Utilization)of)Multiple/Criteria)Decision)Analysis)(MCDA))to)! Support)Healthcare)Decision)Making) FIFARMA,!2016! ! ! interventions! that! address! a! specific! need.! An! effort! should! be! made! to! Key(Points(for(Decision(Makers) allocate! sufficient! budget! for! the! MCDA%is%a%decision.making%tool%with% reimbursement! of! medicines,! allowing! increasing%use%in%the%healthcare%sector,% more! flexibility! in! healthcare! decision! including%HTA%(Health%Technology% Assessment).%By%using%multiple%criteria%in% making.! ! Systems! that! operate! with! a! fixed! costJeffectiveness! threshold! risk! a%comprehensive,%structured%and%explicit% ignoring!need:!where!society!feels!there! manner,%MCDA%fosters%a%transparent,% is! a! great! need,! we! are! willing! to! pay! participative,%consistent%and%legitimate% 1 much! more! and! thus! accept! less! decision.making%process.%A%deliberative % efficiency;!while!in!conditions!perceived! (partial)%MCDA%may%be%a%more% as!minor!or!for!which!there!are!already! pragmatic,%agile%approach,%especially% very! effective! treatments,! we! may! be! when%newly%implemented.! less!willing!to!cover!a!new!intervention,! ! even! if! it! has! an! excellent! incremental! I. INTRODUCTION! This! paper! aims! to! present! MCDA! as! a! costJeffectiveness! ratio! (Aitken,! 2014).!! decisionJmaking!tool!that!can!be!applied! Emphasis! on! costJeffectiveness! risks! in! the! healthcare! sector! due! to! the! reducing! equity! in! patient! access! to! comprehensive! and! consistent! yet! innovative! medications.! ! A! 2014! study! flexible! and! transparent! methodology;! performed! by! the! IMS! Institute! (Aitken,! fostering! collaboration! amongst! all! 2014)! compared! costJper! QALY! focused! countries!(CPQ)!to!countries!that!used!a! healthcare!stakeholders.!!! more! holistic! assessment! approach! ! Current! HTA! approaches! have! (nonJCPQ).!!This!study!concluded!that:! overemphasized! costJeffectiveness,! • Patients! in! CPQ! countries! have! less! access! to! new! cancer! drugs! than! incremental! costJeffectiveness! ratio! patients! in! nonJCPQ! countries;! (ICERs)! and! thresholds.! Too! much! reimbursement! decisions! take! emphasis!on!costJeffectiveness!presents! longer;! and! new! cancer! drugs! have! limitations! on! holistic! decision! making! historically! been! adopted! more! in! that! it! excludes! important! factors! slowly!at!lower!rates! such!as!innovation,!disease!severity,!size! • CPQ! analyses! are! subject! to! many! of! patient! population,! equity,! or! clinical! uncertainties! and! inconsistencies! guidelines!(Marsh!et!al,!2014).!Also,!lack! due! to! the! nature! of! the! variables! of! costJeffectiveness! is! not! a! necessary! used!and!their!interpretation! or!sufficient!condition!to!reject!access!to! treatments,!especially!in!the!case!of!rare! • CPQ! countries! do! not! necessarily! spend! less! overall! on! cancer,! but! diseases!(McKenna!et!al,!2015).! they!may!achieve!less!for!patients!! FIFARMA! recognizes! that! while! ! important,! the! role! of! costJeffectiveness! is! limited! in! helping! choose! among! Placing!too!much!weight!on!few!criteria! (efficacy! and! costs! only)! and! narrow! !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! perspective!(not!societal)!can!negatively! 1!A!deliberative!MCDA!can!also!be!considered!a!Multiple! impact! patient! equity! in! access! to! Criteria!Decision!Making!(MCDM)! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!1! !! Utilization)of)Multiple/Criteria)Decision)Analysis)(MCDA))to)! Support)Healthcare)Decision)Making) FIFARMA,!2016! ! medications.!!FIFARMA’s!recommends!a! healthcare!decision!making!is!achievable! multiple! set! of! criteria! for! a! more! by! utilizing! a! systematic! process,! holistic!and!fair!valuation!approach.! referencing! real! world! examples! and! ! ongoing! research! from! various! decision! The! emphasis! on! and! utilization! of! making!bodies!and!countries.!This!paper! MCDA!in!healthcare!decision!making!has! is! in! line! with! FIFARMA’s! position! that! increased! over! the! past! 5! years,! as! an! efficient! HTA! process! should! be! demonstrated! by! the! increase! in! transparent,! fair,! consultative,! and! publications! since! 2011! (Marsh,! Lantis,! focused!on!clinical!excellence.! Neasham,! Orfanos,! and! Caro,! 2014)! and! ! the! prevalence! of! the! topic! in! II. MCDA!AS!A!DELIBERATIVE!TOOL!IN! international! healthcare! congresses! HEALTHCARE!DECISION!MAKING! such! as! by! the! International! Society! of! A! serious! concern! for! patients,! Pharmacoeconomic! Outcomes! Research! clinicians,! and! other! stakeholders! is! the! (ISPOR),! including! the! Latin! America! narrowness! and! lack! of! transparency! in! Conferences! (eg! the! ISPOR! 5th! Latin! healthcare!decision!making,!especially!in! America!Conference).!!!ISPOR!has!also!a! regards!to!coverage!and!reimbursement.!! dedicated! Task! Force! for! MCDA,! MCDA% Notable! deficiencies! in! decision! making! for% Healthcare% Decision% Making,% have! prompted! proposals! to! use! MCDA! Emerging% Good% Practices% Task% Force% because! it! has! the! potential! to! consider! <http://www.ispor.org/MultiJCriteriaJDecisionJ whatever! criteria! a! stakeholder! judges! AnalysisJguideline.asp>! publishing! reports,! relevant! (Marsh! et! al,! 2014)! ! MCDA! guidelines!(Devlin!et!al,!2016).! takes! into! consideration! the! different! MCDA! can! be! applied! on! a! macro! or! institutional! contexts! while! fostering! a! micro! level! at! various! stages! of! the! comprehensive,! consistent,! transparent,! health! technology! development! and! and! flexible! approach.! ! ! By! structuring! assessment! process! (Goetgherbeur,! the! process! of! selection! and! evaluation! 2015).!!!For!this!paper,!emphasis!will!be! of! alternatives,! MCDA! quantifies! placed! on! the! utilization! of! MCDA! in! evidence! to! identify! best! alternatives! HTA! processes! across! Latin! America! and! helps! eliminate! contradictions! given! decision! makers! and! appraisal! between! stakeholders! (Thokala! and! committees! can! systematically! appraise! Duenas,! 