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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
L. Kandolf Sekulovic, J. Guo, S. Agarwala, A. Hauschild, G. McArthur, G. Cinat, A. Wainstein, C. Caglevic, P. Lorigan, H. Gogas, M. Alvarez, R. Duncombe, C. Lebbe, K. Peris, P. Rutkowski, A. Stratigos, AM. Forsea, L. De La Cruz Merino, M....
Jazyk angličtina Země Velká Británie
Typ dokumentu časopisecké články, multicentrická studie
- MeSH
- compassionate use trials MeSH
- dávkové mechanismy MeSH
- dodržování směrnic MeSH
- hrubý domácí produkt MeSH
- klinické zkoušky jako téma statistika a číselné údaje MeSH
- koupě zacílená na zvýšení kvality a hodnoty péče MeSH
- léky zkušební ekonomika zásobování a distribuce terapeutické užití MeSH
- lidé MeSH
- melanom farmakoterapie ekonomika epidemiologie sekundární MeSH
- náklady na léky MeSH
- předpisy - poplatky MeSH
- průzkumy a dotazníky MeSH
- směrnice pro lékařskou praxi jako téma MeSH
- socioekonomické faktory MeSH
- vývoj člověka MeSH
- zdravotní priority MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- Geografické názvy
- Evropa MeSH
- Latinská Amerika MeSH
- Rusko MeSH
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 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 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
Medico en Instituto Nacional de Cancerologia Mexico City Area Mexico
National Cancer Institute Kiev Ukraine
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
Citace poskytuje Crossref.org
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