Transcript CADTH - Heart and Stroke Foundation of New Brunswick

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.
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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 unpublished data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