Drug manufacturer AbbVie had added its best-selling cancer medicine Imbruvica to its restrictions on 340B pricing when hospitals use contract pharmacies, effective April 1.
AbbVie contractor 340B ESP posted a policy update from AbbVie on its website on March 1. The six-page document appears to be nearly identical to AbbVie’s original late December 2021 notice to covered entities except for two small changes on the last page—Imbruvica’s inclusion on the list of covered products, and a short note below the list stating, “340B Integrity Initiative will become effective for Imbruvica on April 1, 2022.”
One 340B hospital pharmacy official said she only learned about the 340B pricing restrictions on Imbruvica from the hospital’s 340B third party administrator, not AbbVie. An AbbVie spokesperson said yesterday that on March 1 the company “shared a letter updating our 340B integrity initiative to include Imbruvica with all covered entities that have purchased Imbruvica.” The drug is used to treat certain types of lymphoma, leukemia, and other cancers.
AbbVie’s 340B pricing restrictions now apply to 25 of its products, led by its blockbuster immunosuppressant Humira. Under its policy, hospitals must submit claims data on 340B contract pharmacy utilization to 340B ESP to be able to use bill to / ship to arrangements for the designated drugs with an unlimited number of contract pharmacies. The company is letting hospitals that reject the requirement and that lack an in-house outpatient pharmacy designate a single contract pharmacy to receive and dispense orders of 340B-purchased AbbVie drugs.
Grantee covered entities are exempt from the restrictions.
Pharmacyclics, an AbbVie company, jointly developed and markets Imbruvica with Janssen, a Johnson & Johnson company. All 10 NDCs for Imbruvica are assigned to Pharmacyclics.
AbbVie last month reported U.S. net revenues of $4.3 billion on Imbruvica in 2021. According to an April 2021 Kaiser Family Foundation report, Imbruvica is the fifth top-selling drug overall in the Medicare Part D program and the second top-selling cancer drug in the program.