HCA Warning, 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.

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 situation.

MarcusSame here. We're looking at HCA's profit warning and what it signals for US healthcare access — that's a big one for system sustainability. Then the subcutaneous Leqembi approval and its HEOR implications — that's a game-changer for Alzheimer's. And the FTC settlement with CVS Caremark over insulin pricing — that's a major enforcement move.

SaraThat second one is interesting to me — the HEOR implications of a subcutaneous formulation. We know the drug's efficacy, but the real question is how the route of administration changes the value proposition for payers.

MarcusExactly. And we'll also get into ICER's expansion of scientific advice services. Let's get into it.

MarcusHCA Healthcare issued a profit warning last week, citing lower patient volumes and higher costs, particularly for uninsured patients. This is significant because HCA is the largest for-profit hospital chain in the US, and their struggles could signal broader systemic pressures. We're seeing a pattern where hospitals are absorbing more uncompensated care, which is unsustainable.

SaraThat's true, but what I'm watching is the impact on access to care. When hospitals tighten their belts, they might reduce services in less profitable areas, which often affects vulnerable populations. The budget impact here is twofold: hospitals face financial strain, and patients face reduced access. It's a classic access dilemma.

MarcusExactly, and it connects to the broader conversation around the uninsured rate and how the safety net is fraying. HCA mentioned that the uninsured rate has ticked up, and they're seeing more patients who can't pay. This could lead to a vicious cycle where hospitals cut services, which then reduces access for those who need it most.

SaraWhat strikes me about this is the role of Medicaid expansion—or lack thereof—in states that haven't expanded. HCA operates in many non-expansion states, and that's a key driver of uncompensated care. The opportunity cost here is huge: resources being diverted to cover bad debt instead of investing in care.

MarcusThat's a fair point, though I think payers would see it differently because they're not directly bearing the uncompensated care costs. But for the system, it's a major issue. The part that gives me pause is how this might affect future hospital investments in innovation and technology. If they're losing money, they might not invest in the next generation of treatments.

SaraI wonder if that's the full picture though. HCA also mentioned that they're seeing more patients with complex needs, which require more resources. So it's not just about the uninsured; it's also about the acuity of patients. That's a trend we've seen post-pandemic, and it's putting pressure on the entire system.

MarcusThat connects to something I keep coming back to: the sustainability of the US healthcare system. If major players like HCA are struggling, it's a red flag. And for pharma, it means that value arguments need to be even sharper because hospitals are under more pressure than ever to justify every dollar spent.

SaraThe FDA approved subcutaneous Leqembi for Alzheimer's, which is a big deal because it's a more convenient administration route compared to the current IV formulation. From a payer perspective, this could change the value equation. The drug is already approved and reimbursed in many places, but the subcutaneous version might lower the burden on infusion centers and reduce costs associated with IV administration.

MarcusThat's one read — I'd frame it slightly differently. The convenience factor is important, but the real HEOR question is whether this leads to better adherence and, consequently, better outcomes. If patients are more likely to stick with treatment because it's easier to administer, that could improve the cost-effectiveness profile. The evidence so far doesn't show a significant difference in efficacy, but real-world data might tell a different story.

SaraThe part that gives me pause is the budget impact. Even if the drug price remains the same, the shift to subcutaneous could lower the overall cost of administration, which might make it more attractive to payers. However, we have to consider that some payers might view this as a minor reformulation and not a breakthrough, so the reimbursement landscape might not change dramatically.

MarcusWhat strikes me about this is the precedent it sets for other biologics. If Leqembi's subcutaneous version is successful, we might see more high-cost drugs moving to subcutaneous administration to improve convenience and reduce costs. That could have implications for how HEOR teams design their studies—maybe more focus on real-world adherence and comparative effectiveness.

SaraThat's fair, though I think payers would see it differently. They might be more concerned about the cost of the drug itself rather than the administration route. The opportunity cost here is high: every dollar spent on a high-cost Alzheimer's drug is a dollar not spent on other treatments. So the value proposition has to be rock-solid.

MarcusI wonder if that's the full picture though. The patient experience is a key part of value, and if a more convenient route improves quality of life, that should be captured in HEOR assessments. The challenge is how to quantify that in a way that payers recognize. Maybe we'll see more use of patient-reported outcomes in these submissions.

