Analysis of Reimbursement Outcomes for Oncology Therapies in Quebec, Canada
Author(s)
Rachel Chu, MSc1, Nahla Nacef, MD, Dentistry2, Emna Abdennadher, MSc2, Liga Bennetts, PhD1.
1Amaris Consulting, Montreal, QC, Canada, 2Amaris Consulting, Tunis, Tunisia.
1Amaris Consulting, Montreal, QC, Canada, 2Amaris Consulting, Tunis, Tunisia.
Presentation Documents
OBJECTIVES: Recommendations from the Institut national d'excellence en santé et en services sociaux (INESSS) are crucial in ensuring patient access to new oncology drugs in Quebec. We sought to analyse features of oncology drugs and evidence submitted to INESSS, and the resulting reimbursement recommendations, with a focus on submissions using Phase 2 data and with ORR as a primary or secondary endpoint.
METHODS: Reimbursement recommendation reports published Jan 1, 2022-Aug 1, 2024, from first INESSS evaluations for general or innovative oncology medicines were retrieved from the INESSS website. Information on indication, product, pivotal trial design, outcomes assessed, and final decision were extracted.
RESULTS: We retrieved 78 reports, of which 55 included Phase 3 trials in the clinical evidence, and 19 Phase 2 as the pivotal evidence. Eighty-four percent (46/55) of assessments based on Phase 3 trials and 63% (12/19) based on Phase 2 trials received a positive reimbursement recommendation. There were 17 drug reviews with pivotal Phase 2 trials that included the ORR outcome as a primary or secondary endpoint; of these, 7 had negative reimbursement decisions. Most (6/7) of these negative decisions were due to therapeutic value not being recognized; in one case INESSS judged that reimbursement would not be appropriate from a distributive justice standpoint. Improvement of ORR in submitted evidence was reported in 94% (16/17) of submissions. Six Phase 2 trials with negative reimbursement decisions had improvement in ORR in submitted evidence, however in all six cases INESSS noted substantial uncertainty or critiqued methodological robustness in the findings.
CONCLUSIONS: More than half of all submissions for oncology therapies based on Phase 2 evidence that included ORR received positive recommendations for reimbursement. These findings contribute to our understanding of assessments of therapeutic value and factors influencing reimbursement decisions.
METHODS: Reimbursement recommendation reports published Jan 1, 2022-Aug 1, 2024, from first INESSS evaluations for general or innovative oncology medicines were retrieved from the INESSS website. Information on indication, product, pivotal trial design, outcomes assessed, and final decision were extracted.
RESULTS: We retrieved 78 reports, of which 55 included Phase 3 trials in the clinical evidence, and 19 Phase 2 as the pivotal evidence. Eighty-four percent (46/55) of assessments based on Phase 3 trials and 63% (12/19) based on Phase 2 trials received a positive reimbursement recommendation. There were 17 drug reviews with pivotal Phase 2 trials that included the ORR outcome as a primary or secondary endpoint; of these, 7 had negative reimbursement decisions. Most (6/7) of these negative decisions were due to therapeutic value not being recognized; in one case INESSS judged that reimbursement would not be appropriate from a distributive justice standpoint. Improvement of ORR in submitted evidence was reported in 94% (16/17) of submissions. Six Phase 2 trials with negative reimbursement decisions had improvement in ORR in submitted evidence, however in all six cases INESSS noted substantial uncertainty or critiqued methodological robustness in the findings.
CONCLUSIONS: More than half of all submissions for oncology therapies based on Phase 2 evidence that included ORR received positive recommendations for reimbursement. These findings contribute to our understanding of assessments of therapeutic value and factors influencing reimbursement decisions.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HTA13
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Oncology