药品的定价与价值

DavidTaylorProfessorofPharmaceuticalandPublicHealthPolicy,TheSchoolofPharmacy,UniversityofLondonTheValueandPricingofMedicinesinapostblockbusterage(?)SISFoundationDebatesonHealthEconomicsRoyalCatalanAcademyofPharmacy,Barcelona,June28th2010Thispresentation–DiscussesthereasonsforandgoalsofpharmaceuticalpricingpoliciesanddrugpricecontrolsinEuropeandglobally–OutlinesUKexperiencewiththeNHSPharmaceuticalPriceRegulationSchemeandthepossibilityof‘valuebased’/costeffectivenessanalysisbasedpricing–AnalysesfromaEuropeanperspectiveissuesrelatingtothefuturefundingofbothnewdrugdevelopmenthealthserviceimprovement“AfoolknowsthepriceofeverythingandthevalueofnothingMichaelRawlinsandOscarWildeMyinterestsandprejudices(?)Ihaveworkedinorwiththepharmaceuticalindustry,healthcharities,theNHS,professionalbodies,governmentagenciesandUniversitiesIpersonallystillregardtheresearchbasedpharmaceuticalindustryasthemostvaluableofalltheseimportanthumanassetsWilliamAllenThepublichasmultiple,sometimesconflicting,interestsinmedicinesandhealthcare.TheyrangefromensuringaffordableaccesstoexistingtreatmentstoinvestingintherapeuticandscientificprogressforfuturegenerationsMedicinesareatypicalhightechnologyproducts.Oncedevelopedandintroducedtothemedicalmarkettheycannormallybecopiedatrelativelylowcost.Ineconomicterms,theirsupplytypicallyinvolveshigh‘sunk’costsandlowmarginalcostsofproductionThecurrentfinancialcrisisfacingEuropeiscreatingariskthatcuttingmedicinescostswillbeusedasanemergencyeconomicregulatorinwaysthatmaythreatentheviabilityofnotjusttheresearchbasedpharmaceuticalindustry.EstablishedpatternsofmedicinessupplyviapharmaceuticalwholesalingandcommunitypharmacyarealsoatriskTheinherentcomplexityofmanyofthepolicyissuesinvolvedinpharmaceuticalsectordecisionsisabarriertobalancedpublicdebate.ButafailuretodaytovaluethepharmaceuticalsectorappropriatelywouldimposeverysignificantcostsontwentyfirstcenturyEuropeChangingresearchanddevelopmentchallenges–Thegreatageof‘receptor-ology’isdrawingtoitsend.Communitypharmacywillincreasinglybeconcernedwithlowcostgenericmedicinessupply,unless/until‘personalisedmedicine’becomesarealityoutsidethecontextofspecialisedhospitalcare–Theresearchchallengesinvolvedintreatingconditionssuchasthecancersandtheneurologicaldiseasesaremorecomplexanddifficultthanthosefacedinthepast.DevelopmenttimesandcostsareincreasingalongwithregulatoryconstraintsanddrugpriceandspendingcontrolsProfessorSirJamesBlack1924-2010TheVBPofferasdevelopedintheUKbyYorkandNICE–IntheUKmodeladvocatedbyofficialbodiessuchasNICEandtheOFTvaluebasedpricingseekstolinkthemaximumpriceofapatented(orothersinglesourcemedicine)toanaffordablelevelofcosteffectiveness,judgedbythecostperincrementalQALYdelivered(theICER)–VBPaspirestodelivergreaterfairnessandequityinhealthcareresourceallocation.Logically,itsproponentsmaywishforittobeappliedinallareasofhealthcare.However,othercommentatorsbelievethatthescopeofVBPshouldbeexpandedtoincludeindustrialandothercommunitybenefitsProfessorsAlanWilliamsandAlanMaynardPharmaceuticalspendingintotalhealthspendingSource:Pharmaceuticalpricinginaglobalmarket,OECD,2008PharmaceuticalretailpricecomponentsSource:Pharmaceuticalpricinginaglobalmarket,OECD,2008SomekeydatesinUKandEUdrugpricing–1948TheNHSandABPIestablished–1952PrescriptionchargesandtheKoreanWar–1956/7TheVPRS,laterthePPRS,firstestablished–Circa1960Thalidomide–1965Directive65/65/EEC–1968theUKMedicinesAct–1973TheUKenterstheEuropeanUnion–The1980s–fromHatchWaxmanintheUStoextendedEuropeanpatentlives(SPCs)–1995theEMEAestablishedinLondon–1999NICEestablished–2005The2005PPRSandthepublicationofanOFTstudyonitsrelevancetotoday’srequirements–2009ThelastPPRS?–2010AndrewLansleybecomeSecretaryofstateforHealthinanewCoalitio0n.InSpain1000millionEuroiscutfrominnovativemedicinescosts.SimilaractionistakenincountriessuchasItalyandGreeceWhatarewetryingtodowithpricingpolicies?–Correctmarketimperfections?–Minimisedrugcosts?–Protectnationalorregionalindustry?–Set‘fairaverage’costrelatedprices?–Delivermarginalcostrelatedprices?–Rewardcurrentinnovators?–Protectthepoorest,nationallyand/orinternationally?–Assurelongterminnovationandinvestmentinhealthpromotingresearch?Approachesto(drug)priceregulation–Freepricing–requiresdemandsidecompetency–Profitcontrol–theUKPPRS(notetheAverch-Johnsoneffect)–Internationalcomparisonbasedpricecontrols(whichcountries,whyandhow?)–Referencepricing(whichmedicinegroups,andatwhatpricelevels?)–Tendering–seerecentdevelopmentsinTheNetherlands–Risksharingandprice/volumebasedagreements–‘Valuebased’pricing.Thatis,HTA/CEAbasedpricingbasedonICERsIntheUKAlzheimer’sdiseasecareprovidesagoodillustrationofafieldwheretheactualcostofadisputedmedicinemayonlybe2,000Euroayear,buttheincrementalcostperQualityAdjustedLifeYeargainedmaybejudgedtobewellinexcessof30,000EuroProblemswith‘valuebasedpricing’–Impliesthattheclinicalvalueofamedicinecanbedeterminedataroundhalfwaythroughitspatentlife(ieatthetimeoflaunch)?Thisisnotinrealitythecase,especiallywithagentssuchasanticancermedicines–Underminesthevalueofindividualandpopulati