SaraHonestly, this one caught me off guard a bit. I expected the subcutaneous version to be a minor update, but the potential to change the treatment paradigm is significant. For HEOR teams, it's a chance to demonstrate the broader value beyond clinical endpoints.

MarcusThe FTC settled with CVS Caremark over insulin pricing allegations, accusing them of steering patients to more expensive insulin products while receiving rebates from manufacturers. This is a major enforcement action that highlights the opaque nature of pharmacy benefit manager (PBM) practices. The settlement includes $68 million in penalties and changes to how CVS handles insulin.

SaraThat's one read — I'd frame it slightly differently. The real issue here is the lack of transparency in the PBM rebate system. The settlement is a step forward, but it doesn't address the root cause of high insulin prices. For payers, this is frustrating because they're caught in the middle between manufacturers and PBMs, and the budget impact is enormous.

MarcusExactly, and it connects to the broader conversation around drug pricing reform. The IRA has already targeted insulin for Medicare, but this settlement shows that the private market is also problematic. The part that gives me pause is how this will affect future PBM practices. Will they change their behavior, or will they find new ways to steer patients?

SaraWhat strikes me about this is the precedent it sets for other high-cost drugs. If the FTC is going after insulin, they might look at other therapeutic areas where PBMs have significant influence. The opportunity cost here is huge: if PBMs are steering patients to more expensive drugs, that wastes resources that could be used elsewhere in the system.

MarcusThat connects to something I keep coming back to: the need for more transparency in drug pricing. Without it, it's impossible for payers to make informed decisions. For HEOR teams, this means they need to be even more vigilant about understanding the total cost of care, including rebates and administrative fees.

SaraI wonder if that's the full picture though. The settlement also includes provisions for CVS to provide more information to patients about insulin costs, which could empower them to make better choices. But for the system, the real win would be if this leads to more competition and lower prices.

MarcusThat's a fair point, though I think payers would see it differently because they're already dealing with the fallout of high prices. The HEOR implications here are about demonstrating the value of alternative treatments and the importance of fair pricing in value assessments.

SaraICER announced an expansion of its scientific advice services, offering more tailored support to companies early in the development process. This is significant because it could help developers design better trials and generate more payer-friendly evidence. For HEOR teams, this is a chance to engage with HTA bodies before finalizing their evidence strategies.

MarcusThat's one read — I'd frame it slightly differently. The expansion is a response to industry demand for earlier engagement, which is a positive step. But I'm curious about the implications for the quality of evidence. If companies are getting advice early, they might design trials that are more aligned with payer expectations, but there's a risk of bias if the advice is too prescriptive.

SaraThe part that gives me pause is the cost of these services. ICER's advice isn't cheap, and smaller companies might not be able to afford it. That could create a divide between well-resourced developers and those with fewer resources. The budget impact here is indirect but real: if only big players can access early advice, it could stifle innovation.

MarcusWhat strikes me about this is the potential for more alignment between industry and payers. If developers understand what payers need early on, they can generate evidence that is more likely to be accepted. That could reduce the risk of late-stage failures and improve the efficiency of the development process.

SaraThat's fair, though I think payers would see it differently. They might worry that early advice could lead to evidence that is too narrowly focused on what the payer wants, rather than the broader patient population. The opportunity cost here is the potential loss of generalizability in the evidence.

MarcusI wonder if that's the full picture though. ICER has emphasized that the advice is meant to be guidance, not a guarantee of coverage. So there's still room for developers to innovate. The HEOR takeaway is the importance of early evidence planning and the value of engaging with HTA bodies throughout the development lifecycle.

SaraHonestly, this one caught me off guard a bit. I expected ICER to expand its services, but the scale of this expansion is notable. For HEOR teams, it's a reminder that the landscape is evolving, and they need to be proactive in seeking out these opportunities.

SaraA lot to think about today. I'll be watching how the HCA situation plays out in other hospital systems and what that means for access to care.

MarcusSame — and for me the thread running through today is the theme of value: how we define it, measure it, and ensure it's sustainable in an increasingly strained system.

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.