药品的定价与价值

DavidTaylorProfessorofPharmaceuticalandPublicHealthPolicy,TheSchoolofPharmacy,UniversityofLondonTheValueandPricingofMedicinesinapostblockbusterage(?)SISFoundationDebatesonHealthEconomicsRoyalCatalanAcademyofPharmacy,Barcelona,June28th2010第一页，共十九页。ThispresentationDiscussesthereasonsforandgoalsofpharmaceuticalpricingpoliciesanddrugpricecontrolsinEuropeandgloballyOutlinesUKexperiencewiththeNHSPharmaceuticalPriceRegulationSchemeandthepossibilityof‘valuebased’/costeffectivenessanalysisbasedpricingAnalysesfromaEuropeanperspectiveissuesrelatingtothefuturefundingofbothnewdrugdevelopmenthealthserviceimprovement“Afoolknowsthepriceofeverythingandthevalueofnothing"MichaelRawlinsandOscarWilde第二页，共十九页。Myinterestsandprejudices(?) Ihaveworkedinorwiththepharmaceuticalindustry,healthcharities,theNHS,professionalbodies,governmentagenciesandUniversities IpersonallystillregardtheresearchbasedpharmaceuticalindustryasthemostvaluableofalltheseimportanthumanassetsWilliamAllen第三页，共十九页。Thepublichasmultiple,sometimesconflicting,interestsinmedicinesandhealthcare.TheyrangefromensuringaffordableaccesstoexistingtreatmentstoinvestingintherapeuticandscientificprogressforfuturegenerationsMedicinesareatypicalhightechnologyproducts.Oncedevelopedandintroducedtothemedicalmarkettheycannormallybecopiedatrelativelylowcost.Ineconomicterms,theirsupplytypicallyinvolveshigh‘sunk’costsandlowmarginalcostsofproductionThecurrentfinancialcrisisfacingEuropeiscreatingariskthatcuttingmedicinescostswillbeusedasanemergencyeconomicregulatorinwaysthatmaythreatentheviabilityofnotjusttheresearchbasedpharmaceuticalindustry.EstablishedpatternsofmedicinessupplyviapharmaceuticalwholesalingandcommunitypharmacyarealsoatriskTheinherentcomplexityofmanyofthepolicyissuesinvolvedinpharmaceuticalsectordecisionsisabarriertobalancedpublicdebate.ButafailuretodaytovaluethepharmaceuticalsectorappropriatelywouldimposeverysignificantcostsontwentyfirstcenturyEurope第四页，共十九页。ChangingresearchanddevelopmentchallengesThegreatageof‘receptor-ology’isdrawingtoitsend.Communitypharmacywillincreasinglybeconcernedwithlowcostgenericmedicinessupply,unless/until‘personalisedmedicine’becomesarealityoutsidethecontextofspecialisedhospitalcareTheresearchchallengesinvolvedintreatingconditionssuchasthecancersandtheneurologicaldiseasesaremorecomplexanddifficultthanthosefacedinthepast.Developmenttimesandcostsareincreasingalongwithregulatoryconstraintsanddrugpriceandspendingcontrols

ProfessorSirJamesBlack1924-2010第五页，共十九页。TheVBPofferasdevelopedintheUKbyYorkandNICEIntheUKmodeladvocatedbyofficialbodiessuchasNICEandtheOFTvaluebasedpricingseekstolinkthemaximumpriceofapatented(orothersinglesourcemedicine)toanaffordablelevelofcosteffectiveness,judgedbythecostperincrementalQALYdelivered(theICER)VBPaspirestodelivergreaterfairnessandequityinhealthcareresourceallocation.Logically,itsproponentsmaywishforittobeappliedinallareasofhealthcare.However,othercommentatorsbelievethatthescopeofVBPshouldbeexpandedtoincludeindustrialandothercommunitybenefitsProfessorsAlanWilliamsandAlanMaynard第六页，共十九页。Pharmaceuticalspendingintotalhealthspending

