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ROUBAIXSTRATEGIESINC.
Roubaix[ru-bae]:
• The“Paris-Roubaix”isoneofthemostdifficultsingle-dayprofessionalcyclingracesintheworld. Atmorethan250km,cyclistsmusttransitionbetweenpavedroadsandcenturies-oldcobblestonepaths. JustlikemarketaccessinCanada,negotiatingthesechallengingconditionsrequiresstrategicplanning, carefulpreparation,superiorteamwork, andabitofcourage.
TheRoadtoMarketAccess
1. Overview2. Regulatory3. Pricing4. Budgets5. HealthTechnologyAssessment(HTA)6. Patients7. Pan-CanadianPharmaceuticalAlliance(pCPA)8. PrivateDrugPlans
AccesstoInnovativeMedicinesinCanada:FromConcepttoMarket
HC HTA pCPA PLAs pCPARenegotiations?
LOE
20-YEARPATENTTERM
PublicDrugPlanReimbursement
PMPRB/PRICING
8-12YEARS 12-8YEARS
PrivateDrugPlanReimbursement
©RoubaixStrategies Inc.Allrights reserved.
Thousandsofcandidates Pre-Clinical– Clinical(Ph1-3)
PMPRB=PatentedMedicinesPricesReviewBoard;HC=HealthCanada;pCPA=pan-CanadianPharmaceuticalAlliancePLAs=ProductListingAgreements;LOE=LossofExclusivity;HTA=HealthTechnologyAssessment;
AccesstoInnovativeMedicinesisGenerallyLongerinCanadavs.CountrieswithComparableHealthcareSystems
Source:InnovativeMedicinesCanada,AccesstoNewMedicinesinPublicDrugPlans:CanadaandComparableCountries,2016AnnualReport
1Familyphysicians/generalpractitionersandotherswhoprescribedrugsindifferentsettings,includingthehospitalenvironment2pan-CanadianOncologyDrugReview3LocalHealthIntegrationNetworksinOntario4Includesorganizationssetuptoadviseinsurers/employerssuchaspharmacybenefitmanagers,benefitadvisors
MarketAccess:TheMostImportantFunctioninCanadianDrugReimbursement
Stakeholder Description 2008 2013 2018Practitioners:Physicians FP/GPs1 , specialists, residents 5.0 3.0 2.0 Pharmacists Hospital/community pharmacy 0.5 0.5 0.5 Nurses RNs, nurse practitioners 0.0 0.0 0.0Payers/Managers:
Government Drug Plans Federal/provincial/territorial (includes cancer agencies) 3.0 3.0 2.5
Drug Approval/Advisory Groups
pCPA, Common Drug Review, pCODR2
and government drug expert groups 0.5 1.5 2.0
Regional Health Authorities Different provincial models (e.g. Alberta Health Services, LHINs3) 0.0 0.0 0.0
Private Drug Plans Insurers, employers and other third parties4 1.0 1.0 1.5
Consumers: Consumers at large, and organizations (seniors’/women’s groups, disease associations, consumer groups)
0.0 1.0 1.0 Consumers/Disease Groups
Total 10.0 10.0 10.0Source:IMSBrogan
SpecialtyDrugsAccountfor80%ofNewHTASubmissionsNoAmountofMarketingCanOvercomealackofDrugPlanFunding
3.5
5.5
1.0
CourtesyJanssenPharmaceuticals
BytheTimeaPatentedDrug/BiologicisApprovedbyHealthCanada,ithas~10yearsofMarketExclusivity
HC HTA pCPA PLAs pCPARenegotiations?
LOE
20-YEARPATENTTERM
PublicDrugPlanReimbursement
PMPRB/PRICING
8-12YEARS 12-8YEARS
PrivateDrugPlanReimbursement
©RoubaixStrategies Inc.Allrights reserved.
Thousandsofcandidates Pre-Clinical– Clinical(Ph1-3)
PMPRB=PatentedMedicinesPricesReviewBoard;HC=HealthCanada;pCPA=pan-CanadianPharmaceuticalAlliancePLAs=ProductListingAgreements;LOE=LossofExclusivity;HTA=HealthTechnologyAssessment;
HealthCanadaReviews
• HealthCanadareviewsDrugSafety,Efficacy,andManufacturingQuality• NOC=NoticeofCompliance;NOC/c=NOCwithConditions• ProductMonographsprovideinformationonapprovedindicationsforuse,(claimsthatcanbemadebythemanufacturer)clinicaldata,safetydata
• RegulatoryTransparencyisEvolving• HCreviewerreports:CADTHrequiresandisgrantedaccesstoreviewthese.• Listofdrugandhealthproductsubmissionsunderreview(SUR)hasbeenpostedsinceApril2015
• OnMarch9,2017proposestoproactivelymakecertainsubmittedclinicalinformationpubliclyavailablefollowingcompletedreviews
PharmaceuticalPricingOccursinaGlobalMarketWhichAffectsDecisionsMadeHere
Canadarepresents~2%ofglobalpharmaceuticalmarket1
Source: PMPRB 2015 Annual Report (published 2016)
CanadianPatentedMedicinesDrugPriceYOYChangesConsistentlyBelowtheCPI
CPI = Consumer Price IndexSource: PMPRB 2015 Annual Report (published 2016)
CanadianPatentedMedicinesDrugPricesareatParorLowerThanThreeComparatorCountries
Source: PMPRB 2015 Annual Report (published 2016)
ThereisGrowingAttentiononCanadian(andGlobal)DrugPricing
• PMPRBisconsideringunprecedentedchangestoitsscopeandmandate,asking:
• IsPMPRBrelevantintoday’smarket?
