Hospitals Go Back to Purchasing Remdesivir from Distributor

October 06, 2020 - HHS recently announced that American hospitals can go back to purchasing Gilead’s COVID-19 antiviral, Veklury (remdesivir), directly from the drug’s distributor starting. 

Over the past five months, the US government has overseen the allocation of remdesivir due to the drug’s limited supply to ensure fair and equitable distribution to COVID-19 patients. 

President Trump secured the majority of the manufacturer’s supplies for the American people, part of the administration’s work to manage scarce resources needed to combat COVID-19. But federal government oversight of the antiviral’s allocation is no longer necessary, HHS stated in the announcement.

“Over the past five months, HHS rapidly, fairly, and equitably worked to distribute approximately 150,000 treatment courses of donated Veklury and make more than 500,000 treatment courses of the commercial drug available to help treat patients in US hospitals,” said HHS Secretary Alex Azar. 

“Now, federal government oversight of the allocation of Veklury is not required because the drug is no longer a scarce resource—a tribute to progress we have made against COVID-19 and to the strength of our partnerships with the private sector.”

On October 1, 2020, FDA revised the emergency use authorization for remdesivir, removing the US government’s role in directing the allocation of the drug, HHS said. 

The decision to expand the use of remdesivir stemmed from the agency’s ongoing review of the May emergency use authorization of the drug, which showed that it may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in severely ill patients. 

Back in June, Gilead released positive results from its Phase 3 clinical trial evaluating remdesivir as a COVID-19 drug, which found that patients in the five-day remdesivir treatment group were 65 percent more likely to see clinical improvement at Day 11 versus individuals receiving standard care.

The study results indicated that if remdesivir is given to patients earlier in the disease progression, there will be notable improved clinical outcomes for patients. 

The revised emergency use authorization identified Gilead and its distributors as “responsible parties” for the distribution of remdesivir. 

Additionally, the HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR) recently generated allocation numbers and found that the current supply of remdesivir exceeds market demand. 

Specifically, of the 500,000 treatment courses made available in the US between July and September 2020, state and territorial health departments accepted 84 percent of their allocations.

But, only 32 percent of the total allocation was legitimately purchased by hospitals in their jurisdictions, ASPR noted. 

Throughout the course of the project, the organization allocated over 70,000 treatment courses, including the reallocation of 200,000 treatment courses that were not initially accepted by state and territorial health departments. 

HHS stated that Gilead is expected to produce sufficient quantities of remdesivir to meet current needs and future demands from any waves of COVID-19.

Hospitals will continue to pay no more than Gilead’s wholesale acquisition price, which is approximately $3,200 per treatment course.

AmerisourceBergen will continue to be the main US distributor of remdesivir through the end of 2020 and will sell the product directly to hospitals. 

“Since the COVID-19 pandemic began, Gilead has worked diligently to ramp up production and rapidly expand the supply of our investigational antiviral drug Veklury (remdesivir) by making significant investments to increase internal manufacturing capacity, expand our contract manufacturing network and implement process improvements,” Gilead said in a statement.

Additionally, the company donated 1.5 million vials of remdesivir for evaluation as an investigational agent in clinical trials globally. 

“The increased supply of Veklury will expand access to the medicine to additional appropriate patients with COVID-19, offering the potential for patients to recover faster and, in turn, increase healthcare provider capacity and reduce healthcare system costs,” Gilead concluded. 
HHS urges individuals to visit the ASPR website to learn more information about remdesivir and the strategy used to allocate and distribute the drug in the US.