Sorting Out Remdesivir Supplies Amid COVID-19
The US Department of Health & Human Services has left it up to state health departments to decide how to distribute remdesivir to hospitals.
Following the FDA’s Emergency Use Authorization (EUA) for remdesivir for treatment of severely ill patients with coronavirus disease 2019 (COVID-19) on May 1st, initial distribution of the drug caused confusion about how the supplies were being allocated to hospitals, which left many health care providers urging for more transparency.
As a result, US Department of Health & Human Services (HHS) offered more details: state health agencies would be responsible for allocating their remdesivir supplies to the hospitals that they see as needing it most, since “state and local health departments have the greatest insight into community-level needs in the COVID-19 response, including appropriate distribution of a treatment in limited supply.”1
Health care providers are responsible for contacting their state health department to receive remdesivir supplies, according to HHS’ news release.1
The HHS’ Office of the Assistant Secretary for Preparedness and Response described its plan for distributing Gilead Sciences’ donation of approximately 607,000 vials of remdesivir, which launched on the evening of May 7th.1 In the press release, HHS announced its commitment to delivering cases, each containing 40 vials of remdesivir, to 6 states: Connecticut (30 cases), Illinois (140 cases), Maryland (30 cases), Michigan (40 cases), and New Jersey (110 cases).1 HHS also said in the release that it is committed to delivering remdesivir to all 50 states and territories, but did not provide details on how or when this will be accomplished.1
According to a New York Times report, many hospital officials had expressed confusion concerning how the cases have been distributed, citing that many regions and states with high infection rates have been left out of the initial remdesivir delivery.2
Conan McDougall, professor of clinical pharmacy at the University of California San Francisco (UCSF), created an unofficial map based on a survey conducted from May 7 to 10, which was last updated on May 14. The survey was sent to health care systems across the United States to gauge where hospitals are receiving remdesivir. The data, which is based on reports from pharmacy departments and infectious disease experts, showed that many regions of the country have not been offered supplies of the drug.2,3
Prior to HHS’s May 9th announcement, the American Society of Health-System Pharmacists (ASHP) sent a letter recognizing the lack of transparency in current methods of allocating remdesivir, and urged Vice President Mike Pence to offer a clearer timeline for commercial availability and distribution.
Currently, methods of acquiring remdesivir for hospitals are limited. Thomas P. Lombardi, PharmD, FASHP, systems director of pharmacy and chair of the Institutional Review Board at St. Peter’s Health Partners in Albany, New York, explained the 4 ways that hospitals can receive the drug.
The first is being enrolled in a Gilead clinical trial, which is “probably the most complicated,” Lombardi said in an interview with Drug Topics®.
“This requires primary investigators, it involves enrolling into a specific study, and it tends to be some of the larger organizations that are enrolled. Most of the studies are not enrolling additional sites at this point in time, so it's difficult to achieve it that way,” he said.
The second method is through a compassionate use program from Gilead, which is limited to pregnant women and children 18 years or younger.
“In that situation, the provider and the physician would have to contact Gilead directly and request compassionate use for the drug for that individual patient, so it's an individual request,” Lombardi said.
The third way is through an expanded access program, Lombardi told Drug Topics®: “This is an investigation protocol, which the hospital has to apply by identifying a primary investigator, a physician, who will then apply to be into the protocol, and the protocol would have to be reviewed by their institutional review board and they would have to go through that process. In that case, then only that 1 individual provider would be able to prescribe the drug for any patient with COVID, and there's very specific inclusion criteria for patients to receive at the provider would have to enroll each patient one at a time.”
That leaves the most recent method: EUA. “This is where most of the organization will probably receive their remdesivir. At this point, it’s being allocated primarily through state departments of health,” Lombardi continued.
As of the time of the interview, 2 sites with St. Peter’s Health Partners have enrolled in the extended access program and have received remdesivir. “We have remdesivir through that program. The other thing is that the protocol for the expanded access will be modified to mirror the inclusion criteria and the use criteria that are in the EUA availability of the drug,” Lombardi told Drug Topics®.
Daniella Ferri, PharmD, BCPS, clinical pharmacy specialist infectious diseases at St. Peter's Hospital in Albany, New York, told Drug Topics® about her experience with the expanded access program at her hospital: “So far, we have not encountered any issues. We enroll patients and we receive products,” Ferri said.
Julie Bennett, PharmD, BCIDP, clinical pharmacy specialist infectious diseases at Samaritan Hospital in Troy, New York, confirmed the presently effective expanded access program at her hospital in an interview with Drug Topics®: “At Samaritan Hospital, we are also enrolled in the expanded access program, and right now we have adequate supply to treat our patients at this time,” Bennett said.
The experts noted that it is important to differentiate what program a hospital is receiving remdesivir supplies from.
“Our hospitals are part of Trinity Health, which is a national organization, and we do meet and we discussed this and there has been some frustration for some of the sites on how much they would be allocated and how they would be getting it; but this is all unrolling within the last 2 weeks and the distribution is still occurring.”
“We have yet to have any experience with the emergency use authorization; we have so far experienced the expanded access only,” Ferri said.
Another factor to take into account is that although remdesivir is authorized for use in hospitals by the FDA, the decision was based on preliminary data and is still awaiting sufficient data to determine whether remdesivir is associated with lower mortality rates.1
Michael Ganio, PharmD, FASHP, senior director of pharmacy practice and quality at ASHP, explained that the fast-changing environment amid the COVID-19 pandemic will soon reveal how or if remdesivir will be allocated to US hospitals.
“There are still a lot of questions about how remdesivir will be sold and distributed after the donated supply runs out. Gilead has announced that they are increasing production and have contracted with generic manufacturers to make the drug more available worldwide. They anticipate 500,000 treatment courses will be available by October, but so far we do not know about pricing or how that drug will be distributed,” he wrote to Drug Topics® in an email.
“This is a very fluid situation, so we’re learning as we go along,” Bennett added.
Gilead’s donation to the United States is expected to treat an estimated 78,000 hospitalized patients with COVID-19 under the EUA over the next 6 weeks.1
References:
1. HHS announces shipments of donated remdesivir for hospitalized patients with COVID-19. News Release. US Department of Health & Human Services; May 9, 2020. Accessed May 11, 2020. https://www.hhs.gov/about/news/2020/05/09/hhs-ships-first-doses-of-donated-remdesivir-for-hospitalized-patients-with-covid-19.html.
2. Kolata G. Haphazard Rollout of Coronavirus Drug Frustrates Doctors. The New York Times. 2020. https://www.nytimes.com/2020/05/08/health/coronavirus-remdesivir-hospitals.html. Accessed May 11, 2020.
3. MacDougall C. Remdesivir Emergency Use Authorization Distribution Map. Public Tableau website. https://public.tableau.com/profile/conan.macdougall#!/vizhome/RemdesivirEUAMap/Sheet1?publish=yes. Published May 6, 2020. Accessed May 18, 2020.
