Senate Letter on Insulin Offers an Opportunity to Set the Record Straight on Assistance

It’s the day before a long weekend, so let me try to keep this one short-ish. Shout-out to everyone still checking email, and I hope everyone finds their beach soon. The moonrise over the ocean is going to be spectacular tonight.

A couple of Senators sent a letter to the leaders of the three big insulin manufacturers, asking pointed questions about their patient assistance options out of a concern that the programs are too hard to access.

This feels like an unintentional softball, and I’m hoping industry takes a huge swing.

My impression is that patient assistance -- especially in diabetes -- has been incredibly well-honed over the past decade to make things as easy as possible for patients. That doesn’t mean that the safety net has zero holes, only that a tremendous amount of time and effort has gone into weaving that net tighter and tighter.

So this is, ironically, a great opportunity to respond, loudly and broadly, to the request, pointing out that the assistance programs are robust and easy to use.

In fact, there may be an irony baked in here.

I suspect that one of the reasons that patient assistance programs are under-used is the inaccurate perception that they’re hard to access. That inaccurate perception is tied, in part, to efforts like the one from Sens. Maggie Hassan and Tina Smith, who are essentially promoting an out-of-date and, frankly, harmful convention wisdom.

• Breaking news: Amgen struck a deal with the FTC that will allow the acquisition of Horizon to go through. It’s not a surprise, but it does remove questions about the when and how.

• STAT got to the bottom of one of the mysteries of the CMS list of meds to be price-controlled: how did Stelara make the cut, given that there will be biosimilar competition well ahead of when price-controls kick in? Turns out, the part of the law that exempts drugs from price controls if they have (or will soon have) biosimilar competition only applies to “short monopoly” meds that have been on the market less than 16 years. Stelara just barely missed that deadline, so the impending biosimilar launch does them no favors. Expect to hear a lot more about this, especially from the biosimilar companies.

• Quick hits on IRA-related litigation:

  • Bloomberg Law expects that Novo will soon file a lawsuit focused on the way that CMS bundled a bunch of their insulins together.

  • The outlet also has an overview of all eight existing cases that is useful as a reference point, and they have details -- which haven’t been written about -- about the briefing schedule in the Astellas case.

  • No media outlets have mentioned, but it’s probably important to note that there is a judge now assigned to the AstraZeneca lawsuit … and it’s a Trump appointee. Make of that what you will.

• Boy, this AARP analysis is problematic. It purports to show how much money the meds on the CMS list have made from Medicare over the past six years, only it a) doesn’t adjust for rebates and b) claims, in a footnote, that very few drugs are rebated, which is manifestly not the case for the 10 selected drugs. There are other issues, too, but it’s a long weekend, so I’ll spare you. Needless to say, it’s an analysis done in bad faith, and I hope it’s treated as such.

• I’m going to have to spend more time with the analysis, but there is a new study showing that Wegovy is not a particularly cost-effective weight-loss approach for teenagers, even though it works well. This is exactly the kind of work we’re going to see a lot more of, and it’s going to fuel a lot of discussion about how -- and for whom -- obesity meds are covered. Buckle up.

• Axios has a piece about whether or how a Republican could roll back the IRA. I’m not sure it’s a particularly helpful look. My take is that if the government wanted to blunt the impact of the IRA -- for Part D meds, anyway -- they would just adopt the “ceiling” prices set under the law, which would have a limited impact on price.

• There’s new Harris data out on pharma’s reputation that suggests that about 45% of Americans are OK with the industry, way better than the number before the pandemic, but way worse than the pandemic-era peaks. More on this next week.

• I don’t think this four-minute NPR piece on whether the IRA will impact innovation is remotely fair or complete, but it’s worth flagging so you all can see the thought process of those who believe there is not an association between revenue and research.