Tell me a Story. If you’ve been reading my stuff for a while, you know that I love a good lawsuit filing. Sometimes the lawyers get a little spicy. Teva filed suit against the federal government for the Inflation Reduction Act and it has a few gems:

• The IRA’s Drug Price Negotiation Program (DPNP) is a fiction.
• CMS rendered both of those Congressionally imposed limitations illusory by fabricating a new definition of a statutory term… Qualifying Single Source Drug.
• The promise of fairness is another mirage.  The statute sets a ceiling for the initial offer but, for most drugs, no floor for CMS’s ultimate demand,
• CMS gets the first, last, and only word.

The suit is different from others that have been filed because, while it recognizes the challenges other brand manufacturers have brought up, it also talks about the harm done to the generic/biosimilar manufacturers. Because of the way negotiation is done with qualifying single source drugs defined as all formulations (even ones that are new to the market), generic manufacturers may find themselves competing against price controls and not market prices when they launch. And who is going to pick a generic if a branded product is the same price? We’ll see if this suit gets further than others we’ve seen. (H/T Brian Reid for pointing out this suit!)

Intentions. The New York Times had two articles this week about 340B that are must-reads. One is about Apexus, a 340B middleman that helps administer the program. More scripts, more $ so yes, incentivized to see the program grow. The second story is about 340B and community health centers and how when list prices dropped for some drugs, they paid more. Drug pricing never gets boring. Article links gifted.

Here’s my take. The 340B program has gotten huge and the actual intent of the program is unclear. Is about getting drugs to the un/under insured? Is it about using drugs as a way of making revenue that can then be shared with the un/under insured (in any way the hospital chooses)? It can and has been argued lots of different ways. So why don’t we start by defining the word patient and what the revenue can (or at least what it cannot) be used for. I am not holding my breath.

Mark Told You. Pharmacy benefit reform got another nudge this week when the Federal Trade Commission released its second interim staff report on pharmacy benefit managers (PBMs). And, wait for it, PBMs are marking up specialty generic drugs. If you’ve listened to anything from Mark Cuban over the past few years, this is no surprise. And logically, PBMs make money where they can but, are they worth it? What are we getting for the money we’re paying them? Point fingers at pharma but we’re getting innovation that eventually will go generic.

Avoiding. Late last week the Part D advance notice and Part D redesign instructions came out along with 2027 negotiation elements. I kept hoping someone would write about them so I’d be more motivated to dig in. A week in and still pretty quiet so I’ll add it to my official to-do list for next week.

Guilty. Red Dye No. 3 is going away. I flipped over the Swedish Fish I was eating and saw they were Red 40. Whew.