2012).! An! additional! benefit! is! health!technology!in!light!of!a!multitude! that! MCDA! can! help! sharpen! signals! to! of! decision! criteria.! It! should! be! noted! manufacturers! in! advance,! to! focus! on! that! MCDA! can! also! be! effectively! used! providing! data! that! matters! most! to! for!tenders!and!contracts.!!FIFARMA!and! decision! makers! (Marsh,! Caro,! and! its! represented! member! organizations! Muszbek,!2012).! maintain!that!healthcare!decisions!must! MCDA! provides! a! framework! for! be! high! quality! and! autonomous,! while! breaking! down! a! complex! decision! into! relevant! to! the! local! market! conditions! more! manageable! components,! defining! and! patient! populations.! ! A! secondary! and! understanding! the! relationship! goal! of! this! paper! is! to! show! that! the! between! these! components.! Additional,! implementation! of! MCDA! into! but! not! mandatory,! steps! would! be! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!2! !! Utilization)of)Multiple/Criteria)Decision)Analysis)(MCDA))to)! Support)Healthcare)Decision)Making) FIFARMA,!2016! ! measuring! each! component,! and! then! the! performance! of! other! criteria! combining! them! to! identify! solutions.!! (Devlin!et!al,!2016).!!! MCDA! also! serves! the! difficult! task! of! ! quantifying! stakeholders´! priorities! and! It!should!be!noted!that!while!there!is!no! preferences!while!forming!a!transparent! rule! on! how! many! criteria! should! be! link! between! judgments! and! decisions! included!in!an!analysis,!a!higher!number! (Baltussen!and!Niessen,!2006).!!! of! criteria! increases! the! complexity! and! ! cognitive! effort,! introducing! the! risk! of! By! taking! into! account! and! measuring! tiring!decision!makers!and!reducing!the! criteria! other! than! costJeffectiveness! or! quality! of! responses.! (Thokala,! Devlin,! budget! impact,! as! for! example! equity! in! Marsh,! and! Ijzerman,! 2015).! ! It! is! patient! access! and! local! health! system! FIFARMA’s! position! that! criteria! should! priorities,! MCDA! ensures! that! social! remain! straightJforward! in! order! to! preferences,! epidemiological! priorities,! reduce! the! likelihood! of! uncertainty! in! and! ethical! values! are! not! neglected! in! outcomes.! the!decision!making!process.! Upon! reviewing! literature! of! MCDA! In! regards! to! approaches! within! MCDA,! utilized! in! healthcare! decision! making! FIFARMA! supports! the! broad! position! (Golan,! et! al! 2011;! Toumi,! 2013;! Marsh! approach! adopted! by! the! ISPOR! Task! et! al,! 2014;! Endrei! et! al,! 2011;! Sussex,! Force! (Devlin! et! al,! 2016).! ! The! MCDA! 2013)!including!the!EVIDEM!framework! ISPOR!TF!included!MCDA!methods!“that% <https://www.evidem.org/>,! FIFARMA! help% deliberative% discussions% using% recommends! the! criterion! listed! in! explicitly% defined% criteria,% but% without% Table1.! Additional! criteria! may! be! quantitative% modelling.% …Decision% included! if! considered! pertinent! to! the! makers% can% find% this% “partial”% respective! context! (country,! group! of! [deliberative]%form%of%MCDA%a%useful%way% patients,! indication! etc).! A! brief! of% summarizing% the% relevant% evidence,% to% explanation!of!the!criteria!is!provided!in! help% structure% their% deliberations% about% the! footnotes.! Selection! and! extensive! which%alternatives%are%best”%(Devlin!et!al,! definition! and! application! of! each! 2016).!!.% criterion! may! be! reached! via! consensus! ! among! all! stakeholders! respecting! III. MCDA!CRITERION!FOR!INCLUSION!!! legitimacy!of!the!participative!process.!! In! order! to! facilitate! a! holistic! and! fair! CostJeffectiveness! is! not! recommended! assessment! of! any! healthcare! as! a! criterion! to! avoid! doubleJcounting! technology,! criteria! included! in! the! given!economic!impact!and!effectiveness! decision! making! process! must! be! already!listed!as!separate!criteria.! relevant! to! local! market! conditions! and! ! comprehensive! in! that! they! include! ! considerations! of! all! relevant! ! stakeholders! and! ethical! values.! ! The! ! ISPOR! MCDA! Task! Force! recommends! Table!1:!FIFARMA!recommended!MCDA!criteria! selecting! and! structuring! criteria! that! for!healthcare!decision!making! are! nonJredundant! and! independent! of! ! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!3! !! Qualitative) Criterion) Quantitative)Criterion) Utilization)of)Multiple/Criteria)Decision)Analysis)(MCDA))to)! Support)Healthcare)Decision)Making) FIFARMA,!2016! ! ! ! ! ! ! ! ) Description)of)Criteria) ! Added)therapeutic)benefit/innovation2) IV. REALJWORLD!EXAMPLES!! Improved!efficacy/effectiveness) MCDA! is! more! than! an! academic,! Improved!safety) theoretical! decision! making! model.! ! It! Unmet!medical!need!addressed!by!new! has!been!successfully!applied!to!various! technology! therapeutic! areas! and! types! of! Quality!of!life!(patients,!families,! healthcare!decisions!in!countries!around! caregivers)) Economic)Impact3) the! world.! ! Table! 2! displays! examples! Economic!impact!from!a!societal! illustrating!how!decisionJmaking!bodies! perspective!! apply! MCDA.! ! This! table! is! meant! to! Local)health)system)priorities) capture! actual! utilization! versus! Disease!severity/progression4! research! or! recommendations! for! Health!prioritization5! Clinical)guidelines)and)international) utilization.!!Note!that!this!is!by!no!means! health)standards) an!exhaustive!list!of!real!world!examples! Completeness!in!international!and!local! of! MCDA! utilization.! ! Literature! on! the! clinical!practice!guidelines! Medications!approved!by!globally! utilization! of! MCDA! is! sparse! and! it! is! recognized!healthcare!organizations6!! assumed! that! many! more! formal! and! Quality)of)evidence) informal!examples!exist.!!The!successful! Integrity!and!consistency!of!evidence) utilization! of! MCDA! for! various! Relevance!and!validity!of!evidence! therapeutic!areas,!as!cited,!indicates!that! Equity)7! Patient!access! MCDA! can! be! applied! effectively! to! Other! support!healthcare!decision!making.! Sustainability!of!manufacturer!business! practices8!! Capacity!of!local!system!to!use!appropriate! interventions! !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! 2!Innovation! (eg! breakthrough! designation! therapy)! can! be! captured! via! subcriteria! (eg! effectiveness,! safety! QoL)! or! an! as!an!independent!criterion!including!broader!definition!!(eg! training!and!publications!through!clinical!trials!in!country)! 