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ContentslistsavailableatScienceDirect

Health

Policy

jo u r n al h om ep age :w w w . e l s e v i e r . c o m / l o c a t e / h e a l t h p o l

A

new

proposal

for

priority

setting

in

Norway:

Open

and

fair

Trygve

Ottersen

a,∗

,

Reidun

Førde

b

,

Meetali

Kakad

c

,

Alice

Kjellevold

d

,

Hans

Olav

Melberg

e

,

Atle

Moen

f

,

Ånen

Ringard

g

,

Ole

Frithjof

Norheim

a

aDepartmentofGlobalPublicHealthandPrimaryCare,UniversityofBergen,POBox7804,5018Bergen,Norway

bCentreforMedicalEthics,UniversityofOslo,POBox1130,Blindern,0318Oslo,Norway

cDepartmentofTechnologyandeHealth,South-EasternNorwayRegionalHealthAuthority,POBox404,2303Hamar,Norway

dDepartmentofHealthScience,UniversityofStavanger,4036Stavanger,Norway

eDepartmentofHealthManagementandHealthEconomics,UniversityofOslo,POBox1089Blindern,0318Oslo,Norway

fDepartmentofNeonatology,OsloUniversityHospital,POBox4950,0424Oslo,Norway

gAkershusUniversityHospital,POBox1000,1478Lørenskog,Norway

a

r

t

i

c

l

e

i

n

f

o

Articlehistory:

Received30June2015

Receivedinrevisedform3December2015 Accepted10January2016

Keywords:

Healthpolicy Healthcarereform Ethics Socialjustice Politics Jurisprudence Economics Evidence-basedmedicine Patientparticipation Healthcarerationing

a

b

s

t

r

a

c

t

Healthsystemsworldwide struggletomeet increasingdemands forhealthcare, and Norwayisnoexception.Thispaperdiscussesthenew,comprehensiveframeworkfor pri-oritysettingrecentlylaidoutbythethirdNorwegianCommitteeonPrioritySettingin theHealthSector.Theframeworkpositsthatprioritysettingshouldpursuethegoalof“the greatestnumberofhealthylifeyearsforall,fairlydistributed”andcentresonthreecriteria: 1)Thehealth-benefitcriterion:Thepriorityofaninterventionincreaseswiththeexpected healthbenefit(andotherrelevantwelfarebenefits)fromtheintervention;2)Theresource criterion:Thepriorityofaninterventionincreases,thelessresourcesitrequires;and3)The health-losscriterion:Thepriorityofaninterventionincreaseswiththeexpectedlifetime healthlossofthebeneficiaryintheabsenceofsuchanintervention.Cost-effectiveness playsacentralroleinthisframework,butonlyalongsidethehealth-losscriterionwhich incorporatesaspecialconcernfortheworseoffandpromotesfairness.Inlinewiththis, cost-effectivenessthresholdsaredifferentiatedaccordingtohealthloss.Concrete imple-mentationtoolsandopenprocesseswithuserparticipationcomplementthethreecriteria. Informedbytheproposal,theMinistryofHealthandCareServicesispreparingareport totheParliament,withtheaimofreachingpoliticalconsensusonanewpriority-setting frameworkforNorway.

©2016TheAuthors.PublishedbyElsevierIrelandLtd.Thisisanopenaccessarticleunder theCCBY-NC-NDlicense(http://creativecommons.org/licenses/by-nc-nd/4.0/).

夽 OpenAccessforthisarticleismadepossiblebyacollaboration betweenHealthPolicyandTheEuropeanObservatoryonHealthSystems andPolicies.

Correspondingauthor.Tel.:+4755586100.

E-mailaddresses:[email protected](T.Ottersen),

[email protected](R.Førde),[email protected] (M.Kakad),[email protected](A.Kjellevold),

[email protected](H.O.Melberg),[email protected] (A.Moen),[email protected](Å.Ringard),[email protected] (O.F.Norheim).

