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D5   gavura mc auley - indiv pt. funding programs - salon d

D5 gavura mc auley - indiv pt. funding programs - salon d






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    D5   gavura mc auley - indiv pt. funding programs - salon d D5 gavura mc auley - indiv pt. funding programs - salon d Presentation Transcript

    • Individual Patient Funding Programs:Policy ConsiderationsMay 7, 2013Presented by:Glenn McAuley, Senior Pharmacist, Drug Programs Services, Ontario Public Drug ProgramsScott Gavura, Director, Provincial Drug Reimbursement Programs, Cancer Care OntarioPresented to: CADTH Symposium, St. John’s, NL
    • AcknowledgementsRohini NaipaulPharmacist, Provincial Drug Reimbursement Programs, CCOSherry O’QuinnSenior Pharmacist, Drug Programs Services, OPDPLyndee YeungProgram Manager, Provincial Drug Reimbursement Programs, CCOBrent FraserDirector, Drug Program Services, OPDPAmanda ChanProject Coordinator, Provincial Drug Reimbursement Programs, CCO2
    • Overview How does Ontario structure its public drug programs? Why “exceptional” and “compassionate” access? Why develop a policy and program just for cancer drugs? How is Ontario’s Case-by-Case Review program structured? How does it compare to the rest of Canada? What international examples exist? What are the policy lessons?3
    • Key facts of Ontario’s Public Drug ProgramsSeveral distinct programs• e.g. Ontario Drug Benefit (ODB) Program, New Drug Funding Program (NDFP)• The ODB program includes the Exceptional Access and Trillium Programs$4.3 billion in expenditures• Almost 10% of total provincial healthcare spending3.5 million recipients• Including 2 million seniors3,800 distinct DINs funded on the ODB formulary• Additional 850 DINs through the Exceptional Access Program4
    • The Evolution of “Exceptional Access”“Section 8”IndividualClinicalReviewExceptionalAccessProgram5
    • Growth of the Exceptional Access Programfrom 2000 to 201028 37 58 65 84 99 106 87 108 1265079941241431601931731911630501001502000501001502002000-01 2001-02 2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09 2009-10#RequestsReceived(inthousands)#ofEAPBeneficiaries(inthousands)Fiscal YearEAP beneficiaries EAP requests received6
    • Why a “Compassionate Review Policy”?Why• Rare circumstances• Immediately life-, limb-, or organ-threatening conditions• No funded drug, and no funding review expected (i.e., off-label use)What• Considers funding requests in absence of formal review• Not intended to circumvent normal funding consideration processesHow• Criteria* developed to promote consistent and fair decisions• Some published evidence to support use must be provided7Refer to full policy at: http://www.health.gov.on.ca/en/pro/programs/drugs/pdf/compassionate_review_policy.pdf
    • All 5 criteria must be met for CRP consideration8CRPEligibilitySeveritySufficientevidenceClinicalalternativesFundingalternativesCostRefer to full policy at: http://www.health.gov.on.ca/en/pro/programs/drugs/pdf/compassionate_review_policy.pdf
    • EAP requests reviewed by the CRP: from 2009-20131,196 requestsassessed744 requestsapproved81 drugsfunded$1.3M inexpenditures(2009-10 only)9
    • Why develop a special program for cancer?CRP applies to treatments provided by outpatient pharmacies only• Not intended for hospital- or NDFP-based IV treatments• No compassionate access mechanism to fund cancer drugs outside of NDFP criteriaCRP interpretation is challenging in the context of cancer• Most or all cancers are compassionate “life-threatening” cases by default• Criteria is not disease-specificCompassionate cancer cases are often unique• Difficulty in obtaining disease-site expertise• Time-consuming process for EAP pharmacists to research requests10
    • The evolution of “compassionate” access tocancer drugsCCO PilotedSpecialAccessProgram• 2002-3ProposedSpecialAuthorizationProgram• 2006CRP Policypublished• 2009CCO-OPDPPolicy work• 2009-10CBCRPLaunch• 201111
    • OPDP/CCO policy work identified how CRP could beadapted to cancer drugsDose/regimenmodification65%Not fundable30%Compassionate5%Special funding requests received by CCO2009/1012
