EMD Serono wordmark on building
EMD Serono announced extended 340B contract pharmacy restrictions for hospitals in a manufacturer notice on Sept. 1.

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EMD Serono Is the Second Drug Maker Today to Impose Conditions on 340B Contract Pharmacy, and the 21st Overall

EMD Serono today became the 21st pharmaceutical manufacturer to impose conditions on 340B pricing involving drug shipments to contract pharmacies.

Bayer announced conditions on 340B sales involving contract pharmacies earlier today. The companies’ announcements came two days after the U.S. Third Circuit Court of Appeals ruled the 340B statute does not require drug makers to deliver discounted 340B drugs to an unlimited number of contract pharmacies. Federal appeals courts in Washington, D.C., and Chicago are expected to rule soon in similar cases.

An EMDS spokesperson said today’s policy announcement was unrelated to the Third Circuit Court’s Jan. 30 ruling.

According to an email received by a 340B hospital pharmacy official this afternoon, EMDS’s policy takes effect March 1. It affects hospital covered entities only and EMDS’s products Refib (interferon beta-1a) and Gonal-f (follitropin alfa for injection) only. “At EMDS’s discretion, federal grantees will remain eligible to place Bill To / Ship To replenishment orders of 340B priced Rebif and Gonal-f for their contract pharmacies,” the company said.

“Effective March 1, 2023, EMDS will ship Rebif and Gonal-f purchased at the 340B price exclusively to locations registered as 340B covered entities or to eligible child site locations,” the notice said. “Except as permitted below, EMDS will not honor Bill To / Ship To replenishment orders to commercial pharmacies.”

EMDS is letting hospitals without an in-house dispensing pharmacy designate a single contract pharmacy for bill to/ship to replenishment orders of Rebif and Gonal-f. It is using industry contractor 340B ESP to process these pharmacy designations. Hospitals can apply for exemptions to the policy for their wholly owned contract pharmacies.

EMDS is not letting hospitals continue to use multiple contract pharmacies in exchange for giving the company their relevant claims data for contract pharmacy utilization.

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