Cancer Care System in Ukraine 2023

White Paper

Cancer Care System in Ukraine

September 2022

Current Status, Impact of War, Further Development

Foreword

Rightnow,Ukraineisthecentreofattentionofthe entireconsciousworld,whichisstrugglingwiththe medievalmanifestationofaggressionandterrorism onthepartofRussia.

AllaspectsoftheexistenceofUkrainianstatehood areinastateoffiercestruggleagainstchaoticevil, whichhasseteverythingonthedestructionof Ukraine.

TheUkrainianhealthcaresystem,withallits constituentelements,isexperiencingsupercritical loadsandunpredictableinterventionscausedby theRussianinvasionofUkraine:

▪ physical(killingofHCPs,patients,bombing anddestructionoftheinfrastructure)

▪ financial(reductionandreallocationoffunds, drasticdamagetocapital),

▪ systemic(declineandmigrationofpatient populationsandthepopulationingeneral),

▪ conceptual(ongoingreformingandrethinking theroleofthehealthcaresystemandits elements).

ThisWhitePaperwasaimedatshowingthecurrent statusoftheUkrainianCancerCareSystemduring the2014-2021periodasis,incl.epidemiology, regulationandfinancing,infrastructure,and stakeholders.

Wealsotriedtothinkoutideasaboutcancercare furtherdevelopmentdirectionsandlistedobvious gaps.

Thisisapro-bonoresearchconductedbyEirhub aconsultingfirm,focusedondeliveringmarket accessandrecruitmentprojectsforLifeSciences stakeholdersacrossEuropeandinUkraine. ThisWhitePaperwasfullyconductedbyour Ukrainianteamwithoutanyexternalcommercial interestorsponsorship.Wehandledaseriesof face-to-faceinterviewswithcountry’s stakeholders:withPAGs,HCP,oncologycare systemexperts,andofficials,andstudiedmostof thepubliclyavailableinformationonthetopic. WedevelopedthisWPasasetofslidesina businessmanner neatly,briefly,andinformatively. Ourresearchshouldbecontinuedtoidentifyall underlyingpeculiaritiesimpactingcaresystem elementsandthetrajectoryofcancercarein Ukraine.

However,wedonotpursuetheaimofunderlining solutionstotheoncologycaresystemofUkraine. Yetwebelievethatonlyaltogether,uniting endeavourswithprospectiverecipientsofthisWP, wecanbringchangetothepatients'accessto high-qualityoncologycareinUkraineanddrivethe healthcaresystemtowardsbetterperformance evenamidstatoughperiodforourcountry.

Wewillbesincerelygratefulforanyfeedback, correctionsoradditionsfromsystemstakeholders andindustryexperts.

YoucansharethisWhitePaperwithanyonefreely butbydirectlyreferringtoEirhubastheauthor. GlorytoUkraine!

Photo by Piron Guillaume on Unsplash

But first things first:

Russia invaded Ukraine and continues killing Ukrainians to date

Around 5 o'clock on Feb 24, Russia brutally dared to launch the full-scale military invasion of Ukraine.

▪ 13+ mln Ukrainians have been displaced

▪ Tens of thousands of soldiers and civilians were killed by Russians

▪ Russia occupied 20% of Ukrainian land

▪ Russians severely damage Ukrainian economy and infrastructure

▪ 900+ healthcare objects are damaged or destroyed

Important Statement on the Russian Invasion of Ukraine

Russia invaded Ukraine in 2014 by annexing Crimea and partly occupying Luhansk and Donetsk regions. The current full-scale military invasion started on Feb 24th, 2022, and continues to date. Russians bomb Ukrainian cities and kill Ukrainians non-stop.

Morethan2mlnrefugeeshavefledUkraine sincetheRussianinvasionbeganonFeb24, 2022,andover4mlnpeople,10%ofthe population,areexpectedtobeforcibly displacedastheyseeksafety,creatinga wide-ranginghumanitariancrisis.Ukrainehas ahighcancerburden,withmorethan 160,000newdiagnosesin2020alone. Thecountryalsohasoneofthehighest childhoodcancermortalityratesglobally. Thus,Ukraine'scancercaredisparitieswere alreadyhighbeforeRussia’sunprovoked aggressionandwillnowundoubtedlyworsen duetotheconflict.

FirstRussianinvasionofUkrainewasin2014, whenRussiaannexedCrimea,anautonomous peninsulaunderUkrainianjurisdiction,by conductingaforgedandillegalreferendum amidsttheeventsoftheRevolutionofDignity andnotoriousex-presidentYanukovych fleeing.

Subsequently,ananti-governmentseparatist movement,100%organizedandsponsored byRussianFederationtogetherwithregular Russianarmyforces,aroseintheDonetsk andLuhanskregionsofUkraine(namely, Donbas)andcausedactivehostilitiesinthese territoriesbetweenRussianproxiesandthe ArmedForcesofUkraine.Unfortunately,it hasresultedinthetemporarylossofcontrol bytheUkrainiangovernmentoverthese territoriessofar.

For8years,Russiacontinuouslyshelled UkraineintheEastofourcountry.Moreover, thearmedconflicthasbeenfrozenand

regulatedbytheMinskagreements, representedbythreepoliticaldocuments aimingtoinstallpeaceinoccupiedterritories. Armedseparatistgroups,backedbythe Russianregulararmy,hadbeenviolatingthe termsoftheagreementssincethetimethe agreementswerereached,performing constantshellingsofcivilareas.Therefore, Russiahasnevermeanttostopthearmed conflictintheDonbasarea.

OnFeb21,2022,Russiastartedanewstagein thewarescalationintheeastofUkraineby declaringtheintentiontorecognizethe independenceofthewholeDonbasarea, includingterritoriescontrolledbyUkraine,as twoseparatestateentities. Thisintentionwasincitedbythe"alleged" UkrainianshellingsinrealitymadebyproRussianarmedtroopsandappealsofleaders ofpro-Russianproxyseparatistgroupsto recognizetheindependenceofpseudostate entities.Afterthevideospeechvoicedby Putinthatday,hesignedtheordersclaiming theindependencyrecognitionofthepuppet republicsofLuhanskandDonetskcontrolled byproxyseparatistarmedgroupsand Russianofficialsandarmy.

Itwasmadefollowingthesessionwiththe SecurityCouncilofRussia.Besides,the dictatorauthorizedtheFederalAssembly (upperhouseoftheparliament)tosupport hisorders,acknowledgetheindependenceof theso-called"republics",andratifythe friendshiptreatieswithillegalentities.

TheUSA,theUKandothercountrieswarned

itscitizensontheterritoryofUkraineabout thehighchancesofafull-scaleinvasionof UkrainebyRussiaandurgedthemtoleave thecountry.ByFeb22,nearlyallembassy employeeshadbeenevacuatedeithertothe southofUkraineorPoland.Likewise,allair flightstoandfromUkrainewerecancelledby foreignairlines.

OnFeb22,PutinreferredtotheStateDuma (lowerhouseofparliament)toauthorizethe useoftheRussianarmyoutsidethe federation.

Ukrainiantopauthorities,includingPresident VolodymyrZelenskyy,wereawareof intelligencesignifyingthehighpossibilityofa full-scaleinvasionofRussiafrommultiple vectors.However,noonehadeverbelieved thewarwouldhappen.Ithadbeen discoveredonlythenthattheRussian dictatorshiplackedanysenseofratioand internationallawprinciplesandwasfullof hatred,evil,atrocityandperverted imperialism.

OnFeb23,theParliamentofUkraine approvedtheintroductionofthestateof emergencyinUkraine.

Around5o'clockonFeb24,Russia startedthefull-scaleinvasionofUkraineby launchingmissilesatnearlyallUkrainian cities.Thegovernment,parliament,the militarywingandPresidentallstayedinKyiv. Thatdaytheparliamentapprovedthe introductionofmartiallawanddeclared generalmobilization.Sincethen,theArmed ForcesofUkraine,theNationalGuard,the

police,andTeroborona(TerritorialDefence Units localforcesunits)havebeenputting upfierceresistancetoaggression.The Russiantroopstriedtoadvanceinthe Kherson,Donetsk,Luhansk,Sumy,Kharkiv, Chernihiv,ZaporizhzhiaandKyivregionsand wereactivelyheadingtowardsKyiv.Missile strikeshitpredominantlycivilobjects departmentstores,schools,hospitals,railway stationsandblocksofflatsintheresidential areasandcontinuedestroyingcivil infrastructureandkillingthousandsof civilians.

BytheendofMar2022,Russiantroopsseized theKhersonregion,partsofKyiv,Kharkiv, Zaporizhzhia,DonetskandLuhanskregions. YetonApr2,theRussianarmywasdefeated intheKyivregionandwasforcedtoretreatto theborderwithBelarus.

Subsequently,Russiancrimesreferringto brutalhomicides,lootingandtortureof civiliansinBucha,BorodiankaandIrpinwere revealedtothewholeworld,provingthe existenceofpurebarbarism.Intwoweeks' time,RussianslefttheChernihivandSumy regions.

Performingconstantbombings,Russiansput allintentionsonsurroundingandeliminating Ukrainianmilitarystaffandciviliansatthe Azovstalplant.InthemiddleofMay,Ukrainian defendersofthelastoutpostinMariupol weretakencaptiveandtransportedto Olenivka,aformerprison,locatedinthe Donbasareacontrolledbypro-Russian satellitearmedgroups.OnJul29,Russians

blastedthepremiseswithUkrainianmilitary stafftakenhostage.Theirfateisunknownso far.

Russianmilitaryforcesarenotaversetousing weaponsinUkraineprohibitedby internationalhumanitarianlaw,inparticular, clustermunitionsandwhitephosphorus munitionsagainstcivilians.

Currently,theLuhanskregionisentirely occupiedbyRussians,andtheDonetsk region formorethanhalf(55%).

Owingtotheland-leaselaw,endorsedbythe USA,thegenerousbackingoftheUKandthe powerfulsupportofsomewesterncountries, theUkrainianpeople,sidebysidewithbold ArmedForces,keeponstrugglingtoreturn theterritoriesofoverUkraineillegally annexedandseizedbyRussiasince2014.

Wegetshelledeveryday,wegetkilledevery dayasRussiaremainscommittedtoannexing asmuchUkrainianterritoryaspossiblewith nomercyforthecivilpopulationandbyany means(includingterroristmethods).

Thisveryreportwasbeingpreparedunder everydaymissilealerts.

Wedieeverydaytoprotectourcountryand familiesregardlessofthepricemeanttopay. Weurgeeveryonereadingthisreporttobe awareoftheongoingwarinUkraine,support UkraineandstopRussiabysignifyingthatthe civilizedworldwillnotreconcilewithany dictatorshipreadytocrossanylines establishedafterWWIIonitsway.

Sources: Radio Svoboda, NV, Ukrainska Pravda, Human Rights Watch

CONTENTS

▪ Epidemiology

▪ Regulation

▪ CancerCareEvolution

▪ Financing

▪ Stakeholders

▪ DrugsProcurement

▪ MarketAccessPathway

About Eirhub:

▪ Who are we

▪ Contact details

Trajectory of Cancer Care

2. Impact of the Russian Invasion

3. Further Development 4. 1. Cancer Care System in Ukraine

▪ ElementsofCancer Care

▪ Patientsflow

▪ CancerCare Infrastructure

▪ Diagnosticsand TherapyTypesUtilized inUkraine

▪ OnHealthcare Infrastructure

▪ OnCancerCare Infrastructure

▪ OnPatients&Their Families

Disclaimer

Theanalysesandconclusionscontainedinthisreportrefertotheperiodofthecalendar2022andtoinformationanddataavailabletoEirhubanddonotpurporttocontainorincorporatealltheinformation. AlthoughitscontentreflectsEirhub’scurrentexpectationsregardingfutureevents,theanalysesandconclusionscontainedinthisreportarebasedonvariousassumptions,beingbaseduponfactorsandevents subjecttouncertainty.Statementsofexpectation,forecasts,andprojectionsrelatetosuchfutureeventsandarebasedonassumptionsthatmaynotremainvalidforthewholeoftherelevantperiod.Futureresults couldbemateriallydifferentfromanyforecastcontainedintheanalyses.

TheanalysescontainedhereinwereundertakenbyEirhubasofthedatesnotedherein.Eirhubundertakesnoobligationtoreviseorupdateanysuchanalysesoranyforward-lookingstatements.© 2022.Eirhub.Allrightsreserved

CANCER CARE SYSTEM IN UKRAINE

▪ Epidemiology of Cancer in Ukraine

▪ Regulation of Cancer Care

▪ Financing of the Cancer Care System in Ukraine

▪ Cancer Care System Stakeholders

▪ Procurement of Oncology Drugs

▪ Market Access Pathway for Oncology Drugs

Cancer in Europe: Incidence Rates

Theglobalburdenofcanceris growingworldwide,with18.1 million(mln)newcancercases and9.6mlndeathsfrom cancerin2018;23%ofthenew casesand20%ofthedeaths occurredinEurope.

Incidencetrendsforallkindsof cancerhavecontinuedtorise inmanyEuropeancountries, althoughataslowerpacein recentyears.Ukraineis classifiedwithinthelowermiddle-incomegroup,andhad apopulationof44mlnpeople in2018.

AccordingtoGLOBOCAN estimates,therewere170,000 newcancercasesand98,000 deathsfromcancerinUkraine in2018.

Despitethesignificantburden, theage-standardized incidencerates(ASR)258.3per 100,000inmales,203.6per 100,000infemales)areamong thelowestintheregion(1)

Theoncologicalburdenof diseaseinUkraineposes considerablepressurebothon patientsandhealthcare(HC) facilitiestomanageearly detection,diagnosis,

treatment,rehabilitationand palliativecare.Theincidence ofcanceramongthe30-69yo agegroupinUkraineisthe2nd highestamongtheother Europeancountries.

Intheinternalstructureof morbidityin2020,theshareof neoplasms(C00–C97;ICD-10) takesthe3rd placeinUkrainein thegeneraldisease architectureafter cardiovasculardiseases(CVD) andrespiratorysystem diseases.

However,malignantneoplasms constitutedthe2nd maincause ofdeathsofUkrainiansin2020 withahighrateofavoidable deaths.

Thefightagainstmalignant neoplasmsandoverallcancer ratesisoneofthemost importantHCproblemsin Ukraine,therelevanceofwhich isdeterminedbytheconstant growthofmorbidity,frequent failureintimelydiagnosis,high costandcomplexityof treatment,andhighdisability andmortalityrates.

