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C4 - Disruptive Health Technologies Implications for HTA - Levin - Salon G
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C4 - Disruptive Health Technologies Implications for HTA - Levin - Salon G


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  • 1. www.HQOntario.caLeslie Levin MD, FRCP (Lon), FRCPCVice President, Evidence Development and Standards,Health Quality OntarioProfessor of Medicine, University of TorontoStaff Medical Oncologist, Princess Margaret HospitalDisruptive Health TechnologiesImplications for HTACADTH Symposium, May 6-7th 2013
  • 2. 1Disruptive Technology (Christensen, 1997)• Radically transforms markets, creates wholly new markets ordestroys existing markets
  • 3. 2Behavioural Dynamics of AdoptionBarriers• Resistance to change/ Inherent conservativism• Infrastructure malaiseFacilitators• Institutional and professional profiling• Public expectation• Patent laws and limited market exclusivity for non-drugtechnologies
  • 4. 3Barriers to AdoptionPoor pre-market quality clinical trial produceuncertainty• Accuracy versus clinical utility for diagnostic tests• No prospective economic analysis• Research failed to address health system perspectives• Me-too technologies• Lack of generalisability• Inadequate trial design e.g. randomization,concealment, ITT – leading to low quality evidencePolicy including non-affordability,competing pressures
  • 5. Health Technology Life-Cycle Diffusion CurveUTIMER&DDiffusionSteadyStateInflection PointabcUnconditional YesUncertaintyUnconditional NoFieldStudyEvidence& Uncertainty4
  • 6. 5>110 Single Technology Analyses by MAS, PATH &THETA92% Conversion to Policy
  • 7. GRADE(Quality of EvidenceFollowing SystematicReview)Will Further ResearchChange Confidence inthe Estimate?Level of UncertaintyUncertainty Drove Field Evaluation StudiesRecognizing Uncertainty – Effect of GRADE6UncertaintyHighModerateLowVery LowVery unlikelyLikelyVery LikelyAny estimate of effectis very uncertainCertainty
  • 8. 7“Something is Rotten in the State of Denmark”– Hamlet Act 1, Scene 4• Does HTA cover the full spectrum ofevidence required to inform decisionmaking?• RCTs assess efficacy within a“perfect world.” How do we dealwith generalizability/externalvalidity?• How to deal with low quality evidencefrom pre-market evaluation?
  • 9. Pg 8DeviceDevelopmentPre-clinical- Design- Prototyping- Efficacy andsafety testingDeviceManufactureand TestingClinical- Efficacy andsafety testingin patientsDeviceLicensingApplicationto approvesale/usePatients haveaccess to thedeviceMarketing, sales,distribution,education,trainingIs there analternative toEvidence PolicingUptake ofTechnologies?
  • 10. 9Investment RegulationLife-Cycle Diffusion Curve(Pre-Market Evidence Based Analysis)1TIMEDiffusionUnconditional YesUncertaintyR&DUnconditional NoObsolescenceHORIZONDEVELOPTESTUPre-Market Post-MarketSystematic reviewCost-Effectiveness (CE)Effectiveness• EfficacySafety• Value (CE)Affordability• Ethical &societal• Post marketconditionsSystematic reviewCost-Effectiveness (CE)E f f e c t i v e n e s s
  • 11. MaRS: Urban Innovation HubLinking Creative and Business Assets of TorontoDiscovery District Financial District Creative & Arts DistrictGardiner Museum of Ceramic ArtRoyal Ontario MuseumWomen’s CollegeThe MaRS CentreUHN Toronto GeneralHospital for Sick childrenEntertainment DistrictFour Seasons CentreUniversity of TorontoUHN Princess MargaretMount SinaiArt Gallery of OntarioRoyal Conservatory of MusicTIFF & OCADFinancial DistrictToronto RehabRyersonUniversityPg 10
  • 12. Memory at WorkSME and MNETechnologiesPrioritizationand Selectionby EXCITEBoardApplyReview byOHTACsubcommittee- Relevance- Disruptive potential- Identify obsolescence- Magnitude of effect onpatient outcomes andsystem efficiencies- Stage of readiness- OHTAC recommendations- Potential economic benefit- Feasibility- Capacity
  • 13. Memory at WorkSME and MNEIndustryPrioritizationand Selectionby EXCITEBoardApply*Evaluationby EXCITEMethodologicalCentresReview byOHTACsubcommitteeCommunication re - accrual, safety,and recommendations forimprovementMOHLTC andBroaderHealthSystem
  • 14. Pg 14• Assess usability/human factors• Develop education system fortraining end users• Investigate patient preferences• Analyze factors influencing ofuptake• Develop a registry for tracking post-adoption effectiveness + long-termssafety• Knowledge transfer• Safety + Effectiveness• Systematic Review• Economic AnalysisCompleted by:MethodologicalCentresCompleted by:Specialized MethodologicalCentresCore Evidentiary Bundle: Optional Additional Analyses:14
  • 15.  Increased likelihood of adoption Access to a coordinated network of world-class expertise in evaluation of health technologies Early feedback provides insight during formative stage Single, harmonized pre-market process•Duration and cost depends on complexity and protocol design•Evaluations typically require 12-30 months to complete•Company pays the cost which range from C$1-3 million•Consideration for defining conditions of adoption pre-marketPg 15
  • 16. EXCITE - Progress in Year One Endovascular renal nerve ablation Home based apnoea diagnostic RNA disruption to predict chemotherapy response IV delivery not gravity/ electricity/ battery dependent Rapid recovery from stroke in hand/upper limb MRI-guided RTMS for treatment refractory depression Hand held device to detect pneumothorax and fluid IT system to track hospital acquired infections Remote ischemic conditioning Point of care diagnosis of infection in wounds
  • 17. Memory at WorkPg 17 Pg 17Represented Group MembersMaRS BoardRichard Ivey (Chair)Ilse Treurnicht,EXCITE Chief Scientific Officer Dr Leslie LevinIndustry: MEDEC (MNEs)HTX (SMEs)Brian Lewis, Peter RobertsonJohn Soloninka, Peter GoodhandGovernment: MOHLTC,MEDIADM Vasanthi SrinivasanADM Bill MantellHealth System: OHTAC Dr Charles WrightAcademia: Council of Academic Hospitalsof Ontario (CAHO)Karen Michell, Catherine Zahn
  • 18.