3 Economic! impact! refers! to! net! costs! considering! components! such! as! lost! productivity! costs! avoided! (patients,! families,! caregivers)! and! improved! efficiency! in! healthcare!delivery.! 4 !Disease! severity/progression! should! consider! survival! prognosis! with! current! standard! of! care,! disease! morbidity/clinical!disability.! 5!Consideration!of!disease!in!regards!to!local!system’s!public! health!priorities.! 6!World! Health! Organization,! Food! &! Drug! Administration,! European!Medical!Association! 7!Equity! means! all! patients! have! access! to! medications! and! treatment!facilities!regardless!of!income,!gender,!race,!age!or! any!other!status.! 8!Sustainability! of! manufacturer! business! practices! refers! to! environmental!aspects!as!well!as!consistency!and!reliability! in!the!production!of!technologies.! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!4! !! Utilization)of)Multiple/Criteria)Decision)Analysis)(MCDA))to)! Support)Healthcare)Decision)Making) FIFARMA,!2016! ! ! ! Country) Example(s))of)Utilization) Source)) England/UK! i.!Orphan!drugs,!AGNSS/NICE! ii.!Respiratory,!mental,!children’s!health,! cardiovascular,!and!cancer!interventions,! NHS/Primary!Care!Trusts! iii.!Major!capital!expenditures,!NHS! i.!Diagnosis!and!treatment!decisions! ii.!Clinical!trial!design! i.!Healthcare!priority!setting! ii.!Budgeting! iii.!Interventions!for!chronic!nonJcancer! pain! Incorporation!of!patient!involvement!with! MCDA!quantitative!approaches,!IQWIG! i.!Orphan!drug!coverage,!TLV! ii.!HighJcost!biologics,!TLV! Devlin!&!Sussex,!2011! Adams!et!al,!2013! Airoldi!et!al,!2014! Orphan!drug!coverage! Obesity!research!and!prevention! i.!Orphan!drug!coverage! ii.!PublicallyJfunded!healthcare!priority! setting! iii.!AnkleJfoot!repair!in!stroke! EVIDEM!Framework!used!with!medical! devices,!diagnostic!assessments,!and! pharmaceuticals!! Screenings! Healthcare!priority!setting! Hospital!medical!technologies,!OEP! Orphan!drug!coverage,!NHS! Algorithmic!approach!using!1000Minds! software!used!to!analyze!coronary!artery! bypass!graft!surgery,!MoH! Private!health!plan!used!for!liquidJbased! cytology!for!cervical!cancer!screening! Healthcare!priority!setting! Health!interventions!in!the!universal!health! coverage!benefit!package,!NHS! New!health!care!technologies,!Health! Basket!Committee!! Deans!et!al,!2014! Borg!&!Fogelhol,!2007! Van!Til,!2009! Devlin!&!Sussex,!2011! Baeten!et!al,!2010! USA! Canada! Germany! Sweden! Denmark! Finland! The!Netherlands! Italy! France! Norway! Hungary! Scotland! New!Zealand! South!Africa! Ghana! Thailand! Israel! Adunlin!et!al,!2014! Guest,!et!al,!2012! Diaby!et!al,!2015! Tony!et!al,!2011! Danner!et!al,!2011! World!Health!Organization,!2015! Deans!et!al,!2014! Radaelli!et!al,!2014! World!Health!Organization,!2015! Defechereux!et!al,!2012! Devlin!et!al,!2015! Kanters!et!al,!2015! Devlin!&!Sussex,!2011! Hansen!et!al,!2012! Miot!et!al,!2012! JehuJAppiah,!2008! Youngkong!et!al,!2012! Devlin!&!Sussex,!2011! ! ! Table!2:!Real!world!examples!of!MCDA!utilization!to!support!healthcare!decision!making!(exJLatAm)! ! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!5! !! Utilization)of)Multiple/Criteria)Decision)Analysis)(MCDA))to)! Support)Healthcare)Decision)Making) FIFARMA,!2016! ! MCDA! is! also! being! considered! in! many! The! purpose! of! illustrating! these! realJ markets! across! LatAm,! as! reflected! in! world! applications! of! MCDA! is! to! stress! Table! 3.! ! It! should! be! noted! that! that! MCDA! can! be! implemented! as! a! utilization! of! MCDA! in! LatAm! is! even! useful! tool! to! support! healthcare! more! sparsely! published.! ! Information! decision! making! and! foster! a! fair! and! has! been! gleaned! from! local! market! transparent! decision! making! process! insight! as! well! as! the! 2015! ISPOR! 5th! with!a!patientJcentric!approach.!!It!is!the! Latin!America!Conference!presentations! position! of! FIFARMA! that! MCDA! can! be! with!the!exception!of!the!literature!cited! broadly! applied! to! the! HTA! process! in! in!the!table.! order!to!support!healthcare!decision!! ! making.! ! Country) Brazil! Argentina! Colombia! Chile! Dominican! Republic! Ecuador! Implementation)Progress)by)Stakeholders) a.!MCDA!proposal!for!rare!disease,!Interfarma!! b.!MCDA!used!for!hospital!investment,!RJ!Uni.!Hospital!! Incorporation!of!MCDA!into!the!SUMAR!Project,! Ministry!of!Health! Pilot!completed!in!2013!and!MCDA!implemented!for! healthcare!prioritization,!IETS!! Utilization!of!MCDA!in!considering!tender!offers,! University!of!Chile!Hospital!! Seeking!insight!from!external!consultants,!Ministry!of! Public!Health! Prioritization!process!for!HTA!utilizing!MCDA! recommended,!Ministry!of!Public!Health!! Source) Brito!et!al,!2015! Nobre!et!al,!1999! PichonJRiviere,!2015! ! Jaramillo,!2013! “Informe,”!2014! Espinoza,!2015! Sotomayer!et!al,!2015! ! Table!3:!Examples!of!recommended!or!actual!realJworld!utilization!of!MCDA!in!LATAM.! ! ! V. IMPLEMENTATION! CONSIDERATIONS! In! considering! the! implementation! of! MCDA! or! any! other! healthcare! decision! making!process,!sufficient!budget!should! first!be!allocated!for!the!reimbursement! of! medicines.! Furthermore,! policy! setting! should! be! proJinnovation,! meaning! decision! makers! value! additional! clinical! benefits! and! unmet! medical! needs! achieved! by! new! healthcare!technologies.!!!!! The! main! aspects! of! any! MCDA! method! are! 1)! the! alternatives! to! be! appraised,! 2)! the! criteria! against! which! the! alternatives! are! appraised.! Additional! steps!for!quantitative!or!complete!MCDA! would!still!require!3)!scores!that!reflect! the! value! of! an! alternative's! expected! performance! on! the! criteria,! and! 4)! criteria! weights! that! measure! the! relative! importance! of! each! criterion! as! compared! with! others.! (Thokala! and! Duenas,! 2012).! Key! steps! to! conducting! an! MCDA! analysis! as! adapted! from! the! ISPOR! MCDA! Task! Force! (Devlin! et! al,! 2016)! and! MCDM! (Multiple! Criteria! Decision! Making)! Tool! (ZRx! Outcomes! Resources! Inc.)! and! are! reflected! in! Table!4.!FIFARMA!recommends!the!first! three! steps,! which! constitutes! the! deliberative,!partial!MCDA.! