Month: October 2024

PBMs have been increasingly under the regulatory microscope for some time…. and recent focus has never been more intense. The pushback from the industry has also been palpable…. no surprise there….. because there is a lot of $$$s involved with even small changes to the industry model.

While the current election has significantly toned down media attention on PBM healthcare hegemony it is opportune to assess what has happened so far and what changes on the regulatory level can reshape the marketplace.

The article below is thought provoking.  

It frames the key issues and lays out some timely questions…..

• How the role of the PBM has changed over time?
• How drug pricing arrangements vary – and also how they don’t?
• Why cross-subsidization of revenue across drug categories is such a big issue and,
• Who are the new players and their connections to the larger system and the value they may bring…..?

……. just to point out a few.

It is fair to say that the outcome of next month’s election…… especially in Congress,  may have a major impact on the near term future (and fortunes) of PBMs in the US.

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Understanding the debate over PBMs

CLICK HERE to read the full article

…………catching up on FDA approvals

The FDA has approved a new therapy, Pyzchiva (ustekinumab-ttwe) from Samsung Bioepis, as a biosimilar to Janssen Biotech’s Stelara. Pyzchiva is available in a subcutaneous form as well as an infusible. Pyzchiva joins the ranks of only a handful of biosimilars to earn the title of interchangeability with the reference product. 

The approval of Pyzchiva marks the third ustekinumab approval for the US as well as the 14th interchangeable biosimilar.

Pyzchiva is indicated for—–

Adult patients with:

• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
• active psoriatic arthritis;
• moderately to severely active Crohn’s disease; and
• moderately to severely active ulcerative colitis.
• Pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and active psoriatic arthritis.

Prescribing information specifies subcutaneous dosing and administration for Psoriasis and Psoriatic Arthritis while also specifying intravenous dosing instructions for Crohn’s Disease and Ulcerative Colitis.

CLICK HERE for prescribing information

While Pyzchiva did not receive a Black Box warning there are a number of warnings and precautions.

Pyzchiva  will launch in early 2025 when Stelara’s patent exclusivity expires. As such, pricing and distribution plans were not announced.