LUGANO-COPENHAGEN – Over 5000 patients with metastatic melanoma in Europe are denied access to new, life saving drugs every year, according to a survey presented at the ESMO 2016 Congress in Copenhagen.
Metastatic melanoma is an aggressive and deadly skin cancer. With innovative targeted therapy and immunotherapy, patients can survive for many years. Unfortunately new therapies are expensive so, according to a survey conducted by Dr Lidija Kandolf-Sekulovic, over 5000 patients with metastatic melanoma in Europe have no access to these drugs.
“Before 2011 there were no effective treatment options for metastatic melanoma patients, but that has changed tremendously in the last 5 years. We now have medicines which can prolong overall survival of these patients to more than 18 months and, in some patients, durable responses lasting up to 10 years have been reported. However, access to these medicines is limited and patients and physicians are facing increasing difficulties to obtain them. This is especially the case for Eastern and South Eastern European countries, where a majority of patients are still treated with palliative chemotherapy that does not prolong overall survival,” said Kandolf-Sekulovic.
The survey showed that in Western Europe 70% of patients were treated with innovative medicines, while in Eastern Europe less than 10% of patients had access to the latest treatment recommended by current European Guidelines (ESMO, EORTC/EADO) (2).
The study found that the BRAFi+MEKi combination (one of the first-line treatments besides immunotherapy for BRAF mutated metastatic melanoma) was registered in 75% of Western European countries and fully reimbursed in 58%. In Eastern Europe, the treatment was registered in 42% of countries and only reimbursed in 18%, with time consuming administrative work needed to obtain the medicines in all cases.
The survey estimated that around 19.250 metastatic melanoma patients are treated every year in Europe and nearly 7.450 (39.7%) in Eastern and South-Eastern Europe. Of these patients, 5.128 (69%) do not have the access to first-line therapy according to European guidelines. Overall, it can be estimated that in Europe 5.228/19.250 (27%), i.e. almost one third of all metastatic melanoma patients, do not have access to innovative medicines.
In Europe, about 1 in every 100 people will develop melanoma at some point in their life, but important variations exist from one country to another. This number is increasing in almost all European countries. Melanoma is slightly more frequent in females than in males and more frequent in Switzerland, the Netherlands and the Scandinavian countries (Norway, Sweden and Denmark), where about 20 out of 100,000 people are diagnosed each year. From 1999-2012 there has been a 78% recorded increase in Germany. Similar increases were recorded also in the United States, Australia, Norway and Denmark, as well as countries in South-Eastern Europe.
Kandolf-Sekulovic explained: “Our study raises ethical questions on the inequalities that affect survival based on the country of residence in Europe. It is not new that disparities in healthcare can lead to disparities in overall survival of patients, but these disparities are becoming even sharper for patients with chemotherapy resistant metastatic melanoma in whom durable responses lasting for years can be seen in up to 20% of patients if treated with innovative medicines. In European healthcare systems that declare universal access to healthcare, these inequalities must be overcome.”
Dr Alexander Eniu, Chair of the ESMO Global Policy Committee, said: “This study confirms what ESMO has highlighted in the past: access to the best treatment according to evidence based clinical guidelines such as ESMO’s, is not equal across Europe. ESMO advocates for equal access to treatment and care, which is the fundamental right of any patient. Despite the encouraging rate of new medicine development, there are still unacceptable inequalities in the availability and accessibility of new and effective cancer medications across Europe.”
“The present study focuses on melanoma but the ESMO-led European Consortium Study on the availability and accessibility of anti-neoplastic medicines across Europe (3) found that the same was true for other types of cancer, especially rare cancers, in countries with lower economic levels. It is important to continue to provide health authorities with data, and to carry on calling attention to the difficulties patients with incurable diseases are facing, in the hope that equal access will soon be a reality, at least in Europe,” said Eniu.
“This every day situation which is source of a large frustration for metastatic melanoma patients, their families and physicians, needs to be adressed urgently by all stakeholders. We need harmonisation of reimbursement procedures throughout Europe, adjusted programmes for early access to innovative medicines in countries with delayed reimbursement and sustainable pricing for these life saving drugs,” concluded Kandolf-Sekulovic.
Notes to Editors
- Abstract 1389O_PR “More than 5000 patients with metastatic melanoma in Europe per year do not have access to the new life-saving drugs” will be presented by Dr Lidija Kandolf-Sekulovic during the Proffered Paper Session, Public Health and Health Economics on 10 October 2016, 16:30 to 18:00 (CEST) in Room Oslo.
- Diagnosis and treatment of melanoma. European consensus-based interdisciplinary guideline e Update 2016
- ESMO European Consortium Study on the availability, out-of-pocket costs and accessibility of antineoplastic medicines in EuropeAnn Oncol (2016) 27 (8): 1423-1443. doi:10.1093/annonc/mdw213
ESMO’s study on the availability of cancer drugs with data from 46 European countries, found substantial differences in the availability and accessibility to the best available treatments cancers. These differences were more profound in Eastern Europe countries and largely concerned new agent developed and licensed in the past 10 years.
