NIH must ensure sickle cell drug available at reasonable price, group says

Drug prices
NIH must rethink its approach to licensing new drugs to companies to consider the eventual price of these products, an advocacy group says. (Getty/Tero Vesalainen)

The National Institutes of Health must ensure that a possible cure for sickle cell is available to Americans at a reasonable price, a drug price advocacy group said.

Patients for Affordable Drugs said in a report on Monday that NIH has invested $300 million in taxpayer dollars on a gene therapy called LentiGlobin BB305 that could cure sickle cell. The group is worried that if NIH doesn’t press companies on the price of the eventual treatment then it will become too expensive for most people.

Normally, NIH will license the patent to a drug company that brings the new drug to market and gets a royalty payment. However, the agency’s approach has been criticized by advocates upset about the price of new products based on taxpayer-funded research.

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“Given the $1 to $2 million price range of recent gene therapies, we are concerned that a sickle cell cure will be brought to market at a price that is unaffordable for patients and for the taxpayers who supported its development,” the group’s report said.

RELATED: Trump's budget plan puts the squeeze on NIH, boosts FDA

However, NIH told Fierce Healthcare that much of the report is inaccurate. the agency said it does not hold the patent that led to LentoGlobin. 

"NIH and HHS agree that the affordability of drugs is an issue of concern," the agency said. "It is not within the NIH's mission to evaluate or determine drug pricing."

Patients for Affordable Drugs, which is primarily funded by the Laura and John Arnold Foundation, said that NIH can require several commitments from the drug manufacturer before handing over the intellectual property.

The drugmaker could promise to limit the U.S. price to the average price of other comparable nations. Some nations can get drugs at a lower rate because of government-run healthcare systems that require drug companies to negotiate to gain access to the market.

Another suggestion in the report is that a licensing agreement for a new product is based on several metrics. These metrics could include manufacturing costs, the amount of taxpayer dollars invested in the drug and the profit margin for the company over a five-year period.

“The NIH should use its authority to require that inventions developed as a result of taxpayer investment be available at a reasonable price that balances incentives for innovation with patient access,” the report said.

The report is the latest salvo thrown by advocates and critics of NIH on drug pricing. In 2016, a group of 50 House lawmakers implored NIH to use “march-in rights” that enable the agency to strip patent protections for products that aren’t available to the public through “reasonable terms.”

The lawmakers argued that high prices have caused certain treatments to violate the reasonable terms metric. NIH declined the lawmakers’ request.

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