HCA Warning, Leqembi, FTC, ICER Expansion

MarcusWelcome to the Access Brief — your daily briefing on what's moving in HEOR, HTA, and market access. I'm Marcus, and it's great to have you with us today.

SaraAnd I'm Sara. Always good to be here — and I'll say, I've had today's topics circled since this morning. The signals from the US system are particularly telling right now.

MarcusSame here. We're looking at HCA's profit warning and what it signals for US healthcare access. Then the subcutaneous Leqembi approval and its HEOR implications. Also, the FTC settlement with CVS Caremark over insulin pricing. And finally, ICER's expansion of scientific advice.

SaraThat second one about Leqembi is particularly interesting to me — the cost-effectiveness of a new formulation versus the existing one is a question that the field hasn't fully worked out yet.

MarcusExactly. And the FTC settlement could have ripple effects across PBMs. Let's get into it.

MarcusHCA Healthcare issued a profit warning, citing increasing uncompensated care and the impact of Medicaid expansion. This isn't just about HCA; it's a signal that the US healthcare system is under pressure, especially for high-cost therapies. Payers are becoming more cautious about innovative drugs that come with a high price tag.

SaraThat's a critical point. The uncompensated care burden is rising, and it's hitting hospital systems hard. From a payer perspective, this means that the opportunity cost of covering high-cost drugs is becoming more visible. Budget impact is no longer just a theoretical exercise; it's a real constraint.

MarcusExactly. And what's striking here is that this is happening despite the IRA's negotiation program, which was supposed to reduce spending. But the system is still grappling with the cost of innovation. I wonder if this will lead to more aggressive formulary management for new drugs, especially in oncology and neurology.

SaraI'd push back slightly on that — the IRA negotiation program is just starting, and we haven't seen the full impact. But HCA's warning does highlight that the access challenge isn't just about pricing; it's about the entire ecosystem. The part that gives me pause is how this will affect the development of future therapies. If hospitals are struggling, will they be less willing to participate in trials or use new drugs?

MarcusThat's fair, though I think payers would see it differently. They might see this as an opportunity to push harder on value-based contracts. But the real issue is the sustainability of the system. We need more evidence on real-world outcomes to justify these costs.

SaraAnd that's where HEOR becomes even more critical. Generating evidence that shows long-term value is essential. Otherwise, we risk a scenario where innovation is stifled by access barriers.

MarcusThe FDA approved subcutaneous Leqembi for Alzheimer's, which is a step forward in administration. But the price point remains high, and HEOR teams must now demonstrate real-world evidence of adherence and long-term outcomes. The subcutaneous formulation could reduce burden, but will it change the cost-effectiveness equation?

SaraThat's the key question. From a payer perspective, the cost of the drug is the same, and if the outcomes are similar, then the cost per QALY might not improve. The burden reduction is real, but how do we quantify that in value assessments? It's a classic example of where patient-reported outcomes and quality of life measures become critical.

MarcusExactly. And what's interesting is that the approval was based on the same clinical trial data as the original formulation. So the HEOR challenge is now about generating real-world evidence that shows the subcutaneous version leads to better adherence and thus better outcomes. Without that, the value proposition remains weak.

SaraI wonder if that's the full picture though. The burden reduction might also lead to lower caregiver costs, which could be a significant factor in cost-effectiveness models. But that data isn't available yet. The part that gives me pause is whether payers will see enough difference to justify coverage without that evidence.

MarcusThat's a fair point. And we're seeing a trend where payers are demanding more real-world evidence even for drugs with strong clinical data. This could set a precedent for other chronic therapies where administration matters.

SaraAbsolutely. And it highlights the need for HEOR teams to be involved early in development, not just at the point of submission.

MarcusThe FTC settled with CVS Caremark over insulin pricing practices, alleging that CVS inflated prices and harmed patients. This settlement highlights ongoing scrutiny of PBM practices and their impact on drug access. It may lead to more transparency in PBM pricing and rebates.

SaraThis is significant because it's not just about insulin; it's about the entire PBM ecosystem. The settlement exposes how complex rebate structures can obscure true costs. For payers, this means that the net price they pay might not reflect the value of the drug. The opportunity cost here is huge — money spent on rebates could have been used for other therapies.

MarcusExactly. And what's striking is that this settlement comes amid broader efforts to reform PBM practices. The IRA has already limited some PBM practices, but this FTC action adds another layer. I wonder if this will lead to more direct contracting between manufacturers and payers, bypassing PBMs.

SaraI'd frame it slightly differently. The FTC action is about transparency, not necessarily eliminating PBMs. But it does force a re-examination of how rebates are structured. The part that gives me pause is whether this will actually lower costs for patients or just shift the burden elsewhere.

MarcusThat's a valid concern. Historically, PBM reforms haven't always translated to lower patient costs. But this settlement does signal that regulators are taking a harder look at PBM practices. It could lead to more evidence-based formulary decisions.

SaraAnd that's where HEOR becomes even more critical. Demonstrating the true value of a drug in the context of PBM practices is essential. Otherwise, we risk a system where the middlemen are determining access based on opaque criteria.

MarcusICER announced an expansion of its early-phase scientific advice program to cover Phase II and early Phase III trials. This aims to help companies design trials that generate evidence acceptable to HTA bodies. The expansion reflects a growing recognition that early evidence strategy is critical for market access.

SaraThis is a smart move by ICER. From a payer perspective, having companies design trials with HTA in mind from the start can save time and resources later. The opportunity cost of a failed HTA submission is enormous, so this could streamline the process. But I wonder if it will lead to more homogenized trial designs that prioritize HTA acceptability over scientific innovation.

MarcusThat's one way to look at it. But I see it as a way to de-risk development. If companies know what evidence HTA bodies need, they can design trials that generate that evidence without compromising scientific rigor. What's interesting is that this expansion comes as HTA bodies are becoming more involved in early development.

SaraExactly. And it connects to something I keep coming back to: the need for better alignment between regulatory and HTA evidence. If companies are getting advice from ICER early on, they might be able to generate data that satisfies both regulators and payers. But the challenge is that HTA bodies have different requirements across regions.

MarcusThat's true. But ICER's advice is often influential globally. This expansion could set a precedent for other HTA bodies to follow. It's a sign that the industry is moving toward a more evidence-based approach to market access.

SaraAnd it's good for patients too. If drugs are designed with value in mind from the start, we're more likely to see therapies that are both innovative and accessible.

SaraA lot to think about today. I'll be watching how the FTC settlement impacts PBM practices and whether it leads to more transparency in drug pricing.

MarcusSame — and for me the thread running through today is the increasing pressure on the healthcare system to demonstrate value for every dollar spent. Worth sitting with.

SaraThanks so much for listening — really glad you're here with us.

MarcusWe'll be back tomorrow. Show notes and transcripts at outcomes-analytica.no. See you then.

SaraThanks for listening — see you tomorrow.

MarcusBack tomorrow on Access Brief. Show notes at outcomes-analytica.no.