Market Access Crossroads

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, I've had today's topics circled since this morning, particularly the HCA situation and the Leqembi approval.

MarcusSame here. We're looking at HCA's profit warning and its implications for US healthcare access — the system stress signals are hard to ignore. Then the subcutaneous Leqembi approval and what it means for Alzheimer's HEOR evidence generation. Also, the FTC settlement with CVS Caremark over insulin pricing — a major formulary precedent. And finally, ICER expanding scientific advice services — a response to evidence gaps in complex therapies.

SaraThat second one about Leqembi is interesting to me — the budget impact question there is one the field hasn't fully worked out yet, especially with subcutaneous administration changing utilization patterns.

MarcusExactly. Let's get into it.

MarcusStarting with HCA's profit warning — they're citing 'higher-than-expected' uncompensated care costs and labor pressures. What strikes me here is how this reflects broader structural strain in the US system, not just a single system's mismanagement. The uncompensated care line is particularly telling as a barometer for access.

SaraThat's one read — I'd frame it slightly differently though. What HCA's signaling isn't just about costs; it's about the shifting payer-provider negotiation dynamics post-COVID. When systems flag uncompensated care, it's often a proxy for Medicaid expansion gaps and commercial payers pushing harder on reimbursement rates.

MarcusI wonder if that's the full picture though. HCA operates in multiple states with varying Medicaid coverage levels. Their specific geographic footprint might be exposing particular policy fractures — like states that haven't expanded Medicaid seeing higher uncompensated care burdens that cascade into broader system access issues.

SaraThe part that gives me pause is how this could accelerate value-based contracting adoption. If systems are squeezed on margins, they might push harder for risk-sharing models that tie reimbursement to outcomes — which could actually reshape how we approach HEOR evidence generation in the near term.

MarcusThat connects to something I keep coming back to: the IRA's Medicare negotiation pressure is now colliding with provider-side financial stress. We might see more providers becoming active participants in value frameworks rather than passive recipients of pricing.

SaraFair point, though I think payers would see this differently. For them, HCA's warning is a reminder that access isn't just about drug pricing — it's about the entire care continuum's financial viability. If hospitals cut services or reduce capacity, that creates downstream access barriers for therapies we're trying to get to patients.

MarcusExactly. And what's striking here is how quickly these macro-level pressures translate into micro-level access challenges. This isn't just a financial report; it's a warning sign for market access teams about potential disruptions in distribution and administration networks.

MarcusShifting to the subcutaneous Leqembi approval — this is a big deal for Alzheimer's treatment. The subcutaneous formulation changes the administration paradigm from monthly infusions to weekly injections, which could significantly impact patient adherence and real-world utilization patterns. The question is how this shifts the cost-effectiveness calculus.

SaraThat's fair, though I think payers would see this differently. The weekly administration model introduces new logistical challenges — training providers, managing injection sites, potential for errors. Those friction points could lead to higher per-patient costs that aren't captured in traditional RWE studies. The budget impact might be more sensitive than we're modeling.

MarcusI'd push back slightly on that. The data from the subQ trials showed comparable safety and efficacy, and the reduction in infusion-related adverse events could offset some of those logistical costs. But you're right about the evidence gaps — we need more real-world data on how this plays out in community settings versus specialized infusion centers.

SaraWhat strikes me about that is how this formulation might expand the eligible prescriber pool. If neurologists aren't the only ones who can administer it, that could increase access but also dilute the patient selection criteria. That's a classic market access tension: broader access versus potential overutilization.

MarcusThat connects to the HEOR strategy implications. Companies might need to generate evidence on different prescriber types and settings — not just the traditional academic centers. The evidence generation paradigm has to adapt to the expanded delivery ecosystem.

SaraThe part that gives me pause is the precedent this sets for other biologics. If subQ administration becomes the preferred route for high-cost neurological therapies, we'll need entirely new frameworks for assessing cost-effectiveness that account for administration costs and real-world adherence patterns.

MarcusExactly. And what's interesting is how this could accelerate the use of digital endpoints in HEOR studies — tracking injection compliance via apps, for example. This approval isn't just about a new formulation; it's signaling a shift in how we measure value in chronic disease management.

