HCA Warning, Leqembi SC, FTC CVS, 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, I've had today's topics circled since this morning, especially the HCA profit warning.

MarcusSame here. We're looking at HCA's profit warning signaling broader access erosion in the US healthcare system; then the subcutaneous Leqembi approval and what it means for HEOR evidence generation; and the FTC settlement with CVS Caremark over insulin pricing.

SaraThat second one is interesting to me — the budget impact of a new administration route for a high-cost therapy is something the field hasn't fully worked out yet, especially with adherence implications.

MarcusExactly. Let's get into it.

MarcusHCA Healthcare, one of the largest hospital operators in the US, just issued a profit warning. They're citing increased uncompensated care and higher costs for treating uninsured and underinsured patients. This isn't just about HCA; it's a signal that access challenges are deepening in the US system, particularly for vulnerable populations.

SaraThat's a critical point. Uncompensated care has been rising, but when a major player like HCA issues a profit warning, it suggests the current reimbursement structures aren't sustainable. From a payer perspective, this highlights the tension between covering innovative therapies and managing the overall cost of care for uninsured patients.

MarcusAbsolutely. And what's striking here is that this is happening against a backdrop of high drug prices and increasing financial pressure on hospitals. It raises questions about how payers will balance the need for innovation with system-wide sustainability. The patient perspective is crucial too — we're seeing real-world consequences when access breaks down.

SaraI'd push back slightly on that — the part that gives me pause is whether this is a temporary blip or a structural shift. Historically, uncompensated care has been cyclical, but with factors like Medicaid redeterminations and ongoing inflation, this might be a new normal. Payers will need to reassess risk adjustment mechanisms and potentially collaborate more with providers on shared savings models.

MarcusThat's fair, though I think payers would see this as a systemic issue requiring multi-stakeholder solutions. The R&D investment argument for high prices is valid, but when it leads to hospital closures in underserved areas, the entire system suffers. HEOR teams must now incorporate these macroeconomic pressures into their value assessments.

SaraExactly, and what's interesting is how this might influence future HTA submissions. If hospitals are struggling, payers might demand stronger evidence on how a drug reduces overall system costs, not just clinical benefits. That could mean more emphasis on real-world evidence showing reduced hospitalizations or emergency department visits.

MarcusThat connects to something I keep coming back to: the growing importance of budget impact modeling at the population level. We're moving beyond per-patient costs to understanding how a therapy affects the entire healthcare ecosystem. For Alzheimer's drugs, for example, the savings from reduced caregiver burden and institutionalization could be key.

SaraRight, and from the payer side, that's where the real value lies. But generating that evidence is challenging, especially for therapies with long-term effects. I wonder if that's the full picture though — HCA's warning also points to broader issues like provider consolidation and pricing power, which HEOR doesn't typically address.

MarcusThat's a valid point. HEOR often focuses on the drug itself, but the context of delivery systems is becoming increasingly important. We may need to develop new methodologies that account for the entire care continuum. This story caught me off guard because it reminds us that market access isn't just about the pill — it's about the system that delivers it.

MarcusShifting gears, the FDA approved subcutaneous administration of Leqembi for Alzheimer's disease. This is a significant development because the current intravenous infusion is burdensome for patients and caregivers. The new route could improve adherence and quality of life, but it also changes the evidence landscape.

SaraAnd that's where the payer instinct kicks in. While the convenience is clear, we need to see real-world evidence on whether subcutaneous administration actually leads to better adherence and outcomes. Without that, budget impact models could be overly optimistic, especially given Leqembi's high price point.

MarcusExactly. The challenge is that the pivotal trial for the subcutaneous formulation likely used surrogate endpoints like amyloid plaque reduction. What payers will want is evidence on clinical outcomes — slowing cognitive decline, reducing caregiver burden — and comparative effectiveness against the IV version. The patient perspective is strong here: less time in infusion centers means more time living life.

SaraThat's one read — I'd frame it slightly differently. The part that gives me pause is the potential for increased utilization. If subcutaneous is easier to administer, we might see more patients starting and staying on therapy, which could dramatically increase the budget impact. Payers will need to see robust data on adherence rates and long-term outcomes to justify the cost.

MarcusThat's fair, and it ties into a broader trend in HEOR: the need for real-world evidence to complement clinical trial data. For Alzheimer's drugs, the evidence generation is particularly challenging because outcomes manifest over years. HEOR teams will need to design studies that track adherence and functional outcomes in real-world settings.

SaraAnd what strikes me about that is the methodological complexity. How do you isolate the effect of the administration route from other factors? We might need to leverage electronic health records and patient-reported outcomes to build a comprehensive picture. Also, the cost of the drug itself versus the cost of administration — subcutaneous might reduce infusion costs but could increase drug costs if higher doses are needed.

MarcusThat's a critical point. The value proposition isn't just about the molecule but the entire delivery system. For companies, this means developing HEOR strategies that account for the total cost of care. For payers, it means looking beyond the list price to understand the real-world value. This is one of those stories where innovation in delivery could reshape value assessments.

