[Ip-health] ESMO 2016 Press Release: Thousands of melanoma patients in Europe have no access to new life saving drugs | ESMO

Ophira Ginsburg ophiraginsburg at gmail.com
Fri Oct 7 11:35:19 PDT 2016


http://www.esmo.org/Conferences/ESMO-2016-Congress/Press-Media/
Thousands-of-melanoma-patients-in-Europe-have-no-access-to-new-life-saving-
drugs

ESMO 2016 Press Release: Thousands of melanoma patients in Europe have no
access to new life saving drugs

Date: 07 Oct 2016
Topic: Melanoma
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.

- END-

Notes to Editors

References

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.

Disclaimer

This press release contains information provided by the authors of the
highlighted abstracts and reflects the content of those abstracts. It does
not necessarily reflect the views or opinions of ESMO and ESMO cannot be
held responsible for the accuracy of the data. ESMO spokespeople quoted in
the press release are required to comply with the ESMO Declaration of
Interests policy and the ESMO Code of Conduct.

About the European Society for Medical Oncology

ESMO is the leading professional organisation for medical oncology.
Comprising more than 13,000 oncology professionals from over 130 countries,
we are the society of reference for oncology education and information. We
are committed to supporting our members to develop and advance in a
fast-evolving professional environment.

Founded in 1975, ESMO has European roots and a global reach: we welcome
oncology professionals from around the world. We are a home for all
oncology stakeholders, connecting professionals with diverse expertise and
experience. Our educational and information resources support an
integrated, multi-professional approach to cancer treatment. We seek to
erase boundaries in cancer care as we pursue our mission across oncology,
worldwide.

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



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