HCA Profit Warning & SubQ Leqembi

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

SaraAnd I'm Sara, market access strategy. Always good to be here — and I'll say, today's HCA news has me thinking hard about the real-world access implications we're seeing across the U.S. system.

MarcusSame here. We're looking at HCA's profit warning signaling deeper U.S. healthcare access pressures. Then subcutaneous Leqembi's approval and what it means for HEOR evidence generation. The FTC's insulin pricing settlement with CVS Caremark. And ICER's expanded scientific advice program.

SaraThat second one about subQ Leqembi is particularly interesting — the HEOR community needs to figure out how to capture real-world adherence data now that administration burden is reduced.

MarcusExactly. Let's get into it.

MarcusStarting with HCA Healthcare's profit warning. They're citing rising labor costs, supply chain issues, and shifting outpatient volumes. This isn't just a company problem; it's a bellwether for U.S. hospital sustainability and access pressures. When the largest for-profit chain struggles, it signals systemic strain.

SaraThat's one read — but I'd frame it slightly differently. What strikes me is the outpatient shift. HCA's moving patients away from higher-cost inpatient settings, which reduces their short-term costs but creates longer-term access gaps for complex care. Payers are seeing this too — it's a budget impact question we haven't fully modeled yet.

MarcusFair point. And the labor costs piece matters for HEOR — if staffing shortages persist, we may need to adjust our cost-effectiveness models to reflect real-world delivery constraints. The outpatient shift also challenges our traditional value assessments that assume fixed care settings.

SaraExactly, and what's interesting is how this connects to the IRA's hospital price negotiation framework. If hospitals face financial pressure, will they absorb IRA cuts or pass them to payers through increased service fees? That's a dynamic we should be watching.

MarcusThat's a forward-looking thread. For now, the key takeaway is that HCA's warning reflects structural pressures that will require HEOR models to become more adaptive to changing care delivery patterns.

SaraRight, and from the payer side, this reinforces the need for value assessments that consider total system costs, not just drug price tags. The shift to outpatient care could actually increase overall spending if not managed carefully.

MarcusWhich brings us back to the importance of real-world evidence generation in these evolving settings. Let's move to Leqembi.

MarcusSubcutaneous Leqembi's approval based on identical Phase 3 data to the IV formulation is significant. It reduces administration burden — no more 2-hour infusions or facility requirements. But the HEOR community hasn't yet established how to capture adherence benefits in routine care settings.

SaraThat's one read — I wonder if that's the full picture though. The part that gives me pause is that we're approving a new formulation without new efficacy or safety data. For payers, this raises the question: should we value the convenience improvement separately, or is this just a delivery mechanism change? The budget impact could be substantial if uptake is high.

MarcusThat's fair, though I think payers would see it differently. The convenience isn't trivial — reducing facility access barriers could expand patient eligibility, especially in rural areas. Our value frameworks need to capture both expanded access and adherence gains. The FDA's reliance on existing data is pragmatic but creates evidence gaps for HEOR.

SaraPragmatic, yes, but risky. What if real-world adherence doesn't match trial conditions? We'll need post-marketing studies to confirm that the subQ version delivers the same outcomes. The HEOR community should be pushing for those now, not waiting for problems to emerge.

MarcusAbsolutely. And this connects to a broader trend: as formulations improve, our value assessments must evolve beyond pure clinical endpoints to include practical benefits that affect system-level costs. The convenience here could reduce caregiver burden and indirect costs — things we've historically undervalued.

SaraWhich is precisely why I'm concerned about payer pushback. If we can't quantify those benefits convincingly, we risk subQ versions being seen as premium-priced versions without added value. The evidence generation strategy needs to address that proactively.

MarcusA critical point. Now, the FTC's insulin settlement with CVS Caremark.

MarcusThe FTC settlement forcing CVS Caremark to change PBM practices around insulin pricing is significant. It requires lower-cost insulin to be available at reduced patient costs, directly addressing affordability. This aligns with broader FTC scrutiny of PBM anti-competitive practices.

SaraThat's one read — I'd frame it slightly differently. What strikes me is the narrow focus on insulin while leaving other high-cost biologics untouched. The settlement addresses a symptom but not the root cause of PBM practices. For HEOR, this creates a precedent for selective value assessments based on political pressure rather than comprehensive evidence.

MarcusA valid concern. The insulin focus does feel politically driven, which complicates our evidence-based approach. But the settlement's requirement for price transparency could actually help our value assessments by providing more real-world cost data. We should leverage that.

SaraLeverage it how? The FTC's approach sets a dangerous precedent where payers might expect similar carve-outs for other therapeutic areas. Our HEOR methodologies need to remain consistent, but this settlement forces us to explain why insulin is different without resorting to emotional arguments.

MarcusThe difference is insulin's life-saving nature and established generics. But you're right — we must maintain methodological rigor. The settlement does create an opportunity to demonstrate how our standard frameworks can deliver fair pricing even for high-impact drugs. It's a test case for value-based access.

SaraWhich we're failing at if we don't address the underlying PBM power dynamics. The settlement might help patients now, but it doesn't fix the structural issues that make biologics unaffordable. That's the thread I'll be watching.

MarcusAgreed. Now to ICER's expanded scientific advice program.

MarcusICER's announcement of expanded scientific advice with earlier engagement and structured pathways is a positive step. It aims to improve evidence quality and timeliness for value assessments. Earlier discussions could help manufacturers design more HTA-friendly trials.

SaraThat's one read — I wonder if that's the full picture though. The part that gives me pause is whether this expansion will actually reduce uncertainty or just extend the timeline. Payers need timely decisions, not more advisory processes. And if ICER's advice isn't binding, manufacturers might still proceed with suboptimal evidence generation.

MarcusFair point. The binding nature of advice is indeed a challenge. But ICER's structured pathways could create clearer expectations for what evidence payers need, potentially reducing later disputes. For HEOR, this means we need to engage earlier in development to align on endpoints and data requirements.

SaraBut what if the advice conflicts with FDA requirements? We've seen that happen before. The transatlantic divergence could create conflicting evidence demands. HEOR teams will need to navigate that carefully to avoid duplicative or conflicting studies.

MarcusThat's a real operational hurdle. The expansion does acknowledge that evidence generation needs to be more collaborative. If manufacturers heed ICER's advice early, we might see more efficient R&D that addresses both regulatory and HTA needs. But the proof will be in whether adoption rates increase.

SaraWhich brings me back to the insulin settlement — this ICER expansion could help biologics by providing clearer evidence pathways, but only if payers actually use the advice to inform coverage decisions. Otherwise, it's just more paperwork for manufacturers.

MarcusA necessary tension in the system. The expansion is a step toward more predictable evidence generation, but its impact depends on payer adoption. We'll be watching how manufacturers respond to the new pathways.

SaraA lot to think about today. I'll be watching how HCA's warning affects U.S. hospital pricing strategies and whether that triggers new access restrictions for high-cost drugs.

MarcusSame — and for me the thread running through today is how external pressures—whether from hospital finances, regulatory settlements, or evidence programs—are forcing HEOR to become more adaptive and pragmatic in our value assessments.

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.