HCA Warning, SubQ Leqembi, FTC Insulin, ICER Advice

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, the profit warning from HCA this morning really underscores the fragility of the US healthcare access model.

MarcusExactly. We're looking at HCA's profit warning and what it means for US healthcare access. Then the FDA's approval of subcutaneous Leqembi — how that shifts the HEOR landscape for Alzheimer's. Plus, the FTC settlement with CVS Caremark over insulin pricing — the ripple effects on PBMs. And ICER's expansion of scientific advice services — what that signals for US value evidence.

SaraThat insulin settlement is particularly interesting to me — it's one of those stories where the policy intent might not match the operational reality for patients.

MarcusAgreed. Let's get into it.

MarcusHCA Healthcare issued a profit warning citing increased uncompensated care and operational costs. This is a significant signal for the US market. The company is one of the largest hospital chains, and their financial pressure often reflects broader systemic issues. What strikes me here is the direct link between uncompensated care and access challenges. When hospitals face losses, they may reduce services or shift costs, which can ultimately limit patient access.

SaraThat's fair, though I think payers would see it differently. The issue isn't just uncompensated care but also the rising costs of providing care. From a payer perspective, this is a symptom of a system where cost-shifting happens, and ultimately, the burden falls on the entire system. What's interesting is how this might accelerate moves towards value-based contracts that tie payments to outcomes, but that's still a long way off.

MarcusThat connects to something I keep coming back to — the role of RWE in demonstrating value in such a volatile environment. If hospitals are under pressure, they might be more open to sharing real-world data to prove the value of interventions. But the challenge is who owns that data and how it's used.

SaraExactly. And the part that gives me pause is the potential for increased consolidation. HCA's struggles might lead to fewer, larger hospital systems, which could further concentrate power in negotiations. That doesn't necessarily improve access for patients in underserved areas.

MarcusThat's a valid concern. We've seen consolidation lead to higher prices in other sectors. But it also creates opportunities for innovative models, like partnerships with pharma to manage chronic diseases more effectively. The key is whether those models are designed with patient access at the core.

SaraI agree, but the history on that is mixed. Often, the incentives aren't aligned. Still, the profit warning is a wake-up call. I'll be watching how other hospital chains respond and whether this leads to any policy shifts.

MarcusThe FDA approved subcutaneous Leqembi for Alzheimer's disease. This is a big deal because it changes the administration from IV to subcutaneous, which is much more convenient for patients. From an HEOR perspective, this could be transformative. Broader administration means more patients can be treated, and it opens the door for more real-world evidence collection. We might see studies that look at long-term outcomes in a more diverse population.

SaraThat's one read — I'd frame it slightly differently. The convenience is a plus, but the cost of subcutaneous administration isn't trivial. And from a payer perspective, the big question is whether the convenience justifies the cost. We know that IV infusions are expensive, but subcutaneous might not be that much cheaper. Also, the evidence for long-term benefit is still limited. Payers will be looking for data that shows sustained benefits in real-world settings.

MarcusThat's fair. I wonder if that's the full picture though. The shift to subcutaneous could also reduce the burden on caregivers and healthcare systems. If patients can administer the drug at home, it frees up infusion centers and reduces costs there. That might offset some of the drug cost. But you're right — we need real-world data to confirm that.

SaraExactly. And what strikes me is the precedent this sets. If subcutaneous administration becomes the norm for biologics, it could change how we design trials and generate evidence. We might see more focus on patient-reported outcomes and quality of life, which are easier to capture with home-based treatments.

MarcusThat's a key point. It could also lead to more decentralized trials, which align with the FDA's recent guidance on decentralized trials. But the challenge is ensuring data quality and patient adherence without the oversight of an infusion center.

SaraTrue. And the part that gives me pause is the equity issue. Not all patients have access to the support needed for self-administration. We might see disparities in who can actually benefit from this shift.

MarcusThe FTC settled with CVS Caremark over allegations of insulin price-fixing. The settlement requires CVS to pay $20 million and change its practices. This is significant because PBMs play a huge role in drug pricing. The allegations were that CVS used its market power to keep insulin prices high, which contradicts their role as cost managers. This could lead to more scrutiny of PBM practices and potentially more transparency in pricing.

SaraThat's one read — I'd frame it slightly differently. The settlement is a win for the FTC, but I'm not sure it will lead to lower insulin prices for patients. The issue is complex: PBMs often get rebates from manufacturers, but those rebates don't always translate to lower out-of-pocket costs. And the $20 million is a drop in the bucket for a company like CVS. What I'm watching is whether this leads to structural changes, like banning spread pricing or requiring more transparency in rebates.

MarcusThat's a fair point. The settlement does include provisions for CVS to change its practices, but enforcement will be key. And what's interesting is the signal this sends to other PBMs. If they face similar scrutiny, they might adjust their behavior. But the question is whether that will actually benefit patients or just shift profits.

SaraExactly. And the part that gives me pause is the potential for unintended consequences. If PBMs reduce their margins, they might push back by increasing other fees or restricting formularies. We've seen that happen before. The real solution might be more competition among PBMs, but the market is already consolidated.

MarcusThat's a valid concern. This settlement could be a step toward more accountability, but it's not a silver bullet. We need broader policy changes to ensure insulin is affordable. I'll be watching how other PBMs respond and whether this leads to any legislation.

MarcusICER announced an expansion of its scientific advice services. This includes more frequent meetings, earlier engagement, and coverage of more disease areas. This is a significant move because ICER is a key player in US value assessments. By expanding these services, they're essentially helping companies design better evidence strategies earlier in development. That could lead to more robust submissions and better alignment with what payers need.

SaraThat's one read — I'd frame it slightly differently. I'm concerned about the capacity implications. ICER already has a backlog, and expanding services might stretch them thin. Also, earlier engagement could be a double-edged sword. Companies might tailor their trials too much to what ICER wants, potentially missing other important endpoints. And what's the incentive for companies to engage early if they're not sure ICER's input will be used in final assessments?

MarcusThat's a fair point. I wonder if that's the full picture though. The expansion might also include more collaboration with payers, which could make the advice more actionable. And if companies engage earlier, they might avoid costly late-stage trial failures by aligning their evidence generation with payer expectations. But you're right about capacity — ICER will need to scale up without compromising quality.

SaraExactly. And what strikes me is the timing. With the IRA and other US pricing pressures, companies are desperate for clarity on value. ICER's expansion could fill that gap, but it also raises questions about the role of HTA bodies in the US. We've seen pushback from industry on ICER's influence, so this might add fuel to that fire.

MarcusThat's a key point. The expansion could make ICER even more central to US market access, but it also increases the scrutiny they face. I'll be watching how companies respond and whether this leads to more engagement or more resistance.

SaraA lot to think about today. I'll be watching how the HCA profit warning affects hospital strategies and whether it leads to any policy shifts.

MarcusSame — and for me the thread running through today is the growing role of evidence in addressing systemic challenges. From subQ Leqembi to the FTC settlement, evidence is at the center of change.

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.