ICER Finalizes Its Approach to Value Assessment. Industry Remains Dissatisfied

The United States does not have a government-sanctioned group that makes determination of the value of a given drug (and it still won’t, even after the Inflation Reduction Act is implemented), which serves to elevate the conclusions of the Institute for Clinical and Economic Review.

As a result, ICER gets a level of attention and scrutiny that far outstrips its explicit authority but is probably appropriate, given the group’s prominence with media, payers and others.

All that to say: it’s worth looking at how ICER plans to conduct its value assessments going forward, especially in light of yesterday’s release of the group’s framework for 2024 and beyond.

The topline conclusion is that ICER’s approach, at its core, isn’t going to change that much. Cencora’s Kimberly Westerich called it “same as it ever was.” (Obligatory link to the Once in a Lifetime music video.)

“Same as it ever was” means that ICER isn’t going to start thinking more broadly about value, either by incorporating a true estimate of all societal costs or by looking more deeply at novel elements of value. There’s also concern about the way that ICER calculates the savings from gene therapies.

Industry had hoped for better.

“Look, value assessment is not a rule, it is a tool comprised of both science and opinion,” NPC’s John O’Brien said via email. “We’re very concerned about the areas that weren’t addressed because they have the potential to harm patients and do a disservice to those who’ve dedicated their lives to the scientific application of value methods.” (NPC’s fuller thoughts are here. All of the public feedback is collected here.)

That doesn’t mean that the framework is entirely static. ICER is moving ahead with plans to think more deeply about clinical trial diversity and will try — in a limited way — to adjust for generic competition and the IRA. And ICER will “evaluate the potential application of the Generalized Risk-Adjusted Cost-Effectiveness framework,” which is pretty interesting and is a place I’m going to have to go back at later.

But that’s fiddling at the edges.

None of this is to say that ICER’s approach is wrong or indefensible. It’s just tilted toward a conservative (in the non-political sense!) way of thinking that tends to play down certain kinds of value and cost-savings.

As one input in a constellation of different ways of thinking about value, ICER’s views would be great fodder for thoughtful dialogue. But that constellation of alternatives doesn’t exist, and the absence of that fuller dialogue is conspicuous and unfortunate.

The fact that proposed PBM regulations in the House and the Senate don’t go particularly deep tends to get glossed over in coverage of the sausage-making. That makes this new Health Affairs piece by Arnold-funded Harvard guys important. It examines three areas where legislation falls short, including a call for more attention to the impact of out-of-pocket spending.

Health Affairs also published this piece, on the realities of insulin price cap laws and proposals. I don’t think any of it is really novel, but, certainly, the mechanics of how insulin price caps work — who pays, who benefits, who ensures that the savings are available — is nonetheless worthwhile.

There is a new filing in from the plaintiffs in the PhRMA IRA lawsuit. I don’t think that document changes the game much. That’s not to say that we can safely ignore all litigation news: Bloomberg Law noted that there could be a ruling this week on the Chamber of Commerce’s request for an injunction to shut the whole price-control thing down, temporarily. My impression is that everyone sees that as a long shot, but if it happens … well, that will really scramble things.

AstraZeneca confirmed to Politico that, yeah, it’ll play ball and start the price-control dance with the government, which probably doesn’t make them happy but isn’t particularly a surprise.

Two would-be FTC commissioners — nominees to fill the two Republican slots at the agency — were asked about PBMs during a confirmation hearing yesterday, but I can’t find any evidence that they said anything interesting.