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!6! !! Utilization(of(Multiple9Criteria(Decision(Analysis)(MCDA)(to)! Support)Healthcare)Decision)Making) FIFARMA,!2015! ! ! formalized! approach,! and! validation! of! Typically,!the!most!complex!parts!of!the! the! process! are! required! for! MCDA! MCDA! process! is! determining! how! to! implementation.! ! Organizational! change! measure! criterion’s! performance! and! will! also! be! necessary! and! therefore,! manage!uncertainty!in!outcomes9.!!! engaging! experienced! independent! It!is!out!of!the!scope!of!this!paper!to!do!a! consultants!is!recommended.! deep! dive! into! measurement! models.!! ! FIFARMA!recommendation!is!that!MCDA! ! Steps)to) Description) be! implemented! in! a! deliberative! Implementation) manner!and!not!rigid,!fixed!mechanism.! Define)the) Identify)type)of) ) ! objectives) decision,)alternatives,) ) and)relevant) As! with! any! complex! decision! making! ) stakeholders) process,! the! output! of! MCDA! is! subject! ) to! uncertainty! and! the! impact! of! this! Select)the)criteria) Influenced)by)scientific) Deliberative) literature)and)specific) MCDA) uncertainty! should! be! addressed.! ! It! is! local)needs) the!view!of!the!ISPOR!MCDA!Task!Force! Measure)the) Options)must)be)able)to) and! FIFARMA! that! uncertainty! not! be! alternative’s) incorporate)qualitative) and)quantitative) included! as! a! criterion! in! MCDA.! ! A! performance) information,) scenario! analysis! or! sensitivity! analysis! “performance)matrix”) is! recommended! for! considering! this! to)summarize) impact,! but! it! is! out! of! the! scope! of! this! Score!options!and! Scoring!helps!produce!an! paper! to! analyze! and! explain! these! aggregate!scores!! overall!estimate!of!value! payJoff!for!each! approaches!(Thokala!et!al,!2015).! alternative! ! Apply!scores!and! Multiply!the!alternatives’! Although! MCDA! may! present! such! weights!to!rank! scores!on!the!criteria!by! methodological! variety,! its! main! alternatives! the!weights!and!sum!to! contribution! is! indeed! the! deliberative! get!the!total!scores!! Perform!a!scenario!or! process! allowed! still! by! the! partial! Explore!and! analyze!uncertainty! sensitivity!analysis! approach.!!!MCDA!has!proven!significant! Validate!and! Interpret!outputs!and! value! in! that! it! is! possible! to! interpret!finds! align!with!decision! systematically! assess! any! disease! in! maker!priorities!to! context!of!the!treatment!that!is!available! support!decision!making! and! local! market! priorities! ! (Omelyanovsky,! Fedyaevam,! and! Table! 4:! MCDA! implementation! considerations,! Rebrova,! 2015).! ! Consensus,! a! Deliberative!MCDA!highlighted! !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! !The! types! of! MCDA! models! that! are! most! commonly! used! include! weighted! sum! or! value! measurement,! outranking,! and!goals!programming.!!Although!there!is!no!consensus!on! the! best! MCDA! to! utilize,! the! weighted! sum! or! value! measurement!model!is!most!utilized!in!healthcare!decisionJ making.!(Marsh!et!al,!2014).!!The!value!measurement!model! assesses! interventions! based! on! an! overall! benefit! score.!! This! benefit! score! is! calculated! as! the! weighted! average! of! the!criteria.!! 9 ! ! ! MCDA!can!be!implemented!at!the!macro! and! micro! levels,! such! as! national! and! state,! or! at! the! hospital! and! healthcare! provider!levels.!!It!should!be!noted!that! successful!implementation!of!MCDA!will! be!an!iterative!process.!!Prior!to!a!broad! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!7! !! Utilization(of(Multiple9Criteria(Decision(Analysis)(MCDA)(to)! Support)Healthcare)Decision)Making) FIFARMA,!2015! ! roll! out! of! MCDA,! it! is! recommended! to! analysis! in! healthcare:! a! systematic! pilot! the! methodology,! in! prioritized! review! and! bibliometric! analysis.”! high!cost!disease!states!such!as!oncology! Health!Expect.!2014!Oct!2018.! or! orphan! diseases,! for! which! costJ 4) Aitken! M.! Impact! of! costJper! QALY! effectiveness! limitations! are! even! reimbursement! criteria! on! access! to! stronger.! cancer! drugs.! IMS% Institute% for% ! Healthcare% Informatics.! September! VII.!SUMMARY! 2014.! In! conclusion,! MCDA! is! a! structured,! 5) Airoldi!M,!Morton!A,!Smith!JA,!Bevan! transparent,! participative,! consistent! G.! STARJJpeopleJpowered! and! legitimate! tool! to! support! prioritization:! a! 21stJcentury! healthcare! decision! making! as! it! solution! to! allocation! headaches.! provides! a! systematic! framework! for! Med! Decision! Making! 2014! breaking!down!a!complex!decision!into!a! Nov;34(8):965J75.! transparent! and! rationale! process! that! 6) Baeten! SA,! Baltussen! RMPM,! UylJde! incorporates!the!priorities!and!values!of! Groot! CA,! Bridges! J,! Louis! WN.! stakeholders.! ! RealJworld! examples! of! Incorporating! equityJefficiency! effective! MCDA! implementation! in! interactions! in! costJeffectiveness! healthcare! decision! making! in! both! the! analysis:!three!approaches!applied!to! public! and! private! sector! validate! that! breast! cancer! control.! Value! Health.! MCDA!can!be!applied!to!facilitate!holistic! 2010;13(5):573–9! assessments.!!It!is!the!view!of!FIFARMA! 7) Baltussen,! Rob,! and! Louis! Niessen.! that! MCDA! should! strongly! be! “Priority! Setting! of! Health! considered!as!a!tool!to!support!HTA!and! Interventions:! The! Need! for! MultiJ broader! healthcare! decision! making! Criteria! Decision! Analysis.”! Cost% such! as! the! contracts! and! tenders! Effectiveness% and% Resource% Allocation! process! in! order! to! foster! transparency,! 4! (2006):! 14.! PMC.! Web.! 14! Oct.! fairness,! and! collaboration! amongst! 2015.! stakeholders.! 8) Borg! P,! Fogelholm! M.! Stakeholder! ! appraisal! of! policy! options! for! VII.!REFERENCES!! responding! to! obesity! in! Finland.! Obes!Rev.!2007;8(Suppl2):47J52.! 1) Access! to! new! medicines! in! Europe:! 9) Brito! A,! Fagundes! M,! Nunes! O,! Technical!review!of!policy!initiatives! Simones! M,! Hirai! S,! Lazarini! P.!! and! opportunities! for! collaboration! “Proposra! para! Incorporacao! de! and! research.! ! World! Health! medicamentos! em! Doencas! Raras:! Organization! Regional! Office! for! Definicao!de!Criterios!para!Avaliacao! Europe.!2015.! de! Reembolso! de! Medicamentos! 2) Adams!B,!Megget!K,!Bowie!C,!Hone!J.! Orfaos! para! Tratamento! de! Doencas! “Orphan! Drugs,! Raw! Deal?”! Raras! no! SUS.”! Interfarma,! February! PharmaTimes!Magazine,!May!2013.!! 2015.! 3) Adunlin! G,! Diaby! V,! Xiao! H.! 10)Danner! M,! Hummel! JM,! Volz! F,! et! al.! “Application!of!multicriteria!decision! Integrating! patients'! views! into! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!8! !! Utilization(of(Multiple9Criteria(Decision(Analysis)(MCDA)(to)! Support)Healthcare)Decision)Making) FIFARMA,!2015! ! health! technology! assessment:! Experiences! from! Hungary.! Value% in% Analytic! hierarchy! process! (AHP)! as! Health.%17!(2014)!487J489.! a! method! to! elicit! patient! 18)Espinoza,! Manuel! Antonio.! “Análisis de Decisiones Multicrietrios. Es la preferences.! Int! J! Technol! Assess! mejor manera de conducir decisiones Healthcare!2011!Oct:!27(4):369J75.! en! Latinoamerica.” ISPOR! LA! Chile! 11)Deans! M,! De! Rosch! M,! Voisin% E.!! 2015.! “Regulatory! approval! and! market! access:! a! winning! combination! for! 19)Guest! J,! Harrop! JS,! Aarabi! B,! Grossman! RG,! Fawcett! JW,! Fehlings! drug! launch! optimization.”! MG,! et! al.! Optimization! of! the! www.scriptsregulatorsaffairs.com,! decisionJmaking! process! for! the! October!2014.! selection! of! therapeutics! to! undergo! 12)Defechereux! T,! Paolucci! F,! Mirelman! clinical! testing! for! spinal! cord! injury! A,! Youngkong! S,! Botten! G,! Hagen! TP! in!the!North!American!Clinical!Trials! et! al.! Healthcare! priority! setting! in! Network.! J! Neurosurg! Spine.! Norway! a! multicriteria! decision! 2012;17(1!Suppl):94–101.! analysis.! BMC! Health! Serv! Res.! 20)Golan! O,! Hansen! P,! Kaplan! G,! Tal! O.! 2012;12:39J45.!! Health! technology! prioritization:! 13)Devlin! N,! Ijzerman! M,! Marsh! K,! Which! criteria! for! prioritizing! new! Thokala! P.! MCDA! for! Healthcare! technologies! and! what! are! their! Decision! Making! –! An! Introduction:! relative! weights?! Health% Policy.! Report! 1! of! the! ISPOR! MCDA! Volume! 102,! Issues! 2J3,! October! Emerging!Good!Practices!Task!Force.! 2011,!Pages!126J135.! Value!in!Health,!vol.19!issue!1!2016.! 14)Devlin! N,! Sussex! J.! “Incorporating! 21)Hansen!P,!Hendry!A,!Naden!R,!et!al.!A! new! process! for! creating! points! Multi! Criteria! in! HTA:! Methods! and! systems! for! prioritising! patients! for! Process.”!Office!of!Health!Economics.! elective! health! services.! Clinical! March!2011.! Governance:! An! International! 15)Diaby!V,!Goeree!R,!Hoch!J,!Siebert!U.! Journal!2012.!! MultiJcriteria! decision! analysis! for! health! technology! assessment! in! 22)Héctor!Eduardo!Castro!Jaramillo!MD,! MSc,! PhD.! “Uso! de! Analysis! de! Canada:! insights! from! an! expert! Decision! MultiJCriterio! Para! panel! discussion.! Expert! Rev! Priorizar! en! Colombia.”! Pharmacoecon! Outcomes! IETS.ORG.COM.!2013.! Res.2015;15(1):13J9.! 16)Dolan! JG,! Boohaker! E,! Allison! J,! 23)Informe! de! Evaluacíon.! ! Licitacíon! Publíca! Para! la! Adquisicion! de! Imperiale! TF.! Patients'! preferences! Infliximab! 100MG! Para! el! Hospital! and! priorities! regarding! colorectal! Clinco! de! la! Universidad! de! Chile.!! cancer! screening.! Med! Decis! Making! 09.09.14.! 2013!Jan;33(1):59J70.! 24) JehuJAppiah! C,! Baltussen! R,! Acquah! 17)Endrei! D,! Molics! B,! Agoston! I.! C,!Aikins!M,!d’Almeida!SA,!Bosu!WK,! Multicriteria!Decision!Analysis!in!the! et!al.!Balancing!equity!and!efficiency! Reimbursement! of! New! Medical! in!health!priorities!in!Ghana:!the!use! Technologies:! RealJWorld! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!9! !! Utilization(of(Multiple9Criteria(Decision(Analysis)(MCDA)(to)! Support)Healthcare)Decision)Making) FIFARMA,!2015! ! of! multicriteria! decision! analysis.! 31)Omelyanovsky! V,! Fedyaeva! V,! Value!Health!J!Int!Soc!Pharmacoecon! Rebrova! O.! Application! of! MultiJ Outcomes!Res.!2008;11(7):1081–7.! Criteria!Decision!Analysis!in!Russian! 25)Kanters! TA,! Hakkaart! L,! RuttenJvan! Healthcare.! ! Health% Policy.! Mölken! MP,! Redekop! WK.! Access! to! March/April!2015.! orphan!drugs!in!western!Europe:!can! 32)!PichonJRiviere,! A.! IP3:! “Planes! de! more!systematic!policymaking!really! Beneficios! en! salud! en! help! to! avoid! different! decisions! Latinoamerica:! Cúal! es! el! Estado! about! the! same! drug?! Expert% Rev% Actual! y! Cúales! son! los! Desafios! Pharmacoeconomics% Outcomes% Res.! Futuros”,!ISPOR!LA!Chile!2015.! 2015;15(4):557J9.! 33)Radaelli! G,! Lettieri! E,! Masella! C,! 26)Marsh! K,! Caro! J,! Muszbek! N.! ! “Does! Merlino! L,! Strada! A,! Tringali! M.! the! Future! Belong! to! MCDA?”! ISPOR! “Implementation! of! EUnetHTA® CONNECTIONS! Core! Model! in! Lombardia:! the! VTS! November/December!2012.! framework.”!Int!J!Technology!Assess! 27)Marsh! K,! Lanitis! T,! Neasham! D,! Healthcare.!2014!Jan;30(1):105J12.! Orfanos! P,! Caro! J.! Assessing! the! 34)Sotomayor! R,! Sanchez! X,! Armijos! L.! Value! of! Healthcare! Interventions! “Health! Technology! Assessment! in! Using! MultiJCriteria! Decision! Ecuador”! Health! Policy! In! Latin! Analysis:!A!Review!of!the!Literature.! America,! ISPOR! Latin! American! PharmacoEconomics.! 2014;! 32:345J Consortium! News! Across! Latin! 365.! America.! Volume! 3,! Issue! 1,! 28)McKenna! C,! Soares! M,! Claxton! K,! February/March!2015.! Bojke! L,! Griffin! S,! Palmer! S,! 35)Sussex!J,!Rollet!P,!Garau!M,!Schmitt!C,! Spackman!E.!!“Unifying!Research!and! Alastair! K,! Hutchings! A.! ! A! Pilot! Reimbursement! Decisions:! Case! Study! of! Multicriteria! Decision! Studies!Demonstrating!the!Sequence! Analysis! for! Valuing! Orphan! of! Assessment! and! Judgments! Medicines.!2013!Dec;!16(8):1163J69.! Required.”! ! VALUE! IN! HEALTH! 18! 36)Thokala! P,! Devlin! N,! Marsh! K,! (2015)!865!–!875.! Ijzerman! M.! ! MCDA! for! Healthcare! 29)Miot! J,! Wagner! M,! Khoury! H,! DecisionsJ! Emerging! Good! Practices:! Rindress! D,! Goetghebeur! MM.! Field! Report! 2! of! the! ISPOR! MCDA! Task! testing! of! a! multicriteria! decision! Force!DRAFT.!2015.! analysis! (MCDA)! framework! for! 37)Thokala! P,! Duenas! A.! “Multiple! coverage! of! a! screening! test! for! criteria! decision! analysis! for! health! cervical! cancer! in! South! Africa.! Cost% technology! assessment.”! Value! Effective% Resource% Allocation.! 2012! Health.!2012!Dec;15(8):1172J81.! Feb!29;10(1):2! 38)Tony! M,! Wagner! M,! Khoury! H,! 30)Nobre! FF,! Trotta! LTF,! Gomes! LFAM.! Rindress! D,! Papastavros! T,! Oh! P,! MultiJCriteria! decision! making:! an! Goetghebeur! MM.! Bridging! health! approach! to! setting! priorities! in! technology! assessment! (HTA)! with! healthcare.! ! Stat! Med.! 1999;! multicriteria! decision! analyses! 