1. Background

Healthsystemsworldwidestruggletomeetincreasing demands for health care. This is true across all payer systems and for rich and poorcountries alike [1,2]. To manageincreasingdemandsisachallengealsoforNorway, despitebeingoneoftherichestcountriesintheworldand havingalongtraditionofsystematicprioritysettingatthe nationallevel[3].Inresponse,thethirdNorwegian Com-mittee onPriority Setting in theHealth Sectorrecently laid out a new, comprehensive framework for setting priorities.Thispaperpresentsanddiscussesthatproposal. http://dx.doi.org/10.1016/j.healthpol.2016.01.012

0168-8510/© 2016 The Authors. Published by Elsevier Ireland Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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The first Norwegian priority-setting committee was appointedbytheCabinetin1985[4].Theimpetuswasthe recognitionthattechnologicalinnovationcalledforan in-depthassessment oftherelationshipbetweenmedicine, ethics,andeconomics.Initsmandate,theCommitteewas askedtoconsiderfiveprinciplesordimensions:severityof disease;equalopportunitiesfortreatment(independently of geographic, social, and age-dependent differences); waitingtime;health-economicaspects;andthepatient’s responsibilityfor hisorhercondition.In itsfinalreport 2yearslater,theCommitteesuggestedthatallfivewere important, but recommendedseverity ofdisease asthe maincriterionforprioritysetting.

In 1996, the Cabinet appointed the second official priority-settingcommitteetoupdatetheexisting priority-settingguidelines.Theunderlyingmotivationwastheever increasingpossibilitiesfordiagnosisandtreatment,aswell as an increasing number of elderly and chronically ill people.Ontopofthis,thecriteriaproposedbythefirst com-mitteewereseenastoogeneralandasleavingtoomuch roomforindividualinterpretationandjudgment.Initsfinal reportthefollowingyear,theCommitteeproposedthree criteria:severityofdisease,benefit,andcost-effectiveness [5].TheCommittee’srecommendationsprovidedthebasis forthesubsequentPatients’RightsAct,priority-setting reg-ulations,nationalguidelinesforprioritysetting,andthe establishmentofapermanentcouncilforprioritysetting inhealthcare[6].

Even with this system in place, the run-up to the general election in 2013 was dominated by heated debatesonhealthpolicyandprioritysetting.Therewas considerabledisagreementastowhethercertain expen-sive cancer drugs—and ipilimumab for skin cancer in particular—should be reimbursed by the state, and the existingcriteriawereagainwidelyconsideredasbeingtoo unspecifictoprovideguidanceinsuchdifficultsituations [7].Againstthisbackdrop,theCabinetappointedinJune 2013athirdcommittee;theNorwegianCommitteeon Pri-oritysettingintheHealthSector.The14memberswere selectedbytheMinistryofHealthandCareServiceswith theaimofrepresentingawiderangeofstakeholdersand typesofexpertise.TheCommitteewaschairedbya physi-cianandprofessorofmedicalethics,andothermembers includedtwopatientrepresentatives,twopracticing clin-icians,twohigh-leveldirectorsinthehealthsector,two formermembersofparliament,and professorsofethics, law,andeconomics.Allmembershadthesamestanding, includingtheuserrepresentatives.Thefinalreport, enti-tled“Openandfair–prioritysettinginthehealthservice”, wasreleasedonNovember12,2014[8].

2. Thenewframework

TheCommitteeproposedanewframeworkforpriority settinginNorway.Theframeworkcomprisesfourgeneral principles.Prioritysettingshould:

•pursuethegoalof“thegreatestnumberofhealthylife yearsforall,fairlydistributed”;

•bebasedonclearcriteria;

•beopen,systematic,andinvolveuserparticipation;and •besupportedbyacoherentsetofeffectiveinstruments. Thefirstprincipleunderscoresthatthegoalisnotonly tomaximise populationhealth, but alsoto ensurethat healthylifeyearsarefairlydistributed.Thisgoallaysthe foundationforasetofcriteria,processes,andinstruments.

