US Nabs Bulk of World Remdesivir Supply

03.07.2020 - As the global coronavirus pandemic shows no signs of abating, the US “America first” approach to preventing and treating Covid-19 has again provoked worldwide concern.

As in the earlier controversy over the US getting a vaccine first, the conversation was again political when on Jun. 30 reports surfaced that the US government had nailed down the lion’s share of a drug with potential to be a key weapon in fighting the virus.

The antiviral remdesivir, developed by US drugmaker Gilead Sciences for Ebola treatment but never used, has moved into the spotlight as a stop-gap treatment for Covid-19 in the absence of a vaccine or while waiting for one.

Like hydroxychloroquine before it, remdesivir has been touted by US president Donald Trump as a “game changer,” though experts say there is no evidence that this is a miracle drug, either. In one US clinical study, as yet not peer reviewed, it was shown to reduce patients’ risk of dying from the virus and cut recovery time by as much as four days.

While removing its earlier Emergency Use Authorization for hydroxychloroquine, the US Food and Drug Administration (FDA) has meanwhile awarded that status to remdesivir.

Gilead initially donated 1.5 million doses of the treatment to countries worldwide, a volume it said should suffice for around 140,000 treatment courses. According to the US Department of Health & Human Services (HHS), nearly 1 million doses had been reserved for the US, but inventories are now dwindling as virus cases soar.

To increase supply, the drugmaker had already promised to manufacture more than 500,000 treatment courses by October this year and more than 2 million by December, without specifying where the drug would be distributed. This week it became clear.

Under the freshly inked US supply agreement that Health Secretary Alex Azar (a former Eli Lilly executive) called an “amazing deal negotiated by Donald Trump,” Washington has secured the more than 500,000 new treatment courses for itself.

Through the end of September, the exclusive doses will be distributed to US hospitals for $520 per vial, or $3,120 per treatment course for patients with private insurance. For patients on government-sponsored insurance, Gilead will charge $390 per vial, or $2,340 per treatment course. The latter price also has been determined for national health care systems outside the US.

Controversy over price and US exclusivity

Along with US exclusivity, there has been controversy over what some perceive as a high price for a drug that has never been administered. Given its “modest therapeutic utility,” Gilead’s price for remdesivir is likely more than 250 times greater than its manufacturing costs, the nonprofit Institute for Clinical and Economic Review estimated.

Some analysts had predicted that a course of treatment could cost as much as $5,000.

In a statement, Gilead CEO Daniel O’Day, said “there is no playbook for how to price a new medicine in a pandemic,” while at the same time pointing to the company’s donations, the last of which were distributed at the beginning of this week.

In reaction to the news of the US deal, the World Health Organization (WHO) said it was working to verify reports that the country that is taking steps to exit the organization is hoarding the drug.

Hoarding by private resellers was a major issue for hydroxychloroquine, driving the treatment previously prescribed for lupus and rheumatoid arthritis out of the ballpark.

Washington’s move also has faced criticism within the country itself.  “This is a US-first policy,” Rena Conti, a health care economist at Boston University, remarked. “Access is guaranteed to the US, but worldwide demand could potentially outstrip supplies.”

Conti said she was “unaware of any other policy, except perhaps in bioterrorism drugs, where there might be country-specific supplies.”

Speaking to US broadcaster CNN, Andrew Hill, a senior visiting research fellow at Liverpool University in England, called a situation where a single country requisitions the whole supply of a drug for a life threatening disease “unprecedented."

UK business minister Nadhim Zahawi appealed to governments and companies worldwide to cooperate on finding treatments for coronavirus, lauding UK pharma major AstraZeneca's international deals to supply hundreds of millions of doses of a vaccine globally if one is produced at Oxford University.

Others were less perturbed by the US coup.  Germany’s health minister Jens Spahn said he expects that Europe will be supplied with remdesivir when it becomes generally available. Germany has secured sufficient reserves for now, he commented.

Generics producers awarded free licenses

Farasat Bokhari, associate professor at the University of East Anglia (UEA) specialized in health policy, noted that Gilead has provided free licenses to produce and distribute remdesivir. The list includes Mylan, Cipla, Ferozsons Laboratorie, Hetero Labs and Jubilant  Life Sciences, all of which have plants in India and Pakistan.

“The licenses are royalty free for now and firms are free to set their own prices and export to another 127 countries,” Bokhari said. “Hopefully, these companies will be able to step up and provide supplies throughout the world.

Even other firms that did not receive a license from Gilead may start making the drug under the provisions of the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, the professor added. This, he said, allows least developed countries (LCD) to issue compulsory licenses in certain situations.