18(23):3345J54.! (MCDA):! field! testing! of! the! EVIDEM! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!10! !! Utilization(of(Multiple9Criteria(Decision(Analysis)(MCDA)(to)! Support)Healthcare)Decision)Making) FIFARMA,!2015! ! framework!for!coverage!decisions!by! a!public!payer!in!Canada.!BMC%Health% Services% Resources.! 2011! Nov! 30;11:329.! 39)Toumi,! M.! “MCDA! Utiliztion! for! Public! Health! Decision! Process.”! ISPOR!LA!Buenos!Aires!2013.! 40)Van! Til! JA.! Integrating! preferences! into! decision! making:! the! treatment! of! ankleJfood! impairment! in! stroke.! Twente! University,! Enschede,! Netherlands.!2009.! 41)Youngkong! S,! Baltussen! R,! Tantivess! S,! Mohara! A,! Teerawattananon! Y.! Multicriteria! decision! analysis! for! including!health!interventions!in!the! universal! health! coverage! benefit! package! in! Thailand.! Value% Health.! 2012,!SepJOct;15(6):961J70.! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!11! !! Utilization(of(Multiple9Criteria(Decision(Analysis)(MCDA)(to)! Support)Healthcare)Decision)Making)APPENDIX) FIFARMA,!2015! ! I. REAL!WORLD!EXAMPLES!OF!MCDA! UTILIZATION! ! A. The!United!Kingdom!! i. The! Advisory! Group! for! National! Specialized! Services! (AGNSS)! developed! a! framework! utilizing! MCDA! to! support! reimbursement! decisions! for! orphan! drugs.! ! In! 2012,! National! Institute! for! Health! and! Care! Excellence! (NICE)! then! assumed! responsibility! for! analyzing! orphan! drugs! using! the! framework! presented!by!AGNSS.! ii. Use! of! MCDA! in! a! Local! Healthcare! Plan! in! the! English! NHS:! MCDA!was!utilized!to!support!the!Isle!of! Wight! Primary! Care! Trust! (PCT)! in! the! allocation! of! resources! across! 21! interventions! in! five! priority! areas:! respiratory,! mental! and! children’s! health,! cardiovascular! disease,! and! cancer.! Interventions! were! assessed! on! three!criteria:!increased!health!(reduced! mortality! and! increased! quality! of! life);! reduced! health! inequalities;! and! operational! and! political! feasibility.! The! resulting! estimate! of! value! was! combined! with! data! on! the! cost! to! estimate! “valueJcost! triangles”,! which! were! ordered! to! construct! an! efficiency! frontier.!! Key! stakeholders! were! engaged! in! the! analysis:! clinicians,! council! representatives,! voluntary! sector! representatives,! nurses,! public! and! patients’! representatives,! hospital! managers! and! the! ambulance! service.! Participants!agreed!on!the!interventions! to! be! evaluated! and! the! research! team! collected! data! on! the! performance! of! these!interventions.!Stakeholders!scored! the! interventions! using! a! 0J100! visual! analogue!scale,!and!weighted!the!criteria! using!a!swing!weighting!approach.!! Interviews! with! participants! revealed! the!benefit!of!the!MCDA!approach.!First,! most! stakeholders! found! the! approach! accessible,! something! the! authors! attribute! to! their! being! continuously! engaged! in! the! design! and! implementation! of! the! MCDA,! and! the! use! of! visual! aids! to! communicate! results.! Second,! stakeholders! found! the! approach! acceptable,! except! in! a! minor! of! cases,! such! as! palliative! care,! which! generated! benefits! that! fell! beyond! the! three! criteria.! Third,! stakeholders! appreciated! the! logic! of! the! approach,! which! they! considered! “an! advance! on! just!sitting!around!a!table!and!talking!it! through”! (Airoldi,! Morton,! Smith,! and! Bevan,!2011).! ! B. Canada! Tramadol! for! chronic! nonJcancer! pain! was! selected! by! the! public! health! plan! for! assessment.! Based! on! extensive! literature! review! 14! criteria! for! the! MCDA! Core! Model! and! 6! qualitative! criteria! for! the! Contextual! Tool! as! developed! by! EVIDEM! were! utilized.!! During! workshop! sessions,! committee! members!tested!the!framework!in!three! steps! by! assigning:! 1)! weights! to! each! criterion! of! the! MCDA! Core! Model! representing! individual! perspective;! 2)! scores!for!tramadol!for!each!criterion!of! the!MCDA!Core!Model;!and!3)!qualitative! impacts! of! criteria! of! the! Contextual! Tool! on! the! appraisal.! Utility! and! reliability! of! the! approach! were! explored!through!discussion,!survey!and! testJretest.!Agreement!between!test!and! retest! data! was! analyzed! by! calculating! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!12! !! Utilization(of(Multiple9Criteria(Decision(Analysis)(MCDA)(to)! Support)Healthcare)Decision)Making)APPENDIX) FIFARMA,!2015! ! intraJrater! correlation! coefficients! (fictitious)! hepatitis! C! treatment! (ICCs)! for! weights,! scores! and! MCDA! alternatives! that! were! composed! of! value! estimates….Overall,! the! various! treatment! characteristics! framework!was!found!useful!by!the!drug! (attributes,! e.g.! outcomes)! and! that! advisory! committee! in! supporting! differed! according! to! the! levels! of! the! systematic! consideration! of! a! broad! characteristics.!The!results!of!all!of!these! range!of!criteria!to!promote!a!consistent! choices! were! analysed! using! logistic! approach! to! appraising! healthcare! regression! models! to! estimate! the! interventions.”!(Tony!et!al,!2011).! importance!(weighting)!of!the!individual! ! treatment! attributes.! ! Overall,! MCDA! C. Germany:!The!Case!of!IQWIG! was! carried! out! in! a! realJworld! context! In!2010,!the!German!Institute!for!Quality! and! was! successfully! used! to! increase! and! Efficiency! in! Healthcare! (IQWiG)! rational,! transparent,! and! fair! priority! initiated! a! study! to! explore! the! use! of! setting.! (Danner,! Hummel,! and! Volz,! MCDA! methods! as! a! means! of! 