2.1. Criteria

Clearcriteriaarecrucialforsystematicprioritysetting [9,10].TheCommitteeproposedthreecriteria:

Thehealth-benefitcriterion:Thepriorityofan

inter-ventionincreaseswiththeexpectedhealthbenefit(and otherrelevantwelfarebenefits)fromtheintervention

Theresourcecriterion:Thepriorityofanintervention

increases,thelessresourcesitrequires

Thehealth-losscriterion:Thepriorityofanintervention increaseswiththeexpectedlifetimehealthlossofthe beneficiaryintheabsenceofsuchanintervention.

Thesecriteriaaretobeconsideredtogetherandapplied throughoutthehealthsector,whichincludesallregulators, payers,andproviderswithinthenationalhealthsystem. Atthesametime,thewaythecriteriaareusedwilldiffer acrossthedecision-makinglevels.Atthemacrolevel,one mayutilizethemostpreciseformsofthethreecriteriaand conductelaborate,quantitativeanalysesofbenefits,costs, andhealthlosses.Atthemicrolevel,healthpersonnelcan employthegeneraldefinitionsofthethreecriteriaupon whichtoexerttheirclinicaljudgment.

2.1.1. Summaryofthecriteria

Thehealth-benefitcriterionisprimarilyconcernedwith benefitsintermsofhealthylifeyears,anditcanthusbe appliedtoanytypeofintervention.Onemeasureofthis kindisquality-adjustedlifeyears(QALYs),whichismuch debated,yetwidelyusedinmanycountries[11,12].

Theresource criterion is motivatedbya concernfor opportunitycosts.Withinagivenbudget,the implemen-tationofoneinterventionimplieshealthbenefitsforgone elsewhere.Thecriterionpertainstobothfinancialand non-financial resources,including health personnel,hospital beds,andmedicalequipment.Acost-effectiveness crite-rioncanrepresentthehealth-benefitandresourcecriteria. Theextenttowhichitdoespartlydependsonwhetherthe effectivenessunitcorrespondto“benefits”asgivenbythe health-benefitcriterionandwhetherthecostsadequately captures“resources”asgivenbytheresourcecriterion.

Thehealth-loss criterionisintendedtocaptureakey aspectoffairness:theconcernfortheworseoff.The Com-mitteesuggestedthattheworseoffarethosewhohave alargerhealthlossoverthecourseoftheirlifetimeasa resultoftheircondition[13,14].Thislosswasdefinedasthe differencebetweenalongandhealthylife,andthelength andqualityoflifeofthepatientgroup.Thislossreflected current,past,andfuturehealth.

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Fig.1.Healthlossesandhealth-lossclassesassociatedwithselectedconditions.

Health-lossclass1includestargetgroupswithahealthlossbetween0and15healthylifeyears;class2includesthosewithagreaterloss,upto30;and class3includestargetgroupswithalossbetween30and45healthylifeyears.EstimatesarebasedonillustrativedatafromtheNationalInstitutefor HealthandCareExcellence(NICE),intheUK,foralimitedsetofinterventions[15].NICEprovidedinformationaboutthegroups’averageageandaverage remainingQALYswithouttheinterventioninquestion.Informationaboutagewascombinedwithquality-adjustmentweightstoestimateaveragehealthy lifeyearsinthepast.TheweightswerebasedondataforNorwayfromtheGlobalBurdenofDiseaseStudy2010andfromStatisticsNorway[16].NICE’s estimatefortheremainingQALYswithouttheinterventionwasthenaddedtotheestimateforpastQALYs,andthissumwassubtractedfromthereference levelof80.Theresultinglifetimehealthlossisinfluencedbothbythegeneralpopulation-relatedhealthlossofthetargetgroupandbytheadditional healthlossthatthegroupexperiencesbecauseoftheircondition.However,theestimatesdonotfullyreflectthehistoriclossofqualityofliferesulting fromthecondition,asdatawerelacking.