Source:Pharmaceuticalpricinginaglobalmarket,OECD,2008

第七页，共十九页。Pharmaceuticalretailpricecomponents

Source:Pharmaceuticalpricinginaglobalmarket,OECD,2008第八页，共十九页。SomekeydatesinUKandEUdrugpricing1948TheNHSandABPIestablished1952PrescriptionchargesandtheKoreanWar1956/7TheVPRS,laterthePPRS,firstestablishedCirca1960Thalidomide1965Directive65/65/EEC1968theUKMedicinesAct1973TheUKenterstheEuropeanUnionThe1980s–fromHatchWaxmanintheUStoextendedEuropeanpatentlives(SPCs)1995theEMEAestablishedinLondon1999NICEestablished2005The2005PPRSandthepublicationofanOFTstudyonitsrelevancetotoday’srequirements2009ThelastPPRS?2010AndrewLansleybecomeSecretaryofstateforHealthinanewCoalitio0n.InSpain1000millionEuroiscutfrominnovativemedicinescosts.SimilaractionistakenincountriessuchasItalyandGreece第九页，共十九页。Whatarewetryingtodowithpricingpolicies?Correctmarketimperfections?Minimisedrugcosts?Protectnationalorregionalindustry?Set‘fairaverage’costrelatedprices?Delivermarginalcostrelatedprices?Rewardcurrentinnovators?Protectthepoorest,nationallyand/orinternationally?Assurelongterminnovationandinvestmentinhealthpromotingresearch?

第十页，共十九页。Approachesto(drug)priceregulationFreepricing–requiresdemandsidecompetencyProfitcontrol–theUKPPRS(notetheAverch-Johnsoneffect)Internationalcomparisonbasedpricecontrols(whichcountries,whyandhow?)Referencepricing(whichmedicinegroups,andatwhatpricelevels?)Tendering–seerecentdevelopmentsinTheNetherlandsRisksharingandprice/volumebasedagreements‘Valuebased’pricing.Thatis,HTA/CEAbasedpricingbasedonICERs第十一页，共十九页。IntheUKAlzheimer’sdiseasecareprovidesagoodillustrationofafieldwheretheactualcostofadisputedmedicinemayonlybe2,000Euroayear,buttheincrementalcostperQualityAdjustedLifeYeargainedmaybejudgedtobewellinexcessof30,000Euro第十二页，共十九页。Problemswith‘valuebasedpricing’Impliesthattheclinicalvalueofamedicinecanbedeterminedataroundhalfwaythroughitspatentlife(ieatthetimeoflaunch)?Thisisnotinrealitythecase,especiallywithagentssuchasanticancermedicinesUnderminesthevalueofindividualandpopulation‘willingnesstopay’asamarketsignal?(Givesmanagersandregulatorsunduecontroloverdefiningvalue)AffordableICERthresholdsareartificialandhighlyvariablebetweensocialgroupsandsocieties?(IfdifferentthresholdsusedVBPwouldnotsolveeitherEUwideorlocalitybasedproblems)Methodologyformeasuringandvaluingqualityoflifecontestable?Failstoconsiderthepostpatentexpirysocietalvalueofinnovationsappropriately?第十三页，共十九页。FundamentalissuesDowegenuinelywanttoinvestsufficientlyinEuropetoleadinnovationinareassuchasapplyinggenomicsandgeneticsbasedknowledgeincontextssuchascancertreatmentandneurology?Couldtimelytherapeuticprogressbeachievedpurelybypublicinvestment,orisabalanceofpublicandprivateinvestmentdesirable?Towhatextentdopricesalonedetermineaccesstomedicinesoroverallspendinguponthem?Ifratesofpharmaceuticalinnovationareslowingandreturnsfalling,shouldpatentprotectionperiodsbeextended?Shouldwebeseekingtochargemarginalcostbased(orlower)pricesfornewmedicinesinpoorcountries,andaboveaveragecostbasedpricesinrichones?Whatchangesareneededinareassuchasthewaywegatherevidenceabouteffectivenessandlicensemedicinesanddiagnosticproducts,andregulatethemthroughtheirlifecycles?第十四页，共十九页。Whatareouroptions?AsingleEuropeanfreepharmaceuticalmarket?AmosaicEUpharmamarket:locallynegotiateddrugpriceswithorwithoutcontrolsoninternaldrugpriceimportationand/orexportation?AlowestpossiblesupplycostEuropeanmedicinesstrategy,usingthehealthcaresysteminHollandasamodel?A‘EuropeanPPRS’,perhapsbasedinpartonCEApricing?第十五页，共十九页。WouldSpainbenefitfromaVBPbasedpricingapproach?IntheUKVBPiscontinuingtoevolve.ThenewSecretaryofStateisseekingfundamentalchangesinNICEandthePPRSIfVBPbasedapproachesbuildinlongtermcommunityinterestevaluationsalongsideimmediatepersonalgaincalculationswouldtheyincreaseratherthandecreasethepricesofinnovativemedicines?CharlesD