Highlights
- •New therapies have dramatically improved the prognosis of metastatic melanoma, but disparities in access to these medicines exist worldwide.
- •BRAFi+MEKi combinations are fully reimbursed in 17 of 34 (50%) countries.
- •Anti-PD1 immunotherapies are fully reimbursed in 17 of 34 (50%) countries.
- •Combination immunotherapy (anti-CTLA4+anti-PD1) is reimbursed in 9 of 34 (26.4%) countries, in 3 countries with restrictions.
- •Patient-oriented research, development, market access and reimbursement mechanisms must be urgently developed.
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
List of abbrevations:
EADO (European Association of Dermato-oncology), MWS (Melanoma World Society), ASCO (American Society of Clinial Oncology), ESMO (European Society for Medical Oncology), NCCN (National Comprehensive Center Network), EORTC (European Organization for Research and Treatment of Cancer), EDF (European dermatology Forum), ASCO NBS 16 (ASCO Framework Net Benefit Score 16), ESMO MCBS (ESMO Magnitude of clinical benefit scale), anti-PD-1 (anti programmed cell death-1), PDL-1 (programmed-cell death ligand-1), GDP (gross domestic product), DALY (disability-adjusted life year)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: October 30, 2018
Accepted:
September 12,
2018
Received:
September 8,
2018
Identification
Copyright
© 2018 Elsevier Ltd. All rights reserved.