• Istheirmandateappropriateforensuring“non-excessive”pricing?
• Doesitneedtochangetoaddressquestionsofaffordability?
BUDGETSEVENBEFORESUBMISSIONSAREMADEFORDRUGREIMBURSEMENT,BUDGETIMPACTANDVALUEFORMONEYARETHEGROWINGFOCUSOFDRUGPLANS
DrugCostsAreRisingSlightly,ButTheirShareofTotalHealthCostsisDiminishing
1. Source:CIHI,NHEXdatabase,postedatIndustryCanada,2016.
15.0%
15.2%
15.4%
15.6%
15.8%
16.0%
16.2%
16.4%
16.6%
16.8%
17.0%
0
50
100
150
200
250
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014f 2015f
TotalHealthExpenditures TotalDrugExpenditures Drugs%ShareofTotalHealthExpenditures
$B %Drugs
PublicHealthcareSpendingCloseto40%ofProgramSpend
Theproportionofgovernment
expendituresallocatedto
healthcarehasstabilizedoverthe
lastdecade.
NoteFinancial Management System data is estimated for 2009 to 2015.SourcesNational Health Expenditure Database, Canadian Institute for Health Information; Financial Management System, Statistics Canada;provincial public accounts, budgets, main estimates.
HealthCanadaApprovesProductforSaleNoticeofCompliance(NOC)
ManufacturerReimbursementSubmissions
Requirementsvarybytypeofdrugplan
Public(Quebec)
INESSS ReviewsbeforeQuebecwillreimburse
PublicRestofCanada(ROC)
CADTH/pCODRbeforepublicdrugprogramswillreview&reimburse
Provincial,Territorial&FederalPublicdrugplans
(NegotiateReimbursementAgreements)
Pan-CanadianPharmaceuticalAlliance
(NegotiateLettersofIntent)
PrivateInsurers
Reimbursementcanvarybyplan
TheRoadtoPharmaceuticalMarketAccessinCanadaisComplex,TravellingThroughVariousChannelstoPatients
CriteriaHarmonization?Variability?ListingDelays?Value-BasedAgreements?
Pre-NOC?
InCanada,ThereisaGapBetweenDrugApprovalandPublicReimbursement
Percentage of new medicines launched and publicly reimbursed by country (IMC 2016 Annual Report)
Percentage of new biologic medicines launched and publicly reimbursed by country (IMC 2016 Annual Report)
IMC: ACCESS TO NEW MEDICINES IN PUBLIC DRUG PLANS: Canada and Comparable Countries (2016)
FormalPatientInputOccursForHTAReviews;YetEngagementExtendsThroughoutDrugLifecycle
HC HTA pCPA PLAs pCPARenegotiations?
LOE
20-YEARPATENTTERM
PublicDrugPlanReimbursement
PMPRB/PRICING
8-12YEARS 12-8YEARS
PrivateDrugPlanReimbursement
©RoubaixStrategies Inc.Allrights reserved.
Thousandsofcandidates Pre-Clinical– Clinical(Ph1-3)
PMPRB=PatentedMedicinesPricesReviewBoard;HC=HealthCanada;pCPA=pan-CanadianPharmaceuticalAlliancePLAs=ProductListingAgreements;LOE=LossofExclusivity;HTA=HealthTechnologyAssessment;
ReimbursementStrategy&NegotiationDevelopmentTimelines
-2yrs-3-6mos.NOC +3-6mos.+6mos.+1yr.
Pre-substrategyProcess
pCPANegotiations
HTARecommendation
ProvincialListings
HTASubmission
ProvincialSubmissions
Reimbursementstrategyconsiderations• ValueProposition• Anticipatedmarketdynamicsandcompetitiveset• Commercialstrategy• Payerenvironment• HealthEconomicModeling• Datagaps/planstoaddress
272727CourtesyJanssenPharmaceuticals
NegotiationTimeframesCanVary,andClosedDealsMayBeRevisitedasMarketChanges
HC HTA pCPA PLAs pCPARenegotiations?
