C1 - Transparency - Sabharwal - Salon B

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  • 1. Transparency in Health Technology AssessmentMona SabharwalMay 6, 2013CADTH Symposium
  • 2. 2013 Copyright pan-Canadian Oncology Drug ReviewWhy have transparency in HTA?• Values based assessment whose values how applied what was considered• Legitimacy and trust public and patients have right to know quality and nature ofinformation may not agree with outcome but need to ensure process wasfair• Quality transparency forces attention to be paid to quality, leading tobetter decision making2
  • 3. 2013 Copyright pan-Canadian Oncology Drug ReviewpCODR’s Approach to Transparency• pCODR has committed itself to transparency and the needto be accountable to patients and the public, andresponsive to industry• pCODR considers it essential that the evidence upon whichpERC recommendations are based be publicly available• Accountability for Reasonableness (A4R)• ethical framework used by pCODR to enact one of GuidingPrinciples• publicity as a component of a fair process involves internal andexternal transparencyQuestion: how much transparency is enough?3
  • 4. 2013 Copyright pan-Canadian Oncology Drug ReviewpCODR Review ProcessUpdated March 31, 20111. ConductPre-SubmissionPlanningactivitiesincludinggettinginput fromPAG andnotifyingPatientAdvocacyGroups2. Prepare& submitRequestfor DrugReview4.2ConductEconomicReview5.Summarize& Reviewwith pERC6. Prepare &PubliclyPost InitialRecomm,PostReviews8. Summarize& Review withpERC3.1 ScreenSubmissionand InitiateReviewProcessEnd‡Industry/TumourGrouppCODR*Variable 5 business days 70-90 business days 12 business days 10 business days 20 business days7.1 GetFeedbackfromSubmitter(and impactedmanufacturer)7.3 GetFeedbackfrom PatientAdvocacyGroup7.2 GetFeedbackfrom PAGPatientAdvocacyGroups9. Prepare &Publicly PostFinalRecomm &Post Input12 business days*Includes pCODR Secretariat, ClinicalGuidance Panel, Economic Guidance Panel,pCODR Expert Review Committee (pERC)and Provincial Advisory Group (PAG)4.1.1/4.2.2Clarify infowithSubmitterduringreview4.1ConductClinicalReview3.2 CollectPatientAdvocacyGroupInputEstimated99 – 149business days7.4Eligible forEarlyConversion?No Yes‡Next steps could includeRecommendation implementation,Procedural Review or Resubmission4© 2013pan-Canadian Oncology Drug Review
  • 5. 2013 Copyright pan-Canadian Oncology Drug ReviewPublic posting of review information• Initial pERC recommendation: key messages, summary of pERCdeliberations, relevant background information• Full clinical guidance report• Summary of economic guidance report:• List price• manufacturer and EGP estimates of cost-effectiveness• Final pERC recommendation: key messages, summary of pERCdeliberations, relevant background information• All feedback by stakeholder submitted on an initialrecommendation• Conflicts of Interest of any review participant (no dollar amounts)• pCODR staff, PAG members, clinical and economic guidance panelists, patientadvocacy groups, pERC members5
  • 6. 2013 Copyright pan-Canadian Oncology Drug ReviewpCODR Disclosure of Information Guidelines –Principles• Submitters should keep to a minimum the types and volumeof information they consider to be non-disclosable• Submitters are accountable for self-identifying thatinformation which they consider to be non-disclosable• pCODR recognizes and respects that information ownersretain right to make final decision in relation to release ofinformation into public domain• pCODR reserves right to determine how non-disclosableinformation is used in pERC deliberations, if at all6
  • 7. 2013 Copyright pan-Canadian Oncology Drug ReviewExperiences to Date: Summary of Redactions (as of Mar 31, 2013)Generic Name / BrandNameIndication Recommendation Clinical Report Economic ReportPazopanib (Votrient) mRCC confidential price none confidential priceHR for OS/PFSIpilimumab (Yervoy) melanoma economiccomparatornone economic comparatortime horizonSunitinib (Sutent) pNETS none none noneVemurafenib (Zelboraf) melanoma none time limited ICEReconomic comparatorEribulin (Halaven) MBC confidential price none confidential pricesensitivity analysesEverolimus (Afinitor) pNETS none none HR for OS/PFSCrizotinib (Xalkori) NSCLC confidential price none confidential pricesensitivity analysisBendamustine (Treanda) NHL none safety sensitivity analysesBendamustine (Treanda) CLL none safety sensitivity analysesPazopanib (Votrient) STS none none NoneRuxolitinib (Jakavi) myelofibrosis none none time horizonBendamustinge(Treanda) 1st line CLL none safety modeling assumptionAxitinib (Inlyta) mRCC none indirect comparison none•7
  • 8. 2013 Copyright pan-Canadian Oncology Drug ReviewpCODR’s Approach to Transparency – ProcessIssues• formal process step, submitter and pCODR dialogue in-person• 10-day dispute resolution period to have clear, up-front understanding ofuse of non-disclosable information• if submitter still decides information cannot be disclosed, it will not beincluded in information going to deliberative committee• Important safety information is exempt• under exceptional circumstances, information that owner has decided notbe allowed into public domain could be accepted for inclusion underagreement of confidentiality through time-limited redaction e.g., journalhas publication embargo8
  • 9. 2013 Copyright pan-Canadian Oncology Drug ReviewData sources beyond published literature• FDA review• EMA’s EPAR• Manufacturer on-file data• Peer reviewed meeting abstracts and oral presentations• Company trial registry information• Lead investigatorNotably missing: Health Canada review Investigators from Cooperative Groups/Research Consortia9
  • 10. 2013 Copyright pan-Canadian Oncology Drug ReviewPractical Issues with Transparency• Requires commitment, time and resource, but not “hard”• Submitters need to be thoughtful in putting submissiontogether (not a data dump)• Reviewers need to be thoughtful in questions they ask (nota data dredge)• Timing of data availability can manage many issues ofdisclosure10
  • 11. 2013 Copyright pan-Canadian Oncology Drug ReviewTransparency in HTA – what’s next?• Easier retrieval of clinical data• trial registries detailing results• open data• regulatory submissions especially for new indications• More consistent economic information for disclosure• Better COI information non-pharma research funding sources• non-commercial interests• Open deliberative meetings• consider timeliness of reviews, resource requirements11