Revised Predictions on the Next 15 Drugs to Face IRA Price Controls

It’s a quiet summer Friday, and I’m going to take advantage of the slow news flow to spend a little extra time on one of my favorite activities: handicapping future CMS decisions about which medicines to subject to price controls.

About six weeks ago, I did some back-of-the-envelope calculations to try to guess the next 15 medicines that CMS will select for price controls. 

That announcement is coming in February, but having a sense of what that cohort will look like is useful even now, because it gives hints about the kind of issues, in the aggregate, we may need to think about down the road. 

As the Danes say, it’s hard to make predictions, especially about the future, and Harvard’s William Feldman pointed out almost immediately that at least one of my guesses was likely to be wrong. I thought Invega Sustenna would make the CMS list, but a little-used generic version of an early iteration of the med probably bumps it off the list. 

I have more edits to that list having tuned into a thoughtful webinar from ISPOR yesterday that included an analysis -- still in press -- from Inma Hernandez, Sean Sullivan, and Emma Cousin. They made a fairly compelling case for at least 13 of the 15 medicines likely to be selected and gave a shortlist of drugs that might fill the last two slots.

The analysis laid bare a couple of my missteps in the list I published. I included two Part D biologics (Repatha and Tresiba) that won’t have hit the 11-years-on-the-market threshold for inclusion. And it sounds like Cabometyx will fall under the small-biotech exemption. So I need to strike those.

The Hernandez/Sullivan/Cousin analysis included Tagrisso, which I left off my initial list. Tagrisso’s indications in lung cancer all have orphan designation, so I think that protects the drug. It stays on my list. But that’s a supposition, and I’m always curious if others have a better perspective. 

So, my original list of 15 is down to 11. Which meds are worth adding?

Yesterday’s webinar suggested that Janumet might be a slam dunk, even though its two component parts are not themselves eligible in 2027. So I’ll steal that one for my list. 

Xifaxan is on the list from the webinar. It was originally a bubble product for me, so I feel good about adding that one in. The webinar didn’t mention Lenvima, but that product was also on the bubble for me. I’ll stick that on my list, too. The ISPOR gang has Humalog as a possible candidate -- the price cut on the medicine clouds the crystal ball -- but I’m going to rule it out. 

The webinar had Tradjenta as a sure bet, but it was just outside of my original top 15 because sales are growing slowly. But given the holes left to fill, I now think it’ll sneak in. I’ll put in Otezla as my 15th pick. Hernandez/Sullivan/Cousin didn’t have that on their scorecard, but I think sales are growing fast enough that it’ll squeak onto CMS’ radar.

So below is my revised list, which is similar to -- but not quite the same as -- the ISPOR estimate. 

I bet this is still wrong, and I look forward to you all telling me why. 

• Austedo

• Calquence

• Creon

• Ibrance

• Janumet

• Lenvima 

• Linzess

• Ofev

• Otezla 

• Ozempic

• Pomalyst

• Trelegy Ellipta

• Tresiba

• Xifaxan 

• Xtandi

It was a little weird to wake up this morning to almost no news. The only thing on my radar is the Senate’s passage of a fairly narrow patent reform bill. It’s designed to clear out “patent thickets,” but the Congressional Budget Office estimated that it’ll save the government only about a quarter-billion dollars a year. 

I recognize that that is, objectively, a lot of money. But -- in the context of a $2 trillion global pharmaceutical market, it feels kind of small-ball, especially in an IRA era, where price controls will create a kind of backdoor system for driving down prices later in a med’s lifecycle.

Header image by Ilya Chunin on Unsplash.

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