THE ESMO INTERNATIONAL ANTINEOPLASTIC MEDICINES
THE ESMO INTERNATIONALANTINEOPLASTICMEDICINES SURVEY:HOW AVAILABLE ARE THEWHO ESSENTIAL CANCERMEDICINES?Alexandru ENIU, MD, PhDChair, ESMO Global Policy CommitteeDepartment of Breast TumorsCancer Institute Ion ChiricuţăCluj-Napoca, Romania
Disparities in cancer outcomes (survival )across EuropeDe Angelis, et al: Cancer survival in Europe 1999–2007 by country and age: EUROCARE-5Lancet Oncol, 2013
Factors accounting for cancer outcomesdisparitiesHealthsystem(Late) Stageat diagnosisinfrastructureGeneralpopulationhealth andlifestylePatient Access &Availability ofCancerMedicationDisparities incancer careCancer orce”
ESMO Anti-Neoplastic MedicinesSurveyPerception survey to map access to cancer medicines, including WHOEssential Medicines, reporting on: Approval status ( yes/no) Informative for new drugs Reimbursement ( yes/no) Highlight differences in cancer policies Residual (out of pocket) cost to patients Delays in access due to special authorization Actual availability Drug shortage for old drugs Unavailability in the pharmacy (parallel export) for expensive drugs Two steps: European Data and International Data
Coordinating & Collaborating Partners Coordinating Organization ESMO Collaborating Project Partners1.2.3.4.World Health Organization (WHO), Geneva, SwitzerlandUnion for International Cancer Control (UICC), Geneva, SwitzerlandInstitute of Cancer Policy, Kings College, London, UKEuropean Society of Oncology PharmacistsINTERNATIONAL SURVEY Breast Cancer( adjuvant) Breast Cancer ( metastatic) Lung Cancer Colorectal Cancer Prostate CancerRenal cell CancerGISTMelanoma
Coordinating and CollaboratingPartners Collaborating Project Partners American Society of Clinical Oncology (ASCO) Chinese Society of Clinical Oncology (CSCO) Indian Society for Medical & Pediatric Oncology (ISMPO) Japanese Society of Medical Oncology (JSMO) Korean Association of Clinical Oncology (KACO) Myanmar Oncology Society (MOS) Medical Oncology Group of Australia Incorporated (MOGA) Medical Oncology Society of Peru (SPOM) Middle East Cancer Consortium (MECC)
Example of form :Metastatic BreastCancer
Data reporters ESMO National representatives Known credible professionals nominated by coordinating andcollaborating partners Minimum of 2 reporters for each country nominated Total 439 from 119 countries 185 from 49 European countries, 254 from 70 countries worldwide Respondents 42 oncology pharmacists (22 countries) 147 oncologists 90 Academic cancer centers or hospitals
Response RatesSub Saharan AfricaNorth AfricaMid EastAsia and IndianOcanaN AmericaLatin AM and CarribTotalSurveyedTotalSurveyedCountries Countries percentPop (bil) population 5240%0.3320.332100%45613%0.5620.42375%1734425% 5.7814.48476%
WHO ESSENTIAL MEDICINES LIST 2015Solid Tumors UICC Task Force on EML: UICC, Dana Farber Cancer Institute, ESMO,ASCO, SIOP, US NCI, NCCN International & others New drugs, tumor-specific leomycindocetaxelirinotecananastrozolecalcium tuzumabdacarbazineIfosfamide essentialmedicines/EML2015 8-May-15.pdf
Adjuvant breast cancer:Cost & availability - Tamoxifen
Adjuvant breast cancer: : formulary inclusionand availability : TAMOXIFENAvailabilityAvailabilityFormularyand costto patients Drug shortages affect several essential, old and inexpensive drugs(tamoxifen, doxorubicin, cisplatin, 5-FU, bleomycin ) Not an issue of resources!
