One-third of Europeans with metastatic melanoma denied access to innovative drugs
- 70% of metastatic melanoma patients (n=5,000) in Eastern Europe denied access to innovative drugs
- Access to innovative therapies has been granted for 10% of patients in 41% of Eastern and South Eastern European cancer centres
- Reimbursement approval did not necessarily mean access to the treatment
Access to first-line recommended treatment for metastatic melanoma is denied to over 5,000 patients (70%) in Eastern and South-Eastern Europe, highlighting wide inequalities in treatment across the continent, according to figures from a survey of 30 countries.
Metastatic melanoma has seen an increase in approvals for innovative, targeted therapies and immunotherapies. However, the access to these medicines is restricted, especially in Eastern and South-Eastern Europe, where the majority of patients are still treated with palliative chemotherapy that does not prolong overall survival.
“Almost a third (27%, 5,228/19,250 patients) of all metastatic melanoma patients across Europe, do not have access to innovative medicines.” Dr Lidija Kandolf-Sekulovic, Department of Dermatology, Military Medical Academy, Belgrade, Serbia and co-ordinator for the EADO project access to innovative medicines.
“We found wide discrepancies in access across Europe,” remarked Dr Lidija Kandolf-Sekulovic, Department of Dermatology, Military Medical Academy, Belgrade, Serbia and co-ordinator for the European Association of Dermato Oncology (EADO) project access to innovative medicines. “We estimated that over 19,000 patients are treated for the disease in Europe but 40% (7,500) are treated in South-Eastern Europe and around 70% (5,000) of the latter do not have access to the first-line therapy according to European guidelines,” she said.
Effectively, almost a third (27%, 5,228/19,250 patients) of all metastatic melanoma patients across Europe, do not have access to innovative medicines, she emphasised.
This is despite BRAFi+MEKi combination (one of the first-line treatments besides immunotherapy for BRAF mutated metastatic melanoma) being recommended by 2015/2016 European Guidelines (European Society for Medical Oncology (ESMO), and European Organisation for Research and Treatment of Cancer (EORTC/EADO). “3-year overall survival with these drugs is over 40%, and some durable responses last over 5 years,” informed the researcher.
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, stressed Dr Kandolf-Sekulovic.
Striking differences between Western and Eastern Europe
The study aimed to map access to first-line recommended treatments across Europe. A web-based survey was administered to 35 oncology and dermo-oncology centres from May 2015 to May 2016. Questions were asked on reimbursement of innovative drugs, compassionate use and clinical studies for metastatic melanoma.
Striking differences were found between Western and Eastern Europe, with at least 70% of patients treated with innovative medicines in the former, but access to the same medicines was granted to fewer than 10% of patients in 41% of Eastern and South Eastern European cancer centres.
The researchers also found that reimbursement approval did not necessarily mean access, because further restrictions exist. Sometimes only first-line or only second-line therapies are reimbursed or local hospitals restrict use, according to Dr Kandolf-Sekulovic.
Other findings included discrepancies between registration and reimbursement. BRAFi+MEKi combination therapy is registered in 75% and fully reimbursed in 58% of countries of Western Europe, while in Eastern and South-Eastern Europe, it was registered in 42% and reimbursed in 18% of countries. Similarly, first-line immunotherapy with any of the anti-PD-1 antibodies was registered in Western Europe in every country while in Eastern and South-Eastern Europe it was registered in 10/17 (59%), but reimbursed in 4/17 (23.5%) countries.
Dr Kandolf-Sekulovic pointed out that there was an increasing number of innovative drugs being approved but also an increasing cost per unit, “and this cost is high.” Healthcare systems across Europe all claim universal healthcare access but this is dependent on socio-economic factors, which are poor in South-Eastern Europe and healthcare systems struggle to cope. “We need to see activity at the national level, European level and with industry to overcome these inequalities.”
Plans to tackle this situation include those of the European Health Assessment Technology Group, which is trying to facilitate the economic pricing of these innovative drugs to expedite reimbursement, she said. Furthermore, pricing is not unified and reimbursement is conducted on a national level. “A European Commission recommendation for lists of drugs will help national level decisions about use of these drugs in the future.”
The melanoma specialist also pointed out the importance of industry facilitating market access to new drugs, and also true access to innovative medicines. In particular, the numerous expanded access programs that provide early access, but true access (required after registration) and associated reimbursement is delayed.
Based on Kandolf Sekulovic L, Peris K et al. More than 5000 patients with metastatic melanoma in Europe per year do not have access to new life-saving drugs (1389O_PR). Presented on Monday 10 October 2016.
[button link=“https://medonline.at/infocenter-esmo/“ color=“blue“ target=“blank“ size=“large“]<< Back to Infocenter ESMO 2016[/button]