Biopharmaceutical manufacturer Exelixis said today it is extending its conditions on 340B pricing to contract pharmacies that are wholly owned or under common ownership with a hospital covered entity. The change is effective June 26.
Exelixis announced the change in an email this afternoon to covered entities.
Exelixis makes and sells just two relatively expensive cancer drugs taken orally—Cometriq for advanced thyroid cancer and Cabometyx for advanced kidney, liver, or thyroid cancer. It announced its original conditions in June 2022. Grantee covered entities were and still are exempt “until further notice,” the company said. Due to the exclusion of 340B pricing on orphan drugs for rural and free-standing cancer hospitals, the company’s conditions apply to disproportionate share and children’s hospitals only.
Under the original policy, DSH and children’s hospitals could continue to place bill to / ship to orders for multiple contract pharmacies only if they agreed to provide claims data for Cometriq and Cabometyx to industry contractor 340B ESP.
The policy update announced today extends that condition to DSH and children’s hospitals’ contract pharmacies that are wholly owned or under common ownership.
Hospitals that lack an in-house pharmacy and decline to provide the required claims data “may designate a single contract pharmacy location—whether a contract pharmacy that is wholly owned or under common ownership with the covered entity or a third-party contract pharmacy within the specialty pharmacy network—for the shipment of 340B product,” Exelixis said.
“Exelixis reserves all rights to modify further the 340B program integrity initiative in a manner consistent with law in the future,” the notice said.
