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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
Health Reform Monitor
Implementation of the 2011 Reimbursement Act in Poland:
Desired and undesired effects of the changes in reimbursement policy
夽Paweł Kawalec
a,∗, Anna Sagan
b, Ewa Stawowczyk
c, Iwona Kowalska-Bobko
a, Anna Mokrzycka
aaJagiellonianUniversityMedicalCollege,FacultyofHealthScience,InstituteofPublicHealth,Poland
bEuropeanObservatoryonHealthSystemsandPolicies,UnitedKingdom
cStatSoftPolskaSp.zo.o.,Poland
a r t i c l e i n f o
Articlehistory:
Received28July2015
Receivedinrevisedform9February2016 Accepted12February2016
Keywords:
Reimbursementpolicy Drugpolicy
Reimbursementsystem Pharmaceuticals
a b s t r a c t
TheActof12May2011ontheReimbursementofMedicines,FoodstuffsIntendedforPartic- ularNutritionalUsesandMedicalDevicesconstitutesamajorchangeofthereimbursement policyinPoland.ThemainaimsofthisActweretorationalizethereimbursementpolicyand toreducespendingonreimburseddrugs.TheActseemstohavemetthesegoals:reimburse- mentpolicy(includingpricingofreimburseddrugs)wasoverhauledandtheexpenditure oftheNationalHealthFundonreimburseddrugssawasignificantdecreaseintheyear followingtheAct’sintroduction.Theannualsavingsachievedsincethen(mainlyduetothe introductionofrisksharingschemes),havemadeitpossibletoincludenewdrugsintothe reimbursementlistandimproveaccesstoinnovativedrugs.However,atthesametime,the decreaseinpricesofreimburseddrugs,thattheActbroughtabout,ledtoanuncontrolled outflowofsomeofthesedrugsabroadandshortagesinPoland.Thispaperanalysesthe mainchangesintroducedbytheReimbursementActandtheirimplications.SincetheAct cameintoforcerelativelyrecently,itsfullimpactonthereimbursementpolicyisnotyet possibletoassess.
©2016TheAuthors.PublishedbyElsevierIrelandLtd.Thisisanopenaccessarticleunder theCCBY-NC-NDlicense(http://creativecommons.org/licenses/by-nc-nd/4.0/).
1. Introduction
Thereisnohomogeneousreimbursementpolicyinthe EuropeanUnion(EU).EUMemberStatesarefreetosettheir ownlistsofreimburseddrugs,theirpricesandreimburse- mentlevels,aslongastheycomplywiththeoverallEU regulations,suchastheTransparencyDirective[1,2].The
夽 OpenAccessforthisarticleismadepossiblebyacollaboration betweenHealthPolicyandTheEuropeanObservatoryonHealthSystems andPolicies.
∗ Correspondingauthor.Tel.:+48124332801 E-mailaddress:pawel.kawalec@uj.edu.pl(P.Kawalec).
growthinpublicpharmaceuticalexpenditure(76%inthe outpatientsectorintheEUcountriesonaveragebetween 2000and2009)forcedmanyEuropeancountriestointro- ducenewpricingandreimbursementregulationsaimed at reducing spending on drugs [2]. In Poland, spending ondrugreimbursementbythepublicpayer,theNational HealthFund(NHF),sawa12%growthin2009compared to2008,whichwasthehighestannualgrowthrateinthe 2000–2011period[3].
The Act on the Reimbursement of Medicines, Food- stuffsIntendedforParticularNutritionalUsesandMedical Devices[4](hereinafterreferredtoas“theReimbursement Act”or“theAct”)wasdraftedbytheMinistryofHealth inordertorationalizetheactivityoftheNHFinthefield
http://dx.doi.org/10.1016/j.healthpol.2016.02.010
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/).
ofreimbursementpolicyandtorationalizeitsbudget(i.e.
