Patient Feedback to CMS on IRA: Please, Please Keep Access in Mind

Yesterday was all about Eliquis. First up were the patient listening sessions I keep prattling on about. And while there was some sense that the parade of speakers didn’t shed much light on the topic, it was nonetheless instructive. 

Because if there was one theme that came up again and again, it’s the patients and physicians who really, really need access here. Lower-priced drugs that come with higher barriers to access, or lower-priced drugs where the lower prices don’t make it to patients, are useless. 

And there are surprisingly few protections in the law to make sure that price-controlled drugs are easily available and that the savings generated will flow back to patients. Yesterday only confirmed that. 

(By the way, here are transcripts from the first half-dozen or so speakers. I’ll keep filling this out as I can. The fact that there’s not yet a replay of the event is stymying efforts somewhat.)

And the White House talked about Eliquis, too. This two-minute video of Biden’s press secretary, Karine Jean-Pierre, talking about Eliquis should really be watched by everyone in the industry because it makes two things clear. 

One is that the administration will go hard at overall spending numbers as a rationale for price control. They’re not even nodding to a cost-effectiveness or value argument here. Zero nuance.  

Two is that they’re overpromising when they talk about lower drug prices for huge numbers of Americans. As the CMS input session makes clear, the big gap in the existing law is that a lot of patients are not going to see relief, at least not from price controls. (The out-of-pocket cap and “smoothing” provision will have a bigger impact but on a smaller number of people.)

It’s hard not to watch that video without thinking the White House is setting itself up to underdeliver.

I’m feeling ranty, but that’s not constructive, so let me just say more plainly: this Washington Post op-ed by Lena Wen questioning whether obesity medicines are “worth it,” is wrong. Or, more charitably, it’s so out of date as to be useless. 

The argument relies heavily on an ICER analysis from last year. I know talking about ICER has its own risks, the Wen piece is a fail for broader reasons. 

First off, the effective cost of the medicines is not the list price. There are huge rebates on all of these drugs that mean that the effective price is far, far below the Washington Post-flagged list price of $13,000 a year. 

That was the point made so well in last week’s New York Times story. That story, you’ll remember, even has a quote from ICER noting that the drugs are probably cost-effective by the ICER methodology at their current net price. So for Wen to rely on ICER -- without noting that ICER itself is walking back their conclusion a little bit -- is not the compelling argument she thinks it is. 

Second, she ignored the existing and coming data showing an impact on outcomes. Yes, Wen drops a link to Novo’s SELECT trial data but noted it hasn’t been published. And while that’s all true, I don’t know of anyone who doesn’t think that the coming flood of outcomes data won’t make these drugs look better, from a cost-effectiveness standpoint. 

As I keep saying: those arguments will not age well. It’s cool to have a hot take today, but, boy, will this look dumb in the not-so-distant future. 

And at the risk of being repetitive: there are spending issues with obesity meds! The budget impact thing is real! The fact that Medicare beneficiaries are largely unable to access these medicines is a problem!

But running a piece suggesting that cost-effectiveness is an issue? That is -- on this Halloween morning -- a straw man. 

• Again, on the road this week, so don’t have time to fully consider the implications of the Sarepta trial, which missed its primary endpoint but was positioned as a win nonetheless. I assume it’s going to prompt some uncomfortable commentary on price. Something to watch. 

• The Colorado PDAB is considering pulling its punch when it comes to setting a price for Vertex’s Trikafta. 

• Another one I want to look into more deeply, but Fierce has coverage of the launch of the first Chinese-developed PD-1 … but it won’t be priced disruptively.

• Amgen is not selling very much biosimilar Humira. 

• A bunch of right-wing groups is asking Joe Biden to roll back the IRA. 

• Small, renegade PBMs are launching a small, renegade ad campaign.