Have you been following the activist pressure on the U.S. government to make drugmaker Gilead radically slash its sticker price for the pre-exposure prophylaxis (PrEP HIV prevention) drug Truvada (FTC/tenofovir disoproxil fumarate) to make it vastly more accessible by health departments to end the epidemic?
Then you may already know that, late last week, Gilead announced that it will be donating to the government what the company says is enough Truvada (and then its imminent Gilead successor, Descovy) to put 200,000 uninsured Americans who are at high risk for HIV on PrEP for the next decade.
In a statement, Gilead chief patient officer Gregg Alton said, "We are proud to partner with CDC [the U.S. Centers for Disease Control and Prevention] to dramatically expand access to medication that can help prevent new HIV infections. We believe today's donation, combined with efforts to address the root causes of the epidemic, such as racism, violence against women, stigma, homophobia and transphobia, can play an important role in ending the HIV epidemic in the United States, particularly in parts of the country with the highest burden of disease."
The announcement comes after several months of pressure on the U.S. government, from the PrEP4All Collaboration and other activists, to use the leverage of government-owned patents on Truvada to make Gilead radically drop the sticker price of Truvada. HIV/AIDS activists would like to see the cost go from the current $1,600-$2,000 a month to something in the realm of $50 a month, around what it costs in several other countries.
Activists are wondering if Gilead's donation announcement is the result of talks that the feds have said that they were having with Gilead to better reach President Trump's stated goal of ending the U.S. HIV/AIDS epidemic by 2030.
The announcement also comes shortly after Gilead announced that it would let generic drugmaker Teva start selling a generic version of Truvada next year -- a year before the drug's patent ends. Activists have already said that only one generic of Truvada is not enough to create the kind of competition that would truly drive down the price.
And now, once again, activists are saying that Gilead's donation will not provide the kind of deep systemic access to affordable Truvada that a simple price slash would, and also that many questions remain as to how -- and exactly to whom -- the donated Truvada will be rolled out.
Rochelle P. Walensky, M.D., M.P.H., who helmed a group at Massachusetts General Hospital that analyzed the cost of Trump's plan, told The New York Times that the Gilead donation was "a noble effort -- but it covers less than 20% of the people who need it." She also said: "Let's call a spade a spade. The real cost of Truvada is about $60 a year. If you really wanted to cover everybody, you'd cut the price to everyone."
She was echoed by PrEP4All's Aaron Lord, M.D., who told TheBody, "This is merely a rebranding of [Gilead's pre-existing Truvada giveaway programs] and does nothing new to address barriers." For the past several years, Gilead has offered copay assistance and some full-on programs for Truvada to patients the company deems eligible. But activists have said that the programs don't address the drug's underlying high U.S. price, which puts undue pressure on public payers like Medicaid.
Lord continued, "There is nothing to lead us to believe that this is anything more than just a Descovy marketing scheme." It is estimated that Gilead has thus far made about $3 billion annually from Truvada. "If they want to do something about ending the epidemic, they should significantly lower the price so that public health departments can spend money on programs to improve access instead of spending it on [the] drug and having people jump through administrative hoops to show they have no insurance.
"If this were an unrestricted donation," Lord added, "and the public health department could use the drug however they wanted, it would be a bigger deal. But our understanding is that is not the case."
Asked about this, Gilead rep Ryan McKeel said via email, "Our donation supports a greatly accelerated effort [so] that uninsured individuals at risk for HIV, as identified through the CDC program, can quickly receive medication at no cost. ... HHS [the Department of Health and Human Services] will have control over the administration of it, including eligibility criteria."
In an email, an HHS representative said, "The administration ... and its grantees will broadly advertise this donation, including at federally qualified health centers [community health centers that specifically provide care to underserved communities]] and affiliates. There will be a particular focus on underserved, high-risk, and low-income areas. We intend to partner with federal, state, and private entities to get as much of these drugs to as many qualified patients as quickly as possible. Patients can go to one of the thousands of federally qualified health centers. With just their name, date of birth, and last four digits of their Social Security numbers, we can verify whether they are uninsured. If they are uninsured and medically qualify for a prescription, they will be provided with a paper or electronic verification that they can then use at their local pharmacy or mail-order pharmacy to get HIV prevention medication at no cost to them."
But Tim Horn, director of medication access and pricing at NASTAD, said he had several questions about that. "How will 'uninsured' be determined, and by whom?" he asked. "Will there also be financial eligibility criteria, similar to Gilead's [other patient assistance programs]? Will clients who are eligible for insurance be required to pursue that? Will there be citizenship requirements that may prevent undocumented people vulnerable to HIV infection accessing free PrEP?"
The HHS rep did not reply to two requests for answers to those questions.
Echoing other activists, Horn also said that the Truvada (and eventually Descovy, once the Food and Drug Administration approves it for PrEP) donation "will undoubtedly help to expand access to PrEP. However, a long-term, sustainable approach to PrEP access requires a competitive generic market. We believe federal, state, and community partners should be cautious not to allow this donation program to build an artificial market [benefiting Gilead], undercutting the ability of the generic market to bring down costs and expand access to far more people than Gilead's donation program will be able to reach."
Speaking on behalf of PrEP4All, Lord said, "We are absolutely continuing our demands to CDC that they enforce their patents on Truvada."