reduceitsspendingonreimburseddrugs).Anotherobjec- tivewastomakepricesofreimburseddrugsuniformacross thecountrybyintroducingfixedpricesandfixedwholesale andretailmarginsandtoimplementanewwayofcalcu- latingthem,whichwouldcomplywiththeEUaccounting standards(CommissionRegulation(EC)No1126/2008of3 November2008)andEUtransparencyregulations(mainly CouncilDirective89/105/EECof21December1988relat- ingtothetransparencyofmeasuresregulatingtheprices ofmedicinalproductsforhumanuseandtheirinclusionin thescopeofnationalhealthinsurancesystems[5]which recommendsthatreimbursementdecisionsaremadeon thebasisofa credibleassessmentofdatafromthebest availableclinicaltrialsandanassessmentofclinicaleffec- tivenessandallowsforexperts’opinionstobeadditionally takenintoaccount).
2. Policycontentandprocess
TheReimbursementActcameintoforceon1January 2012 as partof a package of healthcare acts that also included: theActontheInformationSystemsin Health Care, the Act on Patient Rights and the Patient Rights Ombudsman,theActontheProfessionsofPhysicianand Dentist,andtheActonTherapeuticActivity.Itlaiddown,in onelegalact,therulesforthereimbursementofmedicines, foodstuffs intended for particular nutritional uses, and medicaldevices.ThekeychangesintroducedbythisAct aresummarizedinTable1.
2.1. Pharmaceuticalcostcontainmentmeasures
In order to alleviate budgetary pressures, the Act introducedseveralmechanismstodecreaseexpenditure onreimburseddrugs:(1)theActdefinedapercentageof thetotalfundsforguaranteedbenefitsthat canbeused fordrugreimbursement–thispercentagewassetat17%(it usedtobe18%ormore);(2)whentheamountspenton drugreimbursementexceeds17%,allMarketingAuthori- sationHolders(MAHs)ofthereimburseddrugswillhave tocovertheextraexpenditure(apay-backmechanism);
(3) theAct made statutory prices based on mandatory negotiations,setpricelimitsforgenericdrugs(setat75%
oftheoriginaldrugprice)andintroducedadjustedfixed wholesaleandretailmargins(thepricingprocessforreim- burseddrugsisdepictedinFig.1).Beforetheintroduction oftheAct,therewerenofixedpricesforreimburseddrugs, whichmeantthataccesstoreimburseddrugswasunequal.
Priceshadacharacterofmaximumpricesandpharmacies couldchargelowerpricestoattractcustomersandincrease sales.Pricingofgenericswasnotregulated.Thewholesale marginwasrelativelyhighcomparedtootherEuropean countries(8.91%in Polandcompared toless than5% in theCzechRepublic,Greece,Spain,Finland,Italy,Sweden, and Latvia [6]) but manufacturers could offer rebates to pharmacies and this practicewas widespread.There werealsonofixedretailmargins.TheReimbursementAct brought the wholesalemargin down to 5% (from 2014 onwards),prohibitedtheuseofrebates(pharmaciesmay nowfacefinancialpenaltiesiftheyobtainrebatesfromthe
manufacturers),andmaderetailmargindependentonthe wholesaleprice.TheActalsoprohibitedadvertisingand othermarketingof reimburseddrugs,which wasprevi- ouslynotrestricted(Table1).
Anotherimprovementintroduced bytheReimburse- ment Act was the establishment of the Economic Committee,whichisattachedtotheMinistryofHealthand isresponsiblefornegotiatingwithpharmaceuticalcompa- niestheofficialsalespricesforreimburseddrugs,levels of patient co-payments, and indications for reimburse- ment.TheEconomicCommitteemakesrecommendations regarding:(1)thelevelofreimbursement(thiscaneither be(a)100%reimbursementwithnopatientco-payment, i.e.freeofcharge;(b)aflatfee;or(c)partialreimburse- ment–70%or50%),dependingonthecostandduration oftreatment;(2)differencesinthereimbursementlevel, e.g.lowerdrugpricesforcertainpopulationgroups;and (3)reimbursementperiod(2,3or5years).Accordingtothe Act,reimbursementdecisionhastobemadeonthebasisof scientificevidence.Tohavethedrugreimbursed,theMAH hastoproveitscost-effectivenesscomparedtothealter- nativetherapeuticsubstancewhichisalreadyreimbursed frompublicfunds.
