US Access Erosion Signals

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 feel particularly urgent right now.

MarcusSame here. We're looking at HCA's profit warning as a symptom of broader access erosion in US healthcare. Then subcutaneous Leqembi's approval reshaping Alzheimer's value narrative. Also, the FTC-CVS insulin settlement exposing PBM practices. And ICER's expansion of early-phase scientific advice.

SaraThat first one is striking — the budget impact question there is one the field hasn't fully worked out yet. When major providers signal strain, it cascades through the entire evidence ecosystem.

MarcusExactly. Let's get into it.

MarcusStarting with HCA's profit warning. This isn't just a financial miss — it's a symptom of access erosion. We're seeing reimbursement pressures, operational costs, and patient access challenges converge. The signal here is that the US healthcare system's sustainability is under genuine strain.

SaraThat connects to something I keep coming back to: the hidden opportunity costs. When HCA reports pressure, it means other services are being deprioritized. For payers, this isn't just about HCA's stock price — it's about how these system stresses reshape our evidence requirements for new therapies.

MarcusAbsolutely. The part that gives me pause is how this affects R&D incentives. If the system is strained, the value proposition for innovative therapies becomes even more critical. We'll need more robust HEOR to justify investment when the baseline access is precarious.

SaraI'd push back slightly on that — while R&D incentives matter, the immediate issue is how payers interpret this. If HCA's warning signals broader cost containment, we may see even more stringent value assessments. The budget impact question here is one the field hasn't fully worked out yet.

MarcusThat's fair, though I think the industry response will be to double down on real-world evidence showing system-wide benefits. Not just clinical outcomes, but how therapies reduce downstream costs. The question is whether that evidence can be generated fast enough.

SaraExactly. And from the payer side, we're already seeing that shift. The HCA signal makes us ask: can a new therapy actually reduce the total cost burden, not just improve outcomes? That's becoming non-negotiable.

MarcusMoving to subcutaneous Leqembi. This approval fundamentally reshapes the Alzheimer's value narrative. The route of administration changes everything — it's no longer just about efficacy, but about practicality in real-world settings.

SaraWhat strikes me about that is the patient-reported outcomes angle. Subcutaneous administration significantly reduces caregiver burden, which has measurable economic value. But traditional HTA frameworks haven't fully integrated that into cost-effectiveness models yet.

MarcusThat's one read — I'd frame it slightly differently. The real HEOR challenge here is demonstrating comparability to the IV formulation. If we can't show similar real-world outcomes with the new route, the value proposition unravels. The methodological rigor around non-inferiority evidence will be critical.

SaraThe part that gives me pause is the budget impact question. Even with similar efficacy, subcutaneous administration could expand access to patients who couldn't tolerate IV infusions. That means a larger eligible population, which changes the entire economic equation for payers.

MarcusWhat's interesting is how this connects to the HCA signal we just discussed. If we can show that subcutaneous Leqembi reduces system costs by making treatment more accessible and less burdensome, it becomes a solution to the access erosion problem. That's the narrative we need to build.

SaraAgreed. But the evidence requirements will have to evolve. We'll need real-world data showing adherence rates, caregiver time savings, and downstream healthcare utilization. That's beyond traditional clinical endpoints.

MarcusNow, the FTC-CVS insulin settlement. This is a watershed moment for PBM transparency. The settlement exposes how rebate structures can distort insulin access and pricing, regardless of list price.

SaraThat's one read — I'd frame it slightly differently. The real implication is for competitive dynamics. When PBMs are forced to rebate more insulin, it creates space for biosimilars and lower-cost alternatives. That could reshape the entire diabetes market, not just insulin pricing.

MarcusThe part that gives me pause is how this affects value demonstration for new insulins. If the market becomes more price-sensitive, the HEOR bar for next-gen insulins just got higher. We'll need to show not just clinical superiority, but clear economic advantages over existing options.

SaraExactly. And from a payer perspective, this settlement signals that we should expect more scrutiny on rebate practices across all therapeutic areas. The opportunity cost question becomes: are these rebates actually reaching patients, or are they just padding PBM margins?

MarcusWhat's striking here is the precedent it sets. If insulin is being reined in, what's next for high-cost biologics? The HEOR community needs to prepare for similar transparency demands in other therapeutic classes.

SaraAbsolutely. The patient impact angle is crucial too. If insulin becomes more affordable, it frees up budget for other innovative therapies. That's the positive ripple effect we need to quantify.

MarcusFinally, ICER's expansion of early-phase scientific advice. This is a game-changer for evidence strategy. Getting input before Phase 3 can de-risk development and ensure the evidence generated is HTA-ready.

SaraI wonder if that's the full picture though. While early advice is valuable, it creates a new tension between innovation speed and methodological rigor. If we're asking for HTA alignment too early, could it stifle novel approaches that don't fit traditional frameworks?

MarcusThat's fair, though I think payers would see it differently. For them, this is about avoiding late-stage failures. If we can align on evidence requirements earlier, we generate more efficient data that actually informs coverage decisions. The patient benefit is getting therapies to market faster with appropriate evidence.

SaraThe part that gives me pause is the resource question. HTA bodies are already stretched. Can they provide meaningful early-phase advice without compromising their core assessment functions? That's a real operational challenge.

MarcusWhat connects this to our other topics is the access erosion theme. If early-phase advice leads to more efficient development, it could help mitigate the system strains we're seeing with HCA. The key is making sure the advice is actionable, not just theoretical.

SaraExactly. And for Alzheimer's specifically, this could mean more targeted evidence generation for subcutaneous formulations. We're seeing a shift toward pragmatic, patient-centric evidence from the start.

MarcusA lot to think about today. I'll be watching how the FTC settlement reshapes PBM practices and insulin access dynamics. The precedent could ripple through other high-cost markets.

SaraSame — and for me the thread running through today is the convergence of system pressures and evidence evolution. HCA's warning, Leqembi's administration shift, the FTC action, and ICER's advice expansion all point to a redefinition of value in constrained systems.

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.