Market Access Crosscurrents

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 given the shifting sands in US healthcare infrastructure.

MarcusSame here. We're looking at HCA's profit warning and what it signals for US hospital access — that's a critical barometer for drug reimbursement. Then subcutaneous Leqembi's approval and its HEOR implications — how this changes Alzheimer's evidence generation. The FTC settlement with CVS Caremark over insulin pricing — that's reshaping PBM influence. And ICER's expanded scientific advice — what this means for early evidence strategy.

SaraThat second one about Leqembi hits close to home — the budget impact question for chronic therapies with high upfront costs remains unresolved, especially with multiple new agents entering the space.

MarcusExactly. Let's get into it.

MarcusStarting with HCA's profit warning. They cited higher uncompensated care costs and staffing shortages. This isn't just about hospital margins — it's a direct signal of how financial strain in healthcare systems could cascade to drug access. When major hospital networks struggle, it creates downstream pressure on formulary decisions and reimbursement negotiations.

SaraThat's one read — but I'd frame it slightly differently. What strikes me is how this reflects broader systemic fragility. Payers are already facing capacity constraints, and HCA's situation could accelerate risk-averse formulary strategies. The part that gives me pause is how this might disproportionately impact newer, high-cost therapies that rely on hospital administration pathways.

MarcusThat connects to something I keep coming back to — the tension between innovation and system sustainability. HCA's warning specifically mentioned reduced admissions for profitable services. If hospitals cut back on elective procedures where drugs are administered, it creates a vicious cycle for therapies dependent on those settings. The question is whether this forces earlier value discussions or simply delays access.

SaraThe historical precedent here is instructive. During the 2008 financial crisis, we saw similar hospital consolidation leading to tougher PBM negotiations. But what's different now is the sheer scale of uncompensated care — HCA's numbers suggest this isn't cyclical but structural. Payers will likely respond with more stringent step-therapy requirements for hospital-administered drugs.

MarcusI wonder if that's the full picture though — HCA also mentioned improved operational efficiency elsewhere. That suggests the issue isn't purely financial but also about resource allocation. If they're optimizing profitable services, it might paradoxically create more bandwidth for high-value drugs that demonstrably reduce costly complications. The key will be whether HEOR teams can articulate that value early enough.

SaraFair point, though I think payers would see it differently. The operational improvements HCA cited are largely cost-saving measures, not revenue-generating. That means their drug budgets remain under pressure. We're already seeing Medicaid programs using hospital financial distress as justification for prior authorization expansions. This could be the new normal for hospital-facing therapies.

MarcusThat's a sobering outlook. Let's shift to subcutaneous Leqembi — the FDA approved the subcutaneous formulation recently. This is significant because it addresses a major barrier to adoption: the burden of intravenous infusions. From an HEOR perspective, this could dramatically expand the eligible population beyond specialized infusion centers.

SaraThat's true, but what's interesting to me is the budget impact equation. Even with administration cost savings, the drug's price remains substantial. Payers will need real-world evidence on adherence rates and healthcare utilization reduction to justify coverage. The question is whether the convenience translates to meaningful cost offsets beyond the drug acquisition cost.

MarcusExactly, and what's fascinating is how this changes the evidence generation paradigm. With subcutaneous administration, we can collect more robust real-world adherence data through patient-reported outcomes and pharmacy claims. That could finally give us the long-term effectiveness data that's been missing for Alzheimer's therapies. The FDA's approval specifically noted the pharmacokinetic equivalence, but the real test will be whether this formulation improves persistence in real-world settings.

SaraThe part that gives me pause is the opportunity cost. Even with administration savings, we're talking about a therapy that costs hundreds of thousands per patient. If subcutaneous Leqembi only modestly improves adherence, the budget impact might still be prohibitive. Payers will demand head-to-head comparisons with other amyloid-targeting agents, which creates a new evidence challenge for manufacturers.

MarcusThat's a critical point. This is one of those stories where the approval itself is just the beginning. The HEOR community now needs to develop new methodologies to capture the value of administration convenience. We might see more cost-per-year-treated models rather than traditional cost-per-QALY approaches. The precedent here could shape how we value other burden-reducing innovations.

SaraMoving to the FTC settlement with CVS Caremark — $20 million over insulin pricing practices. This isn't just about one PBM; it's a signal that regulators are scrutinizing the entire pharmacy benefit chain. What matters here is how this could change formulary placement and rebate structures for all drugs, not just insulin.

MarcusThat's one read — I'd frame it as a watershed moment for transparency. The settlement specifically accused CVS of steering patients to higher-cost insulins. If this extends to other therapeutics, it could fundamentally alter how rebates are negotiated and distributed. The question is whether this forces more value-based contracting or simply increases administrative complexity.

SaraThe historical precedent is clear: after the 2020 insulin price cap negotiations, we saw PBMs shift more rebates to pharmacy fees. This settlement suggests the FTC is now targeting that behavior. For manufacturers, the implication is that traditional rebate models may become less effective. We might see more direct contracting with health systems instead.

MarcusWhat strikes me is the timing — coming right after the IRA implementation. This creates a double bind for manufacturers: they're facing pressure from both regulators and payers on pricing. The FTC's action could accelerate the move toward outcomes-based agreements, where payment is tied to actual patient outcomes rather than list price minus rebates.

SaraThat's fair, though I think payers would see it differently. The real issue here is the fragmentation of the insulin market. With multiple biosimilars entering, PBMs have even more leverage to steer patients. This settlement might actually reduce that power, which could benefit manufacturers by creating a more level playing field. The challenge will be whether the FTC's actions translate to sustainable price reductions.

MarcusFinally, ICER's expansion of scientific advice services. They're now offering earlier-stage assessments and more specialized methodologies. This is significant because it addresses a major pain point: the gap between early clinical data and HTA readiness.

SaraThat's true, but I'm curious about the budget impact. ICER's advice comes with a price tag, and for smaller companies, that could be a barrier. The question is whether this creates a two-tier system where only well-resourced players can access high-quality early evidence development. Payers might end up relying more on manufacturer-sponsored studies if ICER's services aren't accessible.

MarcusExactly, and what's interesting is how this changes the evidence generation timeline. By getting ICER's input earlier, companies can design trials specifically to address HTA requirements. That could reduce the risk of late-stage surprises. The FDA's recent emphasis on real-world evidence aligns perfectly with this — ICER's advice could help bridge the regulatory and value assessment gaps.

SaraThe part that gives me pause is the methodology rigor. ICER's early assessments will need to clearly distinguish between preliminary signals and robust evidence. If they overstate the certainty of early data, it could create unrealistic expectations. Payers will need transparent frameworks to incorporate these assessments into coverage decisions without compromising their evidence standards.

MarcusThat's a valid concern. This is one of those stories where the intention is excellent but the execution will be key. The potential upside is huge — more efficient evidence generation that benefits both manufacturers and payers. But it requires close collaboration to ensure that early advice doesn't become a substitute for rigorous HTA assessment.

SaraA lot to think about today. I'll be watching how HCA's financial stress translates to formulary decisions across the hospital sector — that could set new precedents for high-cost drug access.

MarcusSame — and for me the thread running through today is how regulatory actions are reshaping the entire value chain. From FTC scrutiny of PBMs to ICER's expanded role, we're seeing a fundamental rethinking of how evidence is generated and valued. 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.