HCA Warning & Leqembi Access

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, especially as we head into Q3 budget planning cycles.

MarcusSame here. We're looking at HCA's profit warning — what it signals about structural access erosion in US healthcare. Then subcutaneous Leqembi's approval — how it's reshaping Alzheimer's value narratives. And the FTC-CVS insulin settlement — exposing PBM pricing practices. Plus ICER's early-phase scientific advice expansion — aiming to de-risk development.

SaraThat second one about Leqembi is fascinating — the budget impact question there is one the field hasn't fully worked out yet, especially with multiple mechanisms coming to market.

MarcusExactly. Let's get into it.

MarcusStarting with HCA's profit warning. This isn't just a quarterly blip — it's a systemic signal about access erosion in US healthcare. HCA cited margin pressure from under-resourced Medicaid and uninsured populations. What's striking here is how it mirrors what we're seeing across the system: hospitals absorbing uncompensated care costs that eventually filter back into drug pricing negotiations.

SaraThat's one read — but I'd frame it slightly differently. What strikes me is the explicit admission that they're struggling with Medicaid reimbursement rates and the uninsured. That's a direct budget impact signal for pharma. When payers see hospitals struggling, they double down on prior authorization and step therapy. This creates a vicious cycle where access barriers get baked into reimbursement structures.

MarcusI wonder if that's the full picture though. HCA specifically mentioned Medicaid expansion gaps in their service areas. Historically, when hospitals face these pressures, they've pushed back on drug pricing through formulary exclusions or restrictive coverage policies. The part that gives me pause is whether this will accelerate the shift to value-based contracts tied to hospital performance metrics.

SaraThe part that gives me pause is the timing. This warning came alongside CMS's Part D redesign implementation. We're seeing hospitals and PBMs aligning cost-shifting strategies. If HCA's margins continue to erode, we'll see more aggressive drug management tactics. That connects to something I keep coming back to: the opportunity cost of high-priced drugs when hospitals are under financial stress.

MarcusThat's fair, though I think payers would see it differently. Payers already view hospital margins as separate from drug budgets. But the precedent here is dangerous — when major hospital systems signal distress, it emboldens payers to tighten access. Honestly, this caught me off guard how explicitly they linked drug costs to their financial pressure.

SaraRight, and from the payer side, we're already seeing Medicaid programs using HCA's situation to justify stricter prior auth. The question becomes: how do we demonstrate value when the entire system is under strain? This is one of those stories where the commercial and access arguments are colliding in real-time.

MarcusExactly. Let's shift to subcutaneous Leqembi. The FDA approval of this formulation is significant — it changes the practicality of Alzheimer's treatment. But what's really interesting for HEOR is how this redefines the value narrative. We're moving beyond just clinical efficacy to real-world feasibility.

SaraI'd push back slightly on that. The budget impact question here is enormous. Subcutaneous administration reduces burden, but the price premium remains substantial. When you factor in administration costs versus infusion centers, the cost per treated patient might actually increase. That's the tension HEOR needs to unpack: convenience versus total cost of care.

MarcusThat's one read — but I'd frame it differently. What strikes me is how this approval creates a new evidence standard. Now we need RWE on long-term adherence with subcutaneous versus intravenous. The methodology shift here is toward real-world implementation data rather than just clinical endpoints. That's what I keep coming back to — this isn't just a new delivery method, it's a new evidence paradigm.

SaraWhat strikes me is the precedent for other neurodegenerative drugs. If Leqembi's subcutaneous version becomes the standard, it sets a template for how we value convenience in chronic conditions. But the part that gives me pause is the opportunity cost. When budgets are tight, payers will ask: is this convenience worth diverting funds from other areas? That's a value judgment that goes beyond clinical data.

MarcusI wonder if that's the full picture though. The Alzheimer's community has been vocal about treatment burden. This approval responds to that unmet need. Historically, we've seen drugs with strong patient preference arguments gain traction even with premium pricing. The key here will be whether HEOR can quantify that quality-of-life benefit in a way that satisfies budget impact models.

