Drug manufacturer Boehringer Ingelheim (BI) this month extended its restrictions on 340B drug sales to hospitals to Ofev, its expensive specialty drug for idiopathic pulmonary fibrosis.
BI lets hospitals without an in-house pharmacy designate a single contract pharmacy location to receive and dispense BI products. Hospitals must register with drug manufacturer vendor 340B ESP to make their contract pharmacy designation.
Community health centers, HIV/AIDS clinics, and other federal grantee covered entities are exempt from BI’s policy, for now. BI initially exempted Ofev and two other specialty drugs,
Gilotrif, and Praxbind, from its policy.
The U.S. Health Resources and Services Administration (HRSA) told BI on Oct. 4 that its policy was illegal and had to end immediately, or BI could face civil monetary penalties. BI sued HRSA in defense of its policy on Oct. 25. A federal district judge stayed proceedings last week.
BI informed covered entities of its policy’s extension to Ofev in letters dated Oct. 29. The change took effect Dec. 1. According to a March 2021 U.S. Government Accountability Office report, a 60-count package of Ofev 150 mg capsules cost individuals or their insurers $10,495 at the retail level.