Download Kristen Chelak

CADTH Therapeutic Reviews
PROCESS OVERVIEW
2015 CADTH Symposium
April 13, 2015
Kristen Chelak
CADTH: Manager, Program and Policy Development
Objectives
• To provide an overview of why CADTH is undertaking
Therapeutic Reviews
• To provide an overview of the CADTH Therapeutic Review
framework and process
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?
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
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
WHAT ARE CADTH THERAPEUTIC REVIEWS?
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.
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
CADTH’s Therapeutic Review Approach
Topic Identification, Refinement and Prioritization Phase
Patient Input
* Multiple
Opportunities for
Stakeholder
Input throughout
the process
Research Phase
Recommendations Phase
Knowledge Mobilization Phase
HOW ARE TOPICS CHOSEN FOR THERAPEUTIC
REVIEWS?
Identification of Topics for Therapeutic
Reviews
Policy Makers,
Government
CDEC, CDR
CADTH Staff
(PDOs, LOs)
Topic
Identification
Environmental
Scans, Horizon
Scans
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
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
HOW CAN PATIENTS BECOME INVOLVED IN THE
THERAPEUTIC REVIEW PROCESS?
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
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?
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
WHAT IS THE ROLE OF OTHER STAKEHOLDERS
(MANUFACTURERS, HEALTH CARE PROVIDERS) IN
THE THERAPEUTIC REVIEW PROCESS?
Stakeholder Engagement
• Opportunities for Project Feedback (10 business days):
• Proposed Project Scope
• List of included studies
• Draft Science Report
• Draft Recommendations Report
Stakeholder Engagement (cont’d)
Therapeutic Review
Process
Stakeholders
Patient
Groups
Public
Health Care Providers
Industry
Project Scoping
Topic Refinement
Proposed Project Scope


 Clinical experts


Active Research Phase
List of Included Studies
Draft Science Report
(clinical and economic)








Recommendations Phase
Draft Recommendations
Report




HOW ARE THERAPEUTIC REVIEW
RECOMMENDATIONS/ADVICE DEVELOPED?
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
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
WHAT HAPPENS AFTER THERAPEUTIC REVIEW
RECOMMENDATIONS/ADVICE ARE FINALIZED?
Therapeutic Review
Recommendations/Advice
• CADTH is an independent, not-for-profit organization
responsible for providing Canada’s health care decisionmakers 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.
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
www.cadth.ca/contact-us/liaison-officers
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
28