The Common Drug Review (CDR) is a single process for reviewing new drugs and providing formulary listing recommendations to participating publicly-funded federal, provincial and territorial drug benefit plans in Canada.  Clinical and economic data is reviewed by the CDR to assess the cost-effectiveness of submitted drugs.  The CDR conducts a systematic review of the clinical evidence and critically appraises an economic evaluation submitted by the manufacturer.

Purpose/Methods: Limitations in manufacturer submitted economic evaluations affect their usefulness in the decision making process.  This presentation discusses the issues encountered in the CDR's first year of operation, when 23 drugs were reviewed.  The limitations and difficulties encountered with appraising submitted economic evaluations are identified and analyzed. 

Results: Of the 23 submitted economic evaluations, 70% had shortcomings.  In general, the methods used by manufacturers were appropriate, but lack of data limited the confidence in results: 39% chose an inappropriate comparator; 43% used surrogate clinical markers which were not extrapolated to meaningful clinical outcomes; 48% used inappropriate data sources or assumptions that affected the credibility of the results.  Economic evaluations with significant limitations are not useful to decision makers.  Insufficient evidence on the part of the economic evaluation to support a price that is equal to or higher than the other comparator drug(s) was the primary economic reason for making a recommendation not to list the drug on drug plan formularies.

Conclusions:  In its first year of operation, the CDR received submissions for a wide range of new drugs.  Although economic information was provided for all manufacturer initiated submissions, the quality of this information was often poor.  To assist manufacturers to submit higher quality economic evaluations, the CDR is reviewing and revising its economic requirements with a view to provide more guidance to manufacturers.