2.1.2. Thenewhealth-losscriterion

Thehealth-loss criterionaddresses thecoreproblem withsetting prioritiessolely onthebasis ofmagnitude ofbenefitsorcost-effectiveness,namelytheproblemthat itignoresthedistributionofbenefitsandisunconcerned withhowbadlyoffpeopleare,aslongasthetotalbenefits arethesame[1,14].Theintroductionofahealth-loss cri-terioncanthusmakecost-effectivenessinformationmore relevantanduseful.

Thehealth-losscriterionwasspecifiedstep-by-step,in away thatalsoeventuallyallowedfor quantificationof healthloss.Asastartingpoint,theCommitteesuggested thatalongandhealthylifecouldbespecifiedby80healthy lifeyears.Thisreferencelevelwasbasedonarangeof nor-mativeandpracticalconsiderationsandnearlycoincides withlifeexpectancyatbirthinNorway.However,itwas madeclearthattheexactnumberisarbitraryandthatany referencelevelneedstobereviewedanddebated.

TheCommitteedemonstratedhowlifetimehealthloss couldbeestimatedusingdatathatareincreasingly avail-able. One illustration built on data from the National

Institute for Health and Care Excellence (NICE) for a selectedsetofnewinterventions.ThisisshowninFig.1. Information about the target groups’ average age and remainingquality-adjustedlifeyears(QALYs)withoutthe intervention in question was used to estimatelifetime healthloss.

Fig.1demonstratesawidevariationinlossesofhealthy lifeyearsacrossconditions.Italsoshowshowthe condi-tionscanbegrouped intothreecategories accordingto lifetimehealth loss.Suchagroupingwassuggestedasa meansoffacilitatingunderstanding,communication,and easeofuse.

Theproposedmeasureofhealthlossalignswith sev-eralothermeasures[1,14,17].Amongtheseistheabsolute QALY shortfall measure, which has beenconsidered by NICE for some time and about which the final deci-sionis stilltobemade [18,19].Asit is usuallydefined, QALYshortfallintegratesonlypresentandfuture health loss—althoughpastlengthoflife,i.e.,age,influences indi-rectly. A criterion based on relative QALY shortfall has alsobeenproposedbyothersandisbeingconsideredby

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1 < 250–500

2 < 500–750

3 < 750–1000

Health-loss class Cost-effecveness thresholds (norwegian kroner in thousands per healthy life year)

Fig.2.Staircasemodelforcost-effectivenessthresholdswithillustrativethresholdvalues.

1,000Norwegiankroner(NOK)≈110Euro(EUR).250,000NOK≈28,000EUR.500,000NOK≈57,000EUR.750,000NOK≈85,000EUR.1,000,000NOK≈

110,000EUR(asofJune30,2015).

NICE.RelativeQALYshortfalliscommonlydefinedasthe ratiobetweendisease-relatedQALYlossandtheremaining QALYsinabsenceofdisease(relativetoageandgender) [20].TheCommittee foundthisuseof relative shortfall unwarranted,primarilydue toitslackofalifetime per-spectiveanditsinadequatesensitivitytothesizeoffuture losses.Withregardtotheterminology,theCommittee sug-gestedthat‘severity’isoftenunderstoodinawaythatis more focusedoncurrent qualityof lifeand prospective healththanlifetimehealthloss[21].

2.1.3. Rejectedcriteria

In its mandate, the Committee was asked to con-sider criteria related to end-of-life care, age, lack of alternative treatment, innovation, and rare diseases. It argued that these characteristics were only relevant to theextentthattheywereindicatorsforbenefit,resource use, or health loss.For example, agewasdeemed rele-vantonlytotheextentitinformedtheuseofthebenefit, resource, or health-loss criteria. The Committee there-fore recommended that the other criteria—and age in particular—shouldnotbeincludedinthepriority-setting frameworkasindependentcriteria.