2011).! incorporating! patient! involvement! into! ! its! HTA! process.! Patient! involvement! is! D. Lombardy,!Italy! widely!acknowledged!to!be!important!in! This! study! describes! the! health! HTA! and! healthcare! decision! making.! technology! assessment! (HTA)! However,! quantitative! approaches! to! framework! introduced! by! Regione! ascertain! patients’! preferences! for! Lombardia! to! regulate! the! introduction! treatment! endpoints! are! not! yet! of! new! technologies.! The! study! outlines! established.! The! project! used! the! the! process! and! dimensions! adopted! to! analytic! hierarchy! process! (AHP)! and! prioritize,! assess! and! appraise! the! conjoint! analysis! (CA)! as! preference! requests!of!new!technologies.! elicitation!methods!for!use!in!HTA.!! The! HTA! framework! incorporates! and! The! AHP! study! included! two! AHP! adapts! elements! from! the! EUnetHTA! workshops:! one! with! twelve! patients! Core!Model!and!the!EVIDEM!framework.! and! one! with! seven! healthcare! It! includes! dimensions,! topics,! and! professionals.! In! the! workshops,! issues! provided! by! EUnetHTA! Core! patients! and! professionals! rated! their! Model! to! collect! data! and! process! the! preferences! with! respect! to! the! assessment.! However,! decision! making! importance! of! different! endpoints! of! is! supported! by! the! criteria! and! MultiJ antidepressant! treatment! by! a! pairwise! Criteria! Decision! Analysis! technique! comparison! of! individual! endpoints.!! from!the!EVIDEM!consortium.) These!comparisons!were!performed!and! The! HTA! framework! moves! along! three! evaluated! by! the! AHP! method! and! process! stages:! (i)! prioritization! of! relative! weights! were! generated! for! requests,! (ii)! assessment! of! prioritized! each!endpoint.! technology,! (iii)! appraisal! of! technology! A!discrete!choice!experiment!(DCE),!the! in!support!of!decision!making.!Requests! choiceJbased! variation! of! CA,! was! used.! received!by!Regione!Lombardia!are!first! Patients! and! healthcare! professionals! prioritized! according! to! their! relevance! were! asked! to! choose! between! two! along! eight! dimensions! (e.g.,! costs,! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!13! !! Utilization(of(Multiple9Criteria(Decision(Analysis)(MCDA)(to)! Support)Healthcare)Decision)Making)APPENDIX) FIFARMA,!2015! ! efficiency! and! efficacy,! organizational! reimbursement! if! it! achieves! 60%! of! impact,! safety).! Evidence! about! the! total! available! points,! and! achieves! at! impacts!of!the!prioritized!technologies!is! least! 40%! of! the! available! points! on! all! then! collected! following! the! issues! and! the!six!criteria.!The!points!achieved!by!a! topics! provided! by! EUnetHTA! Core! technology! are! not! made! public.! Model.! Finally,! the! MultiJCriteria! Between! 2010! and! 2013,! 14! Decision! Analysis! technique! is! used! to! applications! were! consideration! using! appraise! the! novel! technology! and! the! MCDA! method.! Six! resulted! in! a! support! Regione! Lombardia! decision! formal! decision! (supporting! or! making.) rejecting).! Three! were! terminated! The! VTS! (Valutazione! delle! Tecnologie! because! of! a! lack! of! information.! Five! Sanitarie)! framework! was! successfully! cases! are! still! in! progress.! ! (Devlin,! implemented! at! the! end! of! 2011.! From! Ijzerman,!Marsh,!and!Thokala,!2015).! its! inception,! twentyJsix! technologies! ! have! been! processed.! (Radaelli! et! al,! F. South!Africa! 2014).! MCDA! was! utilized! to! assess! liquidJ ! based! cytology! for! cervical! cancer! E. Hungary! screening!for!a!private!health!plan.!!The! MCDA! was! introduced! in! Hungary! in! committee!utilized!14!criteria!input!into! 2010! for! the! evaluation! of! new! hospital! the! MCDA! model! and! 4! contextual! medical! technologies.! The! MDCA! criterions,! extracted! from! literature! includes! the! evaluation! of! six! criteria:! review! and! input! from! the! health! plan.!! healthcare!priorities,!severity!of!disease,! A! workshop! was! held! in! which! the! 14! equity,! costJeffectiveness! and! quality! of! criteria! were! weighted! and! scored! and! life,! budget! impact,! and! international! the! impact! of! the! 4! contextual! criteria! reputation.! These! criteria! and! their! were! discussed.! ! When! appraising! LBC! weights! were! established! by! a! for! cervical! cancer! screening,! the! committee! comprising! the! healthcare! committee! assigned! the! highest! scores! financing!agency,!the!Ministry!of!Health,! to! "Relevance! and! validity! of! evidence"! clinical! experts! and! health! economists.! and! "Disease! severity".! ! Overall,! the! Weights! were! determined! by! allocating! committee! felt! the! framework! brought! 100! points! across! the! criteria! to! reflect! greater! clarity! to! the! decision! making! their! relative! importance.! The! criteria! process! and! was! easily! adaptable! to! and! weights! were! submitted! to! other! different! types! of! health! interventions.!! stakeholders! for! validation.! The! EVIDEM! framework! was! easily! Manufacturers! submit! a! formal! HTA! adapted! to! evaluating! a! screening! report,! including! a! healthJeconomic! technology! in! South! Africa,! thereby! analysis,! clinical! evaluation,! clinical! broadening! its! applicability! in! expert! opinion,! and! detailed! cost! healthcare! decision! making.! (Miot,! calculation.! Technologies! are! then! Wagner,! Khoury,! Rindress,! and! scored! against! the! criteria! by! the! Goetghebeur,!2012).! healthcare! financing! agency.! A! ! technology! is! considered! suitable! for! ! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!14! !! Utilization(of(Multiple9Criteria(Decision(Analysis)(MCDA)(to)! Support)Healthcare)Decision)Making)APPENDIX) FIFARMA,!2015! ! G. Thailand!! concerned,! in! consultation! with! patient! MCDA! was! successfully! utilized! for! groups! and! other! clinicians.! The! MCDA! including! health! interventions! in! the! process! consisted! of! seven! steps! as! universal! health! coverage! benefit! below!! package! in! Thailand.! ! In! 2012,! the! • Rank!patient!case!vignettes!using! National! Health! Security! Office,! the! individual!clinical!judgments!and! institute! managing! the! Universal! then!by!consensus.!! Coverage!Scheme!in!Thailand,!called!for! • Draft! the! criteria! and! the! more! rational,! transparent,! and! fair! categories! within! each! criterion! decisions! on! the! public! reimbursement! for!prioritizing!patients.!! of!health!interventions.!!To!address!this! • PreJtest! the! criteria! and! issue,! “MCDA! was! applied! in! four! steps:! categories!and!refine!them.!! 1)!17!interventions!were!nominated!for! • Consult! with! patient! groups! and! assessment;! 