Supporting Informed Formulary Decision Making: CADTH’s Common Drug Review

Denis Bélanger, Director, CADTH

New Brunswick Stroke SummitNovember 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

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

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unpublished data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

www.cadth.ca

For More Information