PrEP has the potential to curb the spread of HIV, if only people could afford it.

By Grace Burgin, Public Citizen

An ounce of prevention is worth a pound of cure: the old adage could guide us to the end of the HIV/AIDS epidemic.

There is a drug that can prevent HIV. Pre-exposure prophylaxis (more commonly known as PrEP) has been shown to be up to 99% effective at preventing the spread of HIV when taken daily. Estimated savings from avoiding a single new infection of HIV is around $230,000, without taking into account the personal toll the disease has on a patient. HIV prevention is clearly preferable to treatment. However, less than 10% of the at-risk population is taking PrEP, due to stigma and its inaccessible price.

There is only one PrEP drug on the market in the United States. Gilead Sciences manufactures Truvada (emtricitabine / tenofovir disoproxil), a combination of two existing and widely-used HIV medications. A single month’s supply of the drug is priced up to $1600. Truvada costs an estimated six dollars a month to produce, yet Gilead charges 250 times more because they hold a patent, which prevents competition from entering the market. Generic competition would lower the price and remove the high financial barrier for more than 1.2 million Americans at high risk for exposure to HIV. PrEP is a valuable tool in fighting the spread of HIV. But many of us struggle to afford it.

The National Institutes of Health (NIH) paid for Truvada’s development. The U.S. government acknowledges Truvada’s high price when acquiring PrEP abroad, as the President’s Emergency Plan for AIDS Relief (PEPFAR) uses a generic approved by the FDA to support international HIV programs. The price of PEPFAR’s generic is around $6 a month but is not available or approved in America due to Gilead’s patents.

How can we get lower-price generics here in the U.S.?

The path to increasing access to PrEP is actually easier than you might think.  The NIH need only use an existing law to execute march-in rights that would allow a generic competitor. “March-in rights” allow the government to renegotiate the terms of a patent held exclusively by one company and grant access to other parties. The introduction of generics would bring down the highly inflated price put out by Gilead. But the NIH has never used these rights to bring down the price of a medicine.

Never heard of march-in rights?

It’s a pretty technical piece of law that comes out of a 1980 patent reform effort called the Bayh-Dole Act. The law allows for businesses and universities to apply for patents on products developed with federal research dollars. The original intention was to bring those products to the market by incentivizing private parties. Private actors often reap large profits on government-funded research products. March-in rights allow the government to revoke the exclusivity of a patent to protect against abuses to this system for any product developed with public money. If the patent-holding company fails to make sure the product is “reasonably available” to the public, march-in rights can be invoked.

The conditions are right for a march-in on Truvada. Almost 40,000 people were newly diagnosed with HIV in 2016, and that figure doesn’t include the estimated 1 in 7 people that are unaware they are living with HIV. PrEP would decrease the number of new cases if widely used. One study estimated that if 25 percent of an at-risk community used PrEP, new cases of HIV would decrease by 30 percent. Only 10 percent of the most at risk are using PrEP, so the drug is not reasonably available to the public, which should give the government standing for march-in.

The government has the ability and a strong incentive to march-in on Gilead’s patent.

At the estimated list price, it would cost almost 2 billion dollars to provide one month of PrEP drugs to the entire at-risk population that has been determined by the CDC. If programs in the United States were able to purchase at the price available to the U.K. ($462), the cost would drop down to $500 million per month — which is still too costly to be feasible. Removing the monopoly financial barrier, and getting the much lower prices associated with generic competition, could lead to a massive increase in use of the drug and a subsequent drop in new HIV infections.

If prevention is so valuable, why aren’t we fighting for it? PrEP was a groundbreaking public health advancement funded with taxpayer dollars, and Gilead has recouped its contribution many times over. Because of one corporation’s greed, PrEP can’t accomplish its intended life-saving impact. The path to PrEP access is ready and waiting; it’s now up to the NIH to acknowledge the problem and march in on Gilead.