Is the Usage of Immature Survival Data Surviving the HTA Decision?
Author(s)
Sharma J1, Sharma R2, Srivastava T1
1ConnectHEOR, London, LON, UK, 2ConnectHEOR, Edmonton, Canada
Presentation Documents
OBJECTIVES: In health technology appraisal (HTA) submissions for oncology, decision-makers are often presented with incomplete survival data on new treatments, making it difficult to evaluate the long-term benefits of the treatment amidst uncertainty and posing challenges to technology adoption decisions. This study aims to understand how often National Institute for Health and Care Excellence (NICE) UK informs its decisions for cancer treatments using immature overall survival (OS) data alongside understanding its impact on decision-making. METHODS: NICE single technology appraisals (STAs) published between January 2021 and December 2022 for cancer treatments were reviewed. Information on the STA, clinical trial characteristics, data maturity level for OS and recommendations were extracted from the company submissions, evidence review group reports, and final HTA guidance documents by one reviewer and quality checked by the second reviewer to ensure accuracy.
RESULTS:
Of the 68 STAs reviewed, 59% (n=40) had immature OS data. In 26% (n=18) of the submissions, the maturity level of the OS data was not reported, and in the rest 74% (n=50) the information was redacted or not reported. Out of the STAs that used immature survival data, 50% (n=34%) received positive recommendations, 41% (n=28) were recommended with conditions, and 9% (n=6) were not recommended. Additionally, 13% (n=9) of STAs using immature survival data involved a single-arm study design, resulting in indirect treatment comparison. CONCLUSIONS: Using immature survival data may lead to inconsistent and unreliable model results, which may affect reimbursement decisions. There is scope for strengthening the guidelines around effectively using immature survival data to reduce model uncertainty and technology adoption decisions.Conference/Value in Health Info
2023-05, ISPOR 2023, Boston, MA, USA
Value in Health, Volume 26, Issue 6, S2 (June 2023)
Code
MSR34
Topic
Clinical Outcomes, Study Approaches
Topic Subcategory
Clinical Trials, Comparative Effectiveness or Efficacy, Decision Modeling & Simulation, Literature Review & Synthesis
Disease
No Additional Disease & Conditions/Specialized Treatment Areas