2.1.4. Balancingthecriteria

TheCommitteefurthersuggestedhowthethreecriteria couldbebalancedagainsteachother.Akeyfeatureofthe proposalistoassignweightstohealthbenefitsaccordingto thehealthlossofthebeneficiary.Asastartingpoint,a sim-plerule—the“1–2–3rule”—wasproposed,whichcouldbe easilyunderstoodandusedbymultipledecision-makers. Accordingtothisrule,theweightincreasesgraduallywith healthloss.Morespecifically,theweightassignedtothe smallesthealthlossinhealth-lossclasses1,2,and3inFig.1, is1,2,3,respectively.Weightsforlossesgreaterthanthose inclass3werenotspecified.

2.2. Cost-effectivenessthresholds

Thethreecriteria canbeusedeithertodirectlyrank competing interventions or together with predefined thresholds.Cost-effectivenessthresholdshavebeen intro-duced informally in Norway, but never examined and approvedbyParliament.TheCommitteefoundthatsuch thresholdscouldhelpfacilitatepriority-settingbasedon thethreeproposedcriteria.Inparticular,thresholdswere seenasusefulinsituationswherethedecision-makerhas littleinformation abouttheinterventionscompeting for thesameresources[22,23].TheCommitteerecommended thatsuchthresholdsbebasedontheopportunitycostof

implementingtheinterventionbeingconsidered.Within thehealthsector,thiswilllargelycorrespondtothevalue ofthehealthbenefitsforegone,giventheimplementation ofoneparticularintervention insteadof another.It was arguedthatforafocalchoicesituation,thethresholdmost directly reflecting the opportunity cost is equal to the averagecost of a healthy life year—adjusted for health loss—for marginalchanges in thehealth budget.Thisis thesituation wherethe decision-maker haslittleor no informationabouttheinterventionsbeingdisplacedifthe intervention being evaluated is deemed cost-effective; a situationresembling thatof NICE. Thisunderstanding of the threshold is also in line witha recent proposal for the NICE cost-effectiveness threshold, which sug-gestsa thresholdof about

£

13,000(D20,000)per QALY basedondatafrom theEnglishNationalHealthService (NHS)[22].

Ratherthanonesinglethresholdvalue,theCommittee recommendedmultiplethresholds,differentiated accord-ingto theaveragehealth loss ofthe targetgroup. This approachisconsistentwiththethreeproposedcriteria,as itcombinestheconcernforbenefits,costs,andhealthloss, anditbalancestheneedforexplicitlimitswiththeneedfor flexibility.A“staircasemodel”illustratedthresholds val-uesbasedontheaforementionedthresholdfortheEnglish NHS.TheNHSthreshold wasconvertedinto Norwegian kroner,adjusted for differencesin healthspending, and thencombinedwiththe1–2–3ruletodifferentiate thresh-oldsaccordingtodegreesofhealthloss.Itwasassumedthat thedisplacedQALYwasassociatedwiththelowerpartof therangeforhealthlossclass1.Fig.2showstheproposed modelwithillustrativethresholdvalues.

Aninterventionwhosetargetgroupbelongstohealth loss class 2 can be used as an example. The cost-effectiveness ratio of such an intervention could be regarded as reasonable up to 750,000 Norwegian kro-ner(D85,000)perhealthylifeyear.Thestaircasemodel includesthresholdsthatarebothhigherandlowerthanthe cost-effectivenessthresholdsmostfrequentlyusedinthe UKandtheUS.ThethresholdemployedbyNICEintheUKis typically

£

20,000–30,000(D28,000–42,000)perQALY,[24] whileaninformalthresholdof$50,000(D45,000)perQALY iscommonlyusedintheUS[25].

