CLINICAL EFFICACY AND ONCOLOGY REIMBURSEMENT RECOMMENDATIONS IN CANADA BY THE INTERIM JOINT ONCOLOGY DRUG REVIEW (IJODR)
Author(s)
Ciapanna CC1, Shum D2, Milliken D2, Yunger S21McMaster University, Burlington, ON, Canada, 2Hoffmann-La Roche Limited, Mississauga, ON, Canada
Presentation Documents
OBJECTIVES: Overall Survival (OS) has generally been considered the “gold standard endpoint” for cancer therapies as it can be assessed with precise accuracy. Due to long follow up periods, however, crossover effects, subsequent therapies and large trial sizes, OS is becoming a less feasible endpoint. Therefore, there has been a shift towards the acceptance of surrogate endpoints as determinants of clinical efficacy for cancer therapies. In Canada, the iJODR conducts health technology assessments for oncology products and provides funding recommendations to public payers. This study was conducted to determine the significance of various endpoints on decision-making by the iJODR. METHODS: Public recommendations of 23 oncology drugs by the iJODR between March 2007 and December 2010 were reviewed. Recommendations were analyzed according to therapy setting, primary and secondary endpoints and clinical results. RESULTS: Of the 23 submissions, one was for use in the adjuvant setting, measuring Disease Free Survival (DFS) as its primary endpoint and received a positive recommendation. Of the 22 drugs indicated for advanced/metastatic disease, primary endpoints were measured in 12 (55%) through OS, 5 (18%) through Progression Free Survival (PFS) and 6 (27%) through either Response Rates (RR) or Time to Progression (TTP). Secondary endpoints included OS, PFS, toxicity, RR, TTP, Quality of Life or Rate of Progression. Of the 12 drugs with OS as a primary endpoint, 7 (58%) showed statistically significant increases in OS, with 4 (57%) granted a positive recommendation. Of the 5 with no statistically significant OS improvement, 3 (60%) received positive recommendations based on secondary endpoints. Of the 10 drugs with surrogate primary endpoints, 6 (60%) received positive recommendations. CONCLUSIONS: These findings suggest that surrogate endpoints are becoming more commonly used in clinical trials for regulatory approval and accepted as true measures of clinical efficacy for oncology therapies in Canada’s funding decisions.
Conference/Value in Health Info
2011-05, ISPOR 2011, Baltimore, MD, USA
Value in Health, Vol. 14, No. 3 (May 2011)
Code
PCN108
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
Oncology