AnothernoveltyoftheActintheareaofreimbursement istheintroductionofanegativereimbursementcriterion, wherebyreimbursementiswaivedwhenahealthcondi- tioncanbeavoidedbyachangeinlifestyle.Thiscanlead totheexclusionofcertaindrugs,whichcouldimprovethe qualityoflifeforthepatients,fromreimbursement.
UndertheprovisionoftheAct,physiciansweregiven additional obligations in terms of writing detailed pre- scriptionsforreimburseddrugs,includingspecifyingthe reimbursement category. The NHF may impose heavy financial penalties if irregularities in prescribing (e.g.
wronglevelofreimbursementindicatedontheprescrip- tionorwritingaprescriptionforareimburseddrugtoa personnotentitledforreimbursement)aredetected.
2.2. Accesstoinnovativehigh-costdrugs
TheReimbursementAct alsointroduced risk-sharing schemes(RSSs),whichconstitutearelativelynovelmecha- nismforfinancinginnovativemedicinesthatarehigh-cost [7].RSSsaremostlyusedwhenthereisuncertaintyabout thecost-effectivenessofexpensive,innovativedrugs.Dur- ing the health technology assessment (HTA) process a
“thresholdprice”iscalculated,i.e.thepriceatwhichthe Incremental Cost-Effectiveness/Utility Ratio (ICER/ICUR) (theresultofCost-Effectiveness/UtilityAnalysis)doesnot exceedthethresholdofthreetimespercapitaGDP.The MAHoftheexpensivedrugmayreducetheICER/ICURby proposingarisk-sharingscheme(RSS).Itallowsthedis- tributionoffinancialand/orhealthoutcomesriskbetween theMAHandthepublicpayer[7].Inaccordancewiththe ReimbursementAct[4]theproposedRSSscan(1)make theMAH’srevenuedependentonthehealthoutcomes(i.e.
focus onthe health effects); (2) make theofficial sales pricedependentontheMAHassuringthesupply ofthe drugatlowernegotiatedprice(pricediscount);(3)make theofficialsalespricedependentonthedrug’sturnover (price-volumeagreement);(4)maketheofficialsalesprice
Table1
Reimbursementpolicybeforeandafter1January2012.
2004–2011 From2012
Governanceandregulation
Keylegalacts Actof27August2004onHealthcare ServicesFinancedfromPublicSources andtheActof5May2001onPricing
Actof12May2011ontheReimbursementof Medicines,FoodstuffsIntendedforParticular NutritionalUsesandMedicalDevices Rules,conditions,andproceduresforadministrativedecisionmakingintheareaofdrugreimbursement
AdvisorybodytotheMinistryofHealth DrugEconomyTaskForce* EconomicCommittee**
Decision-makingandadvisorybodyat theAgencyforHealthTechnology Assessment
ConsultativeCouncil TransparencyCouncilforthePresidentoftheAgency forHealthTechnologyAssessment***
Rulesforassigningdrugstotheparticularreimbursementcategory Reimbursementlimitgroups
(internalreferencepricing)
Notused Medicinewiththesameinternationalnameor
differentinternationalnamebutwithsimilar therapeuticeffectandsimilarmechanismofaction, withthesamereimbursementindicationsandsimilar clinicaleffectivenessbelongtothesamelimitgroup Rulesandproceduresforsettingtheofficialsalespricesforreimburseddrugs
Pricesofreimburseddrugs Maximumprices;pharmaciescansell drugsatlowerprices
Fixedprices;thesamepricesapplytoallpharmacies
Pricesofgenericdrugs Notregulated Firstgenericdrugonthelist:75%oforiginaldrug price;secondandnextgenericdrugonthelist:price equaltothepriceofthecheapestmedicinewiththe sameactivesubstance
Wholesalemargin 8.91% 7%in2012
6%in2013 5%since2014
