News & Views: 3/8 - 3/14

March 15, 2022

President Biden signed the omnibus appropriations bill which includes a provision to protect the 340B program.

The $1.5 trillion bill for FY 2022 includes a provision that will protect 340B hospitals’ status in the program. Hospitals will be able to introduce evidence proving that they still qualify to participate in the 340B program within 30 days of filing their Medicare cost reports that may indicate otherwise. The policy is similar to both S. 773 and HR 3203 which 340B Health support. To read more, click here.

Researchers from Northeastern University, PORTAL, and Boston University opined on patient assistance programs in a JAMA Viewpoint article.

The researchers illustrate how many patient assistance programs are funded by pharmaceutical manufacturers in an effort to incentivize the use of their products, a tactic which would be illegal if done directly from the manufacturer. Manufacturers are able to evade the anti-kickback statute by making donations to independent charitable organization who then aid qualifying patients. The researchers argue that while many of these programs are questionable attempts to truly help patients, the programs that do increase access to effective treatments or meet unmet needs in a community should be given more flexibility under the statute. To read the full article, click here.

Alvotech, a biosimilar manufacturer, announced a settlement with AbbVie over Humira patents.

The lawsuit was against the notorious patent thicket that protects AbbVie’s blockbuster biologic, Humira, from biosimilar competition. Alvotech’s drug is currently under FDA review and is expected to be the first interchangeable biosimilar for Humira when it launches. In exchange for AbbVie dropping allegations that Alvotech was stealing trade secrets, the settlement postpones Alvotech’s launch to no earlier than July 1, 2023, the date that other biosimilars will be available. While not interchangeable, the first biosimilar, Amjen’s Amjevita, will be available as early as January 31, 2023. To read more, click here.

CIDSA Experts in the News

Rena Conti was announced as one of the witnesses on an upcoming Senate Finance Committee hearing on prescription drug prices. The hearing is scheduled for March 16 at 10AM. To read her full testimony, click here.

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