THE ESMO INTERNATIONAL ANTINEOPLASTIC MEDICINES SURVEY: HOW AVAILABLE ARE THE WHO ESSENTIAL CANCER MEDICINES?
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1 THE ESMO INTERNATIONAL ANTINEOPLASTIC MEDICINES SURVEY: HOW AVAILABLE ARE THE WHO ESSENTIAL CANCER MEDICINES? Alexandru ENIU, MD, PhD Chair, ESMO Global Policy Committee Department of Breast Tumors Cancer Institute Ion Chiricuţă Cluj-Napoca, Romania
2 Disparities in cancer outcomes (survival ) across Europe De Angelis, et al: Cancer survival in Europe by country and age: EUROCARE-5 Lancet Oncol, 2013
3 Factors accounting for cancer outcomes disparities Health system infrastructure (Late) Stage at diagnosis Cancer care infrastructure (priority devices?) General population health and lifestyle Disparities in cancer care Cancer workforce Patient Access & Availability of Cancer Medication
4 ESMO Anti-Neoplastic Medicines Survey Perception survey to map access to cancer medicines, including WHO Essential 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
5 Coordinating & Collaborating Partners Coordinating Organization ESMO Collaborating Project Partners 1. World Health Organization (WHO), Geneva, Switzerland 2. Union for International Cancer Control (UICC), Geneva, Switzerland 3. Institute of Cancer Policy, Kings College, London, UK 4. European Society of Oncology Pharmacists INTERNATIONAL SURVEY Breast Cancer( adjuvant) Breast Cancer ( metastatic) Lung Cancer Colorectal Cancer Prostate Cancer Renal cell Cancer GIST Melanoma
6 Coordinating and Collaborating Partners 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)
7 Example of form :Metastatic Breast Cancer
8 Data reporters ESMO National representatives Known credible professionals nominated by coordinating and collaborating 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
9 Response Rates Total Countries Surveyed Countries percent Total Pop (bil) Surveyed population Percent Sub Saharan Africa % % North Africa % % Mid East % % Asia and Indian % % Ocana % % N America % % Latin AM and Carrib % % % %
10 WHO ESSENTIAL MEDICINES LIST 2015 Solid Tumors UICC Task Force on EML: UICC, Dana Farber Cancer Institute, ESMO, ASCO, SIOP, US NCI, NCCN International & others New drugs, tumor-specific indications Cytotoxics Cytotoxics Cytotoxics Hormones bleomycin docetaxel irinotecan anastrozole calcium folinate doxorubicin methotrexate bicalutamide capecitabine etoposide oxaliplatin dexamethasone carboplatin fluorouracil paclitaxel leuprorelin cisplatin filgrastim rituximab tamoxifen cyclophosphamide gemcitabine trastuzumab dacarbazine Ifosfamide+mesna vinblastine dactinomycin imatinib vincristine vinorelbine
11 Adjuvant breast cancer: Cost & availability - Tamoxifen
12 Adjuvant breast cancer: : formulary inclusion and availability : TAMOXIFEN Availability Formulary and cost to patients Availability Drug shortages affect several essential, old and inexpensive drugs (tamoxifen, doxorubicin, cisplatin, 5-FU, bleomycin ) Not an issue of resources!
