This update presents updates of the NICE health technology evaluations manual (PMG36). Key points include broad engagement with patient groups, industry, and academic experts. The focus is on proposed methods for incorporating patient perspectives, addressing health inequalities, and refining economic evaluation approaches in health technology assessments.

Key Takeaways from the Consultation

• The consultation feedback highlights the importance of systematically including patient and carer perspectives throughout the evaluation process. It recognizes that patient-reported outcomes and lived experiences can differ significantly from generic clinical trial measures.
• There is strong support for NICE’s moves to incorporate quantitative evidence on health inequalities into appraisal processes. This includes methods such as Distributional Cost-Effectiveness Analysis (DCEA). Stakeholders urged clarity on methodology and timelines to prevent unnecessary delays in patient access to new technologies.
• Industry and patient organizations call for more transparency and flexibility in the application of severity modifiers. They also request accelerated research on societal preferences. Concerns are raised about the interplay between uncertainty in evidence and cost-effectiveness thresholds.

Broader Context of Patient Engagement

• NICE values patient engagement and real-world data in health technology evaluations. This ensures that technologies reflect societal values and needs. It aligns with NICE’s increased focus on patient and carer input.
• Distributional Cost-Effectiveness Analysis is gaining recognition globally as a best practice for quantifying the impact of technologies on health inequalities.
• Addressing health inequalities within appraisal frameworks stresses equitable access to innovative treatments as a hallmark of robust healthcare systems.

Implications for Market Access and Reimbursement Policies

• By embedding patient experiences and quantitative health inequality assessments in its methods, NICE is setting a precedent for more holistic value assessments. This may increase confidence among payers and manufacturers. However, it could also lengthen evaluation timelines if not managed carefully.
• Greater transparency and flexibility in severity modifiers and cost-effectiveness thresholds could expand market access for some medicines. This is especially true in areas of unmet need. However, budget impact and opportunity costs remain key considerations for NHS resource allocation.
• These evolving approaches may influence health economics and outcomes research (HEOR) strategies. Companies may need to generate broader evidence packages—covering patient, societal, and inequality impacts—to secure favorable decisions on pricing and reimbursement.

In conclusion, the consultation responses and NICE’s engagement reflect a shift toward more inclusive, equitable, and transparent NICE health technology evaluations. This has significant implications for how value is defined, measured, and rewarded in the UK healthcare system. For further insights, you can explore more about these updates here.