Leqembi SubQ, HCA Access, FTC Insulin, ICER Advice

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, the HCA story this morning really made me pause about the real-world access pressures building.

MarcusSame here. We're looking at the FDA's subcutaneous Leqembi approval — what this means for reducing infusion burden in Alzheimer's care. Then HCA's profit warning and its implications for uncompensated care. The FTC's settlement with CVS Caremark over insulin pricing practices. And ICER's expansion of scientific advice to earlier development stages.

SaraThat second one is critical — the uninsured patient surge isn't just a financial hiccup; it's a structural access challenge with budget implications we haven't fully modeled yet.

MarcusExactly. Let's get into it.

MarcusStarting with the FDA approval of subcutaneous Leqembi for Alzheimer's. This is the first subcutaneous amyloid-targeting therapy, built on the same Phase 3 data as the IV version. The key here is reducing infusion burden — monthly subcutaneous doses versus biweekly IV infusions. That’s a meaningful patient and caregiver convenience shift.

SaraAbsolutely. And from a payer perspective, the absence of new clinical requirements for the subcutaneous formulation is significant. It avoids the evidence generation hurdle that often complicates reformulations. But I wonder about the cost-offset equation — will the reduced administration costs justify the drug's price?

MarcusThat’s where it gets nuanced. The IV version’s price was set before the Inflation Reduction Act negotiation window. Subcutaneous might face different value perceptions. What strikes me is how this could accelerate real-world evidence collection — fewer infusion sites mean more consistent dosing for RWE studies.

SaraThat’s fair, though I think payers would see it differently. The convenience benefit is clear, but without head-to-head cost-effectiveness data, budget impact could be uncertain. The part that gives me pause is whether the price premium for subQ will be sustainable given the IV version’s upcoming negotiation.

MarcusRight, and from the payer side, the opportunity cost argument holds. If resources are diverted to Alzheimer’s treatments, what gets deprioritized? That connects to why HCA’s warning matters — it’s not just one company’s issue.

SaraHCA’s profit warning is stark. They cite rising uncompensated care and higher uninsured treatment costs, directly linking it to the end of continuous Medicaid coverage during the pandemic. This isn’t just charity care; it’s bad debt and operational strain.

MarcusAnd it signals a broader access erosion. The number of uninsured patients increasing means more uncompensated care, which gets passed through to commercial payers via premium increases. I keep coming back to the HEOR implication: how do we model this in cost-effectiveness when the denominator of insured patients is shrinking?

SaraExactly. The budget impact here is immediate and systemic. When safety nets fray, commercial payers absorb the shock. That’s one of those stories where the macroeconomic reality collides with micro-access decisions. Honestly, this caught me off guard in its magnitude.

MarcusThe surprise factor is real. HCA’s scale means this isn’t an anomaly. It forces the question: will we see more health systems exiting markets or consolidating to absorb these costs? Either way, evidence strategies must account for this volatility.

SaraAnd from a value perspective, it challenges the assumption that innovation always bends the cost curve downward. If uncompensated care rises, the system’s ability to fund breakthroughs weakens. That’s a thread worth watching.

MarcusThe FTC settlement with CVS Caremark over insulin pricing is fascinating. $100 million penalty and formulary policy changes. The FTC alleged anti-competitive practices by favoring certain manufacturers, driving up consumer prices.

SaraThat’s one read — I’d frame it slightly differently. The settlement’s formulary mandate requires CVS to cover all insulin types equally, which could increase competition but also complexity. What strikes me is how this affects the insulin rebate system. If formulary access is decoupled from rebate incentives, will we see price erosion or just cost shifting?

MarcusThat’s the critical tension. The FTC’s focus on consumer prices ignores the rebate dynamics that dominate net pricing. Historically, these settlements haven’t moved the needle on list prices. The part that gives me pause is whether this signals a broader FTC crackdown on PBMs or just a targeted insulin move.

SaraI’d push back slightly on that. The insulin market’s unique characteristics—high volume, essential, limited competition—make this precedent-setting. If the FTC expands this to other drug classes, it could reconfigure formulary economics. But the methodology gap here is real: how do you measure anti-competitive behavior in opaque rebate systems?

MarcusExactly. And it connects to the IRA’s negotiation framework. If the FTC is stepping in on insulin, where does that leave drugs subject to IRA price setting? This is one of those stories where the lines between regulation and competition policy are blurring.

SaraICER’s expansion of scientific advice to Phase 1 and Phase 2 interventions is a strategic pivot. They’re now offering advice on early study design to align evidence with HTA requirements. This could de-risk development by generating HTA-friendly data sooner.

MarcusAbsolutely. For sponsors, it’s about avoiding late-stage surprises. What’s interesting is how this shifts the evidence generation timeline. Instead of waiting for Phase 3, you’re designing trials with HTA endpoints in mind from the start. That’s a fundamental change in R&D strategy.

SaraThat’s fair, though I think payers would see it as a double-edged sword. Early advice ensures relevance, but it also risks over-standardizing innovation. The methodological observation here is: can ICER’s advice truly capture the flexibility needed for breakthrough therapies without constraining them?

MarcusThat’s the tension. The opportunity cost angle is compelling—advising early could prevent Phase 3 failures that waste resources. But I wonder if this creates a de facto HTA gatekeeping. The part that gives me pause is how this interacts with FDA’s accelerated approval pathways. If ICER demands robust endpoints early, does that conflict with FDA’s need for surrogate endpoints?

SaraThat’s a key point. The evidence judgment era demands alignment, but the goals aren’t always congruent. For example, a drug might get FDA approval on a surrogate but fail ICER’s cost-effectiveness bar. This expansion could force earlier clarity on that disconnect.

SaraA lot to think about today. I’ll be watching how subcutaneous Leqembi’s access plays out in Medicare Advantage and commercial formularies — the infusion cost savings could tip the value equation.

MarcusSame — and for me the thread running through today is how regulatory and competitive policy shifts are forcing HEOR to evolve earlier in development. The evidence generation timeline is compressing.

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.