OBJECTIVES:

A positive NICE assessment is key to funding in NHS England. However, manufacturers are actively foregoing the English market by not submitting an evidence package to NICE resulting in “terminated appraisal”. This research is aimed at identifying trends in terminated appraisals in relation to therapeutic area, monotherapy vs combination regimen, and date of termination.

METHODS:

This study reviewed Single Technology Appraisals (STAs) and Highly Specialised Technologies (HSTs) published in the NICE website from 2017 to June 2022. Appraisals listed as “Terminated appraisal – non submission” were identified and data were extracted on disease area, active substance, (monotherapy vs combination drug), and date of termination. A comparison of the number of terminated appraisals between non-oncology and oncology products and between monotherapies and combination drugs was made.

RESULTS:

A total of 358 NICE STAs and HSTs were identified of which 60 (17%) were terminated appraisals. Of these, 72% of were for oncology products, and 35% were for combination drugs. Compared with appraisals for non-oncology products, oncology products were almost twice as likely to result in terminated appraisal (11% vs 21%). A similar situation was also observed for monotherapies and combination drugs (14% vs 26%). The annual proportion of non-submissions was around 20% except for 2018 (4%).

CONCLUSIONS:

Challenges in generating robust evidence for oncology products are well known and might explain why a decision to not submit the evidence is more likely to be taken for oncology products. The higher likelihood of combination drugs’ appraisals to result in terminated appraisal, confirming a 2019 ABPI survey’s findings, might be because their added benefit is often not enough to justify their price, and, therefore, access might be particularly challenging in countries relying on cost-effectiveness.