REIMBURSEMENT RECOMMENDATIONS BASED ON PHASE II CLINICAL EVIDENCE FOR ONCOLOGY DRUGS IN CANADA
Author(s)
Milenkovski RB, Yunger S, Shum D
Hoffmann-La Roche, Mississauga, ON, Canada
Presentation Documents
OBJECTIVES: The pan-Canadian Oncology Drug Review (pCODR) evaluates clinical and economic evidence to make formulary listing recommendations to the Canadian provinces and territories, except Quebec, for oncology drugs. Generally, Phase III clinical evidence is the gold standard used by reviewers to make decisions. However, some oncology drugs can receive regulatory approval based on promising Phase II results and thus can be submitted to pCODR. There is limited published research examining the level of clinical evidence required for a positive recommendation. The objective of this study was to identify conditions where submissions may receive positive recommendations from pCODR based only on Phase II data. METHODS: All pCODR decisions from July 2011 to January 2016 were reviewed to determine whether the clinical evidence submitted was from Phases II or III trials. Public sources were used to identify the trials submitted and the recommendation decision. RESULTS: CONCLUSIONS: Regulatory agencies have been willing to approve oncology drugs based on Phase II data while further evidence is collected in Phase III trials. However, only drugs for hematological and rare cancers where Phase III trials are not feasible are likely to receive positive formulary recommendations from pCODR with Phase II evidence. Alternative reimbursement models may be needed to ensure temporary access for patients while additional data is collected and a subsequent pCODR submission is reviewed.
Conference/Value in Health Info
2016-05, ISPOR 2016, Washington DC, USA
Value in Health, Vol. 19, No. 3 (May 2016)
Code
PCN163
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Health Disparities & Equity, Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
Multiple Diseases, Oncology, Rare and Orphan Diseases