Market Access Headlines: HCA, Leqembi, Insulin, ICER

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 with the HCA news.

MarcusSame here. We're looking at HCA's profit warning and what it signals for US healthcare access. Then the subcutaneous Leqembi approval and its HEOR implications. And the FTC settlement with CVS Caremark over insulin pricing. Plus, ICER's expansion of early-phase scientific advice.

SaraThat insulin settlement is interesting to me — the competitive dynamics there could have ripple effects across the entire insulin market.

MarcusExactly. Let's get into it.

MarcusSo HCA, one of the largest hospital operators in the US, just issued a profit warning. They're citing increased labor costs and, more critically, rising uncompensated care. This is a significant signal because it suggests that the safety net for uninsured and underinsured patients is fraying. From an access perspective, we're seeing the real-world impact of coverage gaps and affordability challenges.

SaraThat's one read — but I'd frame it slightly differently. The profit warning is also a symptom of broader system strain. When hospitals face financial pressure, they may reduce services or shift costs elsewhere, which ultimately affects patient access to care. It's not just about uncompensated care; it's about the sustainability of the entire system.

MarcusThat connects to something I keep coming back to: the downstream effects on market access. If hospitals are struggling, they might be less likely to adopt new technologies or therapies, especially those with high upfront costs. This could create a de facto barrier to entry for innovative drugs, regardless of their value.

SaraWhat strikes me about that is the timing. We're seeing this now as the US healthcare system navigates post-pandemic recovery and inflationary pressures. It's a perfect storm that could exacerbate existing disparities in access.

MarcusExactly. And from the patient perspective, this is where the rubber meets the road. If hospitals are cutting back, patients in rural or underserved areas are hit hardest. It's a reminder that access isn't just about reimbursement; it's about the entire care ecosystem.

SaraThat's fair, though I think payers would see it as a system-wide issue that requires policy solutions, not just drug pricing adjustments. The budget impact here is enormous.

MarcusI agree. The HCA warning is a canary in the coal mine for US healthcare access. We'll be watching how this plays out.

MarcusThe FDA approved a subcutaneous formulation of Leqembi for Alzheimer's disease. This is a big deal because the current intravenous administration is a significant barrier to treatment. Now, with a subcutaneous option, we're likely to see broader uptake. From an HEOR perspective, this shifts the evidence generation focus. We'll need real-world data on adherence, patient-reported outcomes, and comparative effectiveness in a more diverse population.

SaraThat's one read — I'd push back slightly on the evidence generation part. The core challenge for Leqembi has always been the risk-benefit profile, particularly ARIA. A subcutaneous formulation might reduce the burden of administration, but it doesn't change the underlying safety concerns. Payers will still be looking for robust evidence on long-term outcomes and cost-effectiveness.

MarcusThat's fair. But the route of administration does impact patient quality of life and caregiver burden, which are critical in value assessments. The HEOR community will need to capture that. Also, the approval might open up treatment to patients who couldn't tolerate IV infusions, which could expand the eligible population.

SaraWhat strikes me about that is the potential for real-world evidence to fill gaps. We'll need post-marketing studies to track ARIA rates in the subcutaneous cohort and see if the safety profile holds. The budget impact could be substantial if uptake increases significantly.

MarcusExactly. And from an innovation perspective, this is a win for patient-centric drug development. The subcutaneous formulation was developed specifically to address a key barrier. It's a model for how to improve access without compromising on evidence.

SaraI'll be watching how payers respond. Will they require additional evidence, or will they see this as a straightforward improvement? The precedent here could shape future Alzheimer's treatments.

MarcusIt's one to watch. The Leqembi subcutaneous approval could be a turning point for Alzheimer's disease management.

MarcusThe FTC settled with CVS Caremark over insulin pricing allegations. The core issue was that CVS allegedly steered patients toward more expensive insulin products, costing them millions. This settlement is significant because it targets the pharmacy benefit manager (PBM) role in drug pricing. From a market access perspective, it highlights the opaque nature of the US insulin market and the need for transparency.

SaraThat's one read — but I'd frame it slightly differently. The real story here is about competition. The FTC's action is part of a broader push to increase competition in the insulin market, which has been dominated by a few players. If PBMs are steering patients away from lower-cost options, it distorts the market and undermines value-based purchasing.

MarcusThat connects to something I keep coming back to: the role of intermediaries in pricing. PBMs have significant leverage, and their practices can create barriers to access for biosimilars and lower-cost alternatives. This settlement could set a precedent for how the FTC approaches PBM behavior in other therapeutic areas.

SaraWhat strikes me about that is the potential for ripple effects. If PBMs are forced to change their practices, it could open the door for more biosimilar uptake and lower prices for patients. But the budget impact on health plans is unclear — they might just shift costs elsewhere.

MarcusExactly. And from the patient perspective, this is about affordability. Insulin is a lifeline, and the high cost has been a crisis. The FTC's action is a step toward restoring competition and putting patients first.

SaraThat's fair, though I think the industry would argue that PBMs play a necessary role in managing formularies and rebates. The challenge is balancing that with fair competition. We'll see if this settlement leads to meaningful change.

MarcusThe FTC settlement with CVS Caremark is a clear signal that the era of unchecked PBM power may be ending. It's a win for market access.

MarcusICER announced an expansion of its early-phase scientific advice program. They're now offering advice even earlier in development, for preclinical and Phase I assets. This is a significant shift because it allows companies to get value assessment input before investing heavily in trials. From an HEOR perspective, this could lead to more efficient evidence generation and earlier alignment with payers.

SaraThat's one read — I'd push back slightly on the efficiency claim. Early advice is valuable, but it also creates uncertainty. Payers might have different expectations at this stage, and companies could face moving targets. The budget impact for HEOR teams is also a consideration — more early advice means more resources dedicated to pre-submission work.

MarcusThat's fair. But the alternative is companies developing evidence in a vacuum, which often leads to misaligned submissions. ICER's expansion could reduce that risk. It's about de-risking innovation and ensuring that the evidence generated is fit for purpose.

SaraWhat strikes me about that is the timing. With the rise of complex therapies like gene and cell therapies, early engagement is critical. But ICER's advice isn't binding, so companies must still navigate multiple HTA bodies. The question is whether this early advice will translate into faster access or just more upfront costs.

MarcusExactly. And from an innovation perspective, this is a positive step. It shows that HTA bodies are adapting to the needs of developers. The key will be whether payers act on this advice and adjust their expectations accordingly.

SaraI'll be watching how companies respond. Will they use this advice to shape their development programs, or will they see it as just another hurdle? The precedent here could shape the future of early HEOR engagement.

MarcusICER's expansion is a recognition that value assessment must start earlier. It could be a game-changer for evidence strategy.

SaraA lot to think about today. I'll be watching how the HCA profit warning impacts hospital adoption of new therapies, especially in underserved areas.

MarcusSame — and for me the thread running through today is the push for greater transparency and competition in drug pricing, from insulin to Alzheimer's treatments. 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.