However,theestimatedagestandardizedincidenceratein

Ukraine,presentedinthe figure,seemstobemuchlower thaninotherEuropean countries.Atglance,itismeant tobeapositivetrendin preventionandearlydiagnosis. Yetinabird'seyeview,this indexdepictsanegative tendencytoward underdiagnosisofoncology provokedbythelowcancer awarenessattheprimary medicalcarelevel,andthelack ofsystematicnationwide publichealthscreening programsaimingtoincrease earlydetectionofcancer.

Morethanhalfofallcancer sitesarediagnosedatthelate stages(III-IV)inUkrainewhich highlightsthecoreproblemof theoncologyservice inefficientdiagnosticstrategy. Besides,thehighratesof cancerrecurrenceare associatedwithinsufficient diagnosticsmethodswhich,in turn,couldmakethecourseof diseasemorepredictableand controllable,lesscostlyand addQALYstoapatientwitha historyofcancer.

Source: GLOBOCAN 2020, WHO, Cancer Atlas, (1) "Adult Cancer Arises because of the Life Lived, and in Children It Is a Congenital Disease", January 2018, Radio Svoboda

The global burden of cancer is growing worldwide, so the incidence trends for all kinds of cancer have continued to rise in many European countries, although at a slower pace in recent years.

Figure 1. Estimated Age-Standardized Incidence Rates (World) in 2020 all cancers, both sexes, all ages

Cancer Incidence Rates by Regions of Ukraine

Theburdenofcanceris distributedunevenlyamong theregionsofUkraine.In2021, Dnipro,Kharkiv,andLviv regionsandKyivcityhadthe highestratesofoncological diseases(morethan7,000), whileChernivtsi,Luhansk,and Volynregionsrepresentedthe lowestincidencerate,withless than3,000newpatientswith cancer.

Theheterogeneityofthe incidencerateofcancercould bepartlyexplainedbythe regionalcharacteristicsofthe incidenceofCOVID-19andthe respectivechangeinaccessto thetreatmentanddetection settings.However,the differentlevelsofmedical personnelcompetence,the presenceofmodern equipment,andthe developmentofthe infrastructurearefactorsthat primarilyaffecttheuneven distributionoftheoncology burdenamongregionsof Ukraine.

Asforthedistributionof oncologicalmorbidityby stages,oncologicaldiseasesat thefirststageweredetected

in23.2%ofpatients,atthe second in24.4%,atthe third in17.9%,atthefourth in21.0%.Atthesametime,in 2020,thereweremore detectedcasesinthefirsttwo stages(25.3%;26.2%)and approximatelythesame detectionlevelatthethirdand fourthstages. Whileremainingonthesame level,thenumberofnew cancercasesatthefourth stageisrelativelyhigh comparedtootherEuropean countriesandindicates significantproblemsinthe organizationofcancer diagnosis.Thereasonsfor underdiagnosingare describedonpage9. Furthermore,in2021,the detectionrateatprofessional examinationsofallmedical facilitieswasatthelevelof 19.8%onaverageinUkraine, from1.4 9.8%intheVolyn, Zakarpattia,Ivano-Frankivsk, Odesa,Cherkasy,and Chernivtsiregionsto50.1%in Kyiv.

Analysisofthelevelof oncologydetectionatthe professionalexaminations

indicatestheineffectiveness ofthelatter.Thisisbecauseof thepoorawarenessofthe populationregardingthe purposeofpreventive examinationsandthe increasinglylowlevelof oncologicalvigilancenotonly amongfamilydoctorsbutalso amongspecialistsin specializedmedicalcare, includinginthediagnosisof theso-calledvisual localizationofSTDs lip,oral cavity,anus,skin,mammary gland,cervix,vulva,vagina, penis,testicle,eye,thyroid gland.

Summarizingthosementioned above,themostproblematic areasintheorganizationof cancercontrolremainthe timelydetectionofoncological diseases,adequatestagingof themalignantprocessaswell asthesystemofdispensary monitoringofpatientswith oncology,withoutthe establishmentofwhichitis impossibletoachievesuccess inincreasingthesurvivalrate ofpatientswithoncology.

Figure 2. Incidence Rates (New Cancer Cases Registered in 2021 all cancers, both sexes, all ages

The burden of cancer is distributed unevenly among the regions of Ukraine due to variance in access to the treatment and detection settings

Cancer Epidemiology in Ukraine: General Trends

 MORBIDITY

Theincidencerateofcanceris distributedunevenlyamongdifferent populationcategories(fortheregion viewturnbacktopage10).Females aremoreoftendiagnosedwithcancer thanmales,whichcouldbeexplained bytheabsenceoftheearlydiagnosis oflungandprostatecancer,themost commononcologicaldiseaseamong males.

Morbidityratesofoncological diseasesamongurbanpopulations prevailoverruralones.Thelatter couldbeexplainedbythelower awarenessoftheruralpopulation aboutpreventativediagnosticand morecomplicatedaccessibilitytothe relativespecialistduetothelocation. Furthermore,in2013-2014morbidity fromoncologicaldiseasesdeclined duetotheRussianannexationof Crimeaandpartialoccupationofthe LuhanskandDonetskregions. Accordingly,thefollowingstatistics showlowerincidenceratesduetothe absenceofpatientsfromthose territories.

Additionally,COVID-19significantly affectedboththemortalityand morbidityratesin2020-2021.The pandemicchangedtheorganization ofthediagnosticprocessandthe abilityofapatienttoentera specializedoncologyinstitution.

MORTALITY ➔

Themortalityrateofoncological diseases,likewisetheincidencerate, wasseverelyaffectedbytheRussian invasionin2013-2014andCOVID-19in 2020-2021.

Morespecifically,itissupposedthat thedeathsofnumerouspatientswith oncologicaldiseaseswereregistered astheonesthathappenedfrom COVID-19.

Inaddition,thereareproblemsin collectingdataonmortalityfrom oncology.

First,oncologyinstitutionshave limitedaccesstoinformationabout deceasedpatients,whichhindersthe studyofsurvivalfromcanceratthe populationlevel.

Secondly,thereisaproblemof determiningthestageofoncological diseaseandartificialunderestimation ofit.

InZakarpattia,Kirovohrad,Mykolaiv, Kherson,Cherkasy,Chernihivregions, andthecityofKyiv,from5to14%of deceasedfromcancerwere registeredaspatientswitha neoplasmdetectedpostmortem, whichindicatesaprobableviolation oftherulesofcancerregistrationand maybemotivatedbythedesireto reducetheindicatorofannual mortality.

Total deaths

RussianinvasionofUkraine:AnnexationofCrimea,partly occupationofLuhanskandDonetskregions Year-to-yeardecline-16.3%

COVID-19 implications

Year-to-year decline-9.1%

The incidence rate of cancer is distributed unevenly among different population categories, whereas women are claimed to be diagnosed with cancer more often than men. In contrast, mortality rates are higher in men than women.

invasionofUkraine:AnnexationofCrimea, partlyoccupationofLuhanskandDonetskregions

Figure 3. Cancer Morbidity: # of New Cancer Cases

Figure 4. Cancer Mortality: # of All Cancer-Related Deaths

Cancer Epidemiology in Ukraine: Morbidity & Mortality

Although I-II stages cover nearly half of all cancer diagnosis stages, the share of IV stages of cancer diagnosis is still large and keeps on steadily growing. Neoplasms located in breast, skin, lungs, and colon cause top-4 most common types of cancer in Ukraine.

Diagnosis, Localizations, Death rates

Asforthedistributionofoncological morbiditybystages,therateofoncological diseases’detectionatthefirstandsecond stageshasbeendecliningsince2014.In turn,thecancerdetectionrateatthethird andfourthstagesandthenon-detected stagehasbeengrowinginthe abovementionedperiod.

Suchstatisticscouldbepartiallyexplained bytheweakregulationandfinancingofthe oncologydetectionprocedure.Referto slides9and10formoreinformationonthis matter.

In2017,MOHcanceledthemandatory dispensarysupervisionandoffered screeningprogramsinstead,launchedonly in2020.Therefore,during2017-20the relevantauthoritiesfailedtoadequately adoptandfinanceanynationalscreening program.

Additionally,generalpractitioners(GPs)lack thepropercompetencetodiagnose oncologyandtimelyreferpatientstothe rightspecialist.Clearguidancetosupport GPsindetectingoncologicaldiseasesatan earlystageisabsent.Theabovementioned factorsseverelyaffectthelevelof oncologicaldetection.However,thisisnot theproblemofUkraineonly.

Furthermore,theCOVID-19pandemic, especiallytransportlimitationandobligatory quarantine,negativelyaffectedthe oncologicaldetectionprocessandledtoa significantreductionincancerdetection rateatthefirstandsecondstagesandan increaseinthequantityofdetectionat

furtherstages.

Movingtothedistributionofoncological morbiditybylocalization,in2021,allpatients weremostoftendetectedwiththefollowing typesofcancer:breast,non-melanomaskin cancer,lungs,colon,rectum,prostate, uterus,stomach,pancreas,andkidney.

Morespecifically,malesmostoftenhad cancerofthelungs,trachea,andbronchi andnon-melanomaskincancer,andinthe femalecategory,breastcancer,nonmelanomaskindiseases,anduterinecancer werethemostcommon.

Generally,theabovementioneddistribution remainsunchangedcomparedtoprevious years.

Proceedingwiththedistributionof oncologicalmortalitybylocalization,in2021, deceasedoncologicalpatientsofallsexes andagesmostcommonlyhavecancer localizedinthelungs,breast,stomach, colon,rectum,prostate,pancreas,kidney, ovary,andcervix.Thisrateremainswithout significantchangescomparedtothe previousyears.

Cancer Care System Regulation

WhiletheotherEasternEuropeancountries undertookanefforttoreformtheir healthcare(HC)systems,anychangesor attemptsforchangesappliedinUkraine wereactuallyapparentandinferior.

Theprocessofdecisionaldecentralization wasbasedonthestructuresof governmentaladministration,whichmadeit superficialandonlypartial.Moreoncancer caresystemregulationisonslide13.

Figure 5. Cancer Diagnosis Stages (% from All New Cases)

Figure 6. Top-10 Most Often Cancer Localizations Diagnosed For The First Time in Ukraine (shares from all new cases, both sexes, all ages, 2021)

Figure 7. Top-10 Most Often Deaths by Cancer Localizations Registered in Ukraine (shares from all new cases, both sexes, all ages, 2021)

Children Care System and Epidemiology in Ukraine

The government plan to create standalone pediatric oncology by separating its vertical from the adult one in 2008 has brought nothing but a separate funding system with the old management approach. Fortunately, the process of inevitable changes has started, driven by NGOs, patient organizations, and the readiness of the government to implement such changes.

Beforeproceedingwiththedetailed descriptionofthepediatriconcologysystem inUkraine,wewouldliketounderlinethat pediatriconcologyfrequentlyinvolves orphandiseasesthatneedspecialattention andimprovementofdiagnosticand treatmentoptions.Italsorequiresadditional trainingofphysiciansinrespectiveareas. However,theUkrainianpediatriconcology systemisstillbasedontheoutdated SemashkomodelsofHCprovision.

Pediatriconcologyiswellfinancedin Ukraine,andtheNHSUallocatesmorefunds perpatientunderthe"PaediatricOncology/ Haematology"packagethanallother existingreimbursedmedicalservices packages.Despitesufficientfinancingfor pediatriconcology,thesefundsarenot reasonablyallocatedbecauseofthe excessivenumberoftreatment infrastructure.

PediatriconcologydepartmentsinUkraine arepresentatalmosteveryregional children'shospital,and,asaresult,more than30centerstreattheseconditions.Such excessivetreatmentfacilitiesforasmall numberofpatientscreateobstaclestothe levelofcare.

Firstly,withthesmallnumberofpatients, mostoftherespectiveoncologistscannot obtainenoughpracticeandaccumulatethe knowledgenecessaryforqualifiedHC provision.

Secondly,despitethegoodfinancingof pediatriconcologypackages(checkpages 22and23),thosefundsaredispersed

betweenhospitals,which,inturn,donot haveenoughfundstobuyhigh-techdrugs andmedicaldevices.Thisproblemwas plannedtoberesolvedbyadoptinganew Strategy-2030(refertopages18-19).Under thisdocument,thegovernmentplannedtwo essentialissues:

1. Centralizationofpediatriconcology facilitiesand

2. Creationofmultidisciplinaryhospitalsfor childrentoprovidecomplextreatment. Thestrategyshouldhavebeenadoptedin Feb2022;however,theprocesswasfrozen aftertheRussiansinvadedUkraine.Apart fromnegativeaspects,thepublic organizationofchildren'soncologyalsohas positiveones.Thefundsprovidedforthe publicprocurementofdrugsusedforthe treatmentofchildren'soncologyaremuch higherthanWHOstandardsforlow-income countries:

▪ targeteddrugs,

▪ accompanyingdrugs,

▪ chemotherapy,

▪ antibiotics,

▪ antifungalagents,

▪ andspecialnutrition.

Furthermore,"Okhmatdyt"Children's SpecializedHospital(Kyiv),which coordinatestheentirecycleofpediatric oncologytreatment,isalsoawell-developed pediatricfacility(checkpage15toseethe structureofthechildren'soncologycare system.)Itservesasareferencecenterfor diagnosisandtreatmentofthemostcomplex casesandhasamodernandwell-equipped

building.

Besides,Okhmatdythasalinearaccelerator (LINAC)—auniquephenomenonforEurope, wherechildrenareusuallysenttoLINACs installedinadultoncologicalhospitals.The haematologiccancerlocalizations,including leukemiasandlymphomas,occupiedhigh positionsamongthetop-10oncology localizationsinchildren.

ExceptforOkhmadyt,thereisanadditional HCinstitutionconsideredpowerfulandthe largestofallregionalcentersspecializedin thetreatmentofsolidtumorsandcentral nervoussystemtumorsinchildren—Western UkrainianSpecializedChildren'sMedical Center(Lviv).Withthebeginningofthewar, itbecameahubthroughwhichmorethan 450childrenwithcancerwereevacuated. Mostofthecasesarecongenitaldiseases provokedbygeneticmutations. Therefore,noscreeningprogramsorother publichealthinterventionsaimtocurbthe incidencerates.

Eventhoughthetreatmentofpediatric hematologyisexceptionallycostly,the respectiveoncologypackagessuccessfully managethedeliveryofmedicalservicesand theprovisionofpharmaceuticalsand medicaldevices.

Thetreatmentoutcomeintreatingchildren's oncologyismuchbetterthaninadults,and thestateisreadytoallocatemorefundsfor therapydrivenbyeconomicaspects,and betterpredictionsregardingachievingfull recoveryreferredtoLYsandQALYs.

