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Supporting Informed Formulary Decision Making: CADTH’s Common Drug Review Denis Bélanger, Director, CADTH New Brunswick Stroke Summit November 27, 2010, Moncton, NB Canadian Agency for Drugs and Technologies in Health (CADTH) Founded in 1989 Independent, not-forprofit, pan-Canadian health technology agency Funded by Health Canada, the provinces and territories CADTH supports informed decisions by providing impartial, evidence-based research and advice CADTH Products and Services CADTH conducts health technology assessments on drugs, non-drug technologies, procedures, methodologies. • • • • Environmental scans Rapid response service Drug formulary recommendations Optimal use advice, recommendations and utilization tools Common Drug Review A single national* process for: conducting objective, rigorous, and timely clinical and economic reviews of drugs, and providing formulary listing recommendations (by CEDAC) to participating publicly funded drug plans Based on scientific and economic evidence submitted by manufacturer and found through systematic literature search strong methodologies * includes all publicly funded drug plans except Quebec Drug Review in Canada Health Canada Responsibility Market Authorization Manufacturer Responsibility Submission of Clinical & Economic Evidence to CADTH Drug Plans Reviews by CADTH PMPRB CADTH Responsibility CEDAC recommendation to drug plans Drug Plan Responsibility Listing Decision Listing Decision Listing Decision Listing Decision What Does CADTH Review? Submission Types new drugs (NOC, Pre-NOC, NOC/c) new indications resubmissions with new clinical or cost information submissions from drug plans Requests for Advice from drug plans Submission to CADTH = a submission to all participating drug plans CADTH Formulary Review Teams Staff and contracted clinical reviewers Staff and contracted health economists Clinical experts Methodologists Information specialists Project managers, submission coordinators, administrative support Peer reviewers (independent of Team) Evidence Considered Manufacturer’s submission clinical data unpublished data pharmacoeconomic evaluation Published studies and documents FDA website Health Canada Reviewer’s Report Additional information requested from the manufacturer CADTH Review Reports Clinical Review systematic review of published and unpublished trials supplemental issues, background on condition Pharmacoeconomic Review critique of manufacturer’s economic evaluation used to determine cost-effectiveness Reports then receive peer review manufacturer’s comments Canadian Expert Drug Advisory Committee A CADTH advisory committee Thirteen members eleven with expertise in drug therapy and evaluation two public members full voting members do not represent any particular region, interest group or organization Follows strict Conflict of Interest Guidelines Meets monthly to consider reviews and make listing recommendations Expert Committee Recommendations Based on established criteria: safety, efficacy and effectiveness of the drug compared to alternatives therapeutic advantages and disadvantages relative to current accepted therapy cost-effectiveness relative to current accepted therapy patient and public impact Challenges for Reviewers/Expert Committee Surrogate endpoints Drugs with limited evidence Drugs with high cost-effectiveness ratios Appropriateness of comparators Drug costs – What price to use? Payer Challenges Medical evidence — regulatory versus payer objectives Efficacy versus effectiveness Lacks comparator data and data on long term use Unclear effectiveness in sub-populations and the “real world” Does incremental benefit support incremental cost? Budgetary impact, appropriate utilization Information gaps and uncertainty Resource challenges Finding the Right Balance Improved clinical outcomes Increased costs Challenges and Opportunities Relationship with industry Individual manufacturers Rx&D and BIOTECanada Input from patients and patient advocacy groups Media and political attention Capacity, timelines, transparency Information gaps and methodological issues Recent Program Enhancements 1. Pre-NOC priority review submissions 2. Resubmissions based on a reduced price during the embargo period 3. Expanded criteria for resubmissions 4. Transparency documents 5. Subsequent entry biologics 6. Patient group input For More Information www.cadth.ca