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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.

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    Authors
    Kandolf, SL
    Guo, J
    Agarwala, S
    Hauschild, A
    McArthur, G
    Cinat, G
    Wainstein, A
    Caglevic, C
    Lorigan, Paul C
    Gogas, H
    Alvarez, M
    Duncombe, Robert
    Lebbe, C
    Peris, K
    Rutkowski, P
    Stratigos, A
    Forsea, AM
    De La Cruz, ML
    Kukushkina, M
    Dummer, R
    Hoeller, C
    Gorry, C
    Bastholt, L
    Herceg, D
    Neyns, B
    Vieira, R
    Arenberger, P
    Bylaite-Bucinskiene, M
    Babovic, N
    Banjin, M
    Putnik, K
    Todorovic, V
    Kirov, K
    Ocvirk, J
    Zhukavets, A
    Ymeri, A
    Stojkovski, I
    Garbe, C
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    Affiliation
    Department of Dermatology, Faculty of Medicine, Military Medical Academy, Belgrade, Serbia
    Issue Date
    2018
    
    Metadata
    Show full item record
    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.
    Citation
    Kandolf SL, Guo J, Agarwala S, Hauschild A, McArthur G, Cinat G, et al. Access to innovative medicines for metastatic melanoma worldwide: Melanoma World Society and European Association of Dermato-oncology survey in 34 countries. Eur J Cancer. 2018 Nov;104:201-9.
    Journal
    European Journal of Cancer
    URI
    http://hdl.handle.net/10541/621416
    DOI
    10.1016/j.ejca.2018.09.013
    PubMed ID
    30388700
    Additional Links
    https://dx.doi.org/10.1016/j.ejca.2018.09.013
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.ejca.2018.09.013
    Scopus Count
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