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Wednesday, February 26, 2025

Does NICE contemplate real-world information (RWD) for HTA evaluations? – Healthcare Economist


The reply is ‘sure’, however the query is in what method? A paper by Che et al. (2024) examines using real-world information (RWD) throughout 2016-2023 HTA assessments. Over this time interval, 11% of HTA submissions included real-world information. Additional, they discover that:

The principle sources of RWD thought of within the submissions had been illness registries and digital well being information. RWD had been primarily used to offer an exterior management arm to allow comparisons inside single-arm trials and to tell long-term remedy results when extrapolating survival information past the trial follow-up. Changes for potential systematic variations between remedy teams have improved over time; nonetheless, roughly one-third of the submissions nonetheless relied on unadjusted remedy comparisons…Over one-third of the submissions relied on naïve and/or unadjusted remedy comparisons…

We see a pattern in the direction of rising use of RWD as a part of NICE HTA submission.

Out of the 64 HTA submissions with RWD, two-thirds (n=44 ) thought of RWD for ECA evaluation solely within the base-case, 9 had been thought of in each the base-case and sensitivity evaluation, and 11 thought of RWD solely in sensitivity/state of affairs evaluation.

Confounding changes had been carried out within the majority of circumstances (30 of 44), with weighting (n=20), matching (n=7), regression (n=4), and simulated remedy comparability (n=2) the approaches used.

Why was RWD not used? For survival extrapolation, quite a few rationales had been offered:

In 20 submissions, the real-world ECA [external control arm] was deemed inappropriate for extrapolation for numerous causes, equivalent to (1) quick follow-up, (2) inclusion of remedies not noticed in UK medical apply, and (3) key endpoints (e.g., progression-free survival) not collected.  

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