INCIDENCE BY LOCALIZATIONS

Figure 8. Top-10 Localizations of Cancer in Children: Estimated agestandardized incidence rates (Ukraine total, 2021, both sexes, children (0-17 years old) All

Figure 9. Number of Registered Children with Cancer, 2012-2021 (Ukraine total, both sexes, 0-17 years old, absolute numbers)

Figure 10. Cancer Morbidity in Children: New Cancer Cases Registered (Ukraine total, both sexes, 0-17 years old, absolute numbers)

Figure 11. Cancer Mortality in Children: Cancer Deaths Registered (Ukraine total, both sexes, 0-17 years old, absolute numbers)

Cancer Care System Regulation

Parliament (Verkhovna Rada)

Therewasashiftofresponsibilities regardingtheownershipoverHCfacilities totheleveloflocalauthorities,andona limitedscale,theprivatesectorwas allowedtoparticipateinthehealth system,butoutsideoftheschemeof publicfinancing,basedondirectpatients’ OOPpayments,primarilyinformal.

BeforetheintroductionoftheHC financingreformin2017,thecancercare system,embracedbythepost-Soviet modelofverticaldeliveryofmedicalcare headedbythepostofthechiefoncologist ofUkraine,wasmanagedbytheprinciples ofobsoleteclinicalprotocolsandmedical equipment,highOOPpaymentsand exclusiveaccesstomedicalcareonlyto specificcategoriesofpeoplewith "connections"amongHCPs.

Executingfinancialflowsfromhospitals' budgetsforfreemedicalcarewas challenging(oneshouldread"impossible") tocontrolandtrack.

Theproblemwiththelackofoptimization ofHCfacilitieshasbeendeepenedbythe planned,generalized,anddefault-free fundingofoncologymedicalservices withoutregulativeclarificationofwho paysforwhatandatwhichamount.

Thisconsiderablydeprivedtherightof patientsthefreemedicalcareunderthe standardofuniversalcoveragedeclared bythestateandhaltedthesystemfrom self-developmentamidsttheabsenceof economiccompetitionamongoncology

clinicsanddeprivationofpatientsas secondaryactorsinthesystem. Therefore,thecancercareprovision structurewascorrupted,ineffective, underdeveloped,anddirected sporadicallywithoutanintricatelong-term strategyforfurtherevolution.

In2020,theintroducedHCfinancing reformforsecondaryandtertiarymedical caredrasticallychangedthedeliveryof cancermedicalcare.Thesinglenational payor NHSU elaboratedoncology packages,whichincludedallneeded interventionstoprovidequalifiedmedical servicesanddeterminedatariff afixed amountofmoneywithincreased/reduced coefficientratesforchild/adultcarepaid totheprovider.StateEnterprise“Medical ProcurementsofUkraine”(MPU)performs centralizedprocurementsofmedicines usedunderthebenefitspackage.

ThisallowedNHSUtocontractonly capableclinicswithnecessarymedical equipmentandhumanresources,control allocationandexecutionofcostand strategicallyplantheannualpurchaseof medicalservicesunderoncology packages.However,NHSUfailstoimpose anykindofcontrolovercompliancewith therequirementsimposedoncontracted serviceprovidersandfulfilmentof contractualobligationsbeingunableto cutoffincapableHCfacilitiesfrom packagefinancing.Mentioned inconsistencyquestionsthequalityof deliveredmedicalcareunderthebenefits

packagetoagreatextent.

the general health care system, remained virtually unchanged throughout the entire period after gaining independence in 1991 Notes:

Worthnotingthatthereisatraditionally evolveddivisionofcancermedicalcare intoadultandchildren’scancercare systemsledbyNCIandOkhmatdyt hospitals,respectively.Bothbranches developseparatelyfromoneanother, guidedbytheprinciplesofselforganization,formingpowerful"cliques" ofprogressiveandqualifieddoctorsunder variousoncologyareasandautonomy.

Bothinstitutionsserveasreferenceclinics forrareanddifficultcasesdiagnosedand treatedinotheroncologycentresand dispensaries.Besides,NCIandOkhmatdyt closelycooperatewithseveralregional oncologyclinicsyetavoidnavigatingthe wholecancermedicalcaredeliveryunder itsdirection.Findmoreonchildoncology careprovisiononpage13.

Aseparatepillarofcancercareis representedbysectoralHCsettings fundedbyotherministriesfromthestate budget.Onlyemployeesofsuch institutionsareeligibletoreceivemedical care,includingoncologicalinthesectoral HCfacilities.

However,thepatientmayberedirectedto thegeneraloncologicalclinicsifthereisa needforhighlyspecializedcareprovision. Inthiscase,iftheministryownsthe allocatedbudgetforthesepurposes,then thepatientreceivesmedicalcare.

Otherwise,thepatientcoversthemedical servicesfromindividualfunds.

Healthcare Committee Cancer Care SubCommittee

Source:

National Academy of Medical Sciences

Ministry of Health

Ministry of Finance MEDTU Other Ministries

Financing Alignment Policy-making

National Academy of Sciences

NHSU

MPU

Sectoral cancer care settings (All hospitals under Ministry of Internal Affairs, Ukrainian Railways, Ministry of Defense etc.)

Other institutes

National Cancer Institute

Okhmatdyt hospitals (Kyiv)

MOH vertical

CMU vertical

Alignment

Regional oncologycenters

Out-patient oncology departments

Figure 12.

Organization of Cancer Care in Ukraine

MRO n.a. Grigoriev IEPOR n.a. Kavetskiy

Adults’ OncologyCare System

Pediatric Oncology System

WUSCMC

Regionalchildren oncology centers

Cabinet of Ministers of Ukraine

The cancer care system in Ukraine, inseparable from

Cancer Care System Evolution 1/4

2002-2006

Oncology National Program

ThestateNationalProgram “Oncology2002-2006”(Program2006)createdastandalonestrategy visionfordevelopingoncology serviceinUkrainefor6yearsin conjunctionwithaseparate developmentroadmapoftheentire HCsystemofUkraine.

Theinitialaimwastoincrease prevention,earlydetection,and treatmentratesofoncological diseasesandreducecancer mortalityanddisabilityrates.

Expected Deliverables

▪ Elaborationofalegal frameworkandsocialand economicregulationstofight againstcancer;

▪ Timelyandearlydiagnosisof oncologydisease;

▪ Monitoringofthepopulation's incidence;

▪ Identifyingneedsandpriorities intheorganizationofoncology careforthepopulationbased onthelevel,dynamics,and structureofoncological morbidity.

Regulatory base

▪ NationalProgram“Oncology” 2002-2006(1)

▪ TheMOHandAMSUOrder #211/47 (2)

Budget

UndertheProgram-2006,thestate budgetcoveredthecentralized procurementofmedicinesfor patientswithoncologyandmedical equipment,whereaslocalbudgets weredispensedforothermeasures envisagedbytheProgram-2006.

Theplannedbudgetforpublic purchasesundertheProgram-2006 for2002-2006constitutedEUR119 mlnandtheactualexpenditure reachedEUR77mln(3) .

Thereisnoconsolidateddataon expendituresfromlocalbudgets.

Execution

TheProgram-2006execution,toa greaterextent,wasassignedtolocal authoritiesandbudgets,too. Besides,theProgram-2006 envisagedbranchesofmeasures attributedtoeachyeartoreach targetindicators.Localstate authoritiesandgovernmentsofeach regionwereresponsiblefor

implementingapprovedmeasures withintheiradministrativejurisdiction usingregionalresourcesand monitoringintermediate performancebytheoncologyclinics anddispensaries.

However,thereisalackof consolidatedanalyticalinformation onprogramimplementationin regions.

Intermsofindicators,in2005,the MOHendorsedOrderunderwhich almost7.8mln18+yowomenwere testedforcervicalcancer.Alongside, patientsunderwentscreeningsfor breast,rectalandlungcancers.(4)

Outcomes

▪ In2017,afterimplementingthe Program-2006,theMOH,for thefirsttime,approved38 nationalclinicalguidelinesfor variousmalignantneoplasms(5) .

▪ Underthecentralized procurementsin2003-2005, oncologyhospitalsand dispensariesreceived18 machinesforRT,1LINAC,8CTs, 31mammographs,2MRIs,29 ultrasoundmachines.

2006-2010 Pediatric Oncology State Program

This Program-2010 was the first document ever to herald the division of cancer care system in Ukraine in two branches children oncology and adult oncology.

Since then, adult and children oncology systems have different budgets, different tariffs paid for provided services and different network of HC providers. The separate budget for children oncology was allocated only in State Budget 2008. Previously, in 2006, the budgets for pharmaceuticals for children with oncology were set aside by the local HC authorities having faced the lack of funds in local budgets in mostly all regions of Ukraine and disability to purchase the needed number of medicines.

Expected Deliverables

▪ Elaboration of the regulatory framework and clinical guidelines in terms of the treatment of children with malignant neoplasms;

▪ Promotion of early diagnosis, and timely treatment of children oncology in PHC

institutions;

▪ Creation of specialized diagnostic centers to provide radiation, morphological and genetic diagnosis of malignant neoplasms;

▪ Improvement of the system of state registration of children with oncological diseases.

Regulatory base

▪ CMU Resolution #983 “On Approval of the State Program on Children’s Oncology in 2006-2010”.(6)

Budget

The total planned cost of the Program for 5 years was set to EUR 52.3 mln (UAH 350 mln):

Purchases of pharmaceuticals were estimated to be EUR 5.8 mln (79%), and medical equipment EUR 1.6 mln (21,3% of the total respectively).

Execution

In 2006, local HC authorities became responsible for executing the Program using the available budget, which resulted in considerable underfunding. Only at the end of 2007 the State Budget for 2008 included a separate funding article for children’s oncology. Consequently, the fullfledged execution of the Program started in 2008 from the detailed and coherent articles in the State Budget 2008.

The program considerably focused on procuring pharmaceuticals for kids suffering from oncohematology conditions.

Most of the funds were set aside for the centralized procurements of medicines (immunosuppressivs, chemo drugs, consumables used for diagnostics), medical devices, and medical equipment.

In turn, the patients were provided with various kits for replacing leukocytes, peripheral stem cells and therapeutic plasma substitutes, systems for leuko- and thrombocytopheresis, and filters for cleaning fluids (SQ40SKLE, RC1VAE) and gases (BB25Y) used in oncohematology

Sources: (1) CMU Resolution "On Approval of the State Program "Oncology" for 2002-2006"; (2) MOH/AMSU Order #1/2 “On Approval of the Measures of the Ministry of Health of Ukraine and the AMS of Ukraine regarding the implementation of the State Program "Oncology" for 2002-2006; (3) National Program “Oncology 2002-2006” 2005 Results and Directions for Further Development of Oncology Care for the Population“; (4) MOH Order #677 “On Approval of the Branch Program on Cervical Cancer Screening,” (5) MOH Order #554 “On Approval of Protocols for the Provision of Medical Care in the “Oncology“ Specialty”; (6) CMU Resolution #983 “On Approval of the State Program on Children’s Oncology in 2006-2010”

While the other post-communist countries undertook an effort to meet these expectations, the Ukrainian health system remained in virtually unchanged form throughout the entire period after the collapse of the Soviet Union. Any changes that were applied, were actually apparent and inferior, including when talking about the Ukrainian cancer care system.

Cancer Care System Evolution 2/4

State Program launched the first ever child-centred separated state program, which full-fledged execution was postponed to 2008. 2010-2016 Oncology National Program faced a considerable funding reduction.

Incontrast,atthattime,the“AdultOncology”program didnotcontainanyitemstotreatoncohematology diseasebutpredominantlychemotherapydrugs. 89%-92%ofallprocuredproductsundertheProgram wereofforeignorigin.

Outcomes

▪ Approvalofclinicalguidelinesforthetreatmentof malignantneoplasmsinchildren;

▪ Establishedtwolevelsofoncologymedicalcare deliveryinUkraine adultandchildren,which determinedthefurtherdevelopmentoftheoncology caresystemnowadays;

▪ Focusonprovidingoncologymedicalcareto childrenwithoncohematologydiseases,whichare severeandplaceasubstantialfinancialburdenon thepatient'sfamily.

2010-2016 Oncology National Program

ThisProgram-2016wasboundtohavebeenapprovedin 2007aftertheterminationoftheProgram-2006yet,due tothesocio-politicalperturbations,itwasendorsedonly attheendof2009.

During2007-2009,withoutthestateprogram,the financingwastiny,sporadic,andoffarpriority.

Expected Deliverables

▪ Improvementofthesystemofprimaryand secondarypreventionofoncologicaldiseasesand earlydetectionofcancer;

▪ Enhancementofmethodsofdiagnosisofmalignant neoplasmsandspecialtreatmentofcancerpatients;

▪ Promotethepalliativecaresystemforcancer patients;

▪ Increasetheavailabilityofmedicalcareforcancer patientsandrecoveryrate;

▪ Reducethemortalityrateofcancerpatientswhodie withinayearafterdiagnosisandmortalityfrom malignantneoplasmsofsomelocalizations(breast, cervix,prostategland).

Regulatory base

▪ TheLawofUkraine“OnApprovaloftheNational ProgramtoCombatwithOncologicalDiseasesupto 2016” (1)

Budget

AccordingtotheLaw,thetotalcostoftheProgramfor8 yearsamountedtoEUR346mln:

receivedonlyEUR2mlnwhichisonly15.2%ofthetotal sumallocated.Therefore,itmaybeclaimedthatthe executionoftheProgram-2016wasenormouslyrestricted bythefunding.Likewise,itreachedlimitedresultswith thisbudgetvolume.

Execution

In2014,thegovernmentissuedtheCMU’sResolution"On SavingStateFundsandPreventingBudgetLosses"#65 dated01.03.2014,introducingamoratoriumonthe financingandamendingofcurrentprogramsand restrictionsontargetedones,withabanonthedesignof newstateprograms.

IthadenormouslycomplicatedtheProgram’s-2016 executionintermsofpharmaceuticalprovisiontopatients withcancerandquestionedtheachievementofthe overseengoals.

Theratiobetweenthestatebudgetandlocalfundsfor8 yearswasestimatedtobe15.9%,meaningfixingthe directresponsibilityoflocalgovernmentsforfundingata determinedrateforthefirsttime.

Traditionally,mostofthefundsweresetasideforthe centralizedprocurementsofmedicines (immunosuppressivedrugs,chemotherapydrugs, consumablesusedfordiagnostics),medicaldevices, medicalequipment,andscientificdevelopmentofthe NCI.

However,inreality,themeasuresundertheProgram-2016

Consequently,considering2016asareferenceyearto estimatethesuccessoftheProgram-2016,30–75%of patientswithvariouslocalizationsofcancerdidnot receivespecialtreatmentin2016,which,ofcourse, affectedthemortalityandsurvivalratesofpatients. Besides,thefinancingofthemedicalservicesdeliveredto thepatientswithoncologywerenotthesubjectofthe discussedProgram-2016,sowemayundoubtedlyassume thattheratesofprovidedmedicalcaredidnotmeetthe modernrequirementsandrealneeds.

