1. CADTH Therapeutic Reviews
Process Overview
2015 CADTH Symposium
April 13, 2015
Kristen Chelak
CADTH: Manager, Program and Policy Development

2. Objectives
To provide an overview of why CADTH is undertaking Therapeutic Reviews
To provide an overview of the CADTH Therapeutic Review framework and process

3. Outline What are CADTH Therapeutic Reviews?
How are topics chosen for Therapeutic Reviews?
How can patients become involved in the therapeutic review process?
What is the role of other stakeholders (manufacturers, health care providers) in the therapeutic review process?
How are therapeutic review recommendations/advice developed?
What happens after recommendations are finalized?

4. Health Technology Assessment informs every health technology decision
CADTH
Independent, not-for-profit organization
Major producer of HTA for drugs, devices, diagnostics, and procedures
Recognized globally as a leader in HTA
Funded by Health Canada, Provinces and Territories
Vision
Health Technology Assessment informs every health technology decision

5. CADTH Products and Services
CDR/pCODR
Drug therapeutic reviews
Rapid response service
Environmental and horizon scans
Mini-HTA, full HTA, and optimal use reports
HTA coordination and brokering services
HTA methods guidance documents
Education and training on HTA

6. What are CADTH Therapeutic Reviews?

7. Purpose of Therapeutic Reviews
Therapeutic Reviews are undertaken to address the following:
Issues regarding effectiveness, either of the class as a whole or of the relative effectiveness of agents within the class
Issues regarding safety, either of the class as a whole or of the relative effectiveness of agents within the class
Issues that affect resource use concerns regarding inappropriate utilization of agents within a class.
To inform drug listing and drug policy decisions and to encourage optimization of drug therapy.

8. CADTH Therapeutic Reviews
A review of the most recent, publicly-available evidence on:
A drug class (e.g. biologics for rheumatoid arthritis)
A therapeutic category (e.g., drug therapies for RRMS)
Outputs:
Science report (Clinical and Economic)
Recommendations
Knowledge Mobilization Tools

9. CADTH’s Therapeutic Review Approach
Topic Identification, Refinement and Prioritization Phase
Patient Input
Research Phase
Recommendations Phase
Knowledge Mobilization Phase
* Multiple Opportunities for Stakeholder Input throughout the process

10. How are topics chosen for Therapeutic Reviews?

11. Identification of Topics for Therapeutic Reviews
Topic Identification
CADTH Staff (PDOs, LOs)
Policy Makers, Government
CDEC, CDR
Environmental Scans, Horizon Scans

12. Topic Selection Criteria
Relevance
Jurisdictional need
Timeliness
Meet requested timelines
If required to be aligned with CDR
Impact
Clinical practice
Population
Cost impact on healthcare system
Duplication of effort
Anticipated uptake of recommendations

13. CADTH Therapeutic Review Project Team
Clinical Researchers
Health Economists
Scientific Advisor
Information Specialist
Program Development Officer
Project Manager
CDEC Discussants (2 technical members, 1 public member)
Specialist/ Clinical Experts (typically 2- 3)
Knowledge Mobilization Officer

14. How can patients become involved in the therapeutic review process?

15. Patient Input
Pilot process for therapeutic reviews initiated in 2012 (MS Therapeutic Review) – evaluation of process currently underway
Reasons for seeking Patient Input for CDR Submissions and Therapeutic Reviews:
Identify unmet needs of existing therapy
Identify treatment outcomes of greatest importance

16. Patient Input (cont’d)
Types of information collected
Impact of Condition
Impact on Caregivers
Patients’ Experiences With Current Therapy
What Are the Expectations for the New Drug or What Experiences Have Patients Had to Date With the New Drug?

17. Patient Input (cont’d)
Patient input is used to ensure elements of the project scope reflect values/needs of patients (e.g., outcomes)
A summary is incorporated into the Therapeutic Review Science Report, which is posted on the CADTH website.
All patient group input submissions in their entirety are posted on the CADTH website at the same time as the related Therapeutic Review Science Reports.
CDEC public member presents information submitted by patient groups to the committee and patient values and preferences are raised throughout the deliberations

18. What is the role of other stakeholders (manufacturers, health care providers) in the therapeutic review process?

19. Stakeholder Engagement
Opportunities for Project Feedback (10 business days):
Proposed Project Scope
List of included studies
Draft Science Report
Draft Recommendations Report

20. Stakeholder Engagement (cont’d)
Therapeutic Review Process
Stakeholders
Patient Groups
Public
Health Care Providers
Industry
Project Scoping
Topic Refinement
 Clinical experts
Proposed Project Scope 
Active Research Phase
List of Included Studies
Draft Science Report (clinical and economic)
Recommendations Phase
Draft Recommendations Report  

21. How are Therapeutic Review Recommendations/Advice developed?

22. Canadian Drug Expert Committee (CDEC)
Composed of individuals with expertise in drug therapy, drug evaluation, drug utilization, along with two public members
Patient input is presented by public member to CDEC
Specialists/Clinical Experts (typically involved as part of the project team) are invited to attend CDEC meetings for Therapeutic Reviews

23. CDEC (cont’d)
Therapeutic Review Reports are used by CDEC in the following ways:
To address policy questions raised by jurisdictions
Information for making recommendations or providing advice regarding the class of drugs included in the therapeutic review
As background for making a listing recommendation regarding a submission to CDR for a drug that is included in the therapeutic review

24. What happens after Therapeutic Review recommendations/advice are finalized?

25. Therapeutic Review Recommendations/Advice
CADTH is an independent, not-for-profit organization responsible for providing Canada’s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs
Recommendations from CADTH Therapeutic Reviews are non-binding
Participating drug plans make their policy decisions based on the CADTH recommendations and other factors, such as drug plan mandates, jurisdictional priorities, and budget impact.

26. Knowledge Mobilization
Project in Brief reports are posted to CADTH website
Other knowledge mobilization tools may be developed upon request of CADTH customers
CADTH Liaison Officers situated across Canada to support knowledge transfer activities

27. Summary
CADTH follows a transparent Therapeutic Review process that incorporates multiple opportunities for stakeholder input
Topics for therapeutic reviews are selected based on jurisdictional need and incorporate clinical experts in the refinement of the project.
Pilot patient input process was introduced for the MS Therapeutic Review in 2012