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E5  cadth ebp panel - sherry o'quinn  - salon d

E5 cadth ebp panel - sherry o'quinn - salon d






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    E5  cadth ebp panel - sherry o'quinn  - salon d E5 cadth ebp panel - sherry o'quinn - salon d Presentation Transcript

    • Challenges, Lessons Learned, and OpportunitiesA Public Funder’s PerspectiveMay 7, 2013Sherry O’QuinnSenior Pharmacist, Ontario Public Drug Programs
    • Landscape: Evidence Building Program in Ontario• Concept of coverage with evidence building means different things todifferent people• International experience• Local experience• Perspective – different goals/priorities between stakeholders• Cancer drug funding in Ontario is a complex environment• Launch of a new program to the landscape brings additional complexity• Setting clear expectations – develop a common understanding of what theprogram is intended to do• Complement the existing evidence-based review process
    • What has gone through the process?EBPproposalsRevisitPLA (3)Funded(2)Pending(1)Did notmeetcriteria(1)Redirectedto ClinicalTrials (1)
    • Sample Reasons for Approval vs. Rejection- Evidence generalizable butsafety not established- Endpoints are clearlydefined, are measurable, andare sufficiently robust tojustify funding or stopping- Implementation is feasible- Lack of expert consensus- Small patient numbers- Long follow-up needed- Existing trials have alreadyanswered the question- Clinical trial intent- Product listing agreementmore appropriate
    • What we have learned: successesMinistry, CCO,Disease SiteGroupcollaborationStakeholderengagementand consultationPotential issuesaddressed inthe program/policydevelopmentphaseCommunicationandTransparencyTwo drug-indications havebeen fundedThere is muchmore to learn…
    • What we have learned: challenges• The devil is in the details…• Proposal development – relevant, timely outcomes for patients,clinicians and decision makers• Limits to outcomes that we can collect• Some questions cannot be answered through EBP• Defining stopping rules a priori• When best to engage stakeholders: manufacturers, external analytics• Logistics of using external analytics group vs. developing internalcapacity• Implementation and knowledge transfer
    • Opportunities• Oral drugs• Evaluate the program/policy after a few products complete thecycle• Stakeholder input• Pushing the current boundaries• Sharing experiences and collaborating with other jurisdictions