Retailmargin Dependssolelyonthepriceofthedrug Calculatedonthewholesalepriceoftheproduct,being thebasisforthelimitinagivenlimitgroup
Publicationofreimbursementlist Onceortwiceayear(irregularly);
publishedasaregulation
Every2months;publishedasanannouncement
Othercostcontainmentmeasures
Individualpriceagreements Notused Statutorypricesarebasedonmandatorynegotiations Risk-sharingschemes(RSSs) Notused Yes;itisamechanismwhichisusedforfinancing
innovativemedicinesthatarehigh-costandallowsthe distributionoffinancialand/orhealthoutcomesrisk betweentheMarketingAuthorisationHolders(MAH) andthepublicpayer
Percentageofthetotalfundsfor guaranteedbenefitsdesignedfor drugreimbursement
18%ormore 17%
Pay-backmechanisms Notused Ifthetotalamountspentondrugreimbursement
exceeds17%,allMAHsofthereimburseddrugsmust coverthedifference(excludingreimburseddrugsfor whichaRSSwasagreedbetweentheMinistryof HealthandMAH)
Source:Authors’owncompilationbasedonthelegalactscitedintheTable.
* Consistsof3representativesoftheMinistryofHealth,3representativesoftheMinistryofFinance,3representativesoftheMinistryofEconomy.
** Consistsof12representativesoftheMinistryofHealthand5representativesofthePresidentoftheNationalHealthFund.
***Consistsof10HTAexperts,4representativesoftheMinistryofHealth,2representativesofthePresidentoftheNationalHealthFund,2representatives ofthePresidentoftheOfficeforRegistrationofMedicinalProducts,MedicalDevicesandBiocidalProducts,2representativesoftheCommissionerfor Patients’Rights.
dependentontheMAHreturningpartofthereimburse- mentamounttothepublicpayer(pay-backagreement);(5) setotherreimbursementconditionswhichwouldincrease accesstothepubliclyguaranteedbenefitsordecreasetheir costs.
TheMinisterofHealthrecognizesthevalueoftheRSSs andhasbeentryingtoincentivizepharmaceuticalcom- paniesto enter intosuch schemesby offering theman exemptionfromthegeneralpaybackschemeiftheyengage
inRSSsinstead.Atthesametime,companiesmaybefined bytheMinisterofHealthiftheagreedrisk-sharingcondi- tionsarenotmet[7].
Apart from the RSSs, another mechanism aimed at increasing access to medicines is the mandatory bi- monthlyreviews ofthereimbursement lists.Beforethe introductionoftheAct,reimbursementlistswereupdated irregularly,atmostonceortwiceayear,whichlimitedthe timelyintroductionofnewdrugs.
Fig.1. PricingofreimbursedmedicinesinPolandaccordingtothe2011ReimbursementAct.
Source:Authors.
3. Policyoutcomes
3.1. Effectsonthestakeholders
3.1.1. Effectsonthepublicpayer
AccordingtotheNHF,itsexpenditureonreimbursed ambulatory care drugs decreased significantly in 2012
by EUR 481 million compared to 2011 (a decrease of 22%) (Fig. 2) [1]. Since then, expenditure on ambula- torydrugshasbeengrowingatabout4.5–5.5%peryear, whichisslightlyhigherthanthegrowthratesobservedin 2010–2011(3.6–3.7%).Before2010,growthinspendingon ambulatorydrugsfluctuatedhighlyfrom0.6%in2007to 12%in2009.
2,003 2,077 2,152
1,671 1,746
1,842
-22%
-25%
-20%
-15%
-10%
-5%
0%
5%
10%
- 500 1,000 1,500 2,000 2,500
2009 2010 2011 2012 2013 2014
Reimbursement expenditure (EUR million) Change over pervious year (%) Fig.2.ReimbursementexpenditureoftheNHFonambulatorydrugs,2009–2014.
Source:Authors’owncalculationsbasedonNHFdata[3]ontheamountofrefund.
