ARE EU JOINT CLINICAL ASSESSMENTS (JCA) BASED ON OUTDATED EVIDENCE? TRACKING EVIDENCE EVOLUTION DURING ACTIVE JCAS USING REAL-TIME AI-ASSISTED LIVING SYSTEMATIC LITERATURE REVIEWS (REAL-SLRS)
Author(s)
Rozee Liu, MSc1, Stefan Walzer, MA, PhD2, Anna Forsythe, MBA, MSc, PharmD3, Andrew Briggs, DPhil4.
1Senior director, Product and Business, Oncoscope AI, Miamia, FL, USA, 2MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany, 3Oncoscope, Miami, FL, USA, 4London School of Hygiene & Tropical Medicine, London, United Kingdom.
1Senior director, Product and Business, Oncoscope AI, Miamia, FL, USA, 2MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany, 3Oncoscope, Miami, FL, USA, 4London School of Hygiene & Tropical Medicine, London, United Kingdom.
OBJECTIVES: EU JCAs are conducted over extended timelines during which new clinical evidence, regulatory decisions, and changes in standards of care may emerge. However, evidence submissions are typically based on static systematic literature reviews (SLRs) that do not support ongoing evidence surveillance. This study evaluated evidence evolution during active oncology JCAs using REAL-SLRs.
METHODS: REAL-SLR oncology libraries continuously identify, screen, extract, validate, and link evidence from publications, conference abstracts, clinical trial registries, regulatory sources, clinical guidelines, and HTA documents. Four oncology products at different stages of JCA review in breast cancer and non-small cell lung cancer were selected. For each assessment, JCA duration, newly published evidence, regulatory developments, and emerging comparator evidence after JCA initiation were evaluated.
RESULTS: The four JCAs represented surveillance periods of 89-369 days. Two of four assessments experienced clinically relevant evidence changes. For camizestrant, seven SERENA-6 publications reported updated progression-free survival, overall survival, quality-of-life, and safety outcomes, and a positive CHMP opinion was issued during the review period. For taletrectinib, two publications reported updated progression-free survival, objective response rate, duration of response, and patient-reported outcomes from TRUST-I and TRUST-II. Continuous monitoring also identified three new comparator therapies for camizestrant and five for sintilimab with phase 2/3 efficacy and safety data, creating additional potentially relevant PICO scenarios. No clinically relevant evidence changes were identified for the remaining two products..
CONCLUSIONS: Although JCA PICOs remain formally fixed during assessment, oncology evidence continues to evolve throughout the review period. Living evidence surveillance identified new efficacy, safety, quality-of-life, regulatory, and comparator data after JCA initiation, demonstrating that evidence available for subsequent national HTA and reimbursement decisions may differ from that available at JCA submission. REAL-SLRs provide a practical framework for prospectively monitoring evidence evolution across the JCA-to-national decision-making pathway.
METHODS: REAL-SLR oncology libraries continuously identify, screen, extract, validate, and link evidence from publications, conference abstracts, clinical trial registries, regulatory sources, clinical guidelines, and HTA documents. Four oncology products at different stages of JCA review in breast cancer and non-small cell lung cancer were selected. For each assessment, JCA duration, newly published evidence, regulatory developments, and emerging comparator evidence after JCA initiation were evaluated.
RESULTS: The four JCAs represented surveillance periods of 89-369 days. Two of four assessments experienced clinically relevant evidence changes. For camizestrant, seven SERENA-6 publications reported updated progression-free survival, overall survival, quality-of-life, and safety outcomes, and a positive CHMP opinion was issued during the review period. For taletrectinib, two publications reported updated progression-free survival, objective response rate, duration of response, and patient-reported outcomes from TRUST-I and TRUST-II. Continuous monitoring also identified three new comparator therapies for camizestrant and five for sintilimab with phase 2/3 efficacy and safety data, creating additional potentially relevant PICO scenarios. No clinically relevant evidence changes were identified for the remaining two products..
CONCLUSIONS: Although JCA PICOs remain formally fixed during assessment, oncology evidence continues to evolve throughout the review period. Living evidence surveillance identified new efficacy, safety, quality-of-life, regulatory, and comparator data after JCA initiation, demonstrating that evidence available for subsequent national HTA and reimbursement decisions may differ from that available at JCA submission. REAL-SLRs provide a practical framework for prospectively monitoring evidence evolution across the JCA-to-national decision-making pathway.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA189
Topic
Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
Oncology