It’s a quick one today.
I’m on the road, attending the Oliver Wyman Health Innovation Summit. I had the opportunity to share the stage yesterday with ICER’s Sarah Emond, and it’s probably worthwhile to list the places where we’re in alignment, rather than my usual list of constructive feedback to the ICER process:
We’ve hit an inflection point in the impact of rising health spend. We’re at an unsustainable level, and something is going to have to give.
The complexity of the system is, in itself, a problem.
Utilization management on interventions with value-based prices is fundamentally anti-patient.
2025 is weird.
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There is a lot more attention today on the FDA “untitled letters” and “warning letters” on DTC advertising.
Bloomberg is all about the celeb names (Oprah! Morgan Freeman! Tracy Morgan!). Endpoints has a more sober list of the companies that have been targeted. STAT is wondering who at the FDA, exactly, is going to pursue all of these alleged violations.
I had linked to the untitled letters yesterday, but not the warning letters. We’re deep into FDA semantics here, but it’s worth noting the difference between untitled letters (which are mostly what pharma received) and warnings letters (which mostly went to online pharmacies).
AgencyIQ had a good explainer here:
A “Warning Letter” sent to a person or company is an official allegation of wrongdoing and threatens immediate action if issues are not addressed to the satisfaction of the FDA. In some cases, the agency may already have taken action before sending the letter. An “Untitled Letter” is generally softer in its approach, outlining the FDA’s concerns and offering the company a chance to either address those concerns or communicate with the agency. Untitled Letters are generally used by the FDA before it would send a Warning Letter and most often (though not exclusively) are for alleged violations related to advertising.
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ELSEWHERE:
It’s the Autumn of 340B, where 340B news is as common as falling leaves. Today’s nugget: All eligible drugmakers will participate in the HHS rebate model pilot, per Endpoints. A rebate model would allow a drugmaker to pay providers after the medicines are dispensed to ensure medicines carry either a 340B price or a “maximum fair price” under the IRA, but not both.
Rep. Buddy Carter thinks that Congress is going to get around to passing PBM reform this year, per this Modern Healthcare interview. I like his optimism. I think it’s going to happen. I’m just going to take the “over” on when Congress actually gets around to it.
The UK’s science minister, Patrick Vallance, is pushing his fellow policymakers to increase what the country spends on medicine as a way of making sure that those in the UK have access to the most powerful therapies. Increasingly, it seems like there is an interest in making something happen in the UK. What remains unresolved is a pathway to do that.
I’m not going to cover the blow-by-blow of the federal spending/shutdown fight. Summarizing process stories in this newsletter isn’t going to do me -- or you! -- any good. But it’s worth noting that ACA marketplace subsidies are at the center of the fight, and if those subsidies don’t get renewed, premiums will rise and lots of Americans will choose to go uninsured. In other words, this is going to be a story that lasts well beyond this battle.
The House Ways and Means Committee took the nonprofit hospital industry to the woodshed in a hearing yesterday. Fierce has a summary of what went down, but it doesn’t include the 340B-abuse testimony from Brown’s Chris Whaley. Which is disappointing … after all, it’s the Autumn of 340B!
I haven’t been tracking the effort by the National Academies to sync research spending with the size of the unmet need, as summarized in this JAMA piece, but it’s a great framework for thinking about where we should be investing our research dollars. I mean, maybe this kind of perspective is a luxury in an era where the whole research apparatus is being dismantled with force, but I’m here for it.
Cost Curve is produced by Reid Strategic, a consultancy that helps companies and organizations in life sciences communicate more clearly and more loudly about issues of value, access, and pricing. We offer a range of services, from strategic planning to tactical execution, designed to shatter the complexity that hampers constructive conversations.
To learn more about how Reid Strategic can help you, email Brian Reid at [email protected].
