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Access to innovative medicines for metastatic melanoma worldwide: Melanoma World Society and European Association of Dermato-oncology survey in 34 countries

. 2018 Nov ; 104 () : 201-209. [epub] 20181031

Language English Country England, Great Britain Media print-electronic

Document type Journal Article, Multicenter Study

Links

PubMed 30388700
DOI 10.1016/j.ejca.2018.09.013
PII: S0959-8049(18)31383-2
Knihovny.cz E-resources

According to data from recent studies from Europe, a large percentage of patients have restricted access to innovative medicines for metastatic melanoma. Melanoma World Society and European Association of Dermato-oncology conducted a Web-based survey on access to first-line recommended treatments for metastatic melanoma by current guidelines (National Comprehensive Center Network, European Society for Medical Oncology [ESMO] and European Organization for Research and Treatment of Cancer/European Association of Dermato-oncology/European dermatology Forum) among melanoma experts from 27 European countries, USA, China, Australia, Argentina, Brazil, Chile and Mexico from September 1st, 2017 to July 1st, 2018. Data on licencing and reimbursement of medicines and the number of patient treated were correlated with the data on health expenditure per capita (HEPC), Mackenbach score of health policy performance, health technology assessment (HTA), ASCO and ESMO Magnitude of clinical benefit scale (ESMO MCBS) scores of clinical benefit and market price of medicines. Regression analysis for evaluation of correlation between the parameters was carried out using SPSS software. The estimated number of patients without access in surveyed countries was 13768. The recommended BRAFi + MEKi combination and anti-PD1 immunotherapy were fully reimbursed/covered in 19 of 34 (55.8%) and 17 of 34 (50%) countries, and combination anti-CTLA4+anti-PD1 in was fully covered in 6 of 34 (17.6%) countries. Median delay in reimbursement was 991 days, and it was in significant correlation with ESMO MCBS (p = 0.02), median market price (p = 0.001), HEPC and Mackenbach scores (p < 0.01). Price negotiations or managed entry agreements (MEAs) with national authorities were necessary for reimbursement. In conclusion, great discrepancy exists in metastatic melanoma treatment globally. Access to innovative medicines is in correlation with economic parameters as well as with healthcare system performance parameters. Patient-oriented drug development, market access and reimbursement pathways must be urgently found.

APHP Dermatology Department University Paris 7 Diderot INSERM U976 PARIS France

Belarusian Medical Academy of Postgraduate Education Minsk Belarus

Carol Davila University of Medicine and Pharmacy Elias University Hospital Bucharest Romania

Centre for Dermatooncology Department of Dermatology Eberhard Karls University Tuebingen Germany

Clinic for Oncology and Radiotherapy Podgorica Montenegro

Clinic of Oncodermatology National Cancer Center Sofia Bulgaria

Department of Clinical Oncology Hospital Universitario Virgen Macarena Sevilla Spain

Department of Dermatology Faculty of Medicine Military Medical Academy Belgrade Serbia

Department of Dermatology Medical Faculty University of Coimbra Portugal

Department of Dermatology Medical University of Vienna Vienna Austria

Department of Dermatology University Hospital Schleswig Holstein Campus Kiel Kiel Germany

Department of Dermatology Vilnius University Lithuania

Department of Dermatovenereology Charles University 3rd Faculty of Medicine and University Hospital Kralovske Vinohrady Prague Czech Republic

Department of Internal Medicine Laiko Hospital and 1st Department of Dermatology Venereology Andreas Sygros Hospital National and Kapodistrian University of Athens Athens Greece

Department of Medical Oncology Universitair Ziekenhuis Brussel Vrije Universiteit Brussel Brussels Belgium

Department of Oncology Odense University Hospital Denmark

Department of Oncology University Hospital Sarajevo Bosnia and Herzegovina

Department of Oncology University Hospital Zagreb Croatia

Department of Urology and Melanoma Peking University Cancer Hospital and Institute Beijing PR China

Divisions of Research and Cancer Medicine Peter MacCallum Cancer Centre Melbourne VIC 3000 Australia

Institute of Cancer Sciences University of Manchester The Christie NHS Foundation Trust Manchester UK

Institute of Dermatology Catholic University of the Sacred Heart Rome Italy

Institute of Oncology and Radiology of Serbia Belgrade Serbia

Institute of Oncology Ljubljana Ljubljana Slovenia

Institute of Post graduation Faculdade de Ciências Médicas de Minas Gerais Brazil

Maria Sklodowska Curie Institute Oncology Center Warsaw Poland

Médica Oncóloga Instituto de Oncología Angel Roffo Universidad de Buenos Aires Fundación CIDEA Buenos Aires Argentina

Medical Oncology Service Oncology Department Clinica Alemana Santiago Faculty of Medicine Clinica Alemana Universidad Del Desarrollo Santiago Chile

Medico en Instituto Nacional de Cancerologia Mexico City Area Mexico

National Cancer Institute Kiev Ukraine

National Centre for Pharmacoeconomics Old Stone Building Trinity Centre for Health Sciences St James's Hospital Dublin 8 Ireland

North Estonia Medical Centre Tallinn Estonia

St Luke's University Hospital and Temple University Bethlehem USA

UniversitätsSpital Zürich Skin Cancer Center University Hospital Zürich Switzerland

University Clinic of Radiotherapy and Oncology Skopje Macedonia

University Hospital Mother Theresa Tirana Albania

References provided by Crossref.org

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