Many Europeans Lack Access To New Medications For Metastatic Melanoma Interview with:

Prof. dr Lidija Kandolf Sekulovi

Prof. Kandolf

Prof. dr Lidija Kandolf Sekulovic MD, PhD
EADO project access to innovative medicines coordinator
Interdisciplinary Melanoma team, Department of Dermatology
Medical Faculty, Military Medical Academy
Belgrade, Serbia What made you set out to organize this survey?

Response: Before 2011 there were no effective treatment options for metastatic melanoma patients, but that have tremendously changed in the last 5 years. Now we have innovative medicines which are able to prolong overall survival of these patients to more than 18 months, and in some patients, durable responses lasting for up to 10 years are not infrequently reported. However, the access to these medicines is restricted, and patients and physicians are facing more and more difficulties to obtain them. This is especially the case for countries of Eastern and South-Eastern Europe, where majority of patients are still treated with palliative chemotherapy that does not prolong overall survival. We wanted to explore this issue more deeply, to map the access to innovative medicines between 1st May 2015 to 1st May 2016, and particularly the access to first-line treatment recommended by ESMO and EDF/EORTC/EADO guidelines that are based on scientific evidence and which are published in 2015 and 2016. What is the impact/burden of melanoma in Europe (incidence/mortality)?

Response: Incidence of melanoma in white race is rising during the last decades, and in Europe it ranges from 19,2/100,000 in Northern Europe to 2,2/100,000 in Greece. Mortality rates of 1,5/100,000 are similar in Western and Eastern Europe, although in recent studies a rise in mortality rates up to 4/100,000 was found in E/SE countries. This could be due to the inefficient primary and secondary prevention, but probably, or at least partly, due to the restricted access to innovative medicines, but this should be further explored in future studies. Also, what is also important is a dramatic rise in incidence of melanoma in white population, due to still inadequate primary prevention of disease. Based on recently presented data from Germany (presented by prof. Garbe at EADO Congress in Vienna), a 6-fold increase is evident during the last 43 years, and from 1999-2012 recorded increase is 78%. Similar increases were recorded also in United States, Australia, Norway and Denmark, as well as countries of South-Eastern Europe. It is extrapolated that the number of new melanoma cases in Germany will increase from 20000 in 2010 to 34400 in 2030. Thus, a burden of disease will also increase, if more effective prevention strategies are not developed.

Based on the data from our survey, it can be 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 the European guidelines (ESMO, EORTC/EADO). Overall, it can be estimated that in Europe 5.228/19.250 (27%), i.e. almost third of all metastatic melanoma patients do not have access to innovative medicines. Although the incidence of metastatic melanoma is lower in comparison to other metastatic cancers, the burden of this disease comes from the fact that it is chemotherapy resistant, and survival of patients is directly correlated to access to innovative medicines What do you think is stopping authorities from giving access to innovative drugs?

Response: Several factors led to this situation. The costs of healthcare are rising during decades, and particularly in the last 10 years in the era of innovative technologies and innovative drugs. Healthcare systems in Eastern and South-Eastern Europe have difficulties in implementing innovation, largely because of socioeconomic factors, particularly healthcare expenditure. However, based on our survey, there are countries with the equal healthcare expenditure that differ in the access to innovative medicines due to the inadequate efficiency of healthcare systems and inappropriate allocation of resources. For example, Hungary, Poland, Slovenia and Czech Republic have almost adequate access to innovative medicines, with some restrictions and time-consuming administrative procedures, but in other countries, especially countries of South-Eastern Europe, reimbursement is in significant delay. Even here there are countries like Bulgaria where these delays are shorter, and in contrast, my country, where innovative medicines are still not reimbursed although efforts of authorities are underway to overcome this situation by the end of this year. Better adaptation of national healthcare systems to the current situation, better allocation of resources, harmonization of legislative regarding import of unregistered medicines, medicines in compassionate-use programs and faster initiation of clinical trials is needed to obtain earlier access to the innovative medicines in our countries not only for metastatic melanoma but also for other cancers.

From European perspective, registration of medicines is common through European Medicine Agency, but delays in pricing and reimbursement varies between EU countries. After 2012 EC Transparency Directive 89/105/EEC that mandated no more than 120 days of delay for national pricing and reimbursement decisions, improvements were registered in some countries of Western and Eastern Europe (like Netherlands, Poland and Hungary). However, since then in other countries significant delays emerged in correlation to affordability of new medicines for national healthcare systems. These delays were caused by the introduction of different additional formal scrutiny (e.g. cost-effectiveness analysis, medico-economic evaluations, restriction in indications which are not scientifically based, implementation of procedures for individual application for medicines which are time-consuming, etc.) from Health technology assessment agencies or Health insurance fund bodies leading to restricted access. Currently there are efforts for harmonization of this step of the process, through EU Health Technology Assessment (EU HTA) group, and this effort could lead to harmonization of pricing until 2019. Also, ESMO is developing magnitude of benefit scales that will aid in assessing the true clinical benefit of every new health technology including medicines. But will it shorten the time to reimbursement is completely another issue. This process is organized under national healthcare systems and at this point most significant delays occur, which are in correlation with national healthcare expenditure, healthcare system efficiency, costs of treatment – i.e. affordability of innovation.

In addition, WHO is developing list of essential medicines for cancer, where melanoma is included for the first time and in our view, innovative treatments must be included in this list.

The cost of medicines is rising in the era of innovation, and more sustainable pricing would also contribute in resolving of this issue. For example, while pricing include some kind of governmental control in European countries during the reimbursement process, this is not the situation in the United States. Industry should also make necessary adjustments in order to ensure fluent research, development and market access of new drugs, but also true access to innovative medicines for patients. For example, pharmaceutical companies have numerous expanded access programs aiming to provide early access, but they are active until the registration of the medicines in EMA, but true access, i.e. reimbursement is in delay and at the date of registration access is stopped in these countries. In dialogue with pharmaceutical companies scheduled here at ESMO, we are aiming to develop an adapted program for early access but also for gaining the real-world data on efficacy and safety of new medicines. It is in their principal interest to develop new markets. What specific messages would you like to send to pharma, policy makers medical societies and patient associations?

Response: As practicing oncologists, in our everyday practice we see patients with metastatic melanoma without a possibility for treatment with innovative drugs. This is an everyday situation in E/SE Europe and a source of large frustration for patients, their families and physicians. But this is also situation oncologists from Western Europe are facing every day when they are contacted by the patients and their families from E/SE Europe asking for treatment that they cannot provide due to the national health insurance restrictions. With this joint project of EADO and ESMO as a leading European oncology organization, we are here to raise the awareness about this problem. Through dialogue with other oncological organizations, WHO expert committee on essential cancer medicines, patients’ advocacy organizations, EU and national policy makers and pharma industry representatives this problem could be solved in the future. Harmonization of reimbursement procedures throughout Europe, adjusted programs for early access to innovative medicines for countries with delayed reimbursement and adjustments of national health systems are needed, and constant efforts will be necessary to achieve this goal in the future. Thank you for your contribution to the community.


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.

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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