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

VisionHealth 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 ReviewsTherapeutic 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

* Multiple Opportunities for Stakeholder Input throughout the process

HOW ARE TOPICS CHOSEN FOR THERAPEUTIC REVIEWS?

Identification of Topics for Therapeutic Reviews

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)

Impact of Condition

Patients’ Experiences With Current Therapy

Impact on Caregivers

What Are the Expectations for the New

Drug or What Experiences Have

Patients Had to Date With the New Drug?

Types of information collected

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

StakeholdersPatient Groups

Public Health Care Providers Industry

Project ScopingTopic Refinement

Clinical experts

Proposed Project Scope

Active Research Phase

List of Included Studies

Draft Science Report (clinical and economic)

Recommendations PhaseDraft 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 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.

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

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