System Stress & Evidence Shifts

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, today's topics feel particularly urgent, with threads that connect directly to sustainability pressures.

MarcusSame here. We're looking at HCA's profit warning and what it signals for US system access — that's a critical bellwether. Then the subcutaneous Leqembi approval and the HEOR evidence landscape shift it creates. Plus the FTC settlement with CVS Caremark on insulin pricing — a landmark moment. And finally, ICER's scientific advice expansion.

SaraThat second one is interesting to me — the subcutaneous formulation evidence question is one where HTA bodies haven't yet established consistent methodologies. The budget impact implications could be significant if we're not careful.

MarcusExactly. Let's get into it.

MarcusStarting with HCA's profit warning. This isn't just a financial report; it's a systemic stress signal. When one of the largest US hospital systems flags financial strain, it reverberates through access decisions. We're seeing capacity constraints, delayed procedures, and intensified cost containment across the board.

SaraThat's one read — but what strikes me is the patient access angle. When systems pull back, it's often high-cost, high-value therapies that face informal rationing first. The part that gives me pause is how this interacts with novel therapies entering the market. More pressure on existing budgets means tougher value conversations.

MarcusThat connects to something I keep coming back to — the innovation paradox. We need new solutions for aging populations, but the system's ability to absorb them is fraying. HCA's warning isn't an outlier; it's becoming a pattern.

SaraI'd push back slightly on that framing. The pattern is real, but the causes are multifaceted. It's not just about new therapies; it's about reimbursement delays, administrative burdens, and underlying inflation. Payers are seeing the same pressure points. The question is whether we can restructure value frameworks to account for system capacity.

MarcusThat's fair, though I think the industry perspective is that we need more efficiency in evidence generation. Real-world evidence showing long-term system savings could mitigate some of this friction. But the timeline mismatch between innovation cycles and system adaptation remains critical.

SaraAbsolutely — and that's where the Leqembi subcutaneous approval comes in. A formulation change shouldn't require a full HEOR reset, but we're seeing inconsistent expectations across jurisdictions.

MarcusExactly. The subcutaneous Leqembi approval is fascinating because it challenges our evidence assumptions. We've long assumed route of administration doesn't fundamentally alter value, but here we have a different delivery method with potential adherence advantages. The FDA approval was straightforward, but HTA bodies are asking: do we need new RCTs?

SaraWhat strikes me about that is the precedent it sets. If we require fresh evidence for every minor formulation change, the evidence generation burden becomes unsustainable. The part that gives me pause is the opportunity cost — resources diverted from novel mechanisms to reformulations. Payers are already skeptical of incremental innovations.

MarcusI wonder if that's the full picture though. From the patient perspective, subcutaneous administration could mean significant quality-of-life benefits that aren't captured in traditional endpoints. If we don't generate evidence for those, we're undervaluing real-world utility. The challenge is finding efficient ways to capture that without duplicating trials.

SaraThat's one read — but the budget impact question there is one the field hasn't fully worked out yet. If adherence improvements lead to higher utilization rates, the system cost could increase even if per-dose costs decrease. We need models that account for both clinical and utilization shifts.

MarcusRight, and from the payer side, that's where the insulin pricing settlement becomes instructive.

MarcusThe FTC settlement with CVS Caremark over insulin pricing is a watershed moment. It's not just about insulin; it's about formulary access and manufacturer transparency. The precedent here could reshape how we approach high-cost, essential therapies in the US.

SaraThat's fair, though I think the real significance lies in the enforcement mechanism. This isn't just a fine; it's a structural change in how pharmacy benefit managers negotiate. The part that gives me pause is whether this creates a template for other therapeutic areas. If we see similar interventions for oncology or rare diseases, the entire pricing calculus shifts.

MarcusI'd frame it slightly differently — this signals a recognition that market power imbalances distort value assessment. When PBMs control access, the patient's perspective gets lost. This settlement forces a more direct value conversation. But the question is whether it actually reaches patients or just shifts costs within the system.

SaraWhat strikes me about that is the operational complexity. Even with good intentions, implementing such changes requires robust data infrastructure. If we don't have real-time utilization data, how do we ensure the savings actually reach patients? The methodology gaps here are significant.

MarcusThat connects to ICER's expansion of scientific advice services. As these complex value questions emerge, having early input becomes crucial.

SaraICER's expansion of scientific advice is a response to the very pressures we've been discussing. When systems are stressed and evidence requirements evolve, getting alignment early prevents downstream conflicts. But I wonder if this creates new bottlenecks. With more demand for advice, does it actually accelerate decisions or just add layers to the process?

MarcusThat's one read — but the alternative is no alignment at all. What I find interesting is how this shifts the industry's approach to evidence generation. If you know the HTA questions upfront, you can design more efficient trials. The challenge is ensuring the advice is truly collaborative rather than prescriptive.

SaraI'd push back slightly on that. The payer perspective is that scientific advice often comes too late in development. By the time companies seek input, the trial design is locked. We need earlier engagement — at the protocol stage, not just before submission. The part that gives me pause is whether ICER's capacity can scale meaningfully.

MarcusThat's a valid concern. What strikes me is the global divergence here. While the US expands advice services, some European systems are tightening requirements. The inconsistency creates real challenges for multinational companies. But ultimately, early alignment saves resources for everyone when done right.

SaraAgreed — and that's where we circle back to the system stress HCA highlighted. Without efficient evidence pathways, these pressures compound. The thread running through today is the urgent need for smarter, more adaptive value frameworks.

SaraA lot to think about today. I'll be watching how the insulin pricing settlement's operationalization plays out — specifically whether it creates meaningful patient access improvements or just administrative reshuffling.

MarcusSame — and for me the thread running through today is the evidence evolution paradox. We need more nuanced evidence for novel approaches, but the system's capacity to absorb that evidence is simultaneously contracting. That tension will define the next phase of market access.

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.