Thesimilartrend wasobserved in total NHFexpen- ditureonthereimbursementofdrugs,which decreased byEUR438millionin2012(17%)comparedto2011.In 2013and2014,whileincreasing,totaldrugexpenditure remainedlowerthanthe2011level(byEUR339million andEUR74million,respectively).Totalspendingonthe reimburseddrugsgrewbyabout4.5%in2013and11.5%in 2014.Thismeansthatthereductioninspendingonreim- burseddrugswaslargelyaone-offeffect.Thismaybein partexplainedbytheincreasedspendingontherapeutic drugprogrammes(seebelow)andbythefactthatthenum- berofdrugsreimbursedfromthepublicfundsinPoland hascontinuedtogrow.BetweenJanuary2012andendof June2014,29neworiginaland7generictherapeuticsub- stanceswereaddedtothereimbursementlist[8].Another 11substancesthathadbeenavailablewithinacustomized chemotherapywerealsoaddedtothereimbursementlist.
Thenumberofitemsonthereimbursementlistforambu- latorymedicinesincreasedfrom2695inJanuary2012to 3743inMay2015[8].
TheNHFalsobenefitedfromtheintroductionoftheRSSs [3],althoughitisdifficulttoquantifythesebenefitsasdata onRSSsisnotpubliclyavailable(neithertheNHFnorthe MinistryofHealthpublishsuchdatainPolandandsuch dataisalsonotavailableforothercountries[7]).According toestimatesbyINFARMA(Employers’AssociationsofInno- vativePharmaceuticalCompanies),in2012and2013,the totalamountreceivedbytheNHFundertheRSSswasEUR 76million,whichismuchhigherthantheexpenditureon reimbursingnewinnovativetherapeuticsubstancesthat wereaddedtothereimbursementlistinthoseyearswhich, accordingtothesamesource,amountedtoEUR3.4million in2012andEUR28.8millionin2013[9].
3.1.2. Effectsonthepatients
TheimplementationoftheReimbursementActresulted inasignificantdecreaseoftheaverageretailpriceofreim- burseddrugsand theaveragereimbursementlimit.The lattermeansahigherlevelofpatientco-payments,while theformerhastheoppositeeffectonthelevelofpatient co-payments.In2013,thelevelofpatientco-paymentsfor thereimburseddrugswashigherbyEUR0.04compared to2010.Between2013and2014,theaveragepatientco- paymentdecreasedbyEUR0.18comparedto2010,which meansthatreimburseddrugshavebecomemoreafford- abletothepatientsinrecentyears[9].InMay2015the averagelevelofco-paymentwasEUR3.19,comparedto EUR3.68inJanuary2012,i.e.adecreaseof24%[8].How- ever,thepricesofnon-reimbursedprescriptiondrugsare stillgrowingasdoestheoverallamountofpatientexpen- ditureondrugs(forbothreimbursedandnon-reimbursed prescriptiondrugs).
The Reimbursement Act also introduced substantial changesin thefield ofspecialized therapies (mainlyfor oncologyandseverechronicdiseases).In2012and2013, theNHF increased its expenditure on therapeutic drug programmes.TotalNHFexpenditureonmedicationsused intherapeuticprogrammesorinchemotherapyincreased byabout36% between2012and 2014[3]. Thenumber of patientstreated withinthe existing therapeutic pro- grammesincreasedfromabout55,000people(excluding
customized chemotherapy)in 2011 to about 64,000 in 2013.Inaddition,5000peopleweretreatedunder13new therapeuticprogrammes.Atthesametime,thenumberof patientscoveredbycustomizedchemotherapydecreased [8,9].
Patientsarealsolikely tohavebenefited frombetter accesstoinnovativedrugsandtodrugsingeneral.Thisis mainlythankstotheRSSs,butalsothankstothemorefre- quentupdatesofreimbursementlists(bi-monthly)andthe introductionofpenaltiesforpharmaciesincaseoffailure toensurethecontinuityofsupplyofreimburseddrugs.
