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Eur J Cancer. 2018 Oct 30;104:201-209. doi: 10.1016/j.ejca.2018.09.013. [Epub ahead of print]

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

Author information

1
Department of Dermatology, Faculty of Medicine, Military Medical Academy, Belgrade, Serbia. Electronic address: lkandolfsekulovic@gmail.com.
2
Department of Urology and Melanoma, Peking University Cancer Hospital & Institute, Beijing, PR China.
3
St. Luke's University Hospital and Temple University, Bethlehem, USA.
4
Department of Dermatology, University Hospital Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.
5
Divisions of Research and Cancer Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, 3000, Australia.
6
Médica Oncóloga Instituto de Oncología Angel Roffo, Universidad de Buenos Aires Fundación CIDEA, Buenos Aires, Argentina.
7
Institute of Post-graduation, Faculdade de Ciências Médicas de Minas Gerais (FCM-MG) - Belo Horizonte (MG), Brazil.
8
Medical Oncology Service, Oncology Department, Clinica Alemana Santiago, Faculty of Medicine Clinica Alemana-Universidad Del Desarrollo, Santiago, Chile.
9
Institute of Cancer Sciences, University of Manchester, The Christie NHS Foundation Trust, Manchester, UK.
10
1(st)Department of Internal Medicine, Laiko Hospital and 1st Department of Dermatology-Venereology, Andreas Sygros Hospital, National and Kapodistrian University of Athens, Athens, Greece.
11
Medico en Instituto Nacional de Cancerologia, Mexico City Area, Mexico.
12
APHP Dermatology Department, University Paris 7 Diderot, INSERM U976, PARIS, France.
13
Institute of Dermatology, Catholic University of the Sacred Heart, Rome, Italy.
14
Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.
15
Carol Davila University of Medicine and Pharmacy, Elias University Hospital Bucharest, Romania.
16
Department of Clinical Oncology, Hospital Universitario Virgen Macarena, Sevilla, Spain.
17
National Cancer Institute, Kiev, Ukraine.
18
UniversitätsSpital Zürich-Skin Cancer Center, University Hospital, Zürich, Switzerland.
19
Department of Dermatology, Medical University of Vienna, Vienna, Austria.
20
National Centre for Pharmacoeconomics, Old Stone Building, Trinity Centre for Health Sciences, St. James's Hospital, Dublin 8, Ireland.
21
Department of Oncology, Odense University Hospital, Denmark.
22
Department of Oncology, University Hospital Zagreb, Croatia.
23
Department of Medical Oncology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel (VUB), Brussels, Belgium.
24
Department of Dermatology, Medical Faculty, University of Coimbra, Portugal.
25
Department of Dermatovenereology, Charles University 3rd Faculty of Medicine and University Hospital Kralovske Vinohrady, Prague, Czech Republic.
26
Department of Dermatology, Vilnius University, Lithuania.
27
Institute of Oncology and Radiology of Serbia, Belgrade, Serbia.
28
Department of Oncology, University Hospital Sarajevo, Bosnia and Herzegovina.
29
North Estonia Medical Centre, Tallinn, Estonia.
30
Clinic for Oncology and Radiotherapy, Podgorica, Montenegro.
31
Clinic of Oncodermatology, National Cancer Center, Sofia, Bulgaria.
32
Institute of Oncology Ljubljana, Ljubljana, Slovenia.
33
Belarusian Medical Academy of Postgraduate Education (BelMAPE), Minsk, Belarus.
34
University Hospital Mother Theresa, Tirana, Albania.
35
University Clinic of Radiotherapy and Oncology, Skopje, Macedonia.
36
Centre for Dermatooncology, Department of Dermatology, Eberhard Karls University, Tuebingen, Germany.

Abstract

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.

KEYWORDS:

Access; Immunooncology; Innovative medicines; Metastatic melanoma; Targeted therapy; Treatment

PMID:
30388700
DOI:
10.1016/j.ejca.2018.09.013

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