2)! nine! interventions! were! other!clinicians.!! selected! for! further! quantitative! • Determine! the! point! values! for! assessment!on!the!basis!of!the!following! the!criteria!and!categories.!! criteria:! size! of! population! affected! by! • Check! the! testJretest! reliability! disease,! severity! of! disease,! and! face! validity! of! the! points! effectiveness! of! health! intervention,! system.!! variation! in! practice,! economic! impact! • Revise! the! points! system! as! new! on! household! expenditure,! and! equity! evidence! emerges! or! clinical! and! social! implications;! 3)! these! judgments!change.!! interventions! were! then! assessed! in! A! survey! of! the! participating! clinicians! terms! of! costJeffectiveness! and! budget! revealed!high!levels!of!‘user’!satisfaction! impact;! and! 4)! decision! makers! with! the! method/software.! The! CABG! qualitatively!appraised,!deliberated,!and! points! systems! have! been! formally! reached! consensus! on! which! accepted! and! are! in! use! throughout! NZ.! interventions! should! be! adopted! in! the! NZ’s! Ministry! of! Health! has! led! projects! package.”! (Youngkong,! Baltussen,! to! create! and! validate! new! points! Tantivess,! Mohara,! and! systems! for! elective! services! –! with! the! Teerawattananon,!2012).!!! ultimate! goal! of! more! equitable! access! ! and! better! patient! outcomes! overall.! H. New! Zealand:! 1000! Minds! Tool! Inspired!by!NZ’s!success,!since!2008!the! Utilization! same! process! has! been! used! in! the! The! MCDA! process! supported! by! public! health! systems! of! Canada’s! internetJbased!software!1000Minds!was! western! provinces.! (Hansen,! Hendry,! performed! by! a! working! group! of! and!Naden,!2012).!! clinical! leaders! for! the! elective! service! ! ! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!15! !! Utilization(of(Multiple9Criteria(Decision(Analysis)(MCDA)(to)! Support)Healthcare)Decision)Making)APPENDIX) FIFARMA,!2015! ! ! II. OVERVIEW!OF!MCDA!PROCESS!&!COMPARISON!OF!APPROACHES! MCDA!Process ! Classification!of!MCDA!Methods! AHP:!Analytical!Hierarchy!Process! PBMA:!Program!budgeting!and!marginal!analysis! ELECTRE:!Elimination!and!Choice!Expressing!Reality! PROMETHEEJGAIA:!Preference!ranking!organization!method!for!enrichment!evaluations! ! ! ! ! ! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!16! !! Utilization(of(Multiple9Criteria(Decision(Analysis)(MCDA)(to)! Support)Healthcare)Decision)Making)APPENDIX) FIFARMA,!2015! ! ) ! Comparison!of!Different!MCDA!Models ! Value!Measurement! Models! Weights! Swing!weights!are!used! to!capture!both!the!effect! of!measurement!scales! and!the!importance!of!the! criteria! Weights!should!satisfy! preferential! independence!of!criteria! and!the!tradeJoff! requirements! Measuring!the! Performance!scores!vi(a),! performance! monotonic!functions!of! of!the!criteria! the!attribute!values!zi(a),! need!to!be!developed!for! all!criterion! i.!Significant!effort!is! needed!to!develop! performance!scores! Presentation! Easy!to!follow!and! of!the!results! enables!further! deliberation,!well!suited! for!good!visual! presentation!of!the! results! Incorporating! Probabilistic!sensitivity! uncertainty! analysis!can!be!used!to! propagate!parameter! uncertainty!quite!easily! Outranking!Approach! Goal!Programming! Weights!are!uninfluenced!by! the!scale!of!the!value! functions.!!They!convey!the! relative!importance!of! criteria!in!the!assertion!that! one!alternative!is!better!than! the!other!!! Weights!do!not!have!to! satisfy!any!condition! Weights!are!attached! to!the!deviations!and! represent!the!relative! importance!of!criteria! by!specifying!an! overall!measure!of! deviation!from!the! goals! Weights!do!not!have!to! satisfy!any!conditions! Easy!to!understand!but! requires!significant! computational!time!to! provide!results.!!! RealJtime!updating!is! not!possible! ! Intuitive!and!easy!to!follow.!! With!right!software,! assumptions!can!be!changed! and!results!can!be!observed! almost!instantaneously! Moderately!easy!to!follow,! can!be!presented!visually!but! difficult!with!multiple! alternatives! Results!easy!to!follow,! but!they!cannot!be! represented!visually! Moderately!difficult!to! include!uncertainty,!need! specialist!software! Quite!difficult!to! include!uncertainty,! complex!stochastic! programming! techniques!needed! ! Source:!Thokala!P,!Duenas!A.!“Multiple!Criteria!Decision!Analysis!for!Health!Technology!Assessment.”! VALUE!IN!HEALTH!15!(2012)!1172–1181.!! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!17! !! Utilization(of(Multiple9Criteria(Decision(Analysis)(MCDA)(to)! Support)Healthcare)Decision)Making)APPENDIX) FIFARMA,!2015! ! ! STRENGTHS!&!CHALLENGES!OF!MCDA! III. ! Strengths/Opportunities! Utility! • Transparency,!if!algorithms!are! public! • Transferability,!adaptable!to!local! markets! • Flexibility,!can!vary!by!therapeutic! area! • Consistent/systematic!decision! progress! • Identifies!social!values!and! encourages!unbiased!decision! making! • Incorporates!societal!preferences! ! Methodology! • Inclusion!of!innovation!as!a! criterion! • More!holistic,!considering!all! relevant!dimensions!not!only! economic!dimensions! • Pragmatic,!userJoriented!and! modular! • Detailed!instructions! Challenges! ! • • • • • Perception!of!complexity!in! implementation! Integration!into!existing!processes! Risk!of!using!MCDA!as!a!formula! rather!than!as!support!for!decision! making/priority!setting! Roles!of!decision!makers!in!making! scientific!and!social!value!judgments! Requires!significant!resources!to! capture!population!preferences! ! • • • • Data!requirements! • Comprehensive!but!modular! • Leverages!technology! ! Capacity/training!requirements! • Community!of!users!and!developers! • Open!participation!to!all! stakeholders,!likely!via! representatives!from!societies! ! Criteria!selection!and!measurement! MCDA!model!selection!and! mathematics! Developing!a!consistent!framework! to!represent!the!relative!importance! of!each!criterion!to!society! Managing!uncertainty!in!meaning!of! results! • • Data!synthesis!by!criteria! Web!integration! • New!paradigm,!limited!training!and! understanding! Limited!MCDA!expertise!in! healthcare! • Source:!Adapted!from!“Lessons!learned!from!a!multiJcriteria!decision!analysis!(MCDA)!framework”! EVIDEM! presentation! to! the! Institute! of! Medicine! in! Washington,! DC.! ! July! 2011! and! Mondher! Toumi’s!“MCDA!Utilization!for!Public!Health!Decision!Process.”!ISPOR!LA!Buenos!Aires!2013.! ! ! Federación!Latinoamericana!de!La!Industria!Farmacéutica!!!! http://www.fifarma.org/! Page!18! !!
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