A STRUCTURED FRAMEWORK FOR CATEGORISING UNMET NEED IN HTA: APPLICATION TO SOLID TUMOR ASSESSMENTS ACROSS EIGHT OECD COUNTRIES
Author(s)
Diana Rebeca Acosta Focil, MD, MSc1, Ahmad Hecham Alani, PharmD2, Mackenzie Mills, PhD1, Panos Kanavos, BSc, MSc, PhD3.
1HTA-Hive, London, United Kingdom, 2Associate Director, Hive Health Optimum Ltd., London, United Kingdom, 3London School of Economics and Political Science, London, United Kingdom.
1HTA-Hive, London, United Kingdom, 2Associate Director, Hive Health Optimum Ltd., London, United Kingdom, 3London School of Economics and Political Science, London, United Kingdom.
OBJECTIVES: To develop and apply a structured framework for categorising and evaluating the role of unmet need in health technology assessment (HTA).
METHODS: A targeted review was conducted using the HTA-Hive database to identify HTA reports for solid tumour indications published between 2020 and 2025. The review covered eight HTA agencies across the UK, Germany, France, Spain, Italy, Sweden, Canada, and Australia. Unmet need statements were systematically extracted from each report. Each statement was extracted and classified into one of three mutually exclusive categories, based on the primary driver explicitly described: (1) Outcome-Based Unmet Need (reflecting suboptimal survival or disease control), (2) Experience-Based Unmet Need (reflecting symptom burden, health-related quality of life, or treatment tolerability concerns), and (3) Availability-Based Unmet Need (reflecting limited or absent treatment options). Reports could include multiple distinct unmet need statements.
RESULTS: Of 799 HTA reports reviewed, a total of 820 unmet need statements were identified, indicating that some assessments referenced more than one unmet need; approximately 86% (n=686) included at least one unmet need statement. Preliminary analysis showed Availability-Based unmet needs were the most frequently observed category, accounting for approximately 55% of all statements. Outcome-Based unmet needs represented around 30% of statements, while Experience-Based unmet needs accounted for approximately 15%. Across agencies, unmet need was most commonly framed around limitations in available treatment options, with fewer statements addressing patient experience or treatment outcomes.
CONCLUSIONS: This categorisation framework provides a structured, reproducible method for identifying and comparing unmet need statements in HTA reports. By promoting consistent characterisation of unmet need, it can enhance transparency in HTA decision-making and inform future cross-jurisdictional comparisons and methodological research.
METHODS: A targeted review was conducted using the HTA-Hive database to identify HTA reports for solid tumour indications published between 2020 and 2025. The review covered eight HTA agencies across the UK, Germany, France, Spain, Italy, Sweden, Canada, and Australia. Unmet need statements were systematically extracted from each report. Each statement was extracted and classified into one of three mutually exclusive categories, based on the primary driver explicitly described: (1) Outcome-Based Unmet Need (reflecting suboptimal survival or disease control), (2) Experience-Based Unmet Need (reflecting symptom burden, health-related quality of life, or treatment tolerability concerns), and (3) Availability-Based Unmet Need (reflecting limited or absent treatment options). Reports could include multiple distinct unmet need statements.
RESULTS: Of 799 HTA reports reviewed, a total of 820 unmet need statements were identified, indicating that some assessments referenced more than one unmet need; approximately 86% (n=686) included at least one unmet need statement. Preliminary analysis showed Availability-Based unmet needs were the most frequently observed category, accounting for approximately 55% of all statements. Outcome-Based unmet needs represented around 30% of statements, while Experience-Based unmet needs accounted for approximately 15%. Across agencies, unmet need was most commonly framed around limitations in available treatment options, with fewer statements addressing patient experience or treatment outcomes.
CONCLUSIONS: This categorisation framework provides a structured, reproducible method for identifying and comparing unmet need statements in HTA reports. By promoting consistent characterisation of unmet need, it can enhance transparency in HTA decision-making and inform future cross-jurisdictional comparisons and methodological research.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HTA64
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
SDC: Oncology, STA: Personalized & Precision Medicine