Evaluation of Rejected Reimbursement Decisions in NICE and CADTH Submissions for Non-Small Cell Lung Cancer

OBJECTIVES: Health technology assessment (HTA) agencies reject submissions that fail to demonstrate adequate evidence for cost-effectiveness, with each agency having distinct requirements and thresholds for acceptability. This study reviewed the reasons for rejection of non-small cell lung cancer (NSCLC) submissions by the UK National Institute for Health and Care Excellence (NICE) and compared against the corresponding submissions from the Canadian Agency for Drugs and Technologies in Health (CADTH).

METHODS: A targeted review identified six NSCLC submissions rejected by NICE (2014–2024) and four corresponding submissions to CADTH (two exclusions due to cancellation and no submission). The reasons for rejection by NICE were categorised and compared to the critiques in the CADTH submissions.

RESULTS: Six HTAs were included from NICE, which were commonly rejected based on multiple grounds. The rejections were primarily due to issues with clinical evidence (6/6 submissions), particularly in trial designs (4/6; 3 of which were pivotal single arm trials), modelling approach and inputs (6/6 submissions), especially indirect treatment comparisons (5/6; 3/5 due to substantial uncertainty, while 2/5 due to methodological problems with the systematic literature review), model outcomes (i.e. whether the result was cost-effective), (5/6 submissions), all due to higher incremental cost effectiveness ratios (ICERs) than the acceptable threshold. Four corresponding CADTH submissions were reviewed, all of which were accepted under conditions including price reductions (4/4) and additional clinical criteria (e.g. specific unmet need and specifying patient subgroups for which the drug is most effective) (3/4).

CONCLUSIONS: While CADTH acknowledged similar issues as NICE regarding clinical evidence and modeling approaches, their consideration of unmet needs and patient values underscored a more flexible approach compared to NICE's stringent requirements. A reverse comparison would be helpful to determine if the agencies are consistent in their criteria for rejecting or approving submissions.