Drug manufacturer Boehringer Ingelheim announced this morning that, starting Aug. 1, all covered entity types will be subject to its conditions on 340B pricing when entities use contract pharmacies to dispense BI products. Until now, its conditions have applied to 340B hospitals and health centers only.
BI imposed conditions on hospitals effective Aug. 1, 2021, and on health centers effective Sept. 1, 2022. It let health centers continue to place bill to / ship to orders for deliveries to multiple contract pharmacies if they agreed to provide related claims data to drug industry vendor 340B ESP. Under the policy update announced today, that option will end.
BI also is ending its policy exception for shipments to contract pharmacies that are wholly owned by a covered entity.
As before, if a covered entity lacks an in-house dispensing pharmacy, it may designate a single contract pharmacy. In a change, that pharmacy now must be located within 40 miles of the parent covered entity, and it may not be a central fill pharmacy. If an entity wishes to designate a wholly owned pharmacy as its single-allowed contract pharmacy, it too must be located within 40 miles of the parent site.
If an entity lacks an in-house pharmacy capable of dispensing BI’s lung fibrosis specialty drug Ofev, it may designate one specialty pharmacy from within BI’s limited distribution network for the product “for the sole purpose of dispensing Ofev at the 340B price to its patients,” BI’s letter to covered entities said. An entity may designate a wholly owned contract pharmacy as its single contract pharmacy for Ofev “provided it meets the contract pharmacy requirements as registered on the HRSA OPAIS database as a contract pharmacy and is not a central fill pharmacy,” the notice said.
“Covered entities must take action by July 14, 2023, in order for the single contract pharmacy location designation to take effect on the effective date of this policy,” the notice said. “Covered entities that have already designated a single contract pharmacy on 340B ESP, based on BI’s previous 340B program contract pharmacy policy, are required to re-designate a single contract pharmacy on the platform.”
BI is the sixth drug maker this month to either impose such conditions for the first time (Organon and Teva) or tighten existing ones (Novo Nordisk, Exelixis, and Bausch).
Twenty-three manufacturers have adopted such policies. BI’s update makes it the eighth whose conditions apply to all entity types.