Outcomes

Overall,theProgram-2016showedlimitedsuccessand effectiveness,failingtoreachtheoverseengoalsby havinglowindicatorsofprioritizeddeliverables(neglect ofdisease,levelofdetectionofI-IIstagesofbreastand cervicalcancers,provisionofspecializedmedicalcarefor cancerpatients).(2)

2006-2010 Children’s Oncology

Table 1. 2010-2016 Oncology National Program Outcomes (according to official sources)

Cancer Care System Evolution 3/4

National Cancer Control Strategy 2030 (Strategy-2030)

Elaboratedatthebeginningoffall 2021,thedraftresolutionofCMU hadnotbeenofficiallyapprovedby thegovernmentsincethewarin Ukrainestarted.Protractedpublic discussionandlackofpoliticalwill resultedinputtingtheStrategyinto theairuntilithadbecomeinacute needofreconsiderationduetothe activehostilitiesinthecountry. Unfortunately,thelong-termvision ofoncologysystemdevelopment createdbyhardworkandgood coordinationbetweenthe stakeholderswentawry.However, webelievetheStrategywillbe adjusted,updated,andsignedas soonasRussiaisdefeatedand withdrawfromUkrainecompletely. Nevertheless,thegoodnewsisthe successfulimplementationof oncologypackagesunderthe nationalbenefitspackage the MedicalGuaranteesProgram, whichwillstimulatethe developmentofoncologymedical careanyway.

Planned Deliverables

▪ Informtargetgroupsabout theneedtoundergo preventivemedical examinationsandtherisk factors;

▪ Promoteearlydiagnosisand timelytreatmentofoncology diseases;

▪ Providecoordinatedandhighqualitymedicalservicesfor thediagnosisandtreatmentof cancerdiseases;

▪ Establishacapableand coordinatedsystemof diagnosisandtreatmentof malignantneoplasmsin childrenbasedona multidisciplinaryapproach, withtheachievementofa5yearoverallsurvivalrateof childrenofatleast80%;

▪ Providequalified psychologicalandpalliative care;

▪ Ensuredatacollectionand analysis,timelyobtainingof high-qualityandreliabledata fordecision-making,and improvingtreatmenttactics;

▪ Recruitenoughspecialists necessarytoprovidehighqualityoncologymedicalcare topatients.

Regulatory base

▪ TheDraftCMUResolution"On CertainIssuesoftheNational Strategyforthe ImplementationofCancer ControlUntil2030"(1)

▪ TheOperationalPlan SupplementedtotheNational CancerControlStrategy (2)

Detailed Measures

▪ PossibleinclusionofHPV vaccinationtotheNational VaccinationCalendar;

▪ Variouspublichealth programstotacklesmoking, lousynutrition,andsedentary lifestyle;

▪ Procurementof20LINACsto regionsandothermedical equipmentforRT;

▪ Elaborationofnewscreening programswithalternative methodsreferredtothe preventionofcolorectal, breast,andcervicalcancer;

▪ Updatetheclinicalguidelines intheareaofdiagnosticsand treatmentofoncological diseases;

▪ ImplementMEAsfor procurementofhigh-priced medicinesagainstcancer.

Budget

Not set

Parliament Healthcare Sub-Committee On Cancer Care

National Health Service of Ukraine

Ministry of Health

State Service of Ukraine on Medicines & Drugs Control “Medical Procurement Of Ukraine” SE

Patient Organizations & Advocacy Groups

National Cancer Control Strategy 2030

World Health Organization experts

Professional Oncology Associations

Business Community and Industry Experts

Adult Cancer Care Givers Pediatric Cancer Care Givers

Sources: (1) Draft CMU Resolution "On Certain Issues of the National Strategy for the Implementation of Cancer Control Until 2030“; (2) The Operational Plan Supplemented to the National Cancer Control Strategy

National Cancer Institute

National Cancer Control Strategy was a long-awaited strategic policy since the completion of the previous one in 2016. After a lasting period of negotiation and alignment, the Strategy was a couple of steps from approval, yet the war had started.

Figure 14. Stakeholders Actively Involved in Development, Public Discussion, and Advocacy of the National Cancer Control Strategy 2030

Cancer Care System Evolution 4/4

The Ukrainian cancer care system evolved very slowly, without the government's significant public interest or strategic focus until 2015-16. Only at that time did real and practical plans for reforming the health care system begin to mature, when public interest in participating in restructuring state functions and institutions increased significantly.

Endorsement of national benefits package consisting of basic medical care packages

Palliative care becomes one of the priorities as a part of the state Program

Local budgets became partly responsible for funding the oncology needs.

All hospitals can sign Agreements with the NHSU and declarations with HCPs Draft of the National Strategy on Health Reform

6 national screening programs were added in the Medical Guarantees Package by NHSU

The CMU approves the Concept of Reforming of the Health Care Financing

Managed entry agreements became an acting instrument to procure innovative oncology drugs

Medical Procurement of Ukraine started acting as the main state procurer

Cancer care medical guarantees package added by the NHSU for the 1st time

“National Cancer Control Strategy 2030” State Program operational plan

cannabis law was voted

Figure 13. State Procurement of CancerRelated Drugs and Medical Devices

Current System Status & National Cancer Control Strategy 2030 (draft)

Challenges

Epidemiology

HighoncologymorbiditycomparedtotheEUcountries

380cases/100.000people thehighestrateinEurope.

+25%newcasesyearlyduringlast10yearsandcontinues growingata2.6-3%rateyearly

National Cancer Control Strategy 2030

Key Program Aims

(iii) (ii) (i)

Decrease morbidity rates

Decrease mortality rates

Increasethequalityof oncologypatients’lives andtheirfamilies

Expected Results

Target Program KPIs

Decreaseofmortalityratesinduced byoncologydiseasesby5-10% I.

Implementation & Financing

cancer

Veryhighmortalityratesfromoncologydiseases

canceristhe2nd frequentmortalityreason

women:breast,stomach,colon,rectum,ovaries,cervix men:lungs,stomach,rectum,prostate,colon

Diagnostics & Treatment

Strategic Targets:

1.Primarypreventionofoncologydiseasesand precancerousconditions

2.Screeningandearlydetectionofoncology diseases

Infrastructure / Pediatric

researchmedical centers 2scientificresearchmedical centers(“Ohmatdyt”)

Insufficientlevelofandaccesstoearlydiagnostics=late diagnoses

Lowlevelofpublicawarenessofcancerprevention

Lowlifequalitylevelofpatientswithcancer

LackofmodernPET/CT,SCT/3DCT,LINAC

OldandtechnologicallyoutdatedCo60/Ir192,gammacameras,xraymachines,infusionmachines,monitoringequipment

Highdisabilityratescausedbyoncologydiseases.

Significantpsychologicalandbudgetburdenonpatient’s families.

Insufficientlowqualityofandaccesstopalliativecare.

Thelevelofconfidenceinthesystemislowenough.

Medical personnel

Asignificantproportionofdoctorswhotreatby“soviet” standards.

LackofRTTs,MedicalPhysicists,Radiologists.

Educationqualityofphysiciansisoftenobsoleteorinsufficient.

3.Equalityandcontinuityofaccesstoacapable networkofhealthcarefacilities,HCPS, diagnostics,andtreatmentofcancer

4.Adequateinfrastructureforprovidinghighquality,coordinated,andaffordabletreatmentof oncologydiseasesinchildren

5.Standardizationofdiagnosis,treatment,and rehabilitationofoncologypatients

6.Rehabilitation,personalandpalliativecarefor oncologypatients,andsupportfortheir caregiversatalllevels

7.DevelopmentofITsystemsforcancer registrationandmonitoringofoncologypatients toidentifyandobservetrendsandevaluatethe resultsofcancercontrolmeasures

8.Increasingthelevelofprofessionaleducationof physicians,nursingstaff,andothermedical personnel

9.Promotionofresearchanddevelopment activitiesinoncology,followedbyadoptingthe resultsintheoncologytreatmentpractice

Decreaseofmorbidityratesinduced byoncologydiseasesby5-10% II.

Increaseinfive-yearsurvivalrates foroncologypatients III.

IV.

Decreaseofmortalityratesin patientsduringthefirstyearafter anoncologydiseaseisdiagnosed by5-10%

Increasethe5-yearsurvivalrateof childrenwithcancertoatleast80% V.

VI.

Developmentofasystemof palliativeandhospicecarefor oncologypatients.

Responsible:

▪ Central,regional,andlocalauthorities,

▪ Civilsociety(NGOs/PAGs(control),

▪ Internationalorganizations(advice)

Legalframework:

Implementation Financing

▪ AstandaloneLaw“OntheNational StateProgramtoFightOncology Diseases2030”mustbedeveloped andvotedinApril2020

▪ EachStrategicTargetmustbe followedbyaregulatorydocument definingsuchTargetKPIspereach Target.

▪ EachyeartheCMUandthepublic agreeonthesetofactivitiestoreach eachTarget.

TheProjectwasexpectedtobefinanced from:

▪ StateBudget,

▪ otherlegalsources,

▪ Internationalorganizations

Notes: *2021 data. SOURCES: DIRAC; National Cancer Register of Ukraine; Ministry of health of Ukraine; Interviews with experts;

NationalCancerInstitute (NCI)

Other Authorities

Cancer Care System Stakeholders

The network of stakeholders involved in cancer care provision is diverse, and it entails high public authorities, healthcare institutions, oncology-oriented NGOs, patient organizations, and private and business entities. An open and accepting environment allows every actor to become a change agent and influence the public policy agenda.

General President of Ukraine Presidentissuesdecreesonvariousissues,including onesrelatingtocancercare.Forinstance,byOrder №261/2021,PresidentcommandedtheGovernment todevelopmechanismsforthepracticalapplication ofpublic-privatepartnershipinHC.

Health Care Oriented

Ministry of Health of Ukraine

MOHdevelopsand implementspoliciesand strategies(suchasthe Strategy-2030).Approves industrystandardsand protocolsinoncology, determinescriteriaand standardsforaccreditation ofHCinstitutions, performsqualitycontrolof drugs,andapprovesRx andOTClists.

National Health Service of Ukraine

Verkhovna Rada of Ukraine

NHSUimplementsstate policyonstatefinancial guaranteesforHCservices tothepublic.In2022NHSU procuredoncological servicesmainlyunder3 specificMGPs: chemotherapeutictreatment, radiologicaltreatment,and treatmentofhaematological andoncohaematological diseases.

TheVerkhovnaRadaofUkraineistheunicameralParliamentofUkraine.Itpasseslawsand strategies,approvesthebudget,andappointsaMinisterofHealth.Furthermore,its CommitteeonNationalHealth,MedicalCareandMedicalInsurancehasaCancerCaresubCommittee,whichformstheagendaofParliamentandpreparesvariousdecisionsrelatedto HCandcancercaresystem.

Cabinet of Ministers of Ukraine

TheCabinetofMinistersofUkraine(CMU)is Ukraine'shighestbodyofstateexecutive power,anditimplementsandformulates policies,issuesresolutions,andorders.

Medical Procurements of Ukraine

MPUisresponsible forthepublic procurementof drugsandmedical devices.In2022, MPUprocures pharmaceuticalsfor adultpatientswith oncologyby108INN and135INNfor childrenoncology.

State Expert Centre of Ukraine

Developsandexpertly examinesmedicinesfor marketingauthorization, organization,andmonitoring oftheCTsandpostauthorizationPVofmedicines. Onlythroughthisinstitution anyoncologydrugmay accessUkrainefor authorizationand reimbursementtoreach patients.

State Service of Ukraine on Medicines & Drugs Control

ThisServiceis responsible formaintainingstate controloverthe importofmedicines intothecustoms territoryofUKRand conductingstate qualitycontrolover drugsbeingsold

State Nuclear Regulatory Inspectorate of Ukraine

SNRIU’sactivitiesare directlycoordinatedby theCMUandwhich ensurestheformation andimplementationof statepolicyinthefield ofnuclearenergy safety.Itissuespermits forcarryingout activitiesinthefieldof nuclearenergyuse, incl.inmedicine.

Cancer Care Oriented Business, & others

National Cancer Institute

NCIistheoldestclinicalandresearch oncologycentreofspecialized,highly qualifiedmedicalcareinUkraine.The NationalCancerRegistryofUkraine operatesunderNCIandcollects variousdatathatdepictthecancer burdeninUkraine

Manufacturers of drugs and medical devices

Legalentitiesengagedin manufacturingand marketingofdrugsand medicaldevicesin Ukraine.

Public Oncology Hospitals

Adultsandchildren regionalandcity oncologydispensaries, out-patientdepartments.

Private Oncology Settings

Privatetreatment settings(in-andoutpatient),diagnostic centersandlaboratories.

Research & Development Public Medical Institutions

Publicstateinstitutionsunder NationalAcademyofMedical Science,andNationalAcademy ofScience.

Patient Organizations & Patient Advocacy Groups

Variousorganizations(PAGs,charityfunds,fundraisers,etc.) engagedinactivitiestosupportandadvocateoncologypatients, theirneedsandinterestsoftheirfamilies.Themostinfluential organizationsinUkraine:Athena.Womenagainstcancer, InspirationFamily,Tabletochki

Professional oncology associations

Variousassociationsof healthcareprofessionalsin oncology physicians,medical physicists,RTTs,radiologists, surgicaloncologists,etc.

Manufacturers of medical equipment

Foreigncompaniesengagedin manufacturingandmarketingof complexhigh-techmedicalequipment areusuallyrepresentedinUkraine throughlocaldistributors.

Wholesalers & Distributors

Legalentitiesengagedinwholesale, distribution,andlogisticsofdrugs, medicaldevices,andmedical equipmentinUkraine.

Pharmacies & Pharmacy chains

Legalentitiesengagedinretailsales ofdrugs,medicalnutrition,medical devicesthatareallowedtobesold throughretailmarket.

International development & donor organizations

Backin2017,internationalorganisationsplayedasignificantroleinadvocatingforthereformofHC financing,providingthenecessaryexpertiseandsupportingtheimplementationofthepolicy.Currently, representativesofWHO,WBandothersareactivelyparticipatinginworkinggroupsundertheMOHto enhancemedicalcaredeliveryatvariouslevels.

