US Market Access 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, I've had today's topics circled since this morning. The signals from the US system are getting louder.

MarcusSame here. We're looking at HCA's profit warning signaling broader access pressures — that's a red flag for system sustainability. Then subcutaneous Leqembi's approval — this changes the administration calculus for Alzheimer's treatments. And the CVS Caremark insulin settlement — that's a major enforcement moment for reimbursement practices.

SaraThat second one is interesting to me — the administration cost shift with subQ formulations could create unexpected budget impacts for payers. We haven't fully modeled that transition yet.

MarcusExactly. Let's get into it.

MarcusStarting with HCA Healthcare's profit warning. They cited a 15% increase in uninsured patients and 10% rise in charity care costs. This isn't just one health system's issue—it's a barometer for uncompensated care spreading through the US system.

SaraThat's one read — I'd frame it slightly differently. What strikes me is the compounding effect: rising commercial premiums are pushing more patients into coverage gaps. The uninsured rate increase correlates directly with high-deductible plan growth.

MarcusThat connects to something I keep coming back to—this is one of those stories where the safety net fraying affects everyone. When HCA redirects resources from planned care to uncompensated emergency cases, it creates downstream access bottlenecks for commercially insured patients too.

SaraThe part that gives me pause is the charity care cost increase. That's not just bad debt—it's active resource diversion. We're seeing health systems cross-subsidize less with each passing quarter.

MarcusRight, and from the payer side, that means higher cost-shifting to commercial plans. The ACA's coverage gaps are widening in real-time, and we're seeing the consequences in quarterly reports.

SaraThis is a system-level stress test. I wonder if that's the full picture though—what about the Medicaid unwinding effects? States haven't fully accounted for the churn in eligibility recalculations.

MarcusFair point. The Medicaid disenrollment rate is still elevated, and that's a separate pressure vector from the commercial market shifts.

SaraShifting to subcutaneous Leqembi. The FDA approval cuts infusion time from 2.5 hours to under 5 minutes. That's clinically significant, but the HEOR implications go beyond convenience.

MarcusAbsolutely. This formulation expands potential administration sites from specialized infusion centers to broader clinical settings. That could increase patient access but also raise costs through expanded facility fees and nursing time.

SaraThat's fair, though I think payers would see it differently. The current reimbursement model heavily discounts infusion centers—subQ delivery might trigger higher per-dose administration payments. We haven't seen the CMS pass-through codes for this yet.

MarcusWhat's striking here is how this mirrors the trastuzumab subQ journey. The initial uptake was slow until payers recognized the resource shift benefits. Leqembi's case is more complex given the monitoring requirements.

SaraThe monitoring point is crucial. Even with shorter infusions, you still need post-administration observation. So the net time savings might be less dramatic than advertised.

MarcusExactly. And this is one where the patient perspective matters—reducing infusion burden is meaningful, but we need real-world evidence on whether that translates to better adherence in Alzheimer's care.

SaraAgreed. The first access barriers will be site-of-service credentialing. Not every community pharmacy has the capability for subQ biologics administration.

MarcusThe FTC settlement with CVS Caremark over insulin pricing—$120 million in penalties and changes to prior authorization practices. This is the first major enforcement action on insulin reimbursement pathways.

SaraI'd push back slightly on that framing. The insulin pricing issue is broader than CVS Caremark—the settlement is about their PBM practices specifically. But you're right, it sets a precedent for how payers handle insulin access.

MarcusTrue. The prior authorization changes are what caught my attention. They're moving toward more streamlined coverage for insulin products, which could create a domino effect for other high-cost biologics.

SaraThat's one read — the precedent matters, but I'm more interested in the enforcement mechanism. The FTC is using consumer protection laws to address healthcare access gaps. That's a novel approach we should watch.

MarcusNovel indeed. Historically, these issues were handled through state pharmacy boards or CMS audits. The FTC's involvement suggests a new level of scrutiny on PBM practices affecting access.

SaraThe budget impact question here is significant. If insulin prior auth becomes more permissive, we might see increased utilization across all payers. The $120 million penalty is just the beginning of the cost implications.

MarcusAnd that's where the patient perspective comes in—this directly affects out-of-pocket costs for insulin-dependent patients. The enforcement might create short-term disruptions but should improve long-term access.

SaraFinally, ICER's expansion of scientific advice offerings. They're adding early evidence assessment and health economic modeling support to their portfolio. This feels like a response to sponsors needing earlier value navigation.

MarcusDefinitely. What's interesting is how this positions ICER as a development partner rather than just an assessment body. The early evidence assessment could help de-risk late-stage HTA failures.

SaraThat's one read — though I think payers would see it differently. More sponsors engaging early with ICER might create unrealistic expectations about what HTA bodies will ultimately accept. We've seen this movie before with NICE scientific advice.

MarcusFair point. The history shows that early advice doesn't guarantee positive recommendations. But ICER's modeling support could help sponsors align evidence generation with real-world data needs.

SaraThe part that gives me pause is the commercial viability angle. Sponsors might over-invest in evidence generation based on early ICER input, only to face different requirements from other HTA bodies. That's a resource allocation risk.

MarcusWhat strikes me is how this connects to the R&D investment side. Better early alignment could reduce late-stage development failures—something the industry desperately needs given the high cost of Alzheimer's drug development.

SaraAbsolutely. But the opportunity cost remains. Every dollar spent on early ICER engagement is a dollar not spent on clinical trials or real-world evidence generation. Payers care deeply about that trade-off.

MarcusWhich is why this expansion makes sense—it's about optimizing evidence generation. The key will be whether ICER can deliver consistent value across different therapeutic areas.

SaraA lot to think about today. I'll be watching how the HCA profit warning translates to other health system financial reports. The uninsured rate increase could trigger broader policy responses.

MarcusSame — and for me the thread running through today is the convergence of enforcement and evidence strategies. From FTC actions to ICER expansions, we're seeing market access becoming more proactive rather than reactive.

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.