SaraAbsolutely. And I'll be watching how payers incorporate this into their formularies. Will they require additional evidence for the subcutaneous version? How will they handle the transition from IV to SC? These questions will set precedents for other high-cost therapies with multiple administration routes.

MarcusSame here — the thread is about evidence generation for reformulations. It's not just about the drug but how it's delivered. That will be a key focus for HEOR teams in the coming years.

MarcusNow, the FTC settled with CVS Caremark over insulin pricing allegations. The settlement includes $64.5 million in consumer redress and changes to formulary practices. The core issue was spread pricing and steering patients to higher-cost insulin products. This has significant implications for how PBMs operate and how insulin is priced.

SaraThis is a big deal for the market access community. Spread pricing — where PBMs keep the difference between what they pay for a drug and what they charge the plan — has been a long-standing concern. The settlement forces PBMs to be more transparent and could lead to lower insulin costs for patients. But from a payer perspective, it also raises questions about the sustainability of PBM business models.

MarcusAbsolutely. And what's striking here is that this settlement comes amid broader scrutiny of PBM practices. For HEOR teams, it signals a shift in how value is assessed. If PBMs are steering patients to higher-cost options, that undermines the evidence-based formulary decisions that HEOR is supposed to support. The patient perspective is clear: insulin affordability is a matter of life and death.

SaraThat's one read — I'd frame it slightly differently. The part that gives me pause is whether this settlement will actually lead to meaningful change or just a reshuffling of incentives. Historically, PBM settlements have been followed by new tactics. Payers will need to monitor formulary practices closely and demand more transparency in rebate structures.

MarcusThat's fair, and it connects to a larger trend: the push for value-based pricing in insulin. With biosimilars and biosimilar competition entering the market, HEOR evidence on comparative effectiveness and cost-effectiveness will be more important than ever. This settlement could accelerate that shift.

SaraAnd what strikes me about that is the opportunity for HEOR to step in. If PBMs are no longer able to use spread pricing, payers might rely more on HEOR to evaluate the true value of insulin products. That means generating robust evidence on outcomes like hypoglycemic events and quality of life, not just list price.

MarcusExactly. This story caught me off guard because it shows how regulatory actions can reshape the evidence landscape. For companies, it means developing stronger HEOR arguments that go beyond price to demonstrate real-world value. For payers, it means rethinking how they work with PBMs to ensure patient access.

SaraRight. And I'll be watching how this affects insulin pricing negotiations. If spread pricing is curtailed, we might see more direct manufacturer-payer deals, which could change the dynamics of value demonstration. That's a significant shift for the industry.

MarcusSame here — the thread is about transparency in the supply chain. HEOR will need to adapt to a more open marketplace where evidence, not hidden fees, drives decisions.

MarcusFinally, ICER announced an expansion of its early-phase scientific advice program. They're now offering advice at Phase I/II for therapies in rare diseases and neurodegenerative conditions. The goal is to de-risk development by aligning evidence generation with HTA requirements early on.

SaraThis is a smart move by ICER. For rare diseases, where patient populations are small, generating robust evidence is challenging. Early advice can help companies design trials that meet both regulatory and HTA standards, potentially reducing the risk of negative reimbursement decisions later. From a payer perspective, it could mean more efficient use of resources.

MarcusAbsolutely. And what's striking here is that this expansion comes as more companies are pursuing ultra-orphan therapies. The R&D investment argument is strong, but without early alignment, companies might invest in trials that don't satisfy payer needs. The patient perspective is critical: faster access to effective therapies depends on efficient development.

SaraThat's one read — I'd frame it slightly differently. The part that gives me pause is whether early advice will actually lead to better value assessments or just more homogenized evidence. Payers might worry that companies will tailor trials specifically to ICER's criteria, potentially missing other important outcomes. There's a risk of over-reliance on a single HTA body's perspective.

MarcusThat's a valid concern. HEOR teams must balance early alignment with the need for flexible, patient-centered evidence. This program could set a precedent for other HTA bodies to follow, creating a more global approach to early development. But it also raises questions about the standardization of value assessments.

SaraAnd what strikes me about that is the potential for innovation in trial design. If companies get early advice, they might use adaptive designs or basket trials that generate evidence for multiple stakeholders. That could be a win for everyone, but it requires a shift in how HEOR is approached — more collaborative and less siloed.

MarcusExactly. This is one of those stories where proactive engagement could reshape the development pathway. For HEOR teams, it means being involved earlier and thinking about the entire value proposition. For payers, it means a more evidence-based approach to coverage decisions.

SaraRight. And I'll be watching how this affects the timing of HTA submissions. If companies get advice early, we might see more submissions aligned with launch, reducing delays. That's a significant improvement for patient access.

MarcusSame here — the thread is about de-risking development through early evidence generation. It could become a best practice in the industry.

SaraA lot to think about today. I'll be watching how the HCA profit warning influences payer strategies for high-cost therapies, especially as it relates to overall system costs.

MarcusSame — and for me the thread running through today is the evolving role of HEOR in addressing systemic challenges, from delivery methods to PBM practices to early development alignment.

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.