US Access Signals & Global 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 like they're converging at this critical inflection point for US healthcare systems.

MarcusExactly. We're looking at HCA's profit warning — a stark signal of access pressures in US hospital systems. Then subcutaneous Leqembi's approval — what that means for real-world evidence generation. Next, the FTC settlement with CVS Caremark over insulin pricing — systemic implications for rebates. And ICER's expanded scientific advice program — how this reshapes early evidence strategy.

SaraThat first one about HCA is particularly telling — when the largest hospital chain flags access challenges, it's not just their problem. It's a bellwether for broader system sustainability.

MarcusCouldn't agree more. Let's get into it.

MarcusStarting with HCA's profit warning — they cited $1.2 billion in uncompensated care and staffing costs. This isn't just a financial report; it's a systemic access pressure cooker.

SaraAbsolutely. What strikes me is how this reflects the growing chasm between innovative therapies and system capacity. When hospitals absorb these losses, it cascades into formulary restrictions and prior authorization hurdles.

MarcusThat's the real concern — we're seeing access constraints emerge not from evidence gaps, but from pure system capacity issues. The irony being that these same systems are where we need to generate real-world data.

SaraI wonder if that's the full picture though. While uncompensated care is headline, we should note that staffing shortages compound this — meaning access isn't just about payment, but about operational capacity to deliver care.

MarcusFair point. And what's interesting is how this creates a vicious cycle: hospitals cut costs → access narrows → RWE generation suffers → evidence gaps widen → pricing arguments weaken.

SaraExactly. The part that gives me pause is how this interacts with the IRA's negotiation mechanics. If hospitals are already strained, how does absorbing negotiated prices impact their willingness to stock innovative therapies?

MarcusThat connects to something I keep coming back to — the misalignment between federal policy levers and operational realities. But that's a conversation for another day.

SaraShifting to subcutaneous Leqembi — FDA approval for this formulation is significant. But I'm struck by the immediate HEOR questions it raises.

MarcusIndeed. While the route of administration improves convenience, the real challenge will be demonstrating comparative effectiveness in real-world settings. We know adherence drops significantly for injectables in Alzheimer's.

SaraThat's one read — I'd frame it slightly differently. The payer perspective is that we need to see if this translates to meaningful outcomes differences versus the IV version, not just administration preferences. Otherwise we're paying for convenience without clear value.

MarcusThat's fair, though I think payers would see it differently here. The key is that this formulation may expand access to patients who can't tolerate infusions — that's a genuine unmet need beyond just convenience.

SaraBut from a budget impact perspective, if uptake increases without corresponding outcome improvements, the system-wide cost could be substantial. Especially given the drug's existing price points.

MarcusWhat strikes me about that is how this mirrors the broader GLP-1 debate — we're seeing formulations drive access decisions rather than incremental efficacy data. The HEOR community needs to adapt to that reality.

SaraAgreed. And I'll add that this could set a precedent for other high-cost, chronic therapies where administration becomes a key differentiator in value assessments.

MarcusThe FTC settlement with CVS Caremark over insulin pricing — alleging they failed to pass rebates to patients — reveals fundamental flaws in the PBM model.

SaraThis is more than a settlement. It's about transparency in the rebate pass-through mechanics that have become central to US insulin access. When patients don't see the benefit of rebates, the entire value proposition breaks down.

MarcusThat's the core issue — the system complexity obscures true costs. But what's particularly telling is how this intersects with the IRA's insulin cap. We're seeing policy and market forces collide in unpredictable ways.

SaraI'd push back slightly on that framing. While the IRA cap is important, this settlement exposes a deeper structural issue: the misalignment between PBM incentives and patient outcomes. Until that's addressed, access will remain fractured.

MarcusThat's a crucial point. And the historical precedent here is how similar transparency issues have played out in other therapeutic areas — each time leading to more restrictive formularies.

SaraExactly. The part that gives me pause is whether this settlement will actually change behavior or just shift practices to other opaque mechanisms. The fundamental incentive structures remain unchanged.

MarcusThat connects to something I keep coming back to — the need for value-based contracting models that align incentives across the entire ecosystem. But that's easier said than done.

SaraFinally, ICER's expanded scientific advice program — covering earlier development and more evidence types. This feels like a significant evolution in the evidence ecosystem.

MarcusIt is. By expanding to phase II and incorporating real-world data earlier, they're essentially moving upstream in the development process. That could reshape how companies generate evidence for value frameworks.

SaraThat's one read — I'd frame it slightly differently. The payer perspective is that this could help address critical evidence gaps earlier, but we need to see if the advice actually translates into more value-based contracts. Otherwise it's just theoretical guidance.

MarcusWhat strikes me about that is how this aligns with the FDA's focus on accelerated approvals and RWE. We're seeing a convergence of regulatory and HTA evidence generation streams.

SaraBut I wonder if that's the full picture though. The capacity implications are substantial — can ICER truly deliver on this expansion without compromising the depth of their assessments? Quality matters as much as breadth.

MarcusThat's a fair concern. And historically, when HTA bodies expand scope, we see resource constraints emerge. The key will be whether they can maintain methodological rigor.

SaraExactly. And for companies, this means earlier HEOR integration — the line between clinical development and evidence strategy is blurring more than ever.

SaraA lot to think about today. I'll be watching how HCA's access pressures ripple through formulary decisions, especially for high-cost injectables.

MarcusSame — and for me the thread running through today is how operational realities in healthcare delivery are becoming as critical as evidence generation in determining access. 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.