UNDERSTANDING EVIDENCE AND REIMBURSEMENT PATHWAYS FOR ONCOLOGY RETREATMENT: A CROSS-COUNTRY ASSESSMENT OF REGULATORY, GUIDELINE, AND HTA PERSPECTIVES
Author(s)
Anna D'Ausilio, MSc1, Himani Jaiswal, Other2, Caroline Delaitre-Bonnin, PharmD3.
1Director, Thermo Fisher Scientific, Milan, Italy, 2Thermo Fisher Scientific, New Delhi, India, 3Thermo Fisher Scientific, Ivry-sur-Seine, France.
1Director, Thermo Fisher Scientific, Milan, Italy, 2Thermo Fisher Scientific, New Delhi, India, 3Thermo Fisher Scientific, Ivry-sur-Seine, France.
OBJECTIVES: As oncology treatment paradigms evolve and patient survival improves, retreatment strategies are increasingly being considered across tumour types, however, the evidence and reimbursement requirements supporting their adoption remain unclear. This study assessed how retreatment is addressed at clinical and health technology assessment (HTA) level, and identified factors associated with retreatment acceptance
METHODS: Six oncology analogues were reviewed: venetoclax in chronic lymphocytic leukemia (CLL), imatinib in chronic myeloid leukemia (CML), trastuzumab in HER2-positive breast cancer, rituximab in follicular lymphoma (FL), cetuximab in metastatic colorectal cancer (mCRC), and nivolumab in resectable non-small cell lung cancer (NSCLC). Published evidence from the United States, United Kingdom, France, Germany, and Japan was reviewed and evaluated to identify evidence-generation patterns associated with reimbursement acceptance across countries.
RESULTS: Acceptance of retreatment varied across therapies and Countries. Clinical guidelines were the primary source of retreatment recommendations, whereas HTA bodies rarely provided explicit assessments. Greater acceptance was observed where prospective clinical evidence was complemented by real world evidence (RWE), as for venetoclax in CLL, imatinib in CML, and rituximab in FL. In contrast, newer therapies generally lacked retreatment-specific evidence, resulting in limited guidance from regulators, HTA agencies, and payers. Key factors supporting retreatment acceptance included demonstration of repeated clinical benefit, clear patient selection criteria, safety monitoring frameworks, and integration into clinical guidelines.
CONCLUSIONS: Retreatment pathways are mainly driven by clinical evidence and guideline adoption rather than HTA recommendations. Prospective and RWE studies may support reimbursement and uptake of retreatment in oncology.
METHODS: Six oncology analogues were reviewed: venetoclax in chronic lymphocytic leukemia (CLL), imatinib in chronic myeloid leukemia (CML), trastuzumab in HER2-positive breast cancer, rituximab in follicular lymphoma (FL), cetuximab in metastatic colorectal cancer (mCRC), and nivolumab in resectable non-small cell lung cancer (NSCLC). Published evidence from the United States, United Kingdom, France, Germany, and Japan was reviewed and evaluated to identify evidence-generation patterns associated with reimbursement acceptance across countries.
RESULTS: Acceptance of retreatment varied across therapies and Countries. Clinical guidelines were the primary source of retreatment recommendations, whereas HTA bodies rarely provided explicit assessments. Greater acceptance was observed where prospective clinical evidence was complemented by real world evidence (RWE), as for venetoclax in CLL, imatinib in CML, and rituximab in FL. In contrast, newer therapies generally lacked retreatment-specific evidence, resulting in limited guidance from regulators, HTA agencies, and payers. Key factors supporting retreatment acceptance included demonstration of repeated clinical benefit, clear patient selection criteria, safety monitoring frameworks, and integration into clinical guidelines.
CONCLUSIONS: Retreatment pathways are mainly driven by clinical evidence and guideline adoption rather than HTA recommendations. Prospective and RWE studies may support reimbursement and uptake of retreatment in oncology.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
MT4
Topic
Health Technology Assessment, Medical Technologies, Organizational Practices
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology