A small company developing a cardiovascular product had a growing evidence base, including two randomized controlled trials (RCTs), one propensity-score matched cohort study, and several before-and-after studies.
However, the evidence was mixed in a way that created uncertainty for market access planning:
- The RCTs showed impact on surrogate endpoints only.
- The matched cohort study demonstrated a statistically significant improvement in a clinically meaningful outcome.
The client wanted to engage with NICE in the UK and begin discussions with hospital and payer stakeholders across Europe. Although a full HTA submission was not immediately planned, the company needed an early view of:
- Whether the product could plausibly be cost-effective in the UK
- Which parameters were driving value (and therefore where to focus evidence generation)
- Whether a future, publishable model could support global market access efforts
Within 1.5 months, MTRC developed a robust early health economic model to estimate the product’s cost-effectiveness from the UK payer perspective over a 10-year time horizon, using a Markov modelling approach.
To keep the work fast and affordable while still decision-useful, the “early model” was intentionally streamlined compared with a full HTA-grade model:
- A targeted (rapid) search was used to identify clinical, epidemiological, utility, and cost inputs
- The model included scenario exploration around alternative effectiveness assumptions
- Formal, comprehensive sensitivity analysis was limited, though we conducted rapid sensitivity/scenario testing on key drivers
This approach allowed the client to obtain an early directional answer while preserving a clear path to developing a future, defensible model suitable for HTA scrutiny and publication.
Using the initial inputs available at the time, the early model suggested the product was not cost-effective under base-case assumptions.
However, scenario and rapid sensitivity testing indicated the product could become cost-effective under certain conditions, particularly when assessed against NICE’s updated threshold of £35,000 per QALY, with changes in key drivers such as:
- Cost of regular care
- Health-related quality of life in the post-treatment state
The early model provided immediate strategic value:
- It clarified that, under current assumptions, the product was unlikely to be cost-effective in the UK (and other European markets);
- It identified the critical cost and utility drivers most likely to shift the conclusion;
- It gave the client a pragmatic roadmap for evidence generation and modelling upgrades.
Based on these findings, MTRC advised proceeding to a comprehensive model, including:
- A systematic, defensible literature review of high-impact clinical, utility, and cost inputs
- A stronger methodological foundation for extrapolating effectiveness beyond study follow-up, including justification of assumptions appropriate for HTA review
If cost-effectiveness is demonstrated in the comprehensive model, the analysis can be prepared for peer-reviewed publication to support market access activities globally.
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