Origins and Ownership of Remdesivir: Implications for Pricing

Abstract

On May 1, 2020, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to allow use of remdesivir — an unapproved drug — for the treatment of hospitalized patients with severe coronavirus disease 2019 (Covid-19). Remdesivir is a viral RNA polymerase inhibitor with antiviral activity against the coronaviruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). It was identified early in January 2020 as a promising therapeutic candidate for Covid-19 due to its ability to inhibit the in vitro activity of SARS-CoV-2.2. While at the time of the EUA decision there was limited evidence on the safety and efficacy of using remdesivir to treat Covid-19, the drug was later shown to shorten the time to recovery by 4 days in a recent clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). It was the first therapeutic shown in a well controlled prospective trial to have any activity against Covid-19.

Although remdesivir has not been shown to improve survival or longterm health, optimism has fueled concern about its accessibility both in the US and around the world. After the EUA was issued, Gilead announced that it would donate 1.5 million doses of remdesivir worldwide, of which 607,000 vials were to be made available in the US, enough to treat an estimated 78,000 hospitalized patients. The federal government was later able to secure 500,000 treatment courses through September 2020. Despite these efforts, it is unclear whether adequate supplies will be available to treat all patients with Covid-19 who require hospitalization each month nationwide.

Concerns have also been raised that not all patients would be able to afford the treatment. Early price estimates have suggested that it could range from $10 per course of treatment as a minimum cost of production to $4,500 per treatment course as measured by cost-effectiveness using a $50,000/QALY threshold. This estimate was later lowered to a range of $2,520 to $2,800 per treatment, assuming dexamethasone as standard of care.7 On June 29, 2020, Gilead announced a price of $520 per vial, or $3,120 per treatment, for privately insured patients, along with a commitment to make the limited supply of the drug available to US patients first. As clinical trials continue, we review the discovery and ownership of remdesivir, focusing on contributions from the US federal government during the course of its development.