Another Dozen Thoughts on the CMS 'Selected Drug List'

I’m still kind of “off,” but this is kind of a big news week. If you didn’t see it yesterday, here are my first dozen thoughts about the first 10 medicines to be price-controlled under the Inflation Reduction Act.

And here are my next dozen:

1. Yesterday, I said, “CMS seems to have decided not to take any big risks around drugs facing generic competition.” Full disclosure: that was not particularly accurate. As some of the coverage noted, Stelara will definitely have biosimilar competition, and NovoLog probably will, making the inclusion of those medicines questionable. “If we see generics emerge and companies start to face more competition, we’ll certainly take that into account,” CMS Administrator Chiquita Brooks-LaSure told Bloomberg. But that’s not the way the law is supposed to work.

2. BMS’ Giovanni Caforio has an op-ed out in the Wall Street Journal that gets into the history of Eliquis and then pivots to Caforio’s issues with the law: it’ll discourage development of pills, and it does nothing to assure that patients will see lower costs or lower hurdles to access. Good to see execs being aggressive.

3. CMS publicized information on how the 10 patient-focused “listening sessions” will work. They’ll kick off Oct. 30 with one focused on Eliquis. The remaining medicines will follow, in alphabetical order. The 90-minute sessions will feature 20 speaking slots, with each speaker given three minutes. That doesn’t feel much like dialogue to me, and I expect that CMS is going to get slammed for turning patient input into a box-checking exercise.

4. As I noted yesterday, pharma shares rose across the board, and the Washington Post wrote a story about it. The share price movement was used to advance a narrative that price controls won’t be as bad as pharma suggests, which is not really a thoughtful way to think about market moves.

5. Biden’s press event yesterday featured a patient, Steven Hadfield. I’m sure that his experience with drug costs is indeed difficult, but -- speaking as a comm pro -- PR people should be very careful about scripting patients, lest you end up with a patient sounding like a talking points memo rather than a human being, as Hadfield does.

6. Politico goes into how Republicans are pushing back against the “negotiation” program, leaning heavily into the innovation message. IMHO, they may see more traction if they borrow a page from Caforio’s book and layer in some discussion of access, too.

7. Public media has reposted Tradeoffs’ coverage of price controls from last month, but it’s worth revisiting that piece for a point that I may have missed when it was first published: Harvard’s Ben Rome suggested that warfarin may “provide a helpful baseline” for setting Eliquis’ price. Warfarin, as a reminder, was first approved in 1948 as rat poison, and its narrow therapeutic window means regular blood testing is required. There are a mountain of studies showing that Eliquis is as cost-effective -- if not more -- than warfarin. So suggesting warfarin is an appropriate comparator for Eliquis is to pivot away from the idea of “value.”

8. NPC has a pretty good list of everything that appears to be broken -- but could possibly be fixed -- with the price-setting process.

9. This piece from the Journal of Managed Care & Specialty Pharmacy was probably the canonical best-guess of what drugs CMS would select, and it turns out that it wasn’t a particularly accurate prediction. But Inma Hernandez, who led the work, provided a thoughtful post-mortem on her methods and the intrinsic difficulty of working with data that lags the information that CMS uses.

10. The American Prospect has its own list of the medicines that it would like to see price-controlled, which offers a useful guide to where the left would like to see more intervention. Humira, Revlimid, Ozempic and Keytruda make the Prospect list, along with six psoriasis meds.

11. Real Endpoints has a hot take on the CMS list: because most of the medicines are already heavily rebated, the government won’t be able to take particularly large cuts. So drugmakers might not be hugely affected, but PBMs will get squeezed because the gross-to-net bubble will pop for price-controlled products.

12. I’m curious about what meds might be up for the next round of this process, where 15 more Medicare Part D drugs get selected. That doesn’t happen until February 2025, which feels like a long, long way away. But I’m here for any analysis of which medicines might make that list. (Bloomberg is suggesting that Ozempic will be part of the Class of 2025.)

Back to the usual format tomorrow.