Asthethresholdvaluesusedweremerelyillustrative, theCommitteealsolaidoutthekeystepstoestablishing a set of operative thresholds. First, the averagecost of gainingahealthylifeyearformarginalchangesinthe Nor-wegianhealthbudgetshouldbeestimated.Second,health lossshouldbetaken intoaccountbyadjustingthe esti-matesothattherearehigherthresholdsforinterventions

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targeting patients with greater loss. The magnitude of theseequity-basedadjustmentswilldependontheweight assignedtoconcernfortheworseoffvis-à-visconcernfor maximising health benefits. Against this background, it wascalledforalargeresearchstudyontheopportunity costsintheNorwegianhealthsector,moreresearchonthe distributivepreferencesofNorwegiancitizens,andfurther publicdeliberationontheequityweightstobeused. 2.3. Processes

Substantivegoalsandcriteriamustbecomplemented withlegitimateprocesses[26,27].TheCommittee empha-sisedtheneed for transparency in thedecision-making process and described how the Accountability for Rea-sonableness framework provides useful guidance for improvinglegitimacy [27,28]. At thesame time, it was acknowledged that there are legitimate limitations to openness. In particular, the Committee highlighted the advantagesanddisadvantagesoftransparencyduringand afternegotiationsbetweenreimbursersand manufactur-ersofdrugs,asmanufacturersoftenofferdiscountsonthe conditionthatthereimburserdoesnotmakethepriceit payspubliclyavailable.

The need for user participation and shared decision makingwasalsoemphasised.Issuesregardingautonomy, qualityofcare,andfairnessallcallforaredefined,more expansiveroleforpatientsandrelativesinpriority-setting processes.ThiswasreflectedintheCommittee’sownwork withthe inclusion of two user representativesand the establishmentof a website askingfor publicinput.The CommitteealsoinitiatedaCitizenPanelstudywith1,653 participants, where the participants were asked about theirviewson theneedfor prioritysetting, therole of priority-settingprocesses,andtheimportanceofdifferent priority-settingcriteria[29].Theresponsesfromthispanel providedinputtotheCommittee’sdeliberationand,in par-ticular,identifiedtopicsforin-depthdiscussion.Partofthe responseswerealsopresenteddirectlyinthereport. 2.4. Instruments

TheCommitteemadeclearthatprioritysettingshould besupportedbya coherentsetofeffectiveinstruments. Theseinstrumentsaretohelpdecision-makersactin accor-dancewithagreedgoals,criteria,andprocesses,butalso tohelpbuildagreementinthefirstplace.Specifically,the Committeeemphasisedharmonisationoflawand regula-tionsandintegrationofthenewcriteria.Itrecommended thatprioritysetting shouldbeseen asa keyleadership responsibility,aswellasa centralpartofeducationand trainingofhealthpersonnelanduserrepresentatives.The importanceofsupportingandrefiningtheexisting priority-setting institutions was emphasised, and among these weretheclinicalethicscommittees,thestandingcouncil onprioritysetting,andthenationalsystemforthe intro-ductionofnewtechnologies.TheCommitteehighlighted overtreatmentandunnecessaryvariationofcareasissues inneedofurgentattention,anditsuggestedestablishinga NorwegianHealthAtlastoidentifyandmonitorlocal prac-ticevariations.

Finally, the Committeedemonstrated how improved collectionand useof information,developmentanduse of guidelines, and design of financing mechanisms can motivateandhelpactorstomakebetterdecisions.Among the financing mechanisms, differentiated userfees was emphasised. It was recommended that thegovernment consider increasingfees for low-priority services,while reducing or eliminating fees for high-priority services. Examples from the former category included blepharo-plasty (eye-lid surgery) and surgery for uncomplicated varicoseveins.Examplesfromthelattercategoryincluded medicalprimarypreventionofdiabetescomplicationsand ofcardiovasculardiseaseforcertainhigh-riskgroups.The Committeeemphasisedthatdifferentiateduserfeesneed notresultinanincreaseofout-of-pocketpaymentsoverall. 2.5. Conclusion:nextstepsandlessonsforother