Theintroductionoffixedofficialpricesandmarginsfor reimburseddrugsresultedinareductionoftheirprices, and, as a consequence, Poland is one of EU countries withthecheapestdrugs[9].Thiscausedoutflowofdrugs to other EU countries and shortages in Poland: phar- maciesbuydrugs fromwholesalersormanufacturersat prices valid in Poland and sell them (via distributors) in Western Europeancountries instead of selling them in Poland,asthisismuch moreprofitable.Accordingto estimates, some200medicationsare missing,including insulin, anticoagulants,anddrugs forParkinsondisease, cancer,andpulmonarydiseases[10].Thisparalleltradein reimburseddrugs isillegalandisprohibited underEU’s directive on pharmaceuticaltrading (tradein other, i.e.
non-reimbursed,drugsisallowed).Thissituationresulted inanongoingprotestofpharmacistswhoinsistonguaran- teeingequalaccesstoreimburseddrugs[10].
3.1.3. Effectsonthephysicians,pharmaciesand manufacturers
The effects on the other stakeholders are not well known.Physiciansarelikelytoprescribereimburseddrugs withgreatercautionandaccuracy.Pharmacistsareobliged toverifyprescriptionsand,incaseofanyconcerns,must contactthesupervisorybodies,i.e.theMainPharmaceuti- calInspectorate,andtheNHF[1].Theprofitsofpharmacies andpharmaceuticalcompaniesareexpectedtodecrease, followingtheintroductionoffixedpricesandmargins,but todatetherehasbeennoreliabledataallowingtoverify this.Theintroductionofsomeexpensive,innovativedrugs tothe reimbursementlistby theNHFhasthe opposite effectandthetotaleffectonthemanufacturers’profitsis difficulttogauge.Theprohibitionofadvertisingandother marketingofreimburseddrugsposesthreattotheexist- enceofsmallerpharmacies.Thismaymeanpooreraccess todrugsifthesepharmaciesareclosed,butsofarthereis noevidenceinthisarea.
3.2. Effectsonpharmaceuticalregulation
One of the undesired effects of theprice reductions resultingfromtheReimbursementAct,wastheoutflow ofdrugsabroadandtheirshortagesonthePolishmarket (seeSection3.1).Thismotivatedthegovernmenttotake action.TheamendmentoftheActonPharmaceuticalLaw, signedbythePresidenton21May2015,willsignificantly tightenthemonitoringofdrugavailabilityandtheirexport toothercountries[8]:
• wholesalersandpharmacieswillbeobligedtoinformthe MainPharmaceuticalInspectorateabouttheavailability ofdrugs;
• basedontheaboveinformation,theMinisterofHealth willpublishthelistofdrugsthatarelikelytobecome unavailableinPoland;
• pharmacistswill beobligedto informtheMain Phar- maceutical Inspector(within24h)aboutthelackofa reimburseddrug;
• thewholesalerthatwantstoexportadrugwithpoten- tiallylimitedavailability willbeobliged toinformthe MainPharmaceuticalInspectorate;thelatterwillhave 30daystoobjectthis;
• anyrefusaltoorderdrugswillhavetobejustifiedbythe wholesaler.
4. Conclusions
TheimplementationoftheReimbursementActbrought aboutnumerous changesthataffectedtheentire health care sector, including patients, physicians, pharmacists, publicofficials,andpharmacists.
ThekeyeffectsweretheeconomicbenefitstotheNHF (lower expenditure on reimbursed drugs) and patients (lower average spending on reimbursed drugs, though co-payments for certain drugs may be higher and the averagespendingonprescriptiondrugsishigher[3],[8]).
Patients also benefitfrom enhanced availability of new drugsbutalsosufferfromshortagesofcertaindrugsdue to (illegal) reverse chain of drug distribution, which is thekey unintendedconsequenceoftheReimbursement Act. Medium and long-term effects of the Act on the expenditureon reimburseddrugs byboth theNHF and the patients and on the access to drugs remain to be seen.
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