MarcusNow to the FTC settlement with CVS Caremark over insulin pricing — they're accused of steering patients to higher-cost insulin products through formulary designs. This is significant because it's the first major settlement targeting PBM formulary tactics specifically for insulin. The implications for market access strategy are profound.

SaraI wonder if that's the full picture though. While the settlement addresses formulary steering, the real access issue is the list price inflation that PBMs have historically enabled through rebate structures. This settlement might change tactics but doesn't solve the underlying pricing model. We're seeing a shift from rebate-based to fee-for-service models, but the financial pressure remains.

MarcusThat's a crucial point. The FTC's focus on steering is a response to patient cost-sharing, but it doesn't address the manufacturer list prices that drive the entire system. The settlement might actually create new complexities — PBMs could develop more opaque steering mechanisms that are harder to detect.

SaraWhat strikes me about that is how this could accelerate value-based contracting for insulin. If PBMs are under scrutiny for steering, they might push harder for outcomes-based agreements that tie reimbursement to glycemic control or adherence metrics. That would fundamentally change how we approach HEOR for metabolic therapies.

MarcusThe part that gives me pause is the precedent for other therapeutic areas. If the FTC is willing to intervene in insulin pricing, which has unique social value considerations, what does that mean for high-cost oncology or rare disease therapies? We might see more regulatory scrutiny on formulary design across the board.

SaraExactly. And this settlement signals that the era of unfettered PBM discretion is ending. Market access teams will need to develop more sophisticated formulary strategies that account for both regulatory scrutiny and patient access imperatives. The risk landscape has shifted significantly.

MarcusThis is one of those stories where the immediate reaction is about insulin, but the long-term implications are system-wide. We're seeing the fragmentation of the traditional PBM model, which will create both challenges and opportunities for evidence-based market access strategies.

MarcusFinally, ICER's expansion of scientific advice services — they're adding more specialized advice tracks for complex therapies and digital health. This is a direct response to evidence gaps in innovative areas, particularly for therapies with novel mechanisms or endpoints. The move could streamline evidence generation but also raises questions about standardization.

SaraThat's one read — I'd frame it slightly differently though. ICER's expansion is actually a recognition that payers are struggling to assess value in emerging areas. By offering more tailored advice, they're trying to bridge the gap between regulatory approval and HTA assessment. But the risk is creating inconsistent evaluation frameworks across different therapy classes.

MarcusI wonder if that's the full picture though. The expansion also reflects the growing complexity of evidence requirements. For therapies like cell and gene therapies, the traditional HTA timelines don't align with development needs. ICER is trying to fill that gap by providing earlier, more flexible engagement.

SaraWhat strikes me about that is how this could impact HEOR resource allocation. Companies might need to invest in multiple advice tracks simultaneously — one for ICER, one for NICE, one for Germany's G-BA. That increases the evidence generation burden, especially for smaller biotechs with limited resources.

MarcusThat connects to something I keep coming back to: the global harmonization challenge. As HTA bodies expand their advice services, we're seeing divergent approaches to evidence generation. This creates a complex landscape for market access teams who need to navigate multiple frameworks without duplicating efforts.

SaraThe part that gives me pause is the potential for advice fatigue. If every major HTA body offers specialized advice, companies might face advice overload, leading to strategic fragmentation. We need more coordination between HTA bodies to ensure advice is complementary rather than contradictory.

MarcusExactly. And what's interesting is how this could accelerate the use of RWE in HTA submissions. As advice becomes more specialized, companies will need to generate real-world evidence earlier to address the specific questions raised by different HTA bodies. This is a significant shift from the traditional RWE timeline.

SaraA lot to think about today. I'll be watching how the HCA situation unfolds and whether it triggers more provider-payer partnerships around value-based contracting. The access pressures we're seeing might force some creative solutions.

MarcusSame — and for me the thread running through today is the growing tension between innovation speed and system sustainability. Whether it's new formulations, insulin pricing, or HTA advice, we're seeing evidence frameworks struggling to keep pace with therapeutic advances.

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.