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Supporting Informed Formulary Decision Making: CADTH’s Common Drug Review
Denis Bélanger, Director, CADTH
New Brunswick Stroke SummitNovember 27, 2010, Moncton, NB
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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)
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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
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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
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Submission of Clinical & Economic Evidence to CADTH
Submission of Clinical & Economic Evidence to CADTH
Reviews by CADTH
Reviews by CADTH
CEDAC recommendation to drug plans
CEDAC recommendation to drug plans
Manufacturer Responsibility
Manufacturer Responsibility
CADTH Responsibility
CADTH Responsibility
Drug Plan Responsibility
Drug Plan Responsibility
Drug Review in Canada
Listing Decision
Listing Decision
Listing Decision
Listing Decision
Market AuthorizationMarket AuthorizationHealth Canada Responsibility
Health Canada Responsibility
PMPRBPMPRB
Drug PlansDrug Plans
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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?
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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
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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
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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
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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
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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
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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?
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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
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Finding the Right Balance
Improved clinical
outcomes
Increased costs
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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
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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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www.cadth.ca
For More Information