Today Gilead holds the HIV drug market with more than 7 such combinations.

FTC-3TC

On account of this pharmaceutical market competition even though the patent for Tenofovir run out in 2017 Gilead still holds the patent for Emtricitabine  till 11/4/2020. On this account generic Truvada cannot be sold in the United States until that time. In Canada though Gilead has struck a secret deal with Teva Pharmaceuticals to sell generic Truvada. The terms of this deal are not currently known.

In Ontario Canada Tenofovir/Emtricitabine is available as a generic agent and is covered by the province for PrEP. The cost for self pay patients at $400 is still not affordable but a bargain compared to $1678 for Truvada in US. Internationally though Truvada is available for about $70 – 500 annually mostly due to agreements that pharmaceutical companies have made with Gilead. Hopefully things are going to be resolved eventually to ensure that access to this medication is available more widely at a price that most can afford.

Currently though I would advise patients who require Truvada but cannot afford the copay to explore using clinical sites such as federally qualified health centers (FQHCs) where they can obtain cheaper medications through the 340B Pharmacy Programs. Gilead also still has its own patient assistance program for which providers and patients can apply if they meet eligibility.

By Dr. Leonard Sowah an Internal Medicine Physician in Baltimore, Maryland

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