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?

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

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 Research Phase Recommendations Phase Knowledge Mobilization Phase * Multiple Opportunities for Stakeholder Input throughout the process

How are topics chosen for Therapeutic Reviews?

Identification of Topics for Therapeutic Reviews Topic Identification CADTH Staff (PDOs, LOs) Policy Makers, Government CDEC, CDR 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    Clinical experts Proposed Project Scope  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 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