Caught my Eye
Cool Idea, But. The Food and Drug Administration (FDA) puts announced a new pilot prioritization program for the review of Abbreviated New Drug Applications (ANDAs) to support generic manufacturing in the U.S. I mean it sounds good, except… there are three criteria for applicants:
- The pivotal bioequivalence testing must be conducted in the U.S. (Check)
- The finished dosage form must be manufactured in the U.S. (Check)
- The active pharmaceutical ingredient (API) supplier must be located in the U.S. (Pause)
Only 9% of API manufacturers are in the U.S.; it’s a big shift to require the API to be manufactured in the U.S. The NYT has an article about how 700 U.S. medicines rely on an ingredient from China (gift link.) Which is the point. National security, preserve the supply. The problem is that generics can be made so cheaply elsewhere, and the economics favor the lowest price (quality for another day). Manufacturing here is an uphill battle.
Predictions are Tough These Days. There is a nice piece in JAMA on how the courts could end up being the ones that decide the fate of Most Favored Nation (MFN) drug pricing. There is talk of how the Center for Medicare and Medicaid Innovation (CMMI) could (will?) issue a demonstration model and how CMMI models are supposed to be tests and not used to unilaterally set national payments. Which is true. But. This Administration tends to lean into going fast and trying stuff and letting the courts figure out what is allowed. And yes, the courts will probably not side with an across-the-board CMMI demo that uses MFN pricing but not before we chase our tails for a while. Or the courts will break with what is expected and say it’s fine.
It’s why I tell clients that they need to prep for a variety of scenarios these days and then the reality will fall somewhere between the options but at least come closer than throwing darts.
Same Same but Different. AstraZeneca signed an MFN deal with the government. Similar to what Pfizer did a few weeks ago.
Not Dead Yet. States continue to move on pharmacy benefit manager (PBM) reform because, let’s be honest, nothing is happening at the federal level right now. California passed a law that would prevent spread pricing (where they charge the payer more than the PBM reimburses the pharmacy.) The law also requires PBMs to pass along all manufacturer rebates and be paid a flat dollar administrative fee for services provided. The law goes into effect January 2026.
Reviewing the Fundamentals – Medicare Part D Open Enrollment
If you’re in Medicare Part D or helping someone who has it, now is the time to review plan options for 2026. Open Enrollment opened this week and there are a LOT of changes. There is a lot more pressure on plans to manage costs with changes in plan liability and we have the first 10 Medicare negotiated drugs coming online.
I was moosing around (sorry) with Medicare Plan Finder (medicare.gov) was curious how coverage had changed so I used my zip code and the top 5 standalone prescription drug plans to see how things are changing year over year.
File Name: Apteka-OE-2026-PDP-Case-Study.pdf
Premiums are a little all over the place with some going up and some down. Deductibles are fairly stable. It looks like the plans that had the standard deductible stuck with it but I will note the AARP Preferred plan in my area went from $0 deductible to $130. Not as bad as $615 but not $0.
I was pleasantly surprised at the reduction in patient out of pocket for Eliquis. Eliquis is one of the newly negotiated drugs and, after the deductible is paid, you can see the monthly amount owed fell considerably for most plans. Then again, I assume the Centers for Medicare & Medicaid Services (CMS) were paying pretty close attention and making sure this was the case.
Most people don’t like to pay attention to Open Enrollment; I was in employee benefits and I don’t like doing it. However, this year it is pretty important to poke around and make sure that beneficiaries are in the best plan for them.
If you need more resources, I’ll point you to MAPRx. There is the Open Enrollment guide and the Medicare Prescription Payment Plan guide. Both are fantastic, if I say so myself.
For the Files
I just liked playing with these Medicare negotiated drug charts from the Pioneer Institute.