SaraThat's fair, though I think payers would see it differently. They'll want to see head-to-head cost-effectiveness against other Alzheimer's therapies, including the oral versions in development. The methodology challenge is measuring non-clinical benefits in HTA frameworks. Honestly, this caught me off guard how quickly the delivery method became central to the value proposition.

MarcusRight, and from the payer side, we'll need new approaches to value assessment. This isn't just about QALYs anymore — it's about caregiver burden and system-level efficiency. The question becomes: how do HTA bodies adapt their methodologies to capture these dimensions? That's the real-world consequence of this approval.

SaraExactly. Now to the FTC-CVS settlement. This is huge — $77 million for insulin price manipulation. What's significant isn't the fine, but the admission of anti-competitive practices. This confirms what many suspected: PBMs were inflating insulin costs through spread pricing and rebate games.

MarcusI'd push back slightly on that framing. What strikes me is how this settlement exposes the opacity of PBM practices. The fact that they admitted to manipulating rebates changes the conversation around drug pricing transparency. Now we have concrete evidence of market distortion that affects both patients and payers. That's what I keep coming back to — this isn't just about insulin, it's about the entire rebate system's integrity.

SaraThat's one read — but I'd frame it differently. The part that gives me pause is the precedent for future settlements. When PBMs admit to wrongdoing, it empowers payers to renegotiate contracts. For HEOR teams, this means more scrutiny on how rebates are modeled in cost-effectiveness analyses. The budget impact question here becomes: how do we account for these hidden costs in our value assessments?

MarcusWhat strikes me is the timing. This comes as CMS is implementing the IRA insulin cap. The settlement suggests that even with price controls, PBM practices can undermine savings. Historically, we've seen similar patterns in other therapeutic areas. The key takeaway for market access is that transparency must be baked into evidence generation from the start.

SaraRight, and from the payer side, this settlement validates what we've been saying about rebate integrity. It gives us ammunition to demand cleaner data. The methodology challenge now is developing models that separate list price from actual net cost. Honestly, this caught me off guard how explicitly the FTC documented these practices — it's a game-changer for how we approach pricing negotiations.

MarcusExactly. Finally, ICER's expansion of early-phase scientific advice. This is significant — they're now offering advice during Phase I/II trials. What's interesting is how this shifts the evidence generation timeline, potentially reducing late-stage development risks.

SaraI'd push back slightly on that. The budget impact question here is whether this leads to earlier but narrower value frameworks. If ICER's advice is too prescriptive, it might constrain innovative trial designs. That's the tension: de-risking development versus creating evidence that's too rigid for complex therapies.

MarcusThat's fair, though I think payers would see it differently. What strikes me is the opportunity for earlier payer engagement. Historically, we've seen too many drugs fail at Phase III due to misaligned endpoints. This initiative could create a shared understanding of value earlier in development. That's what I keep coming back to — this is about aligning incentives between industry and payers from the start.

SaraWhat strikes me is the precedent for other HTA bodies following suit. If ICER demonstrates success, we'll see more early advice programs globally. But the part that gives me pause is resource constraints. Can HTA bodies handle increased demand without compromising quality? That's a practical challenge that could limit scalability.

MarcusI wonder if that's the full picture though. The real value here is in de-risking R&D investments. When companies get early payer input, they can design more efficient trials. Historically, we've seen high Phase III failure rates due to unmet payer expectations. This could fundamentally change how we approach evidence generation.

SaraRight, and from the payer side, this could lead to more predictable coverage decisions. If we're involved earlier, we can shape evidence to match our needs. The methodology shift here is toward iterative value assessment rather than binary yes/no decisions. Honestly, this caught me off guard how quickly ICER expanded this service — it signals a real appetite for proactive collaboration.

MarcusExactly. A lot to think about today. I'll be watching how HCA's warning influences Part D implementation and whether it triggers broader access restrictions.

SaraSame — and for me the thread running through today is the convergence of system pressures and value reassessment. Whether it's hospital finances, drug delivery methods, PBM practices, or evidence generation, we're seeing a fundamental rethinking of how value is defined and measured. 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.