Cancer Care System Financing

MOH acts as a strategic policy-maker in the area of HC cooperating with the MOF and MEDTU in terms of the budget needed to execute proposed policies. NHSU and MPU are strategic purchasers of medical services and pharmaceuticals, medical equipment, respectively

Figure 15. Scheme of the Ukrainian Cancer Care System Financing

Cancer Care System Financing

Policy development

Consideringtherolesofpolicy-makers, MOH,inthepersonoftechnical specialists,elaboratesthepoliticaland strategicframeworkforfurther developmentoftheHCsystem,meaning mentioningprioritymedicalservicesdue toepidemiologyrates,thenecessary volumeofmedicalservices,andforming andupdatingthepositivelistsofdrugs andmedicaldevicestoprovidecancer patientswithandestimatestheexpenses forthefollowingyear.

Thereisnoseparatedepartmentwithin MOHtocoordinateandmanagethe cancercaresystemdirectly.Developed policiesaresubjecttonegotiationand alignmentwiththeMFUandMEDTUas finiteresourcesurgefordebate.

Aftertheconsensusisreached,theMFU elaboratesabillonStateBudgetforthe followingyear,whichthegeneralvoting shouldapproveintheParliament. Allocatedfundsdonotusuallycorrelate withalegislativedemandforfinancing medicalguaranteespackage(MGP set ofmedicalservicespackageswithin varioustherapeuticareas)atarateof notlessthan5%ofGDP.Basedonthe futurestatebudget:

▪ CMUcompilesthedraftlawonthe contentofMGPwhichthe stakeholderswilldiscusswithfurther approvementbytheCMU;

▪ MOHapprovestheprocurement documentsforcentralizedpublic

purchasesofdrugsandmedical devices.

SpeakingofParliamentHCCommittee (incl.itsCancerCareSub-Committee), itscoreresponsibilitiesincludesupport andapprovalofpoliciesintheareaof HCelaboratedbyspecialiststechnocratsfromthegovernmentand communicationwiththepublic, explainingandadvocatingforchanges.

Tovisualizetheabovementioned,refer topages14and21.

Financing

Thereare2differentfundingflows ensuringtheexecutionofthenational benefitspackageandhospitalpurchases ofmedicinesandmedicaldevices neededtosupplytherelevantmedical serviceswithconsumablesanddrugs.

Consideringthestrategicplanningof medicalservices,NHSU,afterreceiving thestrategicvisionoftheMOHon necessarymedicalcareforthefollowing year,elaboratesthedraftMGPand submitsabilltotheMOHforfurther discussionandalignmentofbudget programsreferredtoMGPwithother policy-makers,namely,theMFUand MEDTU.

OnceallfinancialmattersandMGP scopesareset,NHSUcontracts interestedpublicandprivateHC providersforMGPsanddeterminesthe numberofservicesdeliveredbyeach provider.

Intermsofprocurementofdrugs,

medicaldevices,andmedicalequipment, MOHdeterminestheannualquantityof drugsandmedicaldeviceswithins numberoftherapeuticareas.

HospitalsandregionalHCauthorities reportontheneedfordrugsandmedical devicesviaMedData,whichtheMOH Expertgroupsubsequentlyverifieson CentralizedProcurements.

ThatishowtheMOHidentifiesthescope ofconsumableswithineachINNto procureforthefollowingyear.Afterthat, negotiationsoccur,settingasidethe necessaryfundsfromtheMinistryof Finances.

Finally,MPUclarifiesthetechnical specificationsforprocurementitems withMOHandconductsprocurement onlywhenthescopeisdetermined,and therespectivefundsareallocated.

Checkpages14and21togeta helicopterviewofthefinancingsystem.

Sources of Financing

ThecancercaresysteminUkraineis financedfromfoursources:

▪ theStateBudget(NHSUfundsare usedtoprocuremedicalservices, MPU drugs,medicaldevicesand medicalequipment,MOH HC facilitiesunderitscoordination,other ministries sectoralHCsettings),

▪ localbudgetswithcommunity budgets,

▪ privatefunds,

▪ donors(grants,humanitarianaid, etc.).

Cancer Care Medical Packages

ThreeoncologyMGPsareavailableto cancerpatients—”Chemotherapy Treatment,”“Treatmentof Oncohematology,”and“RT.”

Thecostpaidtoprovidersunderthefirst twoMGPsvariesonapatientsubject. Therefore,theproviderreceivesmore fundsfortreatingachildwithcancer, whilethetherapywithinadultoncology costsless.

RegardingRT,theproviderwhoowns modernequipmentlikeLINACorcyber knifeobtainsbetterpaymentfordelivery ofmorehigh-pricedmanipulation.

EachMGPiscomplex,bothunder primarymedicalcare(PMC)and secondarymedicalcare(SMC)levels,as itcontainsdiagnosticsmanipulations,the strategyforthelong-termtreatment itself,coveragefordrugs,medical devices,andotherconsumables,and furthercross-functionalconsultations withnon-oncologyspecialiststotreat relateddiseases.

Ifsurgeryisneeded,thisinterventionis deliveredunderthegeneralsurgery MGP.Apatientwithremissioniseligible toreceiveanoncologyMGPunderPMC.

Tocompare2021,thetariffsforoncology MGPshaveincreasedbynearly30%in 2022duetothestabilisationofthe epidemiologicsituationwithCOVID-19.

Chemotherapy treatment for a child during a period of 9 months

Chemotherapy treatment for an adult during a period of 9 months

Treatment of oncohematology in children

Was not included in 2020

Treatment of oncohematology in adults

Was not included in 2020

Radiotherapy with a Co-60 machine

Radiotherapy with LINAC, BT machine

There are two different funding flows ensuring the execution of the national benefits package and hospital purchases of medicines and medical devices needed to supply the relevant medical services with consumables and drugs.

Notes: MFU Ministry of Finances of Ukraine; MOH Ministry of Health of Ukraine; MEDTU Ministry of Economic Development and Trade of Ukraine; MGP Medical Guarantees Package. Sources: NHSU; MOH; MPU

Figure 16. Cancer Care Medical Packages Tariffs, 2020-2022 (EUR, ths)

Public Procurement of Cancer Drugs

medical care in time and within budget under the benefits package.

Cancerpatientsareentitledtofree pharmaceuticals(usuallyhigh-priced) withinprimaryandspecialized medicalcare.MOHdefinesthescope ofmedicinesunderthestate oncologyprogramforadultsand children.

Centralizedpurchasesofdrugsunder theseprogramsareconductedbythe singleprocurementagentinHC StateEnterprise“Medical ProcurementsofUkraine”(MPU).

Childrenreceivemedsfreeofcharge underthe“MedicinesandMedical DevicesforTreatmentChildrenwith CancerandOncohematological Diseases”program.Adultsare providedwithnecessarytreatmentvia the“ChemotherapyDrugs, Radiopharmaceuticalsand AccompanyingDrugsforTreatment ofCancer”program.

MOHrevisesthescopeofINNs annuallyunderadefinedprocedure ofwhichallinterestedstakeholders maybecomeapartof.

Demand Formation and Strategic Planning

Cancercareclinicsanddispensaries acrossUkraineformanannual demandforpharmaceuticalsbased onthenumberofpatientswhoneed toreceivesuchtreatmentinaspecific

medicalorganization. Afterthat,entitiessubmitayear's demandtotheMOH,whichchecks thecredibilityandconsistencyofthe submitteddata.Finally,whenthe annualnationalneedforeachINNis compiled,MPUgetsauthorizationto conductpublicpurchasesforINNsin theapprovedvolume.

MPUpurchasesmedicinesforayear onwards.Thismeansthatin2022 MPUwillconducttenderswith suppliersformedicinalproducts, whichwillberedistributedto hospitalsin2023.Suppliesofthe previousyeararedeliveredtomedical organizationsduringthecurrentyear fromthewarehousesofMPU.

FurthertransportationofmedstoHC facilitiesbecomesaresponsibilityof hospitalsthemselvesorregionalstate HCdepartments.

Asmentioned,MOHapproves NomenclaturesofINNssubjectto centralizedpurchasesyearly.The program“ChemotherapyDrugs, Radiopharmaceuticalsand AccompanyingDrugsforTreatment ofCancer“includes83INNs,program aimingattreatingchildrenwith cancerconsistsof77INNsand25 itemsofmedicaldevices.

Undermanagedentryagreements,

someoncologydrugsareabouttobe procuredintherecentfutureunder negotiationprocedure,namely:

▪ Alectinib(non-small-celllung cancer),

▪ Gemtuzumabozogamicin,and Venetoclax(acutemyeloid leukemia),

▪ Lanreotide(managementof acromegalyandsymptomscaused byneuroendocrinetumors),

▪ Obinutuzumab(chronic lymphocyticleukemia,follicular lymphoma),

▪ Cabozantinib(medullarythyroid cancer,renalcellcarcinoma,and hepatocellularcarcinoma),

▪ Pembrolizumab(melanoma,lung cancer,headandneckcancer, Hodgkinlymphoma,stomach cancer,cervicalcancer,andcertain typesofbreastcancer),

▪ Brentuximabvedotin(Hodgkin lymphomaandsystemicanaplastic largecelllymphoma).

MPUisauthorizedtoperformthiskind ofpublicpurchase.

Toreceiveabird'seyeviewofthe publicprocurementofoncologydrugs withallstakeholdersinvolved,goback topages14and21.

Centralizedprocurementsofmedicines, immunobiologicalpreparations (vaccines),medicalproducts,other goodsandservices,includingunder MEAs(StateProgram#2301400)

MPU conducts strategic centralized procurements of oncology meds and medical devices one year in advance to allow hospitals to deliver oncology

2. Cancer Care Medical Packages Tariffs 2020-2022 (EUR, ths)

Market Access Pathway for Oncology Drugs in Ukraine

Pharmaceuticals,includingoncology medicines,maybeusedinUKRonly aftertheirmarketingauthorisation (MA)bythecompetentpublic authorities MOHbasedontheState ExpertCentre(SEC) recommendation.AftertheMA certificatewasissued, pharmaceuticalscouldbethrough wholesaleandretailsales.While thosepharmaceuticalsareplannedto bepubliclyprocured,further proceduresandlicensesareneeded.

Toparticipateinanypublicpurchase, themarketingauthorizationholder (MAH)ofacancerdrughastosubmit documentstoSECtoundergothe HTAprocedureinUkraine.Itisa mandatoryrequirementfora pharmaceuticaltoreceiveapositive conclusionaftertheHTAprocedure toaccesspublicprocurements.

Subsequently,theMAHhas5 options:

1)decentralizedprocurements purchaseofmedicinesfromNEML andoutsideitconductedbyhospitals attheexpenseoflocalbudgets, regionalprograms,orwiththefunds theyreceivefromNHSU.

Underthistypeofprocurement,HC institutionsmaypurchaseeither medicinefromNEMLorotherdrugs thatunderwenttheMAiftheneedsin pharmaceuticalsfromNEMLwere fullysatisfied;

2)getenlistedintooncology-specific Nomenclatures adocument(socalled"stateprogram")approved andformedbytheMOH,which includesthenameofnosology,INNs toprocureforitstreatment,and relevantdosageform.

Intotal,thereare33Nomenclatures withinthemechanismofcentralized purchases.MAHsubmitsdocuments tothePermanentWorkingGroup (PWG)oftheMOHonCentralized PurchasesSupporttogetthe particularINN"inserted"inthe annuallistofitemsunderthetwo

oncology-relatednomenclatures:

A. "Chemo,Radiopharmaceuticals andAccompanyingDrugsforthe TreatmentofCancerPatients,"

B. "MedicinesandMedicalDevices fortheTreatmentofChildren, PatientswithOncologicaland OncohematologicalDiseasesand CarryingoutTransplantationof HematopoieticStemCellsfor ChildrenandAdults.“

Afterpublicconsultationsandexpert expertise,thePWGdecideswhether torecommendMOHtoincludenew

INNintheoncologyNomenclatures. MPUisauthorizedtoprocure oncologymedscentrallyunderthe Nomenclatures.Worthnotingthat internationalprocurement organizationssuchasCrownAgents andUNDPperformpublicpurchases attheexpenseofbudgetaryfunds withinseveralnomenclatures,but theyarenotinvolvedinthe procurementofoncologydrugs; 3)and4)inclusionintoNational EssentialMedicinesLists(NEML). NEMLisapositivelistthat accumulatesonlyeffective

medicineswithprovensafetyand clinicalefficacy.OnlyNEML-listed medicinesmaybeprocuredwith budgetaryfunds.Yettobeenlisted intheNEML,adrughastoobtain2+ yearsofclinicalexperiencein Ukraineandbecomeapartofthe NationalMedicinesFormulary.

Afterthat,apharmaceuticalis providedforfreetopatientsat publichospitals.Hospitalsmay procuremedicinesontheirownor delegateMPUthisrighttoperform cumulativeprocurementontheir behalf;

5)enterManaged-EntryAgreements (MEAs)negotiationswithMOHand MPU.

Unfortunately,thereisoftena shortageofmedicinesinHC institutionsduetothesuboptimal formationoftheneedattheregion's level.Therighttoformapplications wastransferreddirectlytohospitals contractedwithNHSUtooptimize theprocessofcollecting applicationsforthepurchaseof medicines

Pharmaceuticals, including oncology medicines, may be used in UKR only after their marketing authorisation (MA) by the competent public authorities. Oncology drugs have to undergo the HTA procedure to participate in public procurements at the expense of budgetary funds.

Figure 17. Scheme of Market Access Pathway for Oncology Drugs in Ukraine

Sources: NHSU; MPU, MOH

TRAJECTORY OF CANCER

CARE

▪ Cancer Care Elements

▪ Patient Flow

▪ Cancer Care Infrastructure

▪ Diagnostics and External Therapy Types Utilized in Ukraine

Cancer Care Elements

A patient with a suspected or confirmed diagnosis of cancer undergoes a patient route from early detection to end-of-life care covered by the national benefits package. Even though the HC reform in 2017 dramatically changed the delivery of medical care, public health interventions are still underdeveloped in Ukraine.

Early Detection & Screening Primary Prevention

Effortstopreventthe occurrencecancer.

Identificationofcancersbefore theyinvadenearbytissueor spreadtonewsites.

Examinationstoconfirmthe diagnosisandmakeitmore precise.

Traditionally,surgeryisconsideredtobe themaincoursetreatmentof oncologicaldiseases

Afterundergoingthefullcycleof oncologytreatment

Thetypeoftreatmentthatis selectedforarecurringcancer dependsonthespecifictypeof cancer,howlargeitis,howit behavesbiologically,andwhat previoustherapywasgiven.

Typesofcaretorelieve symptoms,easedistress, providecomfort,andinother waysimprovethequalityof lifeofpeoplewithcancer.

End-of-lifecareisinitselfa diversesetofservices.

