Biopharmaceutical manufacturer Amgen this afternoon significantly expanded its conditions on 340B pricing when hospitals use contract pharmacies.
Johnson & Johnson announced a similar expansion of its 340B contract pharmacy limits last month. Hospital groups slammed J&J’s new restrictions.
Amgen’s conditions continue to apply to hospital covered entities only. Non-hospital entities remain exempt.
Effective April 11, 340B hospitals without an in-house pharmacy may designate one contract pharmacy and it must be within 40 miles of the hospital parent site, Amgen said in a letter emailed to covered entities today. Hospitals do not have to provide claims data to industry contractor 340B ESP for their designated contract pharmacy, Amgen said.
Amgen will let hospitals with an in-house pharmacy designate one contract pharmacy, but it must be within 40 miles of the hospital parent site and the hospital must provide claims data to industry contractor 340B ESP for both the in-house pharmacy and the designated single contract pharmacy.
Amgen’s original policy dated Dec. 1, 2021, applied to just four drugs: Repatha, Enbrel, Otezla, and Aimovig. It added two to the list: Tezspire and Amjevita.
Hospitals “must take action by March 27th, 2023, in order for contract pharmacy location designations to take effect on the effective date of the policy,” Amgen said in the email to covered entities.
Under Amgen’s old policy, hospitals lacking an in-house pharmacy could designate one contract pharmacy without regard to distance from the hospital parent site. It granted exemptions for hospitals’ wholly owned contract pharmacies. Also, hospitals could contract with multiple pharmacies if they submitted claims data for those pharmacies.
“Amgen believes these measures will strengthen the program,” the company said in a statement. It said it “will continue to work with the Administration, policymakers, healthcare providers, the biopharmaceutical industry and other stakeholders to ensure the [340B] program is executed in a way that benefits patients, the safety net, and the healthcare system as a whole.”