Article
Beyond the Threshold: Why the Right Real-World Evidence is Critical in the New Era of NICE Cost-Effectiveness Assessment
NICE’s evolving approach to cost-effectiveness thresholds has sparked significant debate. Some see it as a step forward for innovation. Others raise concerns about affordability and access. Both perspectives have merit. But amid the policy commentary, a quieter and more practical question is being overlooked:
If the bar is shifting, how do you make sure your evidence can clear it?
The threshold is only part of the story
Cost-effectiveness outcomes are highly sensitive to the inputs behind them. Small changes in assumptions, comparator data, long-term outcomes, and adherence rates can shift an ICER significantly. The threshold sets the target. Your evidence determines whether you hit it.
And yet, evidence strategy is often treated as secondary to price negotiation or outcomes data. That is a risk.
Not all Real-World Evidence (RWE) strengthens a cost-effectiveness case, and this is where many teams underestimate the challenge.
RWE can fill critical gaps that trial data cannot: long-term outcomes, real-world comparators, real-world treatment patterns, healthcare resource utilisation, and subgroup effectiveness. Used well, it strengthens the economic argument and reduces uncertainty.
Used poorly, it can do the opposite.
Poorly curated datasets, unaddressed bias, misaligned endpoints, or weak methodological justification can actively undermine a submission. NICE’s openness to RWE is increasing, but so too are its methodological expectations, as demonstrated by NICE’s RWE Framework.
The question is never