Primarycancerprevention inUkrainecovers:

(1) Healthcounselingand education(conducted bytheGPsand educationalauthorities atthelocallevelandby theCPHatthepublic one)

(2) Environmentalcontrols (ismainlyrepresented bypolicyregulationin thesphereof environmentalpollution andregularsanitary checksatfactories dealingwithpotentially cancerogenic chemicals.)

(3) Productsafety(are coveredbystrategy obligingproducersto indicateonthepackage thesubstanceand directlyexplainthat thesegoodsmaycause oncological diseases.)

Anypatiententitledtothehighriskgroupofdevelopinga certainkindofcancermay undergofreemammography, cystoscopy,hysteroscopy, bronchoscopy,colonoscopy, andgastroscopyuponreferral fromtheattendingphysicianor GPasapartofthescreening programforearlydetectionof cancer.

However,thedetectionrateof canceratthislevelremainslow. Thelowlevelofoncological competencycouldpartly explainthisamongGPandHCP inspecializedfields,suchas dermatologists, ophthalmologists, otolaryngologists,etc.

Furthermore,thepopulation alsocontributedtosucha tendency.Generally,Ukrainians arepoorlyawareofthepurpose andprocedureofpreventive examinationsand,accordingly, donotrefertosuchaservice.

Patientswithasuspected oncologydiagnosiscanobtain laboratorybloodandcerebrospinal fluidtestsandinstrumental studies,suchasMRI,CT, ultrasound,X-ray,andendoscopic examinationprescribedunderthe nationalbenefitspackage.All theseservicescouldbereceived forfreeinspecializedoncology facilitiesinmultidisciplinaryclinical hospitalsuponanoncologistorGP referral.

Besides,supposeapatienthas symptomsprovedbylab examinationsthatmaysignifythe possibilityofcancerand dependingonlocalization,theGP orattendingphysicianissuesa referraltoundergooneorseveral interventionsforearlydetectionof anoncologiccondition (colonoscopy,mammography, bronchoscopy,cystoscopy, hysteroscopy,gastroscopy).In thatcase,NHSUalsoreimburses thecostoftheprocedure.

ChemotherapyandRTareusedin Ukraineatadjuvantandneoadjuvant therapystages.Bothofthesetherapies arecoveredbytheMGPsand, accordingly,reimbursed.

UnderthechemotherapyMGPs,patients areentitledtofreetreatment,which coverslaboratorytests,instrumental studies,pharmaceuticals,intensive therapy,oxygensupport,and analgesia.

TheRTpackageissimilartotheone underchemotherapy.Besides,iftheHC facilityhasalinearaccelerator,gamma, orcyberknife,RTonthisequipmentis alsofreeofcharge.

However,theeffectivenessofRTis questionablegiventhatmostequipment isobsoleteandinsevereneedof modernization.

1. Afterundergoingthecomplete cancertreatmentcycle,the oncologistandtheGPelaborate adynamicobservationplanfor thepatientandconsultthe patientonproperlifestyle,food habits,andphysicalactivity.

2. Besides,atthisstage,patients mayberedirectedtootherHC facilitiestoreceivemedicalcare fornon-cancerconditions,if any.

3. Thefrequencyofcheck-ups, thevolumeofdiagnostic interventionsmade,andthe durationofobservationdepend onthekindoftreatment performedandthepatient’srisk groupreferredtocancer recurrencedeterminedbylab testsandtheoutcomeafterall stagesoftherapyreceived.

4. InUkraine,womenwithahigh riskofbreastcancerrecurrence areentitledtoall-life observationbyanoncologist.

Therearethreetypesof recurrentcancer local, regionalanddistantandeach hasitsowntherapeutic approach.Whenchoosing treatment,theattendingHCP considersthetreatment methodsusedlasttime,the tumortimeandplaceof recurrence,andtumor characteristicsbasedon repetitiveinstrumental examinationsandprevious medicalrecords.

Whetherneoadjuvantor adjuvantchemotherapy/RTor surgerywillbeappliedto eliminatemetastasesdepends onthelocationofmetastases, andtheprevioussensitivityof theprimarytumortothe chemotherapy,RT.

Forinstance,accordingtothe nationalguideline,ifrecurrent localcancerhappensduring thedynamicobservationafter prostatecancertreatment,a patientmayreceiveRT.

Notes: CPH Center of Public Health; GP General Partitioner; MGP Medical Guarantees Package; MRI Magnetic Resonance Imaging

InUkraine,Palliativecareis deliveredattheinpatientand outpatientlevels.

Attheinpatientlevel,patients atspecializedinstitutions couldobtainpainkillers, psychologicalcare,roundthe-clocknursingcare,lab tests,instrumental examination,specialized nutrition,andintensivecare.

Attheoutpatientlevel, specializedpalliativeservices couldbeprovidedbytheGP andmobilepalliativecare brigades;anurseorrelatives performround-the-clockcare afterthetraining.Palliative servicesattheoutpatientlevel aresimilartothoseprovidedin theinpatient.

End-of-Lifecareisnotclearly regulated,andtherelevant servicesaremainlycovered underthepalliativecarenotion. Similartothepalliativeone,this typeofcaremaybeprovided atthepatient’shomebythe mobilebrigadesaround-theclockoratstationaryhospitals. However,theprovisionof publicEnd-of-Lifecareand approachestoitsdeliveryis considerablyunderdeveloped inUkraineduetothelackof trainednursesandmedical personnel,obsoletepremises, andstrongnarcoticpain medicationsusedtorelievethe pain.

Table 3. Stages of Trajectory of Cancer Care in Ukraine

Patients Flow

After the reform of the financing of the HC system in Ukraine, the general practitioners, usually referred to as family doctors, became the gatekeepers to free medical care, including oncology care. After accessing the system, attending therapist determines the further route.

InUkraine,thereis universalcoverageof medicalservicesfor allcitizensregardless ofemploymentstatus, ageorsex.Theonly requirementtoaccess theHCsystemisto signadeclarationwith afamilydoctor(GP). Therefore,ifaperson hassymptomsofany illness,oneneedsto contacttheGPto clarifythepossible diagnosisandreceive areferraltoanarrow specialist,namely oncology.

Ifthepatienthad contactwithan oncologistpreviously, onecouldaddressthis specialistwithoutthe referralofaGP.

Whenapatient accessestheSMC, theattending physicianora conciliumofdoctors workcumulativelyto diagnosecancer, assesstheclinical picture(basedon initialdiagnosticsand

testsmadeinlabsor withthehelpof medicalequipment), conductrisk/benefit analysisandelaborate aplanofcomplex medicalcare interventions, describedindetailson page26.

Iftreatmentrisks outweighthepatient's benefits,palliative careisusually prescribedatthe hospitalorathome. Familydoctorsmay prescribepainkillers forpalliativecare. Mostofthepatient routesaredescribed inclinicalguidelines developedtotreat varioustypesof cancer.

PhysiciansinUkraine muststrictlyadhereto theapproved treatmentprotocols andoverseepatient pathwaysforcancer patientswithdifferent localizations.

A patient may refer directly to onco hospitals

May refer to any GP or receive referrals remotely

Notes: SMC Specialized Medical Care. GP in Ukraine: (1) Monitors patients’ health, (2) Issues referrals for diagnostics procedures, (3) Conducts postoperative observation, (4) Takes part in palliative care delivery

Generalized Patient Pathway for Treatment of Oncology Diseases

Cancer Care Infrastructure

Oncology care public infrastructure: specialized public treatment settings

Cancer Care Centres in Ukraine

As of end of 2021

Source: NCRU, respective hospitals

Territoryof Ukraine

TerritoriesofUkraine temporaryoccupiedby Russia(asofAugust

Hospitalliberatedbythe UkrainianarmyduringMarch-July2022

Oncologyhospitalrecentlyoccupied byRussianforcessince2022

Sources: Ukrainian Association of Medical Physicists

MedicalCenter ofModernOncology

VM

Crimean“OncologicalClinical Dispensary”RepublicanInstitution

Figure 19. Map of Public

Availability of Mv Machines in WE/CEE

Radiotherapy(RT)isoneofthe corecomponentsof multidisciplinarycancercare. Whileabout50%ofallcancer patientshaveanevidence‐based indicationforRT,morethanone outoffourcancerpatientsin Europedonothaveaccesstothe RTtheyneed.

Morespecifically,lessthan17% ofEuropeancountriestreatat least80%oftheoptimal indicationsforradiotherapy,and 46%ofEuropeancountriestreat <70%ofthepatientswithan indicationforradiotherapy

Therearemultiplereasonsfor thisunderutilisation,suchasthe lackofawarenessamong patientsonRT,physician‐related bias,traveldistancetoaRT facility.

Shortageofhumanresources and/orequipment,andeconomic barriersalsoimpactaccessto anduseofRT.Inaddition,the slowandvariableimplementation ofinnovativetreatmentstrategies intoclinicalpracticehasbeen describedasamajorbarrier leadingtosubstantialinequalities incancercare.Withincreasing pressureonHCbudgetsinmost Europeancountries,theradiation oncologycommunityneedstoget

betterinsightintotheequipment andpersonnelrequiredtodeliver safe,high‐qualityandinnovative RTtoallcancerpatientswho needit.

Twomajorfactorsareexpected tobedriversofcancer policymakingforthecoming years.

First,thenumberofcancer patientsamenabletoRTis growing,duetoanincreasing cancerincidence,whichis related,amongstothers,tothe agingofthepopulationinEurope.

Second,thecontinuous introductionofnewtherapeutic andtechnologicaladvances resultsintouncertaintyaboutthe actualresourcesneededto provideaccesstothese innovationsandregularincrease ofcancertreatmentcosts. Furthermore,marketentryofnew high‐endRTtechnologies requireshigherinvestmentand operationalcostswithrelevantly unpredictableeffectivenessat thepopulationlevel.Sucha challengeshouldbeimmediately resolvedbythepolicymakersso astoreasonablyrelocatefunds fortheHCprovision.

Meanwhile,managedentry

agreementscouldhelpto guaranteeearlypatientaccessto newtechnologiesthathave shownconsistentandpromising datafromtheinitialstagesof clinicalapplicationandavoid overspendingofthestatefunds. InUkraine,atleast20new LINACswereplannedtobe procuredundertheNational CancerControlStrategy2030 (page19),howeverRussian invasionofUkrainehasputthese effortsonhold.

Diagnostic procedures

Since2020,ayearoftheCOVID19pandemiceruption,the numberofperformedscreening procedureshasreduced considerably.

Thisdecreasedeepenedin2021, showinganamplefallin conductedEGDinterventions(6%)andbronchoscopy(-6%).

Thenumberofpatientsthat underwentcolonoscopyhas slightlyimprovedcomparedto 2020.Eventhoughseveral screeningprogramswere introducedinApril2020asapart ofsecondarymedicalcare reform,thepatientsandHCPs havenottakenfulladvantageof earlydiagnosisinstruments.

Source: DIRAC (2021); Lievens Y, Borras JM, Grau C. Provision and use of radiotherapy in Europe Mol Oncol 2020 Jul;14(7):1461-1469

Notes: Megavoltage (MV) units are medical devices used to deliver external beam radiotherapy to cancer patients. In DIRAC, a MV unit is either a Radionuclide Teletherapy Unit (RTU) or an Electron Accelerator (EA). In fact, the infographic shows the compound number of both RTUs and EAs. EAs can be circular accelerators (betatron, microtron) and linear accelerators (often shortened to LINAC). Notes: WE Western Europe; CEE Central Eastern Europe; Mv Megavoltage

Ukraine has one of the lowest ratio of megavoltage (Mv) machines per 1,000,000 of population among European countries according to the IAIE normative.

20. Quantity of LINACs per 1 mln of Population in

Radiation Therapy Types Utilized in Ukraine

Since 2020, a year of the COVID-19 pandemic eruption, the number of performed screening procedures reduced considerably, resulting in high mortality rates in 2021. RT, as a widely used kind of oncology treatment, is performed by three types of machines, having their own advantages and drawbacks.

Thisisduetofamilydoctors' lowawarenessaboutthe possibilitytoundergoan interventionforfreeunderthe referralandextensiveusageof detrimentalCTandMRI diagnosticsbynarrow specialists.

ThegradualdecreaseinEGD interventionssince2019 resultedinhighlevelsof mortalityamongpatientswho hadcancerofthestomach,

whichtookthirdplaceinthe top10deathscausesprovoked bycancerlocalizationsin2021.

Giventhatthenumberof performedbronchoscopies alsodroppedsince2019,lung cancercausedthelargest mortalityrateamongother localizationsandbecamethe thirdbiggestindexinthe incidenceratesamongcancer localizationsin2021.

Fordetailedinformationabout morbidityandmortalityratesfor differentcancerlocalizationsin Ukrainerefertopage12. Itbecomesobviousthatthe inefficiencyofearlydiagnosisof cancertoagreaterextentreduces itsmanagementandtreatment capabilitiespoorlyimpactingthe survivalratesofpatientswith cancerandresultinginexcessive deaths.Whypreventionof oncologydiseasesworksbadlyin Ukrainewasexplainedonpages912.

Radiation Therapy in Ukraine

Aswasmentionedbefore,radiation therapyispartofthetrajectoryof cancercareinUkraine.Thiskindof therapiesarecoveredunderthe MGPand,accordingly,reimbursed. Morespecifically,therelevant reimbursedpackageincludes laboratorytests,instrumental studies,radiationassuch, pharmaceuticals,intensivetherapy, oxygensupport,analgesia.

RTisperformedonthemachines thatareavailableatthegiven hospitals.Duetothat,thequalityof theinterventionperformedvaries fromplacetoplace,whichwould beexplainedindetailinthecontext ofthetypesofradiationtherapy machinesusedinUkraine(page

ExternalBeamRadiationTherapy (EBRT)inUkrainecanbe conditionallydividedintothree groups:

1.Obsolete.2D,whichisperformed onoldgammatherapy(GT)units thatcontainaradioactiveCobalt60(Co60).

Unfortunately,GTdevicesarestill widelyusedinUkraine,although theydonotmeetmodern recommendationsforhigh-quality RT(visitpage28togetacquainted withtheRTequipmentpresentedin Ukraine.)Currently,thesethree typesofmachinesarepresentin Ukraine:

▪ AGAT-S(staticGT)

▪ ROKUS-M(rotation/ convergent)

▪ AGAT-R(rotationalGT)

2.Intermediate (3D-conformal, whichincludesmoreorlessmodern LINACs,whichwerequitewidely usedinEuropeandtheUSAin 1980-1990s.)

3.Modern.Consistsprimarilyof patientpositioningsystems(IGRT) anddosedeliverymethods(IMRT andVMAT/RapidArc.)

Protontherapyiscurrently unavailableinUkraine.

