Supporting Informed Formulary Decision Making: CADTH’s Common Drug Review Denis Bélanger, Director, CADTH New Brunswick Stroke Summit November 27, 2010, Moncton, NB

 Founded in 1989  Independent, not-for- profit, 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 Canadian Agency for Drugs and Technologies in Health (CADTH)

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

Submission of Clinical & Economic Evidence to CADTH Reviews by CADTH CEDAC recommendation to drug plans Manufacturer Responsibility CADTH Responsibility Drug Plan Responsibility Drug Review in Canada Listing Decision Market Authorization Health Canada Responsibility PMPRB Drug Plans

 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 What Does CADTH Review?

 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) CADTH Formulary Review Teams

 Manufacturer’s submission  clinical data  unpublished data  pharmacoeconomic evaluation  Published studies and documents  FDA website  Health Canada Reviewer’s Report  Additional information requested from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 Evidence Considered

 Clinical Review  systematic review of published and unpublished trials  supplemental issues, background on condition  Pharmacoeconomic Review  critique of manufacturer’s economic evaluation  used to determine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 CADTH Review Reports

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

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