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NICE DSU Technical Support Document 14

Guidelinepeer-reviewed✓ Source-grounded

This document provides guidance on how to perform survival analysis for economic evaluations in health technology assessments, especially when using data from clinical trials. It emphasizes the importance of carefully choosing and justifying statistical models used to predict long-term survival beyond the observed data, to avoid biased or inconsistent results.

At a glance

Use when

Conducting economic evaluations requiring extrapolation of survival data from clinical trials, particularly in submissions to HTA bodies like NICE

Avoid when

Survival data is short-term and no extrapolation is needed; non-parametric methods are sufficient for the evaluation context; real-world evidence is available to directly inform long-term survival

Inputs

Patient-level survival data from clinical trials, candidate parametric models (e.g., Weibull, exponential, log-normal), statistical fit metrics

Outputs

Justified choice of survival model, extrapolated survival curves with plausible long-term trends, transparent documentation of model selection process

How it works

The guideline reviews survival analysis practices in 45 NICE appraisals in oncology and identifies common shortcomings, such as insufficient model comparison and lack of justification for extrapolation choices. It proposes a structured process for model selection, including assessing the plausibility of extrapolated survival curves and comparing multiple candidate models using statistical and clinical criteria to improve robustness in economic evaluations.

HTA domains
Clinical Effectiveness, Costs & Economic Evaluation, Safety
Assumptions
Long-term survival trends can be reasonably extrapolated from trial data using parametric models; clinical knowledge can inform model plausibility; multiple model comparison reduces bias
Strengths
Provides a systematic, transparent framework for model selection; reduces risk of bias and inconsistency in HTA submissions; grounded in real-world review of past HTAs
Limitations
Focuses on commonly used methods in NICE submissions, not all possible survival analysis techniques; limited discussion of uncertainty quantification in extrapolations; primarily applicable to oncology and similar chronic conditions
Also known as
TSD 14, NICE DSU TSD 14

Questions this answers

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