No Access to Novel Drugs for Many European Melanoma Patients

Liam Davenport

October 07, 2016

COPENHAGEN — Almost 70% of metastatic melanoma patients in Eastern and Southeastern Europe do not have access to the latest, most innovative drugs to treat the disease, reveals a Europe-wide survey.

The survey, which collected data from 30 countries, will be presented here at the European Society for Medical Oncology (ESMO) Congress.

The results show that more than 5000 patients across Europe do not have access to the latest drugs for melanoma, including agents targeting BRAF mutations and novel immunotherapeutics, and that there is a huge disparity between Western and Eastern Europe.

This study "raises ethical questions," said lead researcher Lidija Kandolf-Sekulovic, MD, PhD, Department of Dermatology, Interdisciplinary Melanoma Team, Military Medical Academy, Medical Faculty, Belgrade, Serbia.

"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," she added in a press statement.

Noting that treatment with the latest medications can lead to responses lasting several years in up to 20% of patients, Dr Kandolf-Sekulovic said: "In European healthcare systems that declare universal access to healthcare, these inequalities must be overcome."

Commenting on the findings, Alexandru Eniu, MD, PhD, from Cancer Institute Ion Chiricuta," in Cluj-Napoca, Romania, and chair of the ESMO Global Policy Committee, described equal access to treatment and care as a "fundamental right."

He said: "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."

He noted that the current findings for the treatment of melanoma echo those of a recent European Consortium study on the availability and accessibility of antineoplastic medicines across Europe.

As reported by Medscape Medical News, this survey revealed huge disparities across Europe in the availability and out-of-pocket costs of anticancer drugs used in the treatment of some of the most common cancers, including lung cancer, colorectal cancer, and metastatic breast cancer.

Dr Eniu said: "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.

"This everyday situation, which is source of a large frustration for metastatic melanoma patients, their families, and physicians, needs to be addressed urgently by all stakeholders."

Study Details

Approximately 1 in 100 individuals in Europe will develop melanoma during their lifetime. Although the disease is more common in Switzerland, the Netherlands, and in Scandinavian countries, in recent years, there have been marked increases in the incidence of melanoma in Germany, Australia, Norway, Denmark, and in Southeastern Europe.

The latest drugs to treat metastatic melanoma have been shown to be effective and, in some patients, offer durable responses, but their high costs have led to disparities in cancer care in Europe. This is despite the recent publication of an updated consensus-based interdisciplinary guideline on the diagnosis and treatment of melanoma by three leading European organizations.

To determine the availability of the latest metastatic melanoma therapies across Europe and the number patients who do not have access to guideline-recommended first-line treatment, the researchers conducted a webbased online survey of 35 oncology centers in 30 European countries.

Between May 2015 and May 2016, the centers were sent questions on the number of patients with metastatic melanoma, the percentage of patients treated with the latest drugs, registration and reimbursement data, and information on clinical studies for stage IV disease.

Although within European regions there were disparities between individual countries, there was a stark difference between Western Europe and Eastern and Southeastern Europe in the proportion of patients who were treated with innovative medicines, at 70% vs fewer than 10% of patients.

The picture was similar for the registration and reimbursement of medications. For example, the BRAFi+MEKi drug combination, which is used as a first-line treatment for BRAF-mutated metastatic melanoma, was registered in 75% of Western European countries and fully reimbursed in 58% of countries. This compared with 42% and 18%, respectively, of Eastern European studies.

Moreover, first-line anti-PD1 antibody therapies were registered in every Western European country. In Eastern and Southeastern European countries, however, the treatments were registered in 59% of countries and were reimbursed in just 24%.

Examining the number of metastatic melanoma patients who did not have access to the latest medications, the researchers determined that there were 19,250 patients across Europe with the condition, of whom 7450 (39.7%) were treated in Eastern and Southeastern Europe.

Of those 7450 patients, the team estimated that 5128 (69%) do not have access to first-line therapy, as recommended in the latest European guidelines, yielding a total of 5288 (27%) of patients across all European regions who do not have access to the latest medications for metastatic melanoma.

At a press briefing today, Dr Kandolf-Sekulovic said that drug access "is an emerging problem for the patients, for their families, and also for their physicians, not only for physicians from Eastern but also from Western Europe, because many patients are...trying to gain access [to the drugs], and it is not possible."

She continued: "So this is something that should be addressed by the oncology organizations, and ESMO is one of the main oncology organizations, together with European Association of Dermato Oncology, that can maybe initiate some solutions to this problem."

Josep Tabernero, MD, PhD, from Vall d'Hebron University Hospital, Barcelona, Spain, and president elect of ESMO, commented that problems of access are not confined only to one region of Europe, nor is access limited only with regard to the latest and most innovative medications.

Referring to the previous ESMO survey, he said that, in addition to the "very big" difference in the availability and out-of-pocket costs of drugs between Eastern and Western Europoean countries, there were major differences within Western countries that were often seen in patients with rare, incurable diseases.

He added: "This is not only related to what we call the expensive, innovative cancer drugs but also to those drugs that we call essential, and usually they are not so much expensive but [the lack of availability] is just for shortage reasons and other reasons."

The study was overseen by the European Association of Dermato Oncology, but no funding was needed. The researchers have disclosed no relevant financial relationships.

European Society for Medical Oncology (ESMO) Congress. Abstract 1389O_PR. To be presented October 10, 2016.


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