Point/Counter

Should the US government leverage patents held by the CDC to push down the price of Truvada?

POINT

The federal government should sue Gilead to enforce its patents on PrEP and lower the price of the treatment.

W. David Hardy

I am impressed by the fact that Gilead Sciences did two things: They accelerated the patent expiration date for Truvada (emtricitabine/tenofovir disoproxil fumarate) from 2021 to 2020, giving the rights away for approximately the first 6 months of the sale of generic Truvada to another company, Teva Pharmaceuticals. However, that is oftentimes not a good way to lower medication prices. Because Teva has marketing exclusivity for a period, they will commonly keep the price somewhat high, and the cost remains a barrier. The fact that Gilead has gone one step further and committed to give free Truvada for up to 200,000 people per year for 10 years is another great step in the right direction. My concern about that program is that Gilead already has a free assistance program that people apply for if they have no insurance or financial means to cover the cost of Truvada. Then, they are given the medication for free. That program requires not a small amount of administrative oversight, meaning that someone has to run the program to document that the individuals applying are in fact uninsured and at a certain annual income level.

By sending Truvada to the federal government, Gilead is essentially transferring the administrative responsibilities and cost to the federal government. That is not really a donation. That is donating work to someone else because they would have given those prescriptions away anyway.

It is true that Gilead holds the patent for emtricitabine/tenofovir disoproxil fumarate for the treatment of HIV, because they did develop and fund studies that demonstrated that Truvada works for HIV treatment. However, I think their claim that the CDC does not have the right to patent Truvada for pre-exposure prophylaxis (PrEP) is entirely wrong because they did not develop nor fund the studies that they presented to the FDA for marketing approval of Truvada for PrEP. The CDC and the NIH (American taxpayers!) funded those studies. They did donate the Truvada and placebo tablets used in the studies, but they did not invest the money nor take the risks of developing Truvada for PrEP.

I think that the federal government needs to act on this and sue Gilead for whatever cost they feel necessary. Gilead needs to pony up and say that they will make Truvada available for anyone who wants it and administrate it through a pharmacy or practitioner. They have benefited from the federal government’s research of PrEP tremendously.

W. David Hardy, MD, is chair of the HIV Medicine Association and an adjunct professor of medicine at Johns Hopkins University School of Medicine in the division of infectious diseases. Disclosure: Hardy was a principle investigator on clinical trials with Amgen, Gilead, Jansen, Merck, and ViiV Healthcare. All funds received were collected by Hardy’s institution to run the clinical trials. He has also been on advisory boards for Gilead, Merck and ViiV.

COUNTER

Gilead is committed to ensuring that Truvada for PrEP is accessible to vulnerable populations in the United States.

Editor’s note: Infectious Diseases in Children offered Gilead the opportunity to answer the same question concerning the pricing of Truvada for PrEP. A company statement was provided as a response:

Gilead has been driving scientific advances for more than 30 years, helping turn HIV from a fatal condition to a manageable chronic disease for many patients, and we continue to push toward our ultimate goal of ending the HIV epidemic.

As a matter of principle, Gilead is committed to ensuring that Truvada for PrEP is accessible to vulnerable populations in the U.S. We believe collaborations with government institutions are vital to addressing the HIV epidemic. As part of that ongoing collaboration, we have announced we are donating up to 2.4 million free bottles of HIV prevention medication annually to the CDC for uninsured Americans at risk for HIV up to 2030. Additionally, Gilead reached an agreement to allow the early launch of a generic version of Truvada into the market in the U.S. in 2020, a year earlier than required.

Our donation supports a greatly accelerated effort that uninsured individuals at risk for HIV, as identified through the CDC program, can quickly receive medication at no cost. It is our hope that this donation, along with community efforts to raise awareness and diminish stigma, will increase uptake of PrEP, especially among women and men in the Southern U.S. where we see significant racial disparities in HIV incidence and prevalence.

For those with insurance, we have worked to prevent cost from being a barrier to accessing this groundbreaking HIV prevention medication. The majority of people receiving Truvada for PrEP today who utilize our copay coupons pay less than $5 per bottle.

