Hospitals are expressing relief over being able to administer the COVID-19 drug Veklury in outpatient settings and to be able to buy it finally at a 340B price.

FDA OKs COVID-19 Drug Veklury (remdesivir) for Outpatients, Opening the Way for 340B Pricing

Hospitals caring for patients infected with the highly infectious omicron variant of COVID-19 say they are very relieved to be getting 340B pricing finally on Gilead’s injectable antiviral medication Veklury (remdesivir).

On Friday, the U.S. Food and Drug Administration (FDA) approved Veklury for administration to outpatients with mild-to-moderate COVID-19. It previously was approved for inpatient administration only. 340B discounts apply to covered outpatient drugs only.

Last week’s decision to expand Veklury’s authorized use to outpatient treatment means hospitals now have access to 340B pricing on the drug, which is in very high demand.

“With FDA’s approval of Veklury for use in non-hospitalized patients, Gilead is working with its distributors to enable the ordering of Veklury by qualified outpatient facilities,” a Gilead spokesperson said last night. “We expect increased demand from outpatient settings and are committed to offering eligible 340B covered entities that comply with all 340B program requirements the 340B ceiling price.”

Gilead’s conditional statement about offering 340B price on Veklury might make groups that represent 340B hospitals and other covered entities uneasy.

The federal government initially paid for and distributed 500,000 treatment courses of Veklury in 2020. That ended on Sept. 30, 2020. Gilead set the price to hospitals at $520 per vial for patients with private insurance. The newly accessible 340B price is lower, hospitals confirm.

One hospital said yesterday it first gained access to lower 340B pricing on Veklury a few weeks ago. In late December, Gilead announced that Phase 3 clinical trial results supported Veklury’s use in non-hospitalized patients.

Hospitals said FDA’s approval to administer Veklury in infusion centers and other outpatient settings came in the nick of time. Just yesterday, the FDA halted use of two of the three monoclonal antibodies it approved on an emergency basis to treat COVID-19 in outpatient settings. The two treatments, made by Lilly and Regeneron, “are highly unlikely to be active against the omicron variant,” an FDA official explained. Both were in short supply.

That leaves just one approved monoclonal antibody treatment for COVID-19 for outpatient use. It is made by GlaxoSmithKline and Vir Biotechnology, and hospitals say it, too, is in short supply.

In December the FDA granted emergency use authorization to two COVID-19 oral antiviral drugs that can be taken at home. Supplies of Pfizer’s product are limited, and Merck’s drug is not as effective as hoped.

The upshot is that hospitals’ reliance on Veklury as a drug therapy for COVID-19 remains strong. According to news organization Fierce Pharma, Gilead CEO Daniel O’Day said earlier this month during J.P. Morgan Chase’s annual biotech conference, held virtually this year, that 60% of all U.S. patients hospitalized with COVID-19 are treated with Veklury, up from 30% in October.

“Our Highest Drug Spend Product”

Veklury “has quickly become our hospital’s highest drug spend product over the past six months,” a pharmacy executive at a major metropolitan 340B hospital said. “If we are able to purchase this at 340B pricing versus WAC pricing, this should help considering we have already purchased over 1,000 vials in January.”

“We are launching outpatient infusions this week and had been working on this for a few weeks,” said a senior pharmacy executive at a health system with hospitals in several states. “We were going to go live with it this week even without the FDA labeling change,” he explained, “to help with our therapy gap due to the low supply of monoclonal antibodies that cover omicron.”

“It is very nice to have access to the 340B pricing,” the executive said.

Gilead noted last night to 340B Report that FDA approval to use Veklury on an outpatient basis “is occurring amid the unprecedented demand for early treatment options caused by the current COVID-19 surge.”

“In accordance with the recommendations provided by the National Institutes of Health COVID-19 Treatment Guidelines, which prioritize treatment for those patients who are at the highest risk of progressing to severe COVID-19, Gilead’s goal is to ensure uninterrupted supply for inpatient hospital use while expanding to outpatient facilities as well,” the company said. “Gilead will enable outpatient ordering in a tiered approach that will start with hospital outpatient departments (regardless of the 340B status of those hospital outpatient departments), due to their experience and familiarity with the administration of Veklury; then outpatient ordering will be available to other qualified facilities.”

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