ICER's Leaky Approach to Value Assessment

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The news that the Institute for Clinical and Economic Review is working through tweaks to its value assessment framework didn’t really make much in the way of waves this week. They put out a press release. Patient advocate Gunnar Esiason weighed in on Twitter with some thoughtful objections.

Otherwise, crickets.

I suspect that is, in part, because the nuts-and-bolts of value assessment is a fairly dull event, even for wonks. And ICER isn’t changing much about its approach, further diminishing its news value.

But that doesn’t mean that the process -- open for public comment until the end of the month! -- doesn’t deserve scrutiny. Indeed, ICER’s unwillingness to change ought to be a bigger deal.

Here is the line in the ICER proposal that I’m most obsessed with: “No changes are proposed through which additional dimensions of value would receive a quantified weighting in the reference case incremental cost-effectiveness findings.” That’s ICER saying that it’s going to keep its math as narrow as possible.

We know that value has a lot more elements than those ICER measures. The whole point of the “value flower” -- things such insurance value, the value of hope, scientific spillover -- is that we

can’t accurately talk about cost-effectiveness until we commit to measuring every dimension of value.

The National Pharmaceutical Council calls this the “leaky bucket” problem: when value isn’t defined properly or measured properly, value “leaks” out of the calculus. ICER’s proposed framework suggests that the group is perfectly OK with the holes in its bucket.

And it’s not like ICER speaks for the health economics community. Research out last month from Tufts lamented the narrow value definition used in efforts like the one ICER is undertaking. “Ideally, more HTA organizations will adopt guidelines for measuring societal and novel value elements, including analytic considerations,” they concluded.

Looks like ICER wasn’t listening.

• FDA Commissioner Robert Califf thinks drug prices are too high, and he’s talking about that with CMS, according to STAT and Endpoints coverage from the BIO annual meeting. FDA isn’t allowed to regulate around prices, though, so it’s not clear that Califf is doing anything other than blowing off steam. BIO posted some video clips from the session, if you want to eyeball Califf.

• This will not surprise you: the WSJ editorial board is in support of Merck suing to stop the IRA’s price controls.

• While we’re talking Merck’s IRA suit, Bloomberg has a deeper dive into why Merck might be leading the charge. The seven-word explanation is “Keytruda could face price controls in 2028.”

• It looks like Leqembi is going to get blessed by an FDA ad comm tomorrow. PDUFA deadline is July 6. As we mentioned yesterday, the drug is in Bernie Sanders’ crosshairs. House Democrats are worried about the vague CMS guidelines around reimbursement.

• Massachusetts is about to drop its annual health cost trend report, and the state gave a small preview of those conclusions in a presentation yesterday. Needless to say, health costs are still a concern.

• The IRA includes inflation penalties for generic drugs, which a USA Today op-ed suggests could have the unintended effect of exacerbating shortages.