HTA ACCEPTANCE OF SURROGATE ENDPOINTS IN ONCOLOGY: A CROSS-MARKET ANALYSIS OF ANALOGUES ACROSS AUSTRALIA, CANADA, FRANCE, GERMANY, ITALY, SPAIN AND THE UK (2020-2025)
Author(s)
Nikhil Taxak, PhD1, Thomas Gilboy, BA (Hons)2, Richard Mee, BSc (Hons)2, Keshav Nagaraja, BEc, MBA2, Shrinivas Mukku, PhD2.
1Access Infinity Ltd, Hyderabad, India, 2Access Infinity Ltd, London, United Kingdom.
1Access Infinity Ltd, Hyderabad, India, 2Access Infinity Ltd, London, United Kingdom.
OBJECTIVES: As oncology approvals increasingly rely on surrogate endpoints (DFS, rPFS, MFS, pCR, EFS) rather than overall survival (OS), this research assessed Health Technology Assessment (HTA) acceptance of these surrogates across seven major markets namely, France (HAS), Germany (G-BA), Italy (AIFA), Spain (AEMPS), UK (NICE), Canada (CDA), and Australia (PBAC) and identified the value drivers and barriers shaping payer decisions.
METHODS: Branded solid tumour oncology products approved by FDA, EMA, or Health Canada between January 2020 and December 2025 with surrogate primary endpoints were screened (15 out of 119 records identified; 13 unique brands). Two analogues were prioritised for a deep-dive analysis: Tagrisso (osimertinib in adjuvant EGFR positive NSCLC with DFS) and Talzenna (talazoparib plus enzalutamide in mCRPC HRRm positive with rPFS). HTA outcomes along with rationales, managed-entry mechanisms, and OS data availability/ maturity at submission were extracted from publicly available appraisal reports.
RESULTS: Across 14 HTA decisions (7 markets and 2 case studies), 4 out of 14 were broadly accepting, 9 out of 14 conditional or restricted, and 1 out of 14 rejected. PBAC granted both products with restrictions mirroring CDA. Mature OS was the single most powerful determinant of access across all markets. Tagrisso DFS HR 0.17 received conditional outcomes initially while mature OS HR 0.49 converted CDF status to routine NICE reimbursement and upgraded HAS rating from ASMR IV to ASMR III. Talzenna OS HR 0.89 (non-significant) drove restrictive ratings, with G-BA splitting benefit by biomarker. Surrogate magnitude (HR less than or equal to 0.20) and biomarker precision partially substituted for OS.
CONCLUSIONS: OS remains the universal access trigger; surrogate magnitude, biomarker precision, and managed-entry agreements provide bridges. For APAC, PBAC aligns closely with CDA and AEMPS, suggesting priority reference markets; HAS and GBA signal where surrogate scepticism recurs. Reassessment planning should track OS maturation milestones.
METHODS: Branded solid tumour oncology products approved by FDA, EMA, or Health Canada between January 2020 and December 2025 with surrogate primary endpoints were screened (15 out of 119 records identified; 13 unique brands). Two analogues were prioritised for a deep-dive analysis: Tagrisso (osimertinib in adjuvant EGFR positive NSCLC with DFS) and Talzenna (talazoparib plus enzalutamide in mCRPC HRRm positive with rPFS). HTA outcomes along with rationales, managed-entry mechanisms, and OS data availability/ maturity at submission were extracted from publicly available appraisal reports.
RESULTS: Across 14 HTA decisions (7 markets and 2 case studies), 4 out of 14 were broadly accepting, 9 out of 14 conditional or restricted, and 1 out of 14 rejected. PBAC granted both products with restrictions mirroring CDA. Mature OS was the single most powerful determinant of access across all markets. Tagrisso DFS HR 0.17 received conditional outcomes initially while mature OS HR 0.49 converted CDF status to routine NICE reimbursement and upgraded HAS rating from ASMR IV to ASMR III. Talzenna OS HR 0.89 (non-significant) drove restrictive ratings, with G-BA splitting benefit by biomarker. Surrogate magnitude (HR less than or equal to 0.20) and biomarker precision partially substituted for OS.
CONCLUSIONS: OS remains the universal access trigger; surrogate magnitude, biomarker precision, and managed-entry agreements provide bridges. For APAC, PBAC aligns closely with CDA and AEMPS, suggesting priority reference markets; HAS and GBA signal where surrogate scepticism recurs. Reassessment planning should track OS maturation milestones.
Conference/Value in Health Info
2026-09, ISPOR Asia Pacific 2026, Bangkok, Thailand
Value in Health, Volume 55, Issue S1
Code
HTA7
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
SDC: Oncology