countries

TheCommittee’sreportattractedconsiderable atten-tioninthenationalmediaandgeneratedalivelydebate,in whichtheMinisterofHealthandCareServicesactively par-ticipated.TheMinisterarguedagainstthosewhoclaimed that there wasnoneed to setpriorities in Norway, he emphasisedthatprioritysettingisalreadyaregular fea-ture in today’s system, asserted the need for clearer criteria, and encourageda democratic debateaboutthe proposalandprioritysettingingeneral.Atthesametime, Norway’slargestnewspaperlaunchedanonline priority-settinggame,withabuilt-inopportunitytosubmitadvice totheMinister.Themostdebatedtopicsweretheneedfor prioritysettinginaneconomicallyprivilegedcountrylike Norway;theuseofthehealth-losscriterionandits rela-tiontoage;differentiateduserfees;andtherelevanceand easeofuseofthethreeproposedcriteriainclinicalsettings. Alreadythedayafterthelaunchofthereport,thechairof theDecisionForumofthenationalsystemforthe introduc-tionofnewhealthtechnologiesannouncedthattheForum wouldexpandtoincludeapatientrepresentative.

The Ministryof Health and CareServicesinitiated a nationwidehearingfollowingthecompletionofthereport. Manyresponseswerepositivetothefourgeneral princi-ples,butmanyalsothoughtthatthehealth-losscriterion wasunnecessarycomplexandundulybiasedagainstthe elderly.Whilemanysupportedtheprospectiveaspectsof thehealth-losscriterion,therewasmuchlesssupportfor includingpasthealth,intermsofbothageandpast qual-itylosses.Againstthisbackground,theMinistrydecided not topursuea lifetimehealth-loss criterionand estab-lishedaworkinggrouptoconsideralternativemeasures, undertherubricof“severity”,thataremoreconcentrated onprospectivehealth.Theworkinggrouprecommendedto notincludepasthealthlossesintheassessmentof sever-ity,butalignedwiththeCommittee’srecommendationsin manyotherrespects[32].Forthegrouplevel,theworking groupsuggestedtoassessseverityintermsofabsoluteloss ofprognosis.Thiswasdefinedastheabsolutereductionin futurehealthylifeyearsforpeoplewiththedisease,when comparedwithwhatpeopleatthesameagebutwithout thediseasecanexpect.Forclinicalpractice,theworking grouprecommendedtoassessseveritybasedonarangeof

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factors,includingriskofdeathordisabilityandpain, dis-comfort,andlossoffuturelifeyears.Ageinfluencesseverity indirectlyunderboth interpretations,especiallythrough lossinfuturelifeyears,butthisinfluenceislesstransparent thanforlifetimehealthloss.InformedbytheCommittee’s proposal andthe workinggroup’s recommendationson severity,theMinistrywillsubmita reporttothe Parlia-mentin2016withtheaimofreachingpoliticalconsensus onanewpriority-settingframeworkforNorway.

Norway’sapproachtoprioritysettingmaybeofinterest toregulators,payers,andprovidersinothercountriesfor severalreasons:theexistingapproachisbasedonopen, transparentprocess and debate;prioritysetting is inte-gratedinto lawsand regulations;a standingcommittee onprioritysettingexists;andstandardisedpriority-setting guidelinesformedicalspecialitiesareused.Thenew pro-posal goes further and may be particularly interesting because of its combination of comprehensiveness and specificguidance.Theproposalseeks tointegrate goals, principles,criteria,processes,andinstrumentsforpriority setting intoacoherentwholeandgiveconcrete recom-mendations.Inaddition,theproposedcriteriagobeyond cost-effectivenesstoemphasisefairnessdirectly.

The Committee benefited greatly from insights and experiencesinothercountries,anditsrecommendations cansimilarlybehelpfulforothers.Onlybylearningfrom each other can regulators, payers, and providers best respondtothecommonchallengeofprioritysetting.

Conflictofintereststatement

Theauthorshavenorelevantintereststodeclare.

Funding

Allauthorsreceivedcompensationorsalaryfromthe MinistryofHealthandCareServiceswhileassistingor serv-ingontheCommittee.

Acknowledgments

TheauthorsaregratefultotheCommitteeandeveryone whohassupportedtheCommittee’swork.

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References

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