US Access Signals & HEOR 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 US system signals are particularly telling right now.

MarcusSame here. We're looking at HCA's profit warning exposing US healthcare access pressures — what it means for reimbursement landscapes. Then subQ Leqembi's approval and its HEOR evidence implications. Plus the FTC settlement with CVS Caremark on insulin pricing. And ICER's scientific advice expansion.

SaraThat second one about subQ Leqembi is interesting to me — the real-world evidence generation challenge for novel formulations could reshape how we approach value demonstrations.

MarcusExactly. Let's get into it.

MarcusStarting with HCA's profit warning. They cited rising uncompensated care and Medicaid enrollment as key drivers. This isn't just a hospital issue — it's a direct signal about US healthcare system stress points that will inevitably ripple into drug access decisions.

SaraAbsolutely. The uncompensated care angle is critical here. When hospitals absorb these losses, they pressure manufacturers on pricing and rebates. It creates a vicious cycle where access pressures compound financial pressures for both providers and innovators.

MarcusThat connects to something I keep coming back to: the Medicaid population is growing, and that shifts the entire cost-benefit calculus. If payers are seeing more Medicaid patients, their willingness to pay for high-cost drugs in that segment will be under even greater scrutiny.

SaraI wonder if that's the full picture though. HCA specifically mentioned increased administrative costs too. It's not just uncompensated care — it's the operational burden of navigating complex reimbursement systems that's squeezing margins. That operational friction affects how quickly drugs reach patients in real-world settings.

MarcusFair point. But from the payer side, wouldn't you argue that the underlying issue remains the same: system-wide sustainability? When hospitals struggle, they push back on drug prices, which then affects formulary placement for everyone.

SaraThat's one read — I'd frame it slightly differently. The real tension is between immediate access needs and long-term system viability. Hospitals are caught in the middle. The profit warning is a symptom of that larger structural challenge that HEOR teams must address with more nuanced cost-effectiveness models.

MarcusThat's a crucial distinction. Let's pivot to subQ Leqembi. The FDA approval for subcutaneous administration is significant — it reduces infusion burden and potentially expands access. But what does that mean for HEOR teams?

SaraThe immediate challenge is generating real-world evidence on this new formulation. We need to demonstrate comparable efficacy in a broader population, including those who couldn't tolerate intravenous administration. The evidence strategy must now include head-to-head real-world data against existing treatments.

MarcusAnd the cost implications? If administration costs drop, but drug costs remain high, how does that affect the value proposition?

SaraThat's where the budget impact gets complicated. Lower administration costs could improve the cost per QALY calculation, but only if the drug's list price doesn't offset those savings. Payers will demand evidence showing net system savings, not just patient convenience benefits.

MarcusWhat strikes me about this is the timing. With Alzheimer's treatments under such intense scrutiny, any new formulation must prove its value beyond just delivery method. The HEOR bar is higher than ever.

SaraExactly. And that's why the FTC settlement with CVS Caremark matters so much here. When PBMs manipulate insulin pricing, it erodes trust in the entire system. That mistrust extends to high-cost specialty drugs too. If payers believe the system is rigged against them, they become even more risk-averse about novel treatments.

MarcusThe $77.5 million settlement is just the tip of the iceberg. The transparency commitments are what really matter here. If PBMs are forced to disclose more about their pricing practices, it could fundamentally change how manufacturers negotiate rebates and discounts.

SaraI'd push back slightly on that. The settlement doesn't address the root issue: PBM spread pricing. Until we see structural changes in how rebates are calculated and distributed, transparency alone won't solve the underlying access barriers. It's a procedural fix for a systemic problem.

MarcusThat's fair, though I think payers would see it differently. For them, any increase in transparency is a step forward. If they can finally see the true cost of drugs after all rebates, they can make more informed formulary decisions. That could actually help innovative drugs get fairer consideration.

SaraWhich brings us to ICER's scientific advice expansion. They're moving toward earlier engagement and real-world evidence integration. This is a direct response to the industry's need for more adaptive evidence generation.

MarcusThe shift to early-phase engagement is significant. It allows companies to shape their evidence strategies before Phase III is complete, which could reduce late-stage development failures. But how does this align with traditional HTA timelines?

SaraThe tension there is between flexibility and methodological rigor. HTA bodies need robust evidence, but manufacturers need agility. ICER's approach attempts to bridge that gap by incorporating RWE earlier, but it remains to be seen if HTA bodies will fully embrace this model.

MarcusWhat I find most interesting is the RWE integration aspect. If ICER can establish credible real-world evidence standards, it could revolutionize how we assess value for drugs that don't have long-term trial data. That's particularly relevant for these novel formulations we discussed earlier.

SaraThe part that gives me pause is the practical implementation. Generating high-quality RWE takes time and resources. If companies are engaging earlier, but then face delays in RWE collection, it could create new bottlenecks in the assessment process. The operational feasibility is still unproven.

MarcusThat's a valid concern. But the alternative is sticking with rigid frameworks that don't reflect real-world clinical practice. The industry needs this evolution, even if it's messy at first.

SaraAgreed. The key will be maintaining scientific rigor while allowing for flexibility. If ICER can demonstrate that early engagement leads to better value assessments, it could become the new standard.

SaraA lot to think about today. I'll be watching how HCA's profit warning impacts Medicaid reimbursement policies and whether we see a ripple effect on specialty drug pricing.

MarcusSame — and for me the thread running through today is the growing disconnect between innovative treatments and system-wide sustainability. The HEOR community needs to bridge that gap with more pragmatic evidence strategies.

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.