Figure 22. Utilization of Radiation Therapy Types in Ukraine, 2014-2021

Therapy

Figure 21. Number of Endoscopy Diagnostic Procedures in 2014-2021

endoscopies, mln procedures

Source: Eirhub

IMPACT OF THE RUSSIAN INVASION OF UKRAINE

On Healthcare Infrastructure

Accordingtothesituationalreportby theWHO(Sept2022)(1),Russian invasionofUkrainehasledtothese numbers:

▪ 17.7mlnpeople totalpopulation affectedbytheinvasion

▪ 7.2mlnpeopleleftUkraine;

▪ 7mlnpeopleareinternallydisplaced

▪ 8,199peoplewereinjureddirectly becauseofRussianinvasion;

▪ 5,718Ukrainians(civiconly)were killedbyRussians

AccordingtoClusterMunitionCoalition (CMC) initsnewlypublished13th annualClusterMunitionMonitor2022— condemnedwhatitdescribedasthe extensiveuseofclustermunitionsinthe war,sayingthatUkraine,asofAugust, istheonlycountryintheworldwhere theyarecurrentlybeingused.

ThereportsaysthatRussiahasused clustermunitionsextensivelysince invadingUkraineon24February.

Total Infrastructural Damage

Russia’sinvasionofUkrainehascaused USD108bnindamagetothecountry’s infrastructure,accordingtoastudyby KSEreleasedthesamedayUkraine’s defenceministryestimatedthewarhas left3.5mlnpeoplehomeless.(2)

SincethebeginningofRussia’swar againstUkraine,atleast388

enterprises,18civilianairports,764 kindergartens,23shoppingcenters, 43.7thsagriculturalmachinery,1991 shops,27shoppingcenters,511 administrativebuildings,28oildepots, 105,200privatecars,634cultural facilitieshavebeendamaged, destroyedorseized.

Thetotalamountofrecoveryneeds takesintoaccountonlythe reconstructionofdestroyedobjects accordingtotheBuildBackBetter principle,consideringmodernization, andtheadditionalneedforliquidityfor therestorationofenterprises.

AccordingtotheGovernment’s estimates,takingintoaccountthese categories,thetotalneedforfinancing therecoveryandmodernizationofthe economyisUSD750bn.

Almost350objectsofcriticalheating infrastructurehavebeendamagedor destroyedinthewarandconcludes that,“preparationsforthe2022/2023 winterseasonmaybecomplicatedin Ukraine,especiallyinareasaffected…” bytheRussianinvasion.(3)

Healthcare Infrastructure Damage

AccordingtothesamereportbyKSE, morethan900HCfacilities(publicand privatehospitals,pharmacies, laboratories,anddiagnosticcenters, bloodbanksetc.)weredamagedor destroyedbyRussiansinUkraine.

Estimatedrecoveryneedsjustto rebuildasitwas,UkrainianHCsystem willrequireadditionalUSD2.4bn.

KeycriticalissuesoftheUkrainian healthcareinfrastructureinducedby theRussianinvasion:

▪ Destructionofbuildings,incl. electricity,heat,andwatersupply grids.

▪ Destructionoforstealingvarious medicalequipment(incl.expensive andcomplexdiagnosticandtherapy machines).

▪ Significantliferiskformedicaland nursinghospitalspersonnel.

▪ Lossofpatientsduetointernaland externalmigration.

▪ Interruptionofnecessarytreatment foroncologypatients.

▪ Prematuredeathsduetocutaccess tomedicalcare.

▪ Distortionordestructionoflogistics ofmedicinestoruralareas.

Distorted Treatment Landscape

PatientsremaininginUkraineafterthe invasionfacedawhollychanged treatmentandcarelandscape.While surgicaloncologytreatmentisstill available,patientsfacedalimited supplyofdrugs.

RT,heavilyreliantoncobalt-60 machines,isalsodisruptedbythewar.

Maternityandchildren’shospitalinMariupol(photobyBBC)

HospitalinMariupol(photobyEyePressNews)

AhospitaldamagedbyshellinginSievierodonetsk(photobyBBC)

DestroyedEmergencyAuto(Medscape)

Patientsandtheirfamiliessleepinginthecorridorsofthe NationalCancerInstituteinKyiv(TheGuardian)

Fundamental analysis of the consequences of the Russian invasion on the Ukrainian healthcare infrastructure is yet to come as the war is expected to flow into 2023 at least.

CentralhospitalinIzum(photobyBBC)

On Cancer Care Infrastructure

Oncology infrastructure was hit hard in Ukraine since the Russian invasion of Ukraine in 2014 when Russians annexed the Ukrainian Crimea and occupied the Donetsk and Luhansk regions partly. Unprecedented impact on all aspects of cancer care has put the system in uncontrolled chaos, forcing tens of thousands of cancer patients to put on hold or postpone their vital treatment.

Categories

I

Oncology hospitals occupied by Russia since 2014

II

Recently occupied oncology hospitals by Russia

Recently de-occupied oncology hospitals

Oncology hospitals that lost most of their patients

Oncology hospitals that received and inflow of new patients

Relocated oncology hospitals

Description

Hospitalsthatwereoccupied byRussia8yearsago

Hospitals affected

Hospitalsthatwererecentlyoccupied byRussiasince24th ofFebruary2022 andthatarestillunderRussiancontrol

Hospitalsthatwereliberatedduring theUkrainiancounter-offensivein March-May2022

Hospitalsthatexperiencedasignificant outflowoftheirpatientsduetoaforced internalmigration(mainlyCenterofUkraine)

Hospitalsthatexperiencedan unprecedentedinflowofnewpatients (+100-300%uptotheirexistingcapacities)

Hospitalsthatwererelocatedto saferregionsintheWestof Ukraine

Patients and Patients flow Treatment & Drugs Provision Medical personnel & nursing staff

▪ Crimea:3

▪ Donetskregion:4

▪ Luhanskregion:4

▪ KhersonROD

▪ MelіtopolROD

▪ MariupolCOD

▪ ChernihivMedicalCenterof ModernOncology

▪ SumyROD

▪ KharkivRegionalOncologyCenter

▪ Almostalloncology dispensarieslocatedinthe East,SouthandCenterof Ukraine

▪ Mostoncologydispensaries intheWestofUkraineand CentreofUkraine(Cherkasy, Poltava,Dnipro)

▪ RegionalTerritorialMedical AssociationofKramatorsk

▪ KramatorskCentreofModern Oncology

▪ LuhanskOncologyDispensary

▪ Obsoletemedicalequipment withoutthepossibilityto renovateduetosanctionsin CrimeaandoccupiedEast ofUkraine.

▪ Patientdiscriminationas medicalcareisprovided basedonRussianpassports orpassportsofillegal entities.

▪ Lackofopportunitytobring newtechnologiesand qualifiedmedicalpersonnel.

Infrastructure & equipment

▪ Significantbarriersfor internationalcooperation betweenoccupiedhospitals andglobalmedical community.

▪ 19unitsofCo-60/Ir192and 3LINACsarecaptured.

▪ Significantpatientoutflows.

▪ Emptyingofhospitalcapacities.

▪ Distortionofpatientflows.

▪ Uncontrolledtreatmentquality.

▪ Absenceofneededdrugs.

▪ Ukrainestilltriestodeliverthe neededdrugstopatientsthere.

▪ Mostofpersonnelmigratedto Ukraineorabroad.

▪ Remainedstaffworksunder pressureandwithoutproper workingconditions.

▪ UncontrolledutilizationofRT equipment.

▪ Damagedordestroyedhospital capacities.

▪ 5Co-60and1LINACarecaptured

▪ Slowlyrestoringpatientflows.

▪ Mostofpatientsreceivetreatmentat homeorinothersettings.

▪ RTpatientsarerelocatedtosaferregions.

▪ Treatmentprocessesarerestoring.Focuson outpatientchemotherapy.

▪ Additionalcapacitiesarere-profiledinto militaryhospitals.

▪ Mostdrugsareavailable.

▪ Mostofstaffisonthesite.

▪ KharkivOncologyCenterstaffisplaced amongotherhospitals.

▪ KharkivOncologyCenterisalmost destroyedtogetherwithallexisted equipment.

▪ RTissignificantlyreducedduetothewar risks.

Source: Interview with experts. Notes: ROD Regional Oncology Dispensary; COD City Oncology Dispensary

▪ Mostpatientsmigratedtohospitalsin theWestofUkraineontheirown.

▪ 90%ofchildrenwithcancerwere relocatedfromUkraineinhospitals aroundtheglobe.

▪ Justemergencycareandoutpatient chemotherapy.

▪ Excessesofdrugswererelocatedto otherhospitals.

▪ Treatmentprocessesarerestoring.

▪ Somemedicalstaffmigratesbackas wellaspatients

▪ Theproblemwiththenursingstaff shortagehasdeepened.

▪ AsofJuly2022,hospitals’capacitiesare fullyloadedagain.

▪ Internalprocessesrebuilttosupport evacuationofpatients.

▪ UnderloadedRT/GTequipmentcapacities.

▪ Deliveringallmedicalcareneeds andnotrefusingpatients.

▪ UseofextensiveHCforreprofiling departmentsforactualneeds.

▪ Somedrugswereinscarcitydueto inconsistencybetweendeclaredand realdemand.

▪ Efficientprocessofdrugsredistribution amonghospitalsoverUkraine.

▪ Mostofstaffisonsite.

▪ KramatorskCentreof ModernOncologystarted operatingbasedonStryi CentralHospitalintheLviv region.

▪ LuhanskOncology Dispensary,previously locatedinKreminna temporarilyoccupiedsince May2022,movedtothe RivneAntitumorcenter

▪ Mostloadedfacilitiesreceivedmedical equipmentashumanitarianaid.

▪ Extremeundercapacitiesofexisting equipmentduetounseennumberof newpatients.

▪ RegionalTerritorialMedical AssociationofKramatorsk relocatedtoLviv.

On Patients and Their Families

Morethan2mlnrefugeeshavefled UkrainesincetheRussianinvasion beganonFeb24,2022,andover4mln people,10%ofthepopulation,are expectedtobeforciblydisplacedas theyseeksafety,creatingawideranginghumanitariancrisis.Ukraine hasahighcancerburden,withmore than160,000newdiagnosesin2020 alone.

Ukrainiancancerpatientsfaced unseenchallengesduetotheRussian invasion:

▪ Risksofbeingkilledorinjured(areas ofdirectinvasionorconstant shelling/bombing).

▪ Risksofbeingforcedlydeportedto RussiathroughRussianfiltration camps.

▪ Risksofnotgettingtimelyand complextreatmentprocedures(RT, forexample)orchemotherapy drugs.

▪ Riskofmissingplannedsurgicalor othermedicalprocedures.

▪ Theneedforquickevacuationfrom thewarzone.

▪ Theneedtofindtemporaryor permanentaccommodation.

▪ Increasedexpendituresonnontreatmentneeds:evacuation, accommodation,logistics,etc.

▪ Lossofstableincomesduetoloss ofjobsandaneedtoevacuate.

▪ IncreasedOOPexpendituresfor manynewercancertreatments(ie, newergenerationtargeteddrugsor immune-oncologicaltreatments).

▪ IncreasedriskofgettingCOVID-19 duringtheevacuation.

▪ Delayinregistrationinhospitalsat theevacuationsitedueto overcrowdingandsignificant disorganizationinprocesses.

▪ Cancerchildrenfamilieshadto relocateinfull(meaningallworking familymemberslosttheirjobsor incomesources).Inaddition, fathers,mostlikely,shouldhave stayedinUkraine.

Despitesuchunexpectedobstacles, Ukrainiansociety,volunteers,doctors, businessesandpublicandpatient organizationsjoinedforcesinmany directionsintheoncologycaresystem. Andalso,thankstothesubstantial supportoftheWesternworld,itwas possibletorelocatethemaximum possiblenumberofpatientsfromthe warzone.

SAFER UKRAINE Initiative

Thecountryhasarelativelyhigh survivalratefromchildhoodcancer globally,whichexceeds70%,although

Ukraine'sexistingpaediatriccancer caredisparitieswerealreadyhigh beforeRussia’sunprovoked aggressionandwillnowundoubtedly worsenduetotheconflict.

Immediatelyafterthewarhadstarted, theSAFER*initiativewasorganized undertheauspicesoftheUSA(ST JUDEGLOBALSIOP/SIOP-E,CCI/CCIE)andstakeholdersfromUkraine (TabletochkiandWesternUkrainian SpecializedMedicalCenter)and Poland(HerosiandPolishSocietyof PaediatricOncologyand Haematology).Thisinitiativewasto provideacollaborativeemergency responsetothewarinUkraine,making theprovisionofpediatriconcology careimpossible.

SAFERUKRAINEisaglobalinitiative, whichamongotherthingsentailsa virtualcommandcenterthat coordinatesandmakespossiblethe evacuationoftheillchildtosafe placesinUkrainewithfurthertravelto thehostingmedicalcenter,wherethe essentialtherapywithintheprecise timingmaybeprovided.Theteam helpsfindortranslatemedicalrecords andmanagesthelogisticsassociated withcrossingtheborder.

Owingtothisinitiative,1,200Ukrainian childrensufferingfromoncology diseaseswereevacuatedabroadto

receivehighlyspecializedmedicalcare andcontinuetheirtreatmentinthe prominentmedicalcentersofEurope andNorthAmerica.

GatheredinWesternUkrainian SpecializedMedicalCenter,kidsand theirparents(usuallymums)headed withthehelpofvolunteersand partnerstothetriagehubinPoland, wheretheyunderwentdiagnostic interventionsservingasabasefor furtherdistributiontomedicalcentres inEuropeandtheUSbecausemany smallpatientslosttheirmedical documentwhilefleeinghomeunder Russianshellings

Theevacuationdestinationswere representedby:

▪ 29countries(predominantlytheEU MemberStatesandtheUS);

▪ 182cities;

▪ 204hostmedicalcentres.

Afterthefirst12weeksofthewar,the volumeofpatientsrequesting evacuationdecreased;however, SAFERUkrainecontinuestosupportan averageofonetotwoevacuation requestsperweek.

Theinitiativehasbecomeaproof-ofconceptforglobalhealthintermsof takingrapidmeasuresandeffortsto reacttohealthcarechallenges.

Abrotherandsister arriveatSt.Jude Children’sResearch HospitalinMemphis aftertravelingfrom Ukraineasapartof theSt.JudeGlobal SAFERUkraine project.

Apatientisloaded ontothefirst medicaltrain operatedby MédecinsSans Frontières(MSF)on March31in Zaporizhzhia.

MedicsNataliia Kyniv left,and DmitryMogilnitski, preparesupplies aheadofthefirst patientscoming aboardthetrain.