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Abstract for 1389O_PR
More than 5000 patients with metastatic melanoma in Europe per year do not have access to the new life-saving drugs
L. Kandolf Sekulovic1, K. Peris2, A. Hauschild3, L.V. Demidov4, P. Nathan5, C. Lebbe6, C. Hoeller7, C. Blank8, J. Olah9, H. Gogas10, R. Dummer11, L. Bastholt12, D. Herceg13, A. Stratigos14, B. Neyns15, J. Hansson16, P. Rutkowski17, A.-M. Forsea18, I. Krajsová19, C. Garbe20 *
1. Department of Dermatology, Interdisciplinary Melanoma Team, Military Medical Academy, Medical Faculty, Belgrade, Serbia, 2. Dermatology, Catholic University of the Sacred Heart, Rome, Italy, 3. Department of Dermatology, University Hospital Schleswig-Holstein, Kiel, Germany, 4. Tumor biotherapy, N. N. Blokhin Russian Cancer Research Center, Moscow, Russian Federation, 5. Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood, UK, 6. APHP Service de Dermatologie, INSERM U976 Hôpital Saint Louis, Paris, France, 7. Dpt. of Dermatology and Dermatooncology, Medizinische Universitaet Wien (Medical University of Vienna), Vienna, Austria, 8. Medical Oncology, The Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands, 9. Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary, 10. Medical Oncology, Laikon General Hospital, National and Kapodistrian University of Athens, Athens, Greece, 11. Department of Dermatology, Universitätsspital Zürich, Zurich, Switzerland, 12. Dept. of Oncology, Odense University Hospital, Odense C, Denmark, 13. Clinic of Oncology, School of Medicine University Zagreb University Hospital Center Zagreb, Zagreb, Croatia, 14. Dermatology, National and Kapodistrian University of Athens, Athens, Greece, 15. Oncology, UZ Brussel, Brussels, Belgium, 16. Department of Oncology-Pathology, Karolinska University Hospital, Stockholm, Sweden, 17. Soft Tissue/Bone Sarcoma and Melanoma, MSC Memorial Cancer Centre and Institute Maria Sklodowska-Curie, Warsaw, Poland, 18. Dermatology, Universitatea de Medinina si Farmacie Carol Davila, Bucharest, Romania, 19. Department of Dermato-Oncology, VFN a 1. LF UK Praha, Prague, Czech Republic, 20. Deptartment of Dermatology, University Hospital Tuebingen, Tübingen, Germany
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 analyzed the availability of these innovative therapies in Europe, and estimated the number of patients without access to first-line recommended treatment per current (ESMO, EORTC/EADO) guidelines.
Methods: Web-based online survey was conducted in 34 oncology centers from 29 European countries with questions about the treatment schedules from 1st May 2015-1st May 2016: number of metastatic melanoma patients, percentage of patients treated with any of the new agents, data on registration and reimbursement of innovative medicines and availability of clinical studies for stage IV disease. Descriptive statistics were used to analyze the data.
Results: In Western European countries at least 70% of patients were treated with innovative medicines, while in 41% of centers from Eastern and SE Europe less than 10% of patients had an access. Recommended first-line therapy for BRAF mutated metastatic melanoma, BRAFi+MEKi combination was registered in 75% and fully reimbursed in 58% countries of Western Europe, while in Eastern and SE Europe it was registered in 42% and reimbursed in 3/17 (18%) countries. First-line immunotherapy with any of the anti-PD1 antibodies was registered in Western Europe in every country while in Eastern and SE Europe it was registered in 10/17 (59%), but reimbursed in 4/17 (23.5%) countries. Based on estimated total number of metastatic melanoma patients and percentage of patients treated with innovative therapies, it can be estimated that at least 5000 of patients in Eastern and South-Eastern Europe do not have access to innovative treatments for metastatic melanoma.
Conclusions: Great discrepancy exists in metastatic melanoma treatment across Europe. It is crucial to increase the awareness of national and European policy makers, oncological societies, melanoma patient associations and pharma industry.
*Additional contributors: Bylaite-Bucinskiene M, Zalaudek I, Maric-Brozic J, Vieira R, Babovic N, Kukushkina M, Banjin M, Putnik K, Weinlich G, Todorovic V, Kirov K, Risteski M, Ocvirk J, Ymeri A, Zhukavets A.
Legal entity responsible for the study: European Association of Dermatooncology
Funding: European Association of Dermatooncology, but no funding was needed for the study
Disclosure: All authors have declared no conflicts of interest.
Keywords: melanoma, treatment access, disparities, European