A Comprehensive Review of Health Technology Reassessments for Oncology Drugs in France: Impact on Reimbursement Outcomes 2019-2024
Author(s)
Mark Chalmers, PhD1, PRATEEK KANADE, M. Pharm2, Love Kumar, M. Pharm3, Vidhyasagari Sundaram, MPH4, Darata Zemaitaityte, M. Pharm, MPH5.
1Partner, EY, Dublin, Ireland, 2Ernst & Young, BENGALURU, India, 3Ernst & Young, Gurgaon, India, 4Ernst & Young, Bangalore, India, 5EY, Dublin, Ireland.
1Partner, EY, Dublin, Ireland, 2Ernst & Young, BENGALURU, India, 3Ernst & Young, Gurgaon, India, 4Ernst & Young, Bangalore, India, 5EY, Dublin, Ireland.
OBJECTIVES: This study aims to investigate the key outcomes from the health technology reassessment conducted by the Haute Autorité de Santé (HAS) in France, focusing on the changes in clinical benefit (SMR) and added clinical value (ASMR) levels, as well as the types of additional evidence provided by manufacturers for the reassessment.
METHODS: The list of all HTA assessments published on the website of Haute Autorité de Santé (HAS) from January 2019 to December 2024 was downloaded. From this list, oncology specific assessments were shortlisted and then only re-assessments from the list were identified. These were then analysed for supplementary evidence submitted by manufacturers, inclusion real-world evidence and the impact of all of this on HTA outcomes
RESULTS: Reassessments were primarily initiated by the HAS Transparency Committee (46 out of 88) and manufacturers (42 out of 88). Solid tumors accounted for 63% of the cases, while the remainder were related to hematologic malignancies. Among the 88 reassessments, there was a positive change in SMR for 10 of these cases, while in 5 reassessments, the reimbursement was revised with certain restrictions. Manufacturers provided additional evidence in 85% of cases, including updated safety and efficacy data as well as post-registration studies; however, no direct correlation with HTA outcomes could be established. Real-world evidence was cited in 43 reports but influenced outcomes in only two reassessments
CONCLUSIONS: Re-assessments are typically requested by manufacturers and the Transparency Committee to include additional evidence related to efficacy and safety. In France, these re-assessments have led to significant changes in the SMR, while changes in ASMR have been limited. Limitations associated with population selection, appropriate follow-up, and bias in real-world evidence (RWE) studies hinder any meaningful impact on re-assessment outcomes. Therefore, manufacturers must carefully evaluate the evidence generation requirements to positively influence HTA outcomes.
METHODS: The list of all HTA assessments published on the website of Haute Autorité de Santé (HAS) from January 2019 to December 2024 was downloaded. From this list, oncology specific assessments were shortlisted and then only re-assessments from the list were identified. These were then analysed for supplementary evidence submitted by manufacturers, inclusion real-world evidence and the impact of all of this on HTA outcomes
RESULTS: Reassessments were primarily initiated by the HAS Transparency Committee (46 out of 88) and manufacturers (42 out of 88). Solid tumors accounted for 63% of the cases, while the remainder were related to hematologic malignancies. Among the 88 reassessments, there was a positive change in SMR for 10 of these cases, while in 5 reassessments, the reimbursement was revised with certain restrictions. Manufacturers provided additional evidence in 85% of cases, including updated safety and efficacy data as well as post-registration studies; however, no direct correlation with HTA outcomes could be established. Real-world evidence was cited in 43 reports but influenced outcomes in only two reassessments
CONCLUSIONS: Re-assessments are typically requested by manufacturers and the Transparency Committee to include additional evidence related to efficacy and safety. In France, these re-assessments have led to significant changes in the SMR, while changes in ASMR have been limited. Limitations associated with population selection, appropriate follow-up, and bias in real-world evidence (RWE) studies hinder any meaningful impact on re-assessment outcomes. Therefore, manufacturers must carefully evaluate the evidence generation requirements to positively influence HTA outcomes.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA4
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Oncology