    • The Case-by-Case Review Program ProposalPolicy• Extends and adapts CRP to hospitals• Accepts requests for oral and injectable drugs• Rare clinical circumstances, no other funded options• Immediately life-threatening situations• Not intended to fund in advance of formal evaluation through otherchannels (e.g. pCODR)Eligibility• For all Ontario residents:• NDFP (hospital therapies)• ODB (out-patient therapies)Method ofapplication• Treating physician submits request via CCO website13
    • Cancer-specific adjudication criteriaCBCRPEligibilityDrugClinicalPresentationEvidenceClinicalAlternativesFundingAlternativesCost14Refer to the full policy at www.cancercare.on.ca/cbcrp
    • CBCRP Consideration processPhysician uploadsrequestRequest screened byCCO pharmacistLiterature searchand summaryconductedRequest forwardedto up to 3 clinicalexpertsAt least 2 reviewersmust supportrequestEvaluation andrecommendation toMOHLTCExecutive OfficerDecisionCCO notifiesphysician andhospital (as req’d)Public fundingcommences15Appeal Process
    • Policy and program challengesPhysician uploadsrequestRequest screened byCCO pharmacistLiterature searchand summaryconductedRequest forwardedto up to 3 clinicalexpertsAt least 2 reviewersmust supportrequestEvaluation andrecommendation toMOHLTCExecutive OfficerDecisionCCO notifiesphysician andhospital (as req’d)Public fundingcommences16Appeal Process
    • CBCRP Results: Nov 2011 to Feb 2013101 requestsfor funding28 approvedrequests14 drugs funded(oral and injectable)$490,542projectedexpenditure$261,270actualexpenditure11-dayturnaround17
    • 9 provinces surveyed7 provinces offer similar programsMore than 6,700patients funded per year**depending on the definitionHow does the rest of Canada do it?18
    • PatienteligibilitycriteriaApplicationprocessEvaluation& reviewFinaldecisionmakerOpportunityfor appealPrograms and policies are more different thanthey are similar19
    • Do any of the following inform your eligibilitycriteria or decision-making process?Patient denied from clinical trials,Manufacturer access programs, etc.20
    • The adjudication processStandard sequence of events: Evaluation and review by group or individual medical consultant(s) Final decision made by head of programAdvisorycommitteeMedicaldirectorMedicalconsultantExecutivedirector/officer0 1 2 3# of provincesDecision-makers21
    • Opportunities to appealOncology physiciansSr. medical officerProgram directorCommittee chairMedical director Committee chairClinical expertsTumour groupSystemic treatmentdesignateAppeal assessment22
    • How does Canada compare internationally?23
    • England’s Cancer Drugs Fund is the closestinternational comparator• Fund drugs not reviewed by NICE• Fund drugs not recommended by NICE• Interim approach to new national funding schemeWhy• National list of drugs/indications routinely funded• Special application process for unfunded drugs• £200m/year budget, ends March 2014What• Was a regional program, national as of April 1• Standard Operating Procedure• Reviewed by panels of clinicians; appeal process in placeHow• Rare conditions (<20/year in England) OR• Off-label use and no national policy on use OR• “Clinical exceptionality”Who24Refer to the Standard Operating Procedures at http://www.england.nhs.uk/wp-content/uploads/2013/03/cdf-sop.pdf
    • What are the key learnings?• Craft your policy carefully• Be specific: what’s eligible and what’s not• Rely as much as possible on objective criteria• Public commitments to transparency are preferred• Consult to ensure policy is well understood• Expert clinician engagement in the process adds credibility to evaluations• Reviewer training and review templates help ensure consistency in reviews• Establish an appeal process• Don’t underestimate the complexity and workload required• Commit to performance measures and report on them25
    • For more informationPolicies:OPDP’s Compassionate Review Policy:http://www.health.gov.on.ca/en/pro/programs/drugs/pdf/compassionate_review_policy.pdfCCO’s Case-by-Case Review Program:http://www.cancercare.on.ca/toolbox/drugs/cbcrp/Contacts:glenn.mcauley@ontario.cascott.gavura@cancercare.on.ca