The full-scale invasion of Ukraine made the treatment of patients, especially children, with oncology within precise timing nearly impossible, challenging families, medical staff and the HC system overall

FURTHER DEVELOPMENT OF CANCER CARE IN UKRAINE 4.

Further Development of Cancer Care System (1/2)

Infrastructure Recovering Plan, Clusterization of Hospital District and Public-Private Partnership

Conceptually,initiativesbythe Ukrainiangovernmenttorestorethe country'sinfrastructureinclude actions:(A)former alreadyinitiated beforethefull-scaleinvasionon24th February2022,and(B)latter— initiatedduringtheinvasiontoface newlyemergeddestructions.

Asperformerinitiatives(A),wewould underlinetheHCsystemclusterization andthepossibleintroductionof Public-PrivatePartnershipsinHC.

Asperlatterinitiatives(B),theseare abouttheRecoveryPlanofthe Ukrainianinfrastructure,includingthe HCone.

Infrastructure Recovery Plan

Russianinvasiondamagedor eradicatedvitalinfrastructuralobjects inUkraine roads,citypower,water, heatinggrids,healthcarefacilities, productionfacilities,powerandhydro stations,etc.

TheNationalCouncilforthe RestorationofUkrainefromthe ConsequencesoftheWar(NCRUCW) wascreatedtofacetheemergent needsinrestoringtheUkrainian infrastructure.

Thisinstitutionservesasa consultativeandadvisorybodyunder thePresidentofUkraine.Infact,the decision-makingverticalregarding therestorationofUkraineisbuilt

undertheOfficeofthePresident,not theCMU.

TheNCRUCWconsistsof23working groupsindifferentareas,including theHCone.Thelatterhasfocusedon thefollowingninepriorities:

1. Strengtheningpoliciesand institutionsofthenationalHC systemtoguidetherecovery process.

2. Ensuringthefinancialstabilityof theHCsystem.

3. Restorationandtransformationof theHCfacilitynetwork.

4. Developmentofhealthservicesto meettheneedsofpeople (includingIDPsandwarveterans) causedbythewar.

5. Consolidationandstrengthening ofhumanresourcesoftheHC system.

6. Strengtheningofthepublichealth systemandpreparednessfor healthemergencies.

7. DevelopingelectronicHCand strengtheningitscybersecurity.

8. Strengtheningnational-andlocallevelqualitymanagementsystem.

9. Recoveringthepharmaceutical sector,improvingaccessibility, andproperuseofmedicines.

AttheUkraineRecoveryConference

inLugano(5,6July2022),the NCRUCWpresentedtheRecovery Plan,whichdespitebeingdeveloped indetail,wasquestionedbysociety, business,experts,andother stakeholders.

Duetothat,thePlanissupposedto beaverydraftversionofthe RecoveryStrategy,whichwouldbe significantlyadjustedovertime.

Clusterization of Hospital Districts

Attimesbeforethewarstarted,MOH decidedtolaunchanew infrastructuralstageoftheHCsystem reform:thehospitaldistrictsystem, whichhasalreadybeenincludedin thePlanfortheDevelopmentand RestorationofHCInstitutionsofthe Kyivregion.Theaimof clusterizationistotacklethe excessiveamountofhospitals, optimizethefundingforHC infrastructureandcreateapatientcentricdeliveryofmedicalcare. Hospitaldistrictswouldalsobe createdintheChernihivandSumy regions,whereHCinfrastructurewas severelydamagedbytheRussian army.

Thesystemofhospitaldistricts providesseverallevelsofcare dependingonthecomplexityofthe caseandtheseverityofthepatient's

condition:

▪ superclusterhospitals,

▪ clusterhospitals,

▪ generalhospitals.

Superclusterhospitalswillbe equippedwithasmuchmodern equipmentaspossibleandprovide patientswiththebroadestrangeof services.

Itisplannedtocreatetwo superclusterhospitals(childrenand adultpatients)perregion.

Intheclusterhospital,thepatientwill beabletoreceivemedicalservices forthemostcommondiseases.Also, eachclusterhospital:

▪ mustcover150,000population,

▪ belocatedwithinanhour'stravel timetoreachit.

Generalhospitalswillprovidebasic medicalservicesforpatientsinoneor morecommunities.Eachgeneral hospitalwouldbedesignedfor50-80 thousandpeople.

Itisexpectedthatbringingless complexservicesclosertothepatient andconcentratinghigh-techservices formorecomplexcaseswillimprove theprovisionofHC.

However,intheory,clusterreform couldonlybesuccessfulifthe reductionofthenetworkofhospitals

goessimultaneouslywiththeir modernization.Inthisvein,the announcedreformcausesconcern sinceitprovidesthecreationof clusterswithoutitsmodernization. Furthermore,cancercarecentres havenoprominentrolewithinthis systemand,accordingly,couldremain outoftheboard.

Additionally,itisunclearhownew hospitalswouldbefundedandhow thesefundswillbespent.

Undertheworstscenarios,fundsfor thecancercaresystem,whichis currentlyfinancedbetterthanother packages,wouldbedispersedamong thecluster'shospitaldepartments. Thus,wesupposetheclusterreform isaniceattempttorebuildthe destroyedHCinfrastructure. However,itcouldbecomeinefficient enoughwithoutdetailed specificationsofhowthenewsystem wouldbefinanced,organized, equippedandoperated. Hence,theUkrainianHCsystemisin urgentneedofcentralization, optimizationandmodernizationof medicalcaredelivery.Speakingof children'scancercare,since childhoodcancerisanorphan disease,itisnecessarytocentralize theprovisionofchildhoodcancer caretoconcentrateexperienceand

resources,enablingtheimprovement ofthequalityandoutcomesofcare.

Public-Private Partnerships

AstheHCinfrastructurewas damagedduringtheRussianinvasion, theGovernment,amongothers,plans tointroducethepublic-private partnership(PPP)model(1) to acceleratetherebuildingphaseinthe comingfuture.

TheWHOdescribesPPPsasmeansto “bringtogetherasetofactorsforthe commongoalofimprovingthe population'shealthbasedonmutually agreedrolesandprinciples.”

PPPsarevoluntarycooperative arrangementsbetweentwoandmore publicandprivatesectorsinwhichall participantsagreetoworktogetherto achieveacommonpurposeor undertakeaspecifictaskandtoshare risksandresponsibilities,resources andbenefits.

Inthehealthsector,PPPsinvolvea long-termcontractbetweenaprivate sectorentityandagovernmententity fortheprovisionofhealth-care facilities,equipmentand/orservices. Currentlythereislimitedexperience ofPPPsinUkraineandconsequently limitedcapacitytodesignand implementpoliciesthatfacilitateand optimizetheiruse.

The cancer care system in Ukraine is being developed and reconstructed through the application of the variety of different strategies, such as

Further Development of Cancer Care System (2/2)

Incontrast,thereismuchexperience ofPPPsinothercountriesintheWHO EuropeanRegionandinAustralia, CanadaandtheUSA.

Asubstantialevidencebaseonthe useofhealthsectorPPPsinhighincomecountriesandsomemiddleincomecountriesexists.

Currently,threemodelsofPPPsunder activeconsiderationinUkraine:

1. Specializedclinicalservices/ diagnosticservicesPPP

2. HealthfacilityPPP

3. IntegratedPPP

Forinstance,suchPPP(model1)is beingconsideredincancercare. Thereareplanstoestablishanew radiologycenterattheNCIunderthe PPPmodel.

However,beforeitsapplication, Governmentshouldresolveseveral challenges,suchasthepreparationof specialistscompetenttodealwith public-privatepartnershipprojects andcreatemechanismsforexternal independentscrutiny,including involvingnationalauditors,which currentlydonothavethemandateto undertakeretrospectivevalue-formoneyassessments.

Rebuild or Re-think?

Summarizingtheabovementioned, therearenumerousattemptsto restoretheUkrainianHCsystem.

However,itisessentialtoremember thatrestorationcouldbemadeintwo ways:rebuildingwhatwasbeforethe warandrethinkingorimprovingthe system.

Webelievethesecondwayshouldbe prioritizedsincethesimplerebuilding ofthesovietSemashkoHCmodelmay bringsignificantchallengestothe stateeconomyandpublichealth. Independentofthecurrentconflict, theHCsectorinUkrainefacesseveral criticalshortcomings.

Inparticular,thecountryhasan oversupplyofhospitals,mostunfitfor purposeandcostlytooperate, alongsideanundersupplyofprimary careanddiagnosticfacilities.

Addressingtheselimitationswill requiresubstantialcapitalinvestment, butconstraintsonpublicfinanceswill reducetheGovernment’sabilityto fundthereconfiguration.

Patient-Centric Cancer Care

ThecurrentHCsysteminUkraineis disease-oriented,i.e.,itconcentrates ondisease-specificoutcomes followingpracticeguidelinesfor specificconditions.However,inmost cases,individualshavemultiple illnessesrequiringcomplextreatment. Furthermore,disease-oriented treatmentmaybechallengingwhen patientsmustadheretomultiple guidelines,andthereisaconflict

amongthoserecommendations. Besides,disease-centered recommendationsmaynotbehelpful forpatientswithmultiplehealth conditionswhovaryintheirhealth priorities.Duetosuchdifficultiesin applyingthedisease-centered treatmentconcept,mostdeveloped Europeancountriesagreedtoleanto usepatient-centeredcare.

Optimalcancercareentails coordinationamongmultiple providersandcontinuedfollow-up andsurveillanceovertime.Moreover, manyhealthconditionsare associatedwithcancer.Forexample, peopleofages65yearsandolderare morelikelytohaveoneormore chronichealthproblemsinadditionto livingwithcanceratallstages,which includehighbloodpressure,heart disease,diabetes,andarthritis.(2)

Thepatient-centeredcarebrings opportunitiestoimprovethedelivery ofcancercare.Theadoptionof patient-centeredoncologycareisin itsinfancyglobally.(2)

Thismethodcouldbeexplainedas providingrespectfulandresponsive caretoindividualpatientpreferences, needs,andvaluesandensuringthat patientvaluesguideallclinical decisions.

Suchapartnershipbetweenapatient andrespectivephysicianenables

shareddecision-makingandensures thatcommunicationissensitivetothe needsandcapabilitiesofthepatient. Moreover,thisstrategyinvolvessocial workers,psychologists,andother personneltohelpcoordinatecareand easehealth-relatedburdens, includingpsychosocialissuessuchas anxietyorfinancialstress. Summarizingthosementionedabove, patient-centeredcaremay significantlyimproveUkraine'shealth caresystem.

Suchamethodmaybeespecially valuabletotheoncologicaltreatment, whichishighlytraumatictothe patientbothinthephysicaland mentaldirectionand,accordingly, shouldbedealtwithbyapplyingsuch acomplexapproachaspatientcenteredcare.

Further development and reconstruction of the cancer care system must follow the line of rethinking the pre-war health care system and move from the disease centred care to the patient centred one

Eirhub’s mission: We find synergy in Life Sciences

Who are we: What we do: Market Access Recruitment, Executive Search & Org. Development

Eirhubisaprofessionalconsulting firmprovidingadvisoryservicesfor LifeSciencesindustries stakeholders—Pharma,MedTech, DigitalHealth,andHealthcare. Wesupportorganizationsonmarket accesstopics,regulatoryenvironment assessment,marketanalysisand intelligence,executivesearch,and recruitment.

Wedevelopindustry-,therapeutic areas,andcountry-focusedreports andinsightscoveringregionsfrom WesternEuropetoMENAandCEEto SouthCaucasusandCentralAsia. OurUkrainianrootsinspireustohelp rebuildUkraineanditseconomyto bringnewbusinessesandknowledge intoourcountry.

Our Team

Regulatoryanalysis,processesstaging, stakeholdersmapping,pricelevelsanalysis, timelining,andbudgeting,incl.othermarket entryareas.

Searchandrecruitment,executivesearch, talentsmapping,regulatoryrequirements analysis,andorganizationstructuresmodelling.

Marketing & Strategy Consulting

Tailoredandad-hocadvisingonsales& marketingstrategy,businessstrategy,people management,andbusinessmodellinginthe region.

Reports & Insights

Standardizedandregularcountry-specific reportswhichcoverpharmaceuticalmarket trends,healthcaresystemoverview,market accessroadmap,epidemiology,and demographics.

Partner,MarketAccess& BusinessDevelopment

Partner,ExecutiveSearch, OrganizationalDevelopment, Recruitment

Anastasiia

Manager,MarketAccess &BusinessDevelopment

MarketAccess Specialist

Yulia Foienko Recruitment Specialist

Yevgen Brovko

Anastasiia Maksymenko

Havrysh

Valentyna Khomenko

Appendix 1

List of Figures and Tables

1 EstimatedAge-StandardizedIncidenceRates(World)in2020

2 IncidenceRates(NewCancerCasesRegistered),2021

3

Tables

Table# Name

1 2010-2016OncologyNationalProgramOutcomes(accordingtoofficialsources)

2 CancerCareMedicalPackagesTariffs2020-2022(EUR,ths)

3 StagesofTrajectoryofCancerCareinUkraine

Abbreviations & Definitions

AMSU AcademyofMedicalSciencesofUkraine

ASR Age-standardizedincidencerate

BT Brachytherapy

CAGR Compoundannualgrowthrate.Itisthemeanannualgrowthrateofachosen indicator

CT ComputedTomography

EA ElectronAccelerator

EBRT ExternalBeamRadiationTherapy

EUR Euro

GP GeneralPartitioner/FamilyDoctor

HC HealthCare

IDP InternallyDisplacedPerson

INN InternationalNon-proprietaryName

KSE KyivSchoolofEconomics

LINAC LinearAccelerator

MEDTU MinistryofEconomicDevelopmentofUkraine

MFU MinistryofFinanceofUkraine

MGP MedicalGuaranteesPackage

mln million

MOH MinistryofHealthOfUkraine

MRI MagneticResonanceImaging

NCI NationalCancerInstitute

NCRU NationalCancerRegistryofUkraine

NCRUCW TheNationalCouncilfortheRestorationofUkrainefromtheConsequencesof theWar

NBU NationalBankofUkraine

NHSU NationalHealthServiceofUkraine

OOP Out-of-pocket

PHC PublicHealthCare

PMC PrimaryMedicalCare

PPP Public-PrivatePartnership

PPP Public-PrivatePartnership

RT Radiotherapy

RTT RadiationTherapist

RTU RadionuclideTeletherapyUnit

SE StateEnterprise

SMC SecondaryMedicalCare

SNRIU StateNuclearRegulatoryInspectorateofUkraine

TMC TertiaryMedicalCare

UAH UkrainianHryvnia

BE BRAVE LIKE UKRAINE