US Healthcare Access & Pricing 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, particularly the US healthcare access signals.

MarcusSame here. We're looking at HCA's profit warning and its implications for US healthcare access. Then the subQ Leqembi approval and what it means for HEOR evidence generation. And finally, the FTC settlement with CVS Caremark over insulin pricing and the precedent it sets.

SaraThat second one on Leqembi is particularly interesting to me — the shift to subquentaneous administration could have profound effects on real-world adherence and, by extension, cost-effectiveness models.

MarcusExactly. And the FTC settlement is a major signal for PBM regulation. Let's get into it.

MarcusStarting with HCA's profit warning — they're citing rising uncompensated care costs from uninsured patients and increased administrative burdens. This isn't just a company-specific issue; it's a bellwether for US hospital system financial stress.

SaraI wonder if that's the full picture though. The uninsured rate is part of it, but we're also seeing more patients with high-deductible plans delaying care until it's emergent. The administrative burden piece feels like a distraction from the core problem: payment fragmentation.

MarcusThat's fair, though I think payers would see the administrative burden as a direct consequence of complex coverage rules. What strikes me is how this could force hospitals to prioritize higher-margin services, potentially squeezing access to lower-reimbursed but essential treatments.

SaraWhich creates a vicious cycle — uncompensated care rises, hospitals cut services, more patients become uninsured. The part that gives me pause is how this interacts with the IRA's inflation rebates. Will manufacturers absorb more rebates or pass costs to payers?

MarcusExactly, and what's interesting is that HCA's warning comes amid CMS Part D redesign implementation. The timing suggests these structural changes are colliding in unpredictable ways. I'd push back slightly on the payment fragmentation point — while true, the uninsured rate is rising independently of plan design complexity.

SaraThat's one read — I'd frame it slightly differently. The uninsured rate increase is directly tied to state Medicaid coverage decisions and commercial plan exits from exchanges. The real question is whether hospital consolidation exacerbates this by reducing competition in underserved areas.

MarcusRight, and from the payer side, this signals potential premium increases to cover higher hospital costs. Which loops back to the IRA's price negotiation impact — will manufacturers face pressure to lower prices to offset hospital losses?

SaraThat connects to something I keep coming back to: the IRA was designed for drug pricing, but its effects are spilling into broader healthcare economics. This story caught me off guard because it shows how hospital financial health isn't siloed from pharmaceutical policy.

MarcusOn to Leqembi's subQ approval — same 27% cognitive decline reduction as IV, but with more convenient administration. This could fundamentally change how we model real-world adherence in Alzheimer's disease.

SaraAbsolutely. The IV formulation required infusions every two weeks, which created significant caregiver burden and drop-off in real-world settings. SubQ administration at home could dramatically improve persistence, but we'll need RWE to quantify that impact on long-term outcomes.

MarcusThat's precisely what I'm thinking. HEOR teams will need to pivot from comparing IV to placebo to tracking adherence patterns in community settings. The challenge is that current cost-effectiveness models assume perfect adherence — this approval forces us to confront real-world variability.

SaraAnd what strikes me about that is the timing. With NICE's updated RWE guidance and CMS's increased focus on real-world data, we might see accelerated evidence generation. But the question is whether payers will accept interim RWE for coverage decisions before Phase 4 data matures.

MarcusI'd frame it slightly differently — the subQ route could actually accelerate evidence generation by increasing trial retention. But the methodological shift is significant: we'll need to model both adherence and administration costs separately. What's your take on how this affects the cost per QALY calculations?

SaraThe part that gives me pause is that existing models for Alzheimer's drugs don't account for caregiver time savings. A subQ treatment might have higher drug costs but lower indirect costs. That's a methodological gap we haven't addressed yet.

MarcusExactly, and from the payer side, this could create tension between budget impact and long-term value. If adherence improves, the total cost of care might decrease even with a higher price per dose. I keep coming back to how this reshapes value frameworks — we might need to incorporate caregiver burden as a cost component.

SaraThat's fair, though I think payers would see caregiver burden as part of societal value, not strictly healthcare costs. The real question is whether manufacturers will position this as a total cost of care solution or a price-premium innovation.

MarcusMoving to the FTC settlement with CVS Caremark — $100 million payment and PBM practice changes over anti-competitive insulin pricing. This is the first major enforcement action against PBMs since the IRA's drug pricing provisions.

SaraWhat strikes me about that is the precedent it sets for insulin pricing transparency. The settlement requires CVS to disclose more about how it negotiates rebates, which could expose the 'spread pricing' practices that have inflated insulin costs. But I wonder if this will actually change behavior or just shift practices to other therapeutic areas.

MarcusI'd push back slightly on the 'spread pricing' characterization — while true, the core issue is the lack of pass-through of rebates to patients. The FTC's focus on anti-competitive practices suggests they're targeting PBM consolidation rather than rebate structures. What's your take on whether this could lead to broader PBM regulation?

SaraThat's one read — I'd frame it slightly differently. The settlement specifically addresses insulin, but the 'anti-competitive' language signals a broader concern about PBM market power. The part that gives me pause is whether manufacturers will use this to justify higher list prices, arguing they need to compensate for PBM practices.

MarcusExactly, and from the payer side, this could create a new negotiation dynamic. If PBMs are forced to be more transparent, payers might demand better pass-through terms. But the risk is that insulin manufacturers respond by increasing prices, negating any savings.

SaraThat connects to something I keep coming back to: the IRA's inflation rebates were designed to address manufacturer pricing, but this settlement shows the PBM layer is equally problematic. We might need simultaneous regulation of both to achieve meaningful insulin cost reductions.

MarcusFinally, ICER's expansion of scientific advice to include Phase I/II consultations and RWE strategies. This is a significant shift toward earlier HTA alignment.

SaraAbsolutely. By moving into pre-submission territory, ICER is essentially creating a 'pre-HTA' pathway. This could help sponsors design trials with HTA requirements in mind from the outset, reducing the risk of late-stage evidence gaps.

MarcusThat's precisely what I'm thinking. But I wonder about the operational challenges — ICER will need to expand capacity significantly to handle early-phase advice. What's your take on how this affects sponsor strategy? Will companies engage earlier, or wait until Phase III?

SaraI'd frame it slightly differently — the real value is in RWE strategy development. If ICER helps sponsors plan real-world data collection during Phase II, it could make post-approval submissions more seamless. But the question is whether payers will give early advice the same weight as late-stage submissions.

MarcusExactly, and from the payer side, this could create a two-tiered system: drugs with early ICER advice might get faster reviews. But I keep coming back to the resource implications — will HTA bodies like NICE follow suit, or is this uniquely suited to ICER's US-focused model?

SaraThat's fair, though I think payers would see this as a way to de-risk investments. The part that gives me pause is whether early advice creates 'lock-in' effects, making it harder for HTA bodies to adjust their positions as new evidence emerges.

SaraA lot to think about today. I'll be watching how the FTC settlement plays out in other PBM negotiations and whether it leads to broader pricing transparency.

MarcusSame — and for me the thread running through today is the growing pressure on US healthcare systems to balance innovation with 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.