LOE
20-YEARPATENTTERM
PublicDrugPlanReimbursement
PMPRB/PRICING
8-12YEARS 12-8YEARS
PrivateDrugPlanReimbursement
©RoubaixStrategies Inc.Allrights reserved.
Thousandsofcandidates Pre-Clinical– Clinical(Ph1-3)
PMPRB=PatentedMedicinesPricesReviewBoard;HC=HealthCanada;pCPA=pan-CanadianPharmaceuticalAlliancePLAs=ProductListingAgreements;LOE=LossofExclusivity;HTA=HealthTechnologyAssessment;
ThepCPAisFacingGreaterNumbersofDrugsWaitingforNegotiationspCPANegotiationMix:AsofDec31,201681%ofdrugsundernegotiationswiththepCPAareSpecialtyDrugs.Currently~40+DrugsinActiveNegotiations– MorewaitingWait-timesaregoingup:someestimatesindicate~threemonthsUnclearOperatingFrameworkforpCPA’s MandateandObjectives
Specialtydrugsaregenerallydefinedasthoseproductswithanannualcost> $10,000
68%
45%
23% 14%
5%
75%
46%
25%8%
64%
41%
23%
0%
25%
50%
75%
100%
INDEXMONTH 3MONTHS 6MONTHS 9MONTHS 12MONTHS* 18MONTHS*
Sep2015 Dec2015 Mar2016
4of10DrugsRemaininpCPANegotiationsSixMonthsAfterEngagement
*12&18months:threeandonedrugrespectively**AsofDecember31,2016©RoubaixStrategiesInc.2017contact:[email protected]
%ofDrugsRemainingInpCPANegotiationsAfter“IndexDate”
22drugs
22drugs
24drugs
Now43drugproductsinActiveNegotiations**
ArepCPAObjectivesClear?
pCPAObjectives(Website):
1. Increaseaccesstodrugtreatmentoptions;
2. Achievelowerdrugcostsandconsistentpricing,and
3. ImproveconsistencyofcoveragecriteriaacrossCanada.
HealthCanadaApprovesProductforSaleNoticeofCompliance(NOC)
ManufacturerReimbursementSubmissions
Requirementsvarybytypeofdrugplan
Public(Quebec)
INESSS ReviewsbeforeQuebecwillreimburse
PublicRestofCanada(ROC)
CADTH/pCODRbeforepublicdrugprogramswillreview&reimburse
Provincial,Territorial&FederalPublicdrugplans
(NegotiateReimbursementAgreements)
Pan-CanadianPharmaceuticalAlliance
(NegotiateLettersofIntent)
PrivateInsurers
Reimbursementcanvarybyplan
TheRoadtoPharmaceuticalMarketAccessinCanadaisOnlyBecomingMoreComplex
EmployerDrugPlans
CriteriaHarmonization?Variability?ListingDelays?Value-BasedAgreements?
Delays?Caps?Prior-Authorizations?PharmacyNetworks?
Pre-NOC?
Coordination?
ThePrivateStakeholders 23Insurers3PBMs
~3KBenefitAdvisors
~500KPlanSponsors
~23MPlan
Members
34
Payer
CourtesyJanssenPharmaceuticals
Payervalueexpectationsincreasewithshiftingcost:ButCostManagementActionsShouldDifferBasedonVolumeandRisk
Private PlanSpecialtyDrugExpenditure
13.2%
24.2%
29.9%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
30.0%
35.0%
2007 2013 2015
<3%ofclaimants
2015
16.4%
29.2%
Sources:ESCDrugTrendReports(2014,2016);PMPRB,NPDUIS
Public PlanSpecialtyDrugExpenditure
PrivatePlansTalkAboutIntegratingintothePublicReimbursementProcess.ItisPlausible?
1 6 12
CDRREVIEW
18
PCPANEGOTIATIONS
UPTO15SEPARATEFPTNEGOTIATIONS
HOWMANYPRIVATEPLANNEGOTIATIONS?
ESTIMATEDMONTHSAFTERHEALTHCANADAAPPROVAL
ThepCPAdoesnotnegotiateproductreimbursement.Itnegotiatestheintentionforproductreimbursement
Onmarket
©RoubaixStrategiesInc.contact:[email protected]
The Current LandscapeuEconomicslowdown+Chronicityofdisease+Costofmeds=
↑pressureonemployers=↑pressureonInsurers=↑pressureonPharmamanufacturers
• Prior/SpecialAuthorization• StepEdits• MandatoryGeneric/Therapeuticsubstitution• Tieredformularies• Casemanagement• Preferredpharmacynetworks
uPayersseekingSUSTAINABILITY=OPPORTUNITYforpharmaceuticalmanufacturers