Providing COVID-19 Monoclonal Antibodies Requires Flexibility, Understanding of Emergency Use Authorizations

A panel of experts at the Asembia 2022 Specialty Pharmacy Summit discussed some of the obstacles in providing medications approved under Emergency Use Authorization.

Despite clear clinical evidence showing the benefit of monoclonal antibodies for patients with COVID-19, a panel of experts at the Asembia 2022 Specialty Pharmacy Summit discussed some of the obstacles in providing medications approved under Emergency Use Authorization (EUA).

First, panelist Don Torman, RPh, CSP, manager of pharmacy operations at Amber Specialty Pharmacy, discussed the value of monoclonal antibodies as a treatment option for COVID-19. Unlike vaccines, monoclonal antibodies help to restore, enhance, or mimic the immune system response to the COVID-19 virus. Once approved by the FDA under an EUA, Torman noted that monoclonal antibodies originally had a limited patient population because they were reserved for high-risk patient groups.

EUAs have strict rules and limitations, so Torman added that pharmacies played a unique role. Manufacturers were unable to market the products, so pharmacists reached out to providers, long-term care facilities, and others to make them aware of accessing monoclonal antibodies.

As the pandemic evolved, new obstacles emerged. Although several monoclonal antibody products were originally available, Torman said most have become obsolete as new variants have emerged; however, they must still be administered within 7 to 10 days of symptom onset. To keep up with the rapidly changing landscape of monoclonal antibodies, Torman said Amber Specialty Pharmacy created its own internal COVID-19 taskforce to ensure that accurate information was distributed efficiently.

Panelist Vickie Sykes, senior sourcing manager at Amber Specialty Pharmacy, said she was responsible for managing the procurement of monoclonal antibodies, which had its own set of challenges throughout 2020 and 2021.

Although the National Home Infusion Association launched a pilot program in early 2020 to handle initial access to monoclonal antibodies, the system was then transitioned to direct ordering through Amerisource Bergen. Then, Sykes said federal allocations were reinstated later in 2021 due to higher demand as the Delta variant emerged.

“Procurement during this phase was difficult for all involved,” Sykes said. “However, it was about to get a bit more difficult and a bit more complex.”

Due to the volume of requests, the Department of Health and Human Services (HHS) soon determined that individual states would best be able to determine which cities and regions needed monoclonal antibodies. With this realization, HHS began allocating supplies to the states, which would then distribute supplies to the providers.

As these systems continue to evolve, Sykes said it is essential to educate state allocation officials about specialty pharmacy models and their importance. Pharmacists and other health care providers should also remain aware of various models and rules in different states, and should stay abreast as EUAs for different monoclonal antibodies are paused or discontinued based on evolving COVID-19 variants and data.

“At times it seemed like things were changing every hour, so we stay alert and abreast of any new information coming through,” Sykes concluded.

REFERENCE

Rowe M, Sykes V, Torman D, and Wyant K. Navigating the Pandemic with EUA Therapies. May 2, 2022. Presented at Asembia 2022 Specialty Pharmacy Summit.