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- W2399606097 abstract "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. 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. 16% (10 of 61) of submissions were based solely on Phase II data. 70% (7 of 10) received positive recommendations, of which 71% (5 of 7) were indicated for hematological tumors and 29% (2 of 7) were indicated for skin tumors. Decisions resulting in positive recommendations cited compelling Phase II data, the infeasibility of Phase III trials, small patient populations and/or a lack of alternative effective treatments for the given population. Drugs not receiving positive recommendations were indicated for solid tumors and had ongoing Phase III trials. 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." @default.
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- W2399606097 date "2016-05-01" @default.
- W2399606097 modified "2023-10-18" @default.
- W2399606097 title "Reimbursement Recommendations Based on Phase II Clinical Evidence for Oncology Drugs in Canada" @default.
- W2399606097 doi "https://doi.org/10.1016/j.jval.2016.03.1496" @default.
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