13 Multi-use (WHO) Essential Medicines: Cost & availability Cisplatin Doxorubicin 5-FU CTX (po)
14 Adjuvant breast cancer: TRASTUZUMAB formulary inclusion, cost, preapproval and delays Formulary and cost to patients Availability Preapproval required Delays >4 weeks
15 Trastuzumab Metastatic breast cancer (formulary inclusion and cost to patients): Anti-Her2 therapy
16 Multi-use EML Free <25% cost 25-50% cost Discount >50% and <100% Full cost Not available Missing data High Upper Middle Low Middle Low Country Bleo CarboP CisP Argentina Australia Canada Chile Cyprus Israel Japan Korea, South Oman Qatar Saudi Arabia Singapore United Arab Emirates USA Algeria Brazil China Colombia Iran Kazakhstan Lebanon Malaysia Mexico Peru South Africa Thailand Tunisia Turkey Bangladesh Egypt Ghana India Kenya Morocco Pakistan Palestine Sudan Vietnam Zambia Afghanistan Burkina Faso Tanzania Uganda Zimbabwe COST AND AVAILABILITY Cyclo (IV) Cyclo (tab) DTIC Dox. Epir. Etop (IV) 5FU Ifos. MTX (IV) MTX (tab) VBL VCR
17 Field testing Breast Cancer Medication Trial Setting Primary PFS outcome control Chemo +/- HERA (Neo)Adjuvant DFS 2 y DFS trastuzumab HER-2 positive 77.4% T-DM1 vs capecitabine + lapatinib Trastuzumab + chemo +/- pertuzumab Lapatinib +/- trastuzumab Capecitabine +/- lapatinib Eribulin vs other chemo Paclitaxel +/- bevacizumab EMILIA tumors 2 nd line metastatic after trastuzumab failure PFS & OS 6.4 m 3.2 m PFS PFS HR gain 8.4% 0.54 ( ) 0.65 ( ) OS control OS gain 25 m 6.8 m OS HR 0.68 Later ( ) deterio ration CLEOPATRA 1 st line metastatic PFS 12.4 m 6 m m ( ) m ( ) EGF Geyer, rd line metastatic PFS 2 m 1 m 0.73 ( ) 2 nd line metastatic after trastuzumab failure EMBRACE 3 rd line metastatic after anthracycline & taxane Miller, 2007 Exemestane BOLERO-2 Metastatic after +/- everolimus failure aromatase inhibitor+pfs >6 m PFS 4.4 m 4 m 0.49 ( ) 9.5 m 4.5 m OS 10.6 m 2.5 m 1 st line metastatic PFS 5.9 m 5.8 m PFS 4.1 m 6.5 m 0.6 ( ) 0.43 ( ) 0.74 ( ) QoL ESM0 MCBS A 5 ~ 4 4 NS ( ) 2 NS ~ 2 NS ~ 2
18 Medication Chemotherapy +/- trastuzumab T-DM1 vs lapatinib + capecitabine Trastuzumab + chemotherapy +/- pertuzumab Lapatinib +/- trastuzumab Capecitabine +/- lapatinib Eribulin vs other chemotherapy Paclitaxel +/- bevacizumab Exemestane +/- everolimus Example of using MCBS data: Breast cancer, Romania Setting (Neo)adjuvant HER-2 positive tumours 2nd line metastatic after trastuzumab failure Primary outcome ESMO- MCBS Availability and cost Preapproval (Barrier to access) DFS A Yes Yes PFS and OS 5 No No 1st line metastatic PFS 4 3rd line metastatic PFS 4 No 2nd line metastatic after PFS 3 No trastuzumab failure 3rd line metastatic after anthracycline and taxane OS 2 No 1st line metastatic PFS 2 Yes Yes Metastatic after failure of aromatase inhibitor (with PFS > 6 mth) PFS 2 No
19 Conclusions Disparities exist across Europe and the world in access to the WHO essential cancer medicines Drug shortages affect several essential, old and inexpensive drugs THIS SHOULD BE UNACCEPTABLE! Many cheap generic medicines on the WHO EML are only available at full cost in many low-income countries No/unreliable distribution =major barrier The ESMO Magnitude of Benefit Scale, applied on the availability data (ESMO Antineoplastic Medicines Survey) can inform the process of prioritization access to medicines, when resources are limited
20 Special Acknowledgments Project Leader: European Society for Medical Oncology (ESMO) Coordinating Partners: World Health Organization (WHO) Kings College London Institute of Cancer Policy European Society of Oncology Pharmacy (ESOP) and International Society of Oncology Pharmacy Practitioners (ISOPP) Union for International Cancer Control (UICC) ESMO Logistics Gracemarie Bricalli, Project Manager Nicola Latino, Project Co Manager Tanya Kenny, Project Coordinator Sara Corbino, Survey Coordinator Collaborating 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 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) Collaborators African Organisation for Research and Training in Cancer (AORTIC) Latinamerican & Caribbean Society of Medical Oncology (SLACOM) 104 individual reporters
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