Editor's note: To read our June cover story, click here.

POINT

The federal government should sue Gilead to enforce its patents on PrEP and lower the price of the treatment.

W. David Hardy

I am impressed by the fact that Gilead Sciences did two things: They accelerated the patent expiration date for Truvada (emtricitabine/tenofovir disoproxil fumarate) from 2021 to 2020, giving the rights away for approximately the first 6 months of the sale of generic Truvada to another company, Teva Pharmaceuticals. However, that is oftentimes not a good way to lower medication prices. Because Teva has marketing exclusivity for a period, they will commonly keep the price somewhat high, and the cost remains a barrier. The fact that Gilead has gone one step further and committed to give free Truvada for up to 200,000 people per year for 10 years is another great step in the right direction. My concern about that program is that Gilead already has a free assistance program that people apply for if they have no insurance or financial means to cover the cost of Truvada. Then, they are given the medication for free. That program requires not a small amount of administrative oversight, meaning that someone has to run the program to document that the individuals applying are in fact uninsured and at a certain annual income level.

By sending Truvada to the federal government, Gilead is essentially transferring the administrative responsibilities and cost to the federal government. That is not really a donation. That is donating work to someone else because they would have given those prescriptions away anyway.

It is true that Gilead holds the patent for emtricitabine/tenofovir disoproxil fumarate for the treatment of HIV, because they did develop and fund studies that demonstrated that Truvada works for HIV treatment. However, I think their claim that the CDC does not have the right to patent Truvada for pre-exposure prophylaxis (PrEP) is entirely wrong because they did not develop nor fund the studies that they presented to the FDA for marketing approval of Truvada for PrEP. The CDC and the NIH (American taxpayers!) funded those studies. They did donate the Truvada and placebo tablets used in the studies, but they did not invest the money nor take the risks of developing Truvada for PrEP.

I think that the federal government needs to act on this and sue Gilead for whatever cost they feel necessary. Gilead needs to pony up and say that they will make Truvada available for anyone who wants it and administrate it through a pharmacy or practitioner. They have benefited from the federal government’s research of PrEP tremendously.

W. David Hardy, MD, is chair of the HIV Medicine Association and an adjunct professor of medicine at Johns Hopkins University School of Medicine in the division of infectious diseases. Disclosure: Hardy was a principle investigator on clinical trials with Amgen, Gilead, Jansen, Merck, and ViiV Healthcare. All funds received were collected by Hardy’s institution to run the clinical trials. He has also been on advisory boards for Gilead, Merck and ViiV.

COUNTER

Gilead is committed to ensuring that Truvada for PrEP is accessible to vulnerable populations in the United States.

Editor’s note: Infectious Diseases in Children offered Gilead the opportunity to answer the same question concerning the pricing of Truvada for PrEP. A company statement was provided as a response:

Gilead has been driving scientific advances for more than 30 years, helping turn HIV from a fatal condition to a manageable chronic disease for many patients, and we continue to push toward our ultimate goal of ending the HIV epidemic.

As a matter of principle, Gilead is committed to ensuring that Truvada for PrEP is accessible to vulnerable populations in the U.S. We believe collaborations with government institutions are vital to addressing the HIV epidemic. As part of that ongoing collaboration, we have announced we are donating up to 2.4 million free bottles of HIV prevention medication annually to the CDC for uninsured Americans at risk for HIV up to 2030. Additionally, Gilead reached an agreement to allow the early launch of a generic version of Truvada into the market in the U.S. in 2020, a year earlier than required.

Our donation supports a greatly accelerated effort that uninsured individuals at risk for HIV, as identified through the CDC program, can quickly receive medication at no cost. It is our hope that this donation, along with community efforts to raise awareness and diminish stigma, will increase uptake of PrEP, especially among women and men in the Southern U.S. where we see significant racial disparities in HIV incidence and prevalence.

For those with insurance, we have worked to prevent cost from being a barrier to accessing this groundbreaking HIV prevention medication. The majority of people receiving Truvada for PrEP today who utilize our copay coupons pay less than $5 per bottle.

Editor's note: To read our June cover story, click here.