CMS is Done Hearing from Patients on the IRA. But Did They Listen?

I’m finally through uploading the transcripts from almost all** of the CMS patient-focused listening sessions around the 10 drugs slated for price controls under the Inflation Reduction Act. You can see them here. Thanks to Erica for providing the transcriptions. 

This is the point in the process where I expected to distill the feedback down into a number of lessons that CMS could have, or should have, garnered from the sessions. But I can’t do that. There just wasn’t any there there. 

I mean, yes: there were some themes. There was plenty of feedback about the need to ensure that cost-cutting doesn’t impact access. And drug costs are absolutely a burden for a lot of patients. The $2,000 out-of-pocket cap is going to change lives. 

But in terms of helping CMS understand how to implement price controls? The sessions were thin gruel. 

I’ve talked in the past about how lousy the CMS plan was. Gathering feedback via 200 three-minute speeches, with no questions or discussion, is ridiculous. (Here’s an outline of what CMS should have done.)

Even within that process, CMS failed. About half of the speaking slots went unfilled. Many speakers were given the microphone at multiple sessions, even when they had little drug-specific information to impact. Two speakers were given a platform at in least nine of the 10 sessions. Huge swaths of the advocacy community were absent. Was it because CMS didn’t promote the sessions or ask for specific feedback? Did CMS tell people no? I have no idea. 

All I can see is the outcome, which feels like a box-checking exercise from beginning to end. 

That’s bad for a couple of reasons. The first is that the patient voice can’t be and shouldn’t be taken for granted. If the implementation of the IRA gets screwed up, it’s the patients who are going to get hurt first and hurt worst. Getting patient feedback ought not be something that’s half-assed. 

Second, CMS has an impossible task in pulling together the implementation of the law on the congressionally imposed timeline. They will, by necessity, have to take certain shortcuts. If the process itself isn’t perfect, CMS needs to make sure that the execution is as close to perfect as possible in order to convince people that the IRA is a thoughtful and legitimate policy effort. This kind of effort does not inspire confidence. 

** I had assumed there would be replays, so for the first session — Eliquis — we didn’t create backup recordings. So anyone that wasn’t transcribed in real-time didn’t get transcribed. I’d apologize for that, but I think it’s pretty crappy that CMS didn’t bother making these sessions available. CMS claims that it will post its own transcripts, for what that’s worth.

Regardless of your feelings about coupons and copay assistance, copay accumulators are a lousy solution. In the end, it’s the patient that gets hurt the worst and the insurance company that benefits the most, and that’s really not an outcome that reflects a well-functioning system. 

So it feels surprising that the Biden administration is doubling down on rules that allow broad use of copay accumulators in the face of a court decision that largely barred their use. The government is not only appealing the case, they’re not going to enforce the ruling. 

All of this is laid out clearly in a press release from the three groups that filed the original lawsuit: the HIV+Hepatitis Policy Institute, the Diabetes Leadership Council, and the Diabetes Patient Advocacy Coalition. 

The government’s move hasn’t received any coverage (yet …), but this is definitely an issue to bookmark.

Former FDA Commissioner Scott Gottlieb told attendees at a STAT event that the IRA “won’t hurt drug company earnings as much as people might have projected,” even though he warned about the impact on venture flows into the sector. Scott’s way smarter than I am, but I’d argue the jury is still out on the impact on industry. 

Speaking of that STAT event, there were also comments made by a White House Domestic Policy Council official that may give a peek into how the administration would like to go after industry naysayers: though a focus on patent-extension efforts. 

More pricing news: Biomarin said that Germany will pay about $900,000 per patient for its new gene therapy. The deal will run for three years, and it puts the price at about half of the U.S. net price, per Endpoints coverage.  

This is an interesting ESG report from PatientView that suggests that patients are fairly engaged in ESG issues (or would like to be engaged). The biggest issue with ESG in biopharma is that no one quite knows what it means. The standard ESG definition is kind of centered around carbon emissions and board policies and the like, but it seems like pricing and access — which are somewhat peripheral in generic ESG standards — are a more important yardstick for the industry. 

Nice Francis Collins op-ed in the New York Times about his effort to beat back the hepatitis C epidemic, which has been growing even though there is an effective, available cure. 

I ranted on this a bit yesterday, but here’s an Endpoints piece on the JAMA IM article that seems to argue against not only an exception for single-indication orphan drugs in the IRA, but, really, any favorable treatment for orphan drugs, period. 

I missed posting this among the hockey travel and holiday preparations over the past couple of weeks, but this is a smart take from RA Capital’s Peter Kolchinsky and USC’s Dana Goldman on how and why Medicare coverage of obesity meds could lower prices, expand access, and drive down costs more broadly.