Ruling It. Yesterday afternoon, the Centers for Medicare & Medicaid Services released the MA/Part D final rule. Personally, most of it was not up my alley but I did read over the changes to the changes to an approved formulary sections.
In December 2022, CMS proposed allowing immediate substitution of interchangeable biosimilars or branded biologics but did not finalize that proposal. Then, in November 2022, CMS proposed allowing any biosimilar to be substituted for their reference product as a “maintenance change.”
Midyear formulary substitutions of biosimilars for their reference products would apply to all enrollees (including those already taking the reference product prior to the effective date of the change). Interchangeable biosimilars and branded biosimilars could be substituted immediately; all others could be substituted following a 30-day advance notice to affected enrollees. Or that’s how I read it. Let me know if you think otherwise.
Stomaching the Painful Truth. I remember my mom’s last colonoscopy. The doctor gave her the “all clear” and said she never had to come back because she was too old. On one hand, thrilling and, on the other, a bit humbling. Turns out she’s not alone. JAMA has an article about the risk/reward balance of colonoscopies of those 70 and over.
If you’ve never had one, honestly they aren’t that bad. I had one and did the pills instead of the liquid (recommend) and spent a lovely day watching TV after. Was it awesome? No. But sometimes adulting just is sucking it up. Or, in this case, letting go? (Sorry.)
EPIC Op-Ed. Michael Ward of the Alliance for Aging Research writes about the Inflation Reduction Act and the impact on small molecule innovation. It’s a nice piece that digs into the why we need small molecules (way easier to take, get) and that they are sometimes the way a condition can be treated (blood-brain barrier.) Solution? EPIC Act.
If you’ve been weighting. If you’ve been kind of, sort of watching the obesity drug articles but not digging in; this one by Vox could be for you. It does a nice job of starting to question the value of the drugs in a conversational way. I mean I like that the article recognizes that list is not net (although it references federally mandated rebates which isn’t quite right). And it even touches on quality-adjusted life years (QALYs) and the Institute for Clinical and Economic Review (ICER) which said that Wegovy would be work between $7,500 and $9,800 per patient per year. Not where we are now but given competition and eventual generics…
Wake me when it’s over? Politico reports that President Trump is still favoring a Most Favored Nation approach where the United States pays no more than other countries for certain drugs. Never mind what access in those countries might look like and/or if that is the right price at all (should they be paying more?)
Data. Data. Data. The New England Journal of Medicine had a piece on how data-driven evaluation of clinical trial eligibility criteria could increase access and make trials more inclusive.
The rule caught me off guard. Thursdays at 4 pm are a witching hour… Saved to the desktop to read next week?
HHS proposal for supply chain shortages
CMMI strategy to support person-centered, value based specialty care