Global HTA Shifts & Digital Health

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, particularly the WHO framework discussion.

MarcusSame here. We're looking at WHO's new health technology framework for low-income countries — addressing a critical gap in global evidence generation. Then Australia's TGA digital therapeutics guidance — signaling regulatory maturity for novel interventions. Canada's CADTH combination products pilot — exploring value assessment for complex therapies. And NICE's expanding global influence on HTA standards — reshaping international benchmarking.

SaraThat first one hits home for me — the budget impact question there is one the field hasn't fully worked out yet. How do you assess value when resources are fundamentally constrained?

MarcusExactly. Let's get into it.

MarcusStarting with the WHO framework. This is a significant move to standardize HTA processes in resource-limited settings. The focus is on pragmatic, context-specific evidence generation rather than replicating Western models. What's striking is the emphasis on local burden of disease data and implementation science.

SaraThat's one read — I'd frame it slightly differently though. The part that gives me pause is how this interacts with existing national HTA systems. Are we creating parallel frameworks that could fragment evidence generation? The opportunity cost of developing separate methodologies seems substantial.

MarcusThat connects to something I keep coming back to — the tension between global standardization and local adaptation. The WHO framework explicitly acknowledges this by allowing for context-specific adjustments. But I wonder if that flexibility creates interpretive challenges for manufacturers developing global evidence packages.

SaraWhat strikes me about that is the practical implications for HEOR teams. They'll need to develop modular evidence strategies that can be adapted across vastly different health systems. That's a resource-intensive shift from current approaches.

MarcusAbsolutely. And the WHO's inclusion of implementation costs in value assessments is particularly noteworthy. It moves beyond traditional cost-effectiveness to consider real-world feasibility. That could redefine how we think about value in these settings.

SaraRight, and from the payer side, this raises questions about cross-jurisdictional comparability. If each country applies different weights for implementation factors, how do manufacturers demonstrate consistent value? The methodological complexity here is substantial.

MarcusFair point. The framework does suggest core outcome domains to maintain comparability, but the devil will be in the application. Let's shift to Australia's TGA digital therapeutics guidance — which feels like a natural extension of this conversation.

SaraThe TGA's updated guidance is significant because it creates a clear regulatory pathway for software-based interventions. What I find particularly interesting is their approach to evidence generation — accepting real-world evidence alongside traditional endpoints for certain indications.

MarcusThat's a pragmatic evolution. The guidance emphasizes risk-proportionate evidence requirements, which aligns with the therapeutic value of these tools. But I wonder if this creates challenges for traditional HEOR frameworks that rely heavily on randomized controlled trials.

SaraI'd push back slightly on that. The TGA explicitly requires robust clinical validation, just with flexibility on study design. The key insight here is how digital endpoints are being integrated into HTA — that's the real paradigm shift. Patient-reported outcomes and real-world usage data are becoming primary endpoints.

MarcusThat's fair, though I think payers would see it differently. The budget impact question remains unresolved — how do you model the cost of a therapy that updates continuously? The traditional one-time assessment model breaks down here.

SaraExactly. And that's where Canada's CADTH combination products pilot becomes relevant. They're explicitly developing new methodologies for assessing combination therapies, which often include both drugs and digital components.

MarcusThe pilot's focus on multi-criteria decision analysis is smart. It allows for structured evaluation across different value dimensions beyond cost-effectiveness. But I'm curious about how they'll handle the evidence synthesis challenge — combining disparate data types into a coherent assessment.

SaraWhat strikes me about that is the transparency aspect. CADTH is explicitly involving patients and clinicians in defining value criteria for these complex products. That's a departure from traditional HTA processes and could set a precedent for patient-centric value assessment.

MarcusThat connects to our final topic — NICE's expanding global influence. Their methodologies are increasingly being adopted as reference standards internationally, even in jurisdictions with different healthcare systems.

SaraThe most notable development is how NICE's value assessment framework is being adapted by countries without explicit cost-effectiveness thresholds. They're using the structure while applying local value judgments. That creates both opportunities and challenges for global evidence strategies.

MarcusAbsolutely. The risk is that we end up with superficial adoption without addressing core contextual differences. But the opportunity is a more harmonized approach to value assessment. I keep coming back to how this affects R&D planning — manufacturers now need to consider global HTA implications from the earliest stages.

SaraThat's one of those stories where the practical implications are just starting to emerge. The question is whether this leads to genuine convergence or simply different applications of the same principles.

MarcusLet's wrap up. Sara, what are you watching next?

SaraI'll be tracking how the WHO framework implementation plays out in specific countries, particularly whether it creates new evidence-generation opportunities or just adds bureaucratic layers.

MarcusSame — and for me the thread running through today is the growing recognition that HTA must evolve beyond traditional models to accommodate complex interventions and resource-constrained settings. 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.