Presentation on theme: "CADTH Therapeutic Reviews"— Presentation transcript:
1 CADTH Therapeutic Reviews Process Overview2015 CADTH SymposiumApril 13, 2015Kristen ChelakCADTH: Manager, Program and Policy Development
2 ObjectivesTo provide an overview of why CADTH is undertaking Therapeutic ReviewsTo 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 CADTHIndependent, not-for-profit organizationMajor producer of HTA for drugs, devices, diagnostics, and proceduresRecognized globally as a leader in HTAFunded by Health Canada, Provinces and TerritoriesVisionHealth Technology Assessment informs every health technology decision
5 CADTH Products and Services CDR/pCODRDrug therapeutic reviewsRapid response serviceEnvironmental and horizon scansMini-HTA, full HTA, and optimal use reportsHTA coordination and brokering servicesHTA methods guidance documentsEducation and training on HTA
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 classIssues regarding safety, either of the class as a whole or of the relative effectiveness of agents within the classIssues 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)RecommendationsKnowledge Mobilization Tools
9 CADTH’s Therapeutic Review Approach Topic Identification, Refinement and Prioritization PhasePatient InputResearch PhaseRecommendations PhaseKnowledge Mobilization Phase* Multiple Opportunities for Stakeholder Input throughout the process
11 Identification of Topics for Therapeutic Reviews Topic IdentificationCADTH Staff (PDOs, LOs)Policy Makers, GovernmentCDEC, CDREnvironmental Scans, Horizon Scans
12 Topic Selection Criteria RelevanceJurisdictional needTimelinessMeet requested timelinesIf required to be aligned with CDRImpactClinical practicePopulationCost impact on healthcare systemDuplication of effortAnticipated uptake of recommendations
13 CADTH Therapeutic Review Project Team Clinical ResearchersHealth EconomistsScientific AdvisorInformation SpecialistProgram Development OfficerProject ManagerCDEC 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 InputPilot process for therapeutic reviews initiated in 2012 (MS Therapeutic Review) – evaluation of process currently underwayReasons for seeking Patient Input for CDR Submissions and Therapeutic Reviews:Identify unmet needs of existing therapyIdentify treatment outcomes of greatest importance
16 Patient Input (cont’d) Types of information collectedImpact of ConditionImpact on CaregiversPatients’ Experiences With Current TherapyWhat 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 ScopeList of included studiesDraft Science ReportDraft Recommendations Report
20 Stakeholder Engagement (cont’d) Therapeutic Review ProcessStakeholdersPatient GroupsPublicHealth Care ProvidersIndustryProject ScopingTopic Refinement Clinical expertsProposed Project ScopeActive Research PhaseList of Included StudiesDraft Science Report (clinical and economic)Recommendations PhaseDraft 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 membersPatient input is presented by public member to CDECSpecialists/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 jurisdictionsInformation for making recommendations or providing advice regarding the class of drugs included in the therapeutic reviewAs 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 drugsRecommendations from CADTH Therapeutic Reviews are non-bindingParticipating 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 websiteOther knowledge mobilization tools may be developed upon request of CADTH customersCADTH Liaison Officers situated across Canada to support knowledge transfer activities
27 SummaryCADTH follows a transparent Therapeutic Review process that incorporates multiple opportunities for stakeholder inputTopics 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