HCA Warning, Leqembi SubQ, 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, today's topics are hitting close to home for anyone tracking the US market access landscape.

MarcusSame here. We're looking at HCA's profit warning — what it signals for uncompensated care in the US healthcare system. Then the subcutaneous Leqembi approval — how this new formulation reshapes the Alzheimer's value story. And the FTC settlement with CVS Caremark — the real implications for insulin pricing and PBM practices.

SaraThat second one is particularly interesting — the shift to subcutaneous administration could change the entire cost-effectiveness equation for Alzheimer's drugs, especially considering the time savings.

MarcusExactly. And the FTC settlement is a big deal for transparency in pricing. Let's get into it.

MarcusHCA Healthcare's profit warning is a stark reminder of the access challenges in the US. They reported a 20% increase in bad debt and charity care in Q1 2026, citing rising uninsured rates. This isn't just a company-specific issue; it's a systemic one.

SaraThat 20% jump is significant. It suggests that even large hospital systems are struggling with uncompensated care, which often gets passed on to payers and patients in the form of higher prices elsewhere. The question is, how does this affect the broader access environment?

MarcusExactly. And it's not just about the uninsured. We're seeing more underinsured patients too. HCA operates 94 hospitals and 2,300 sites, so this is a bellwether for the entire system.

SaraI wonder if that's the full picture though. HCA's focus on profit margins might be shifting resources away from lower-margin services, exacerbating access issues in certain communities. That's a pattern we've seen before.

MarcusThat's a fair point, though I think payers would see it differently. They might argue that the underlying issue is the lack of a universal coverage system, which puts the burden on providers. But what's striking here is the scale — a 20% increase in a single quarter is unprecedented.

SaraRight, and from the payer side, this translates to higher costs for everyone. If hospitals are writing off more care, they have to charge more to commercial payers to cover those losses. It's a vicious cycle.

MarcusAnd it hits vulnerable populations hardest. The patient perspective here is critical — we can't ignore the human cost of this trend. But what's the market access takeaway?

SaraThe takeaway is that evidence generation for high-cost therapies must now account for this shifting landscape. If hospitals are struggling, how do you demonstrate value for drugs with high price tags? It's a tough equation.

MarcusThe FDA's approval of subcutaneous Leqembi is a game-changer for Alzheimer's treatment. Reducing infusion time from 2.5 hours to 5-10 minutes is not just a convenience; it's a fundamental shift in how we administer these drugs.

SaraAbsolutely. The time savings alone could improve patient adherence and quality of life. But from a HEOR perspective, the key is whether the clinical evidence holds up — and it does. The same Phase 3 trial (CLARITY AD) showed a 27% reduction in cognitive decline.

MarcusThat's right. The approval is based on the same data as the IV version, so the efficacy is identical. But the administration change could lower the cost burden on healthcare systems. Fewer resources per infusion, less time for patients and caregivers.

SaraI'd push back slightly on that last point. The cost savings might not be straightforward. Subcutaneous formulations often come with higher drug costs, and we don't have real-world data on how this will play out in terms of overall resource utilization.

MarcusThat's a fair read. What strikes me about this is the precedent it sets. If subcutaneous administration becomes the norm for high-cost biologics, it could reshape the entire cost-effectiveness model. We might see more focus on administration costs in HTA.

SaraExactly. And from the payer side, the question becomes: are the time savings enough to justify any potential increase in drug cost? This is where RWE will be crucial. We need to see how this performs outside the trial setting.

MarcusI keep coming back to the patient perspective here. For someone with Alzheimer's, a shorter infusion could mean the difference between getting treatment and not. That's not something you can always quantify in cost-effectiveness models.

MarcusThe FTC settlement with CVS Caremark is a landmark moment for insulin pricing. They're paying $100 million to settle allegations of anti-competitive practices, specifically inflating list prices to increase rebates, which ultimately raised patient costs.

SaraThat $100 million is significant, but the real win is the change in PBM practices. The FTC alleged that CVS inflated list prices to maximize rebates from manufacturers, then passed those costs to patients through higher co-pays. This settlement directly targets that model.

MarcusExactly. And it's not just about insulin. This could set a precedent for how PBMs handle high-cost drugs across the board. The transparency implications are huge — payers will be demanding more clarity on pricing structures.

SaraI wonder if that's the full picture though. While the settlement addresses past practices, it doesn't fundamentally change the rebate system. PBMs will still have incentives to negotiate rebates, and manufacturers will still have list prices. The problem might persist in a different form.

MarcusThat's a valid concern. What strikes me about this case is the focus on anti-competitive behavior. The FTC's action suggests they see PBM practices as a barrier to fair pricing, which is a shift in regulatory focus.

SaraFrom the payer side, the key takeaway is the need for more transparency. If PBMs are inflating list prices, it distorts the entire value proposition. This settlement could push for more pass-through rebates or other reforms.

MarcusAnd for patients, it's about affordability. Insulin is a life-saving drug, and the cost has been a major access issue. This settlement, while not a complete solution, is a step in the right direction.

MarcusICER's expansion of its early-phase scientific advice program is a smart move. Now including Phase 1b and Phase 2 trials, it aims to help companies design trials with HTA relevance in mind — endpoints, comparators, RWE strategies.

SaraThat's a significant shift. Traditionally, scientific advice has been focused on late-stage trials, but by moving earlier, ICER is trying to de-risk development. It could save companies from investing in trials that won't meet HTA requirements.

MarcusExactly. And it's not just about saving costs. It's about aligning innovation with value. If companies design trials with HTA in mind from the start, they're more likely to get timely access once the drug is approved.

SaraI'd frame it slightly differently. From the payer perspective, this is about ensuring that the evidence generated is fit for purpose. If companies get advice early, they might avoid the kind of late-stage surprises that lead to coverage denials.

MarcusThat's fair. What strikes me about this expansion is the proactive stance. ICER is essentially saying, "Let's work together to generate better evidence." It's a collaborative approach that could benefit everyone.

SaraAnd the focus on RWE strategies is particularly timely. As HTA bodies increasingly rely on real-world data, getting that right from the beginning is crucial. This program could help companies integrate RWE more effectively.

SaraA lot to think about today. I'll be watching how the HCA profit warning affects the broader access landscape, especially for high-cost therapies.

MarcusSame — and for me the thread running through today is the push for more transparency and value-based approaches, whether in pricing, trial design, or administration.

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.