BACKGROUND AND OBJECTIVES: The incidence of melanoma is increasing. This places significant burden on societies to provide efficient cancer care. The European Cancer Organisation recently published the essential requirements for quality melanoma care. The present study is aimed for the first time to roughly estimate the extent to which these requirements have been met in Europe. MATERIALS AND METHODS: A web-based survey of experts from melanoma centres in 27 European countries was conducted from 1 February to 1 August 2019. Data on diagnostic techniques, surgical and medical treatment, organization of cancer care and education were collected and correlated with national health and economic indicators and mortality-to-incidence ratio (MIR) as a surrogate for survival. Univariate linear regression analysis was performed to evaluate the correlations. SPSS software was used. Statistical significance was set at P < 0.05. RESULTS: The MIR was lower in countries with a high health expenditure per capita and with a higher numbers of general practitioners (GPs) and surgeons (SURG) per million inhabitants. In these countries, GPs and dermatologists (DER) were involved in melanoma detection; high percentage of DER used dermatoscopy and were involved in the follow-up of all melanoma stages; both medical oncologists (ONC) and dermato-oncologists administered systemic treatments; and patients had better access to sentinel lymph node biopsy and were treated within multidisciplinary tumour boards. CONCLUSION: Based on these first estimates, the greater involvement of GPs in melanoma detection; the greater involvement of highly trained DER in dermatoscopy, dermatosurgery, follow-up and the systemic treatment of melanoma; and the provision of ongoing dermato-oncology training for pathologists, SURG, DER and ONC are necessary to provide an optimal melanoma care pathway. A comprehensive analysis of the melanoma care pathway based on clinical melanoma registries will be needed to more accurately evaluate these first insights.
- MeSH
- incidence MeSH
- lidé MeSH
- melanom * diagnóza epidemiologie terapie MeSH
- průzkumy a dotazníky MeSH
- výdaje na zdravotnictví MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Evropa 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.
- Klíčová slova
- Access, Immunooncology, Innovative medicines, Metastatic melanoma, Targeted therapy, Treatment,
- 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
- Názvy látek
- léky zkušební MeSH
BACKGROUND: Despite the efficacy of innovative treatments for metastatic melanoma, their high costs has led to disparities in cancer care among different European countries. We analysed the availability of these innovative therapies in Europe and estimated the number of patients without access to first-line recommended treatment per current guidelines of professional entities such as the European Society for Medical Oncology (ESMO), the European Organisation for Research and Treatment of Cancer (EORTC), the European Association of Dermato-Oncology (EADO), and European Dermatology Forum (EDF). MATERIALS AND METHODS: Web-based online survey was conducted in 30 European countries with questions about the treatment schedules from 1st May 2015 to 1st May 2016: number of metastatic melanoma patients, registration and reimbursement of innovative medicines (updated data, as of 1st October 2016), percentage of patients treated and availability of clinical studies and compassionate-use programmes. RESULTS: The recommended BRAF inhibitor (BRAFi) + MEK inhibitor (MEKi) combination was both registered and fully reimbursed in 9/30 (30%) countries, and in 13/30 (43%) (all from Eastern Europe) not reimbursed. First-line immunotherapy with anti-PD1 antibodies was registered and fully reimbursed in 14/30 (47%) countries, while in 13/30 (43%) (all from Eastern Europe) not reimbursed. It was estimated that in Europe 19,600 patients with metastatic melanoma are treated, and 5238 (27%) do not have access to recommended first-line therapy. Significant correlation was found between human development index (HDI, UNDP report 2015), (r = 0.662; p < 0.001), health expenditure per capita (r = 0.695; p < 0.001) and the Mackenbach score of health policy performance (r = 0.765; p < 0.001) with the percentage of patients treated with innovative medicines and a number of reimbursed medicines. CONCLUSIONS: Great discrepancy exists in metastatic melanoma treatment across Europe. It is crucial to increase the awareness of national and European policymakers, oncological societies, melanoma patients' associations and pharma industry.
- Klíčová slova
- Access, Health expenditure per capita, Human development index, Immunooncology, Innovative medicines, Metastatic melanoma, Targeted therapy, Treatment,
- MeSH
- akrylonitril analogy a deriváty ekonomika zásobování a distribuce MeSH
- aniliny ekonomika zásobování a distribuce MeSH
- antigeny CD279 antagonisté a inhibitory MeSH
- dávkové mechanismy statistika a číselné údaje MeSH
- disparity zdravotní péče ekonomika statistika a číselné údaje MeSH
- dostupnost zdravotnických služeb ekonomika statistika a číselné údaje MeSH
- experimentální terapie ekonomika statistika a číselné údaje MeSH
- humanizované monoklonální protilátky ekonomika terapeutické užití MeSH
- imunoterapie ekonomika statistika a číselné údaje MeSH
- lidé MeSH
- melanom ekonomika epidemiologie terapie MeSH
- nádory kůže ekonomika epidemiologie terapie MeSH
- protoonkogenní proteiny B-Raf antagonisté a inhibitory MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Evropa epidemiologie MeSH
- Názvy látek
- akrylonitril MeSH
- aniliny MeSH
- antigeny CD279 MeSH
- BRAF protein, human MeSH Prohlížeč
- humanizované monoklonální protilátky MeSH
- MEK inhibitor I MeSH Prohlížeč
- PDCD1 protein, human MeSH Prohlížeč
- protoonkogenní proteiny B-Raf MeSH
