NICE Technology Appraisal Submissions for Non-Small Cell Lung Cancer: Analysis and Insights
Author(s)
Raju Gautam, PhD1, Ratna Pandey, MSc2, Saeed Anwar, MPharm2, Shilpi Swami, MSc1, Tushar Srivastava, MSc1.
1ConnectHEOR, London, United Kingdom, 2ConnectHEOR, Delhi, India.
1ConnectHEOR, London, United Kingdom, 2ConnectHEOR, Delhi, India.
OBJECTIVES: Non-small cell lung cancer (NSCLC) is one of the leading causes of cancer-related mortality and morbidity globally. Over the past decade, the treatment landscape for NSCLC has rapidly evolved with the emergence of targeted therapies and immunotherapies. This study aims to analyze and provide insights on technology appraisals (TAs) submitted to the UK’s National Institute for Health and Care Excellence (NICE) for NSCLC therapies in recent years.
METHODS: The website of NICE was searched to identify TAs guidance published between January-2020-April-2025. Data was extracted on appraisal trends, key Evidence Assessment Group (EAG) critiques, and final recommendations.
RESULTS: Forty-three records were retrieved. Thirteen were excluded (8 terminated TAs; 5 others). Thirty TAs for NSCLC were analyzed. Most TAs were for immune checkpoint inhibitors (n=14) or tyrosine kinase inhibitors (n=10). Most TAs were for locally advanced or metastatic NSCLC (n=25). Most of the study designs of pivotal clinical trials were RCT (n= 17), followed by single-arm study (n= 10). Most appraisals resulted in conditional recommendations (17/30, 57%), often requiring commercial arrangements such as patient access schemes or managed entry agreements, 11 were fully recommended (37%) and two were not recommended (7%). The key critiques by EAG were inadequate model assumption and structure (n=18), followed by uncertainty in clinical evidence (n=14) such as lack of head-to-head trials, immature primary outcome data (OS and PFS), selection of inappropriate comparator, small sample size, uncertainty regarding long-term clinical benefit etc. The EAG also highlighted methodological uncertainty around indirect treatment comparisons (n=9).
CONCLUSIONS: More than half of TAs submitted to NICE for NSCLC therapies received conditional recommendations. While innovative therapies are valued, the EAG prioritizes mature data, robust modelling, and robust comparative evidence to guide reimbursement decisions. Future appraisals must also address challenges related to uncertainty, comparator selection, and treatment sequencing in NSCLC care.
METHODS: The website of NICE was searched to identify TAs guidance published between January-2020-April-2025. Data was extracted on appraisal trends, key Evidence Assessment Group (EAG) critiques, and final recommendations.
RESULTS: Forty-three records were retrieved. Thirteen were excluded (8 terminated TAs; 5 others). Thirty TAs for NSCLC were analyzed. Most TAs were for immune checkpoint inhibitors (n=14) or tyrosine kinase inhibitors (n=10). Most TAs were for locally advanced or metastatic NSCLC (n=25). Most of the study designs of pivotal clinical trials were RCT (n= 17), followed by single-arm study (n= 10). Most appraisals resulted in conditional recommendations (17/30, 57%), often requiring commercial arrangements such as patient access schemes or managed entry agreements, 11 were fully recommended (37%) and two were not recommended (7%). The key critiques by EAG were inadequate model assumption and structure (n=18), followed by uncertainty in clinical evidence (n=14) such as lack of head-to-head trials, immature primary outcome data (OS and PFS), selection of inappropriate comparator, small sample size, uncertainty regarding long-term clinical benefit etc. The EAG also highlighted methodological uncertainty around indirect treatment comparisons (n=9).
CONCLUSIONS: More than half of TAs submitted to NICE for NSCLC therapies received conditional recommendations. While innovative therapies are valued, the EAG prioritizes mature data, robust modelling, and robust comparative evidence to guide reimbursement decisions. Future appraisals must also address challenges related to uncertainty, comparator selection, and treatment sequencing in NSCLC care.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA256
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Oncology