Access Erosion Signals & Leqembi Shift

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 the HCA warning. That's a bellwether moment.

MarcusExactly. We're looking at HCA's profit warning signaling access erosion — what that means for system sustainability. Then subcutaneous Leqembi approval reshaping Alzheimer's value narrative. Also the FTC-CVS insulin settlement exposing PBM practices. And ICER expanding early-phase scientific advice to de-risk development.

SaraThat second one about Leqembi is fascinating — the route administration shift will force entirely new comparative effectiveness analyses. The budget impact calculus changes fundamentally.

MarcusAbsolutely. Let's get into it.

MarcusHCA's profit warning is stark: they cite access challenges for high-cost drugs as a key factor. This isn't just margin pressure; it's a signal that hospitals are absorbing unsustainable costs from innovative therapies. The operational reality of coverage denials at institutional level is hitting bottom lines.

SaraI'd frame it slightly differently though — what strikes me is the system-wide friction point. When payers restrict coverage, hospitals get stuck with uncompensated care costs. That's the access erosion Marcus mentioned, but it's a transfer of financial burden, not just a reduction in utilization. The real question is who absorbs the risk when payers say no.

MarcusThat connects to something I keep coming back to — the hidden costs of restrictive formularies. HCA's experience shows that when payers create access barriers, the system doesn't save money; it shifts costs vertically. The irony is that the very payers enforcing restrictions may end up paying more downstream through uncompensated care subsidies.

SaraExactly, and what's striking here is the timing. This isn't a one-off margin call; it's a structural signal. If major hospital systems are flagging this, it means the current access mechanisms aren't working for high-cost innovations. The patient impact is real — delays in starting therapies, restricted access to new options. That's the human cost beneath the financials.

MarcusRight, and from the payer side, this creates a dilemma. How do you balance budget sustainability with timely patient access? The HCA warning suggests the current approach is creating perverse incentives that ultimately cost more. Maybe we're reaching a tipping point where the system needs new models for sharing innovation costs.

SaraThat's fair, though I think payers would see it differently — they'd argue the issue is misaligned incentives between payers, providers, and manufacturers. The settlement we'll discuss next actually illustrates that tension.

MarcusLet's move to Leqembi. The subcutaneous approval is transformative — no more infusions. But Marcus, what's the HEOR implication? This changes everything from comparative effectiveness to budget impact.

SaraThe part that gives me pause is the administration cost shift. Infusion centers were already struggling with capacity; now you're moving that burden to community settings. The real-world evidence needed to support this shift will be critical. How do you capture the time savings for patients versus the increased nursing time in primary care?

MarcusThat's one read — I'd frame it slightly differently. The core value proposition just shifted dramatically. We now have a drug with similar efficacy but vastly improved convenience. That changes the cost-effectiveness calculation entirely. The QALY gains might be modest, but the disutility reduction from avoiding infusions is substantial. This is one of those stories where the route administration becomes a dominant factor in value assessment.

SaraWhat strikes me about that is the precedent it sets. If we accept that subcutaneous administration alone can justify premium pricing, what does that mean for other biologics? The HTA bodies will need new frameworks for capturing convenience value. And the budget impact question — will this reduce overall system costs by freeing infusion center capacity, or increase them by expanding access to more patients? It's not straightforward.

MarcusExactly. And I wonder if that's the full picture though. The HEOR community has been underestimating the impact of treatment burden. This Leqembi shift forces us to quantify what we've known qualitatively — that how we deliver care matters as much as what we deliver. The evidence generation strategy now needs to capture patient-reported outcomes on treatment burden in a way we haven't done before.

SaraThat connects to the FTC settlement with CVS Caremark over insulin pricing. The key takeaway is that PBMs were using spread pricing to inflate insulin costs while claiming discounts. This isn't just about insulin; it's about transparency in the entire PBM value chain. The settlement exposes how middlemen can create artificial barriers to access.

MarcusI'd push back slightly on that — while the settlement is significant, it's a specific case. What's more telling is the precedent it sets for scrutinizing PBM practices. The FTC's action suggests they're viewing PBMs not just as service providers but as market participants whose pricing practices directly impact patient access. That's a fundamental shift in regulatory perspective.

SaraThat's one read — I'd frame it as exposing the hidden costs of opaque contracting. The settlement shows that what looks like a discount to payers might actually be a markup to patients. The budget impact here is counterintuitive: when PBMs negotiate lower net prices but keep the spread, the system pays more overall. That's the perverse incentive Marcus mentioned earlier, but in the PBM space.

MarcusRight, and what's interesting is how this intersects with value-based contracting. If PBMs are taking margins through spread pricing, that's money that could have been used for outcomes-based arrangements. The settlement might actually accelerate movement toward transparent, value-driven PBM models. The patient impact is clear — insulin affordability remains a crisis, but now we have regulatory momentum for systemic reform.

SaraExactly, and I keep coming back to the opportunity cost. Every dollar spent on PBM margins is a dollar not spent on innovative therapies or patient services. This settlement forces the question: what is the true value that PBMs bring? The answer, increasingly, seems to be less about access and more about extracting value from the system.

MarcusWhich brings us to ICER's expansion of early-phase scientific advice. They're now covering Phase II and Phase III trials, aiming to de-risk development. The core idea is getting HTA perspectives earlier to design better evidence generation. But Marcus, is this realistic? R&D timelines are compressed enough already.

SaraThe part that gives me pause is the operational feasibility. How do you integrate HTA perspectives into Phase II trial design when the primary endpoint is still being established? The risk is that HTA bodies over-constrain innovation by requiring endpoints that may not align with regulatory needs. The budget impact question here is about opportunity cost — time spent on HTA alignment is time not spent on enrollment.

MarcusThat's fair, though I think the industry would see it differently. The alternative is the current model where we spend billions on trials that ultimately don't satisfy HTA requirements. This isn't about constraining innovation; it's about de-risking it. If ICER can signal early what evidence will be valued, we avoid the late-stage failures that cost the system more. The patient benefit is getting effective therapies faster through smarter development.

SaraWhat strikes me about that is the methodological challenge. Early-phase data is inherently noisy. How do HTA bodies make meaningful value assessments when the evidence is preliminary? This could lead to premature judgments that don't hold up in Phase III. The real question is whether this will accelerate development or create new bottlenecks.

MarcusExactly, and I wonder if that's the full picture though. The real value here is in aligning incentives. When developers and HTA bodies collaborate early, they co-create evidence that satisfies both regulatory and value requirements. This isn't about adding steps; it's about replacing the adversarial late-stage negotiations with collaborative planning. The system sustainability benefit comes from avoiding costly pivots when therapies reach market access.

SaraThat's a compelling thread — all four stories today point to the same underlying issue: misaligned incentives creating friction in the access ecosystem. HCA shows the consequences of payer-provider misalignment, Leqembi highlights the need for new value frameworks for innovation, the FTC settlement exposes PBM opacity, and ICER's advice tries to align development with HTA needs. The common thread is system inefficiency.

MarcusSame — and for me the unifying observation is that we're reaching an inflection point where the current access mechanisms are no longer sustainable. Either we redesign the system to align incentives, or we'll see more HCA-style warnings, more Leqembi-style disruptions, and more regulatory interventions like the FTC settlement. The patient impact is too significant to ignore.

SaraA lot to think about today. I'll be watching how HCA's warning influences formulary decisions at other health systems — will this trigger a broader reassessment of high-cost drug coverage policies?

MarcusSame — and for me the thread running through today is the urgent need for transparency. Whether it's PBM pricing, development pathways, or hospital costs, opacity creates access barriers. 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.