Elections, AI, and Value Pricing

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 election angle.

MarcusSame here. We're looking at the 2024 US elections' potential impact on drug pricing policy — why the regulatory landscape could shift dramatically. Then AI's accelerating role in generating real-world evidence for HTA submissions — what this means for evidence generation timelines. Plus, the persistent challenges of value-based pricing in oncology — why this space remains so complex. And finally, how patient-centricity is evolving in HTA frameworks — the next frontier in value assessments.

SaraThat second one is particularly interesting — the budget impact question around AI-generated evidence hasn't been fully mapped yet, especially regarding validation costs.

MarcusExactly. Let's get into it.

MarcusStarting with the US elections — regardless of outcome, we're likely to see significant policy shifts. Both parties have signaled interest in drug pricing reform, though their approaches differ. The real question is how quickly these changes would materialize and what mechanisms might be prioritized.

SaraThat's one read — I'd frame it slightly differently though. What strikes me is how much depends on congressional composition and legislative capacity. We've seen ambitious pricing proposals stall before, even with unified control. The part that gives me pause is the implementation timeline uncertainty.

MarcusFair point. The industry should prepare for potential changes in Medicare Part D negotiations and inflation rebates. But I wonder if that's the full picture though — the political pressure for immediate savings might force accelerated timelines regardless of party control.

SaraThat's true, though I think payers would see it differently. They're already budgeting for potential price adjustments. The bigger issue might be how any new policies interact with existing IRA provisions — that's where the real complexity lies.

MarcusRight, and from the payer side, the opportunity cost implications could be substantial. Any pricing changes would need to be balanced against other therapeutic areas. This is one of those stories where the rhetoric often exceeds the policy reality.

SaraExactly. The system sustainability angle is crucial here. Budget pressures aren't going away, so whatever emerges will be tested against that reality.

SaraShifting to AI in HTA evidence generation — we're seeing tools accelerating data synthesis and analysis. But the validation question remains critical. How do we ensure these outputs meet HTA methodological standards?

MarcusThat's fair, though I think the field is moving faster than many acknowledge. The efficiency gains in processing complex datasets are undeniable. What's striking here is how AI can handle real-world data at scales humans simply can't match.

SaraI'd push back slightly on that. The part that gives me pause is the black-box nature of some algorithms. HTA bodies require transparency, and many AI models don't provide that. The budget impact question around validation costs is significant too.

MarcusThat's a valid concern — but what if we're underestimating the potential? These tools could actually make evidence generation more accessible, especially for smaller companies. The methodological rigor is evolving alongside the technology.

SaraBut the precedent matters. We've seen HTA bodies reject novel evidence approaches before. The key will be demonstrating that AI outputs don't compromise the robustness of assessments.

MarcusExactly. And that connects to something I keep coming back to — the potential for AI to democratize evidence generation. The real opportunity isn't just speed, but enabling more comprehensive value assessments.

SaraThat's true, though I remain skeptical about the resource implications. Implementing these systems isn't trivial, and the learning curve is steep. The system sustainability angle can't be ignored.

MarcusNow to value-based pricing in oncology — the complexity here is unique. Oncology drugs face the dual challenges of high unmet need and extremely high development costs. Traditional pricing models simply don't capture the full picture.

SaraThat's one perspective — I'd frame it as a misalignment between payment structures and value. The budget impact question in oncology is particularly acute because of the sheer volume of new approvals and high prices.

MarcusI wonder if that's the full picture though. The real issue might be the lack of standardized outcome measures across tumor types. How do you compare value between a targeted therapy and an immunotherapy?

SaraThat's fair, though I think payers would see it differently. They're increasingly demanding real-world evidence to confirm trial results. The opportunity cost implications are enormous when you're making coverage decisions for multiple high-cost oncology drugs.

MarcusRight, and from the R&D side, the innovation argument remains compelling. But the sustainability question can't be ignored either. We need models that reward innovation while managing system costs.

SaraThis is one of those stories where the patient perspective is critical. We can't lose sight of the fact that these treatments represent real hope for patients with limited options.

MarcusExactly. The tension between innovation access and system sustainability is particularly acute in oncology. That's why new payment models are emerging, but they're still in early stages.

SaraFinally, patient-centricity in HTA — we're seeing a clear shift toward incorporating patient-reported outcomes and preferences. But how deep does this go? Are we truly changing the assessment frameworks?

MarcusThat's a fair question. The evolution is undeniable — HTA bodies are increasingly giving weight to patient experience data. What's interesting is how this intersects with value-based pricing models.

SaraI'd push back slightly on that. The part that gives me pause is whether we're just adding patient data as another variable rather than fundamentally rethinking value assessments. The budget impact question remains central.

MarcusThat's one read — but I'd argue we're seeing genuine transformation. The methodology is adapting to capture what matters most to patients. This isn't just about adding data points; it's about redefining value.

SaraBut the precedent matters. HTA bodies have historically prioritized clinical outcomes. Changing that requires cultural shifts as much as methodological ones.

MarcusExactly. And that connects to the broader trend toward patient involvement in decision-making. The real opportunity is creating assessments that reflect patient priorities, not just clinical endpoints.

SaraThat's true, though I remain concerned about implementation challenges. Captating patient preferences reliably is methodologically complex. The system needs to balance these new considerations with traditional evidence requirements.

MarcusThis is one of those stories where the patient perspective isn't just an add-on — it's becoming central to how we define value in healthcare.

SaraA lot to think about today. I'll be watching how the US election results translate into actual policy changes — that will set the tone for pricing discussions globally.

MarcusSame — and for me the thread running through today is the tension between innovation and sustainability. Whether it's AI in evidence generation, value-based pricing, or patient-centricity, we're grappling with how to reward innovation while managing system costs.

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.