Multi-use (WHO) Essential Medicines:Cost & availabilityCisplatin5-FUDoxorubicinCTX (po)
Adjuvant breast cancer: TRASTUZUMABformulary inclusion, cost, preapproval anddelaysFormularyand costto patientsPreapprovalrequiredAvailabilityDelays 4weeks
Metastatic breast cancer(formulary inclusion and cost to patients): Anti-Her2 therapyTrastuzumab
CountryHighMulti-use EMLUpperMiddleFree 25% cost25-50% costDiscount 50% and 100%Full costNot availableMissing sIsraelJapanKorea, SouthOmanQatarSaudi ArabiaSingaporeUnited Arab nLebanonMalaysiaMexicoPeruSouth fghanistanBurkina OST AND AVAILABILITYCyclo (tab) DTICDox.Epir.Etop (IV)5FUIfos.MTX(IV)MTX(tab)VBLVCR
MedicationTrialChemo /HERAtrastuzumabT-DM1 vsEMILIAcapecitabine lapatinibField testing Breast CancerSettingPrimary PFS PFS PFS HROS OSoutcome control gaincontrol gainDFS2 y DFS 8.4%0.5477.4%(0.43-0.67)QoL ESM0MCBS(Neo)AdjuvantHER-2 positivetumors2nd line metastatic PFS & OS 6.4 m 3.20.6525 m 6.80.68Laterafter trastuzumabm (0.55-0.77)m (0.55-0.85) deteriofailurerationTrastuzumab CLEOPATRA 1st line metastatic PFSchemo /pertuzumabLapatinib /- EGF3rd line metastatic PFStrastuzumab 104900Capecitabine Geyer, /- lapatinib 2006OS HR2nd line metastatic PFSafter trastuzumabfailureEribulin vsEMBRACE 3rd line metastatic OSother chemoafter anthracycline& taxanePaclitaxel /- Miller,1st line metastatic PFSbevacizumab 2007Exemestane BOLERO-2 Metastatic afterPFS /- everolimusfailure aromataseinhibitor PFS 6 m12.4 m 6 m0.62 40.8 m 15.70.68(0.52-0.84)m (0.56-0.84) A540.739.5 m 4.50.74(0.57m (0.57-0.97)0.93)4.4 m 4 m0.49NS(0.34-0.71)410.6 m 2.50.81m (0.66-0.99)22m1m5.9 m 5.80.6m (0.51-0.70)4.1 m 6.50.43m (0.36-0.54)3NS 2NS 2
Example of using MCBS data: Breastcancer, RomaniaMedicationSettingChemotherapy /trastuzumabT-DM1 vs lapatinib capecitabineTrastuzumab chemotherapy /pertuzumabLapatinib /trastuzumabCapecitabine /lapatinibEribulin vs otherchemotherapyPaclitaxel /bevacizumab(Neo)adjuvant HER-2positive tumours2nd line metastatic aftertrastuzumab failureExemestane /everolimusPrimaryoutcomeDFSPFS and OSESMOMCBSA51st line metastaticPFS43rd line metastaticPFS42nd line metastatic afterPFStrastuzumab failure3rd line metastatic afterOSanthracycline and taxane3Availability and Preapprovalcost(Barrier toaccess)YesNoNoNoNo1st line metastaticPFS2NoYesMetastatic after failureof aromatase inhibitor(with PFS 6 mth)PFS2No2YesYes
Conclusions Disparities exist across Europe and the world in access tothe WHO essential cancer medicines Drug shortages affect several “essential”, old andinexpensive drugs THIS SHOULD BE UNACCEPTABLE ! Many cheap generic medicines on the WHO EML are onlyavailable at full cost in many low-income countries No/unreliable distribution major barrier The ESMO Magnitude of Benefit Scale, applied on theavailability data (ESMO Antineoplastic MedicinesSurvey) can inform the process of prioritization access tomedicines, when resources are limited
Special AcknowledgmentsProject Leader:Collaborating Partners:European Society for Medical Oncology (ESMO) Coordinating Partners: World Health Organization (WHO)Kings College London Institute of CancerPolicyEuropean Society of Oncology Pharmacy(ESOP) and International Society ofOncology Pharmacy Practitioners (ISOPP)Union for International Cancer Control (UICC) American Society of Clinical Oncology (ASCO)Chinese Society of Clinical Oncology (CSCO)Indian Society for Medical & Pediatric Oncology(ISMPO)Japanese Society of Medical Oncology (JSMO)Korean Association for Clinical Oncology(KACO)Myanmar Oncology Society (MOS)Medical Oncology Group of Australia Incorp.(MOGA)Medical Oncology Society of Peru (SPOM)Middle East Cancer Consortium (MECC)ESMO LogisticsGracemarie Bricalli, Project ManagerNicola Latino, Project Co ManagerTanya Kenny, Project CoordinatorSara Corbino, Survey CoordinatorCollaborators African Organisation for Research and Training inCancer (AORTIC)Latinamerican & Caribbean Society of MedicalOncology (SLACOM)104 individual reporters
N America 5 2 40% 0.332 0.332 100% Latin AM and Carrib 45 6 13% 0.562 0.423 75% 173 44 25% 5.781 4.484 76%. WHO ESSENTIAL MEDICINES LIST 2015 Solid Tumors Cytotoxics Cytotoxics . . (IV) Cyclo (tab) DTIC Dox. Epir. Etop (IV) 5FU Ifos. MTX (IV) MTX (tab) VBL VCR Argentina Australia Canada Ch
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We look forward to working with you on the ESMO Congress 2021, an exciting new edition of the most prestigious oncology meeting created in Europe. On behalf of the ESMO 2021 Officers, Solange Peters, Lausanne, Switzerland ESMO President 2020-2022 Congress President Pasi Jänne, Boston, MA, USA ESMO 2021 Scientific Co-Chair Tony SK Mok, Hong .
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