For over 20 years, there has been no effective therapy for patients with advanced melanoma. The breakthrough came with the discovery of two new drugs – ipilimumab and vemurafenib. Both have already been registered, but patients in Poland do not have access to them.
The first in Europe to be registered ipilimumab – a human, recombinant monoclonal antibody blocking CTLA-4 antigen on the surface of T lymphocytes. Blocking the CTLA-4 receptor increases their activity, stimulating the immune system to fight cancer cells. In July 2011, this preparation was registered by the European Commission for use in the European Union in the treatment of previously treated advanced melanoma – inoperable or metastatic. A few months earlier, it was registered by the US Food and Drug Administration (FDA).
In February this year. The European Medicines Agency (EMA) has approved vemurafenib, an oral drug that works by blocking an abnormal protein encoded by a mutant BRAF gene. A mutation of this gene occurs in approx. 60 percent. patients diagnosed with melanoma. Vemurafenib therapy may inhibit tumor growth. Clinical studies show that this happens in 90%. cases.
– After many years of our helplessness in the fight against disseminated melanoma, we have had exciting new therapies that give us, oncologists, new weapons, and our patients – chances for a longer life – says Prof. Piotr Rutkowski, head of the Department of Tumors of Soft Tissues, Bones and Melanomas of the Oncology Center in Warsaw.
They could live longer
The average life expectancy of a patient with advanced melanoma, that is, one that already has metastases (to the lymph nodes, lungs, brain, liver, bones), is only six months. Only every fourth patient manages to survive a year, and every tenth – two years. Modern treatment is able to double the survival time. Unfortunately, Polish patients cannot use it because it is not reimbursed.
Theoretically, until the drug program is introduced, patients should have access to ipilimumab treatment under the so-called custom chemotherapy. However, in practice, all applications for financing the therapy with this drug, which were issued for patients by oncologists, were refused by the National Health Fund. It happened that the National Health Fund refused consent even four times.
– Therapy with this drug requires approximately 250-300 patients in Poland, and only 40 applications were issued. Despite this, none of them received a positive opinion – says prof. Krzysztof Krzemieniecki, Małopolska Voivodship Consultant for Clinical Oncology.
The provincial branches of the National Health Fund usually excused themselves with the lack of a positive assessment of the Health Technology Assessment Agency or raised the financial aspect (the cost of ipilimumab therapy is about PLN 300).
However, there is a chance that new applications will be approved. At the end of April, the Transparency Council of the Agency for Health Technology Assessment took a position on ipilimumab. In the opinion of the Council, this is the first effective treatment for advanced melanoma and should be financed under non-standard chemotherapy until a drug program is established, the condition of which is to reduce its costs by two-thirds.
In the case of vemurafenib, only treatment under the drug program can be considered, because according to the Act on the reimbursement of drugs, foodstuffs for particular nutritional uses and medical devices, in force since the beginning of this year, until the reimbursement procedure is completed, patients cannot be treated with drugs registered after January 1 2012. Such proceedings last up to 180 days, but it is possible to extend it up to 240 days. – In practice, taking into account the time needed for contracting services by the payer and the purchase of a drug through a tender, the time to implement therapy in a patient may be much longer – the manufacturer of verafenib, which is trying to introduce a drug program, informed us.
Late diagnosis
Meanwhile, more and more young people suffer from melanoma. According to prof. Piotr Rutkowski, head of the Department of Tumors of Soft Tissues, Bones and Melanomas of the Oncology Center-Institute. Maria Skłodowsiej-Curie in Warsaw, it is the result of a change in our lifestyle. We go on vacation, where we often sunbathe without filters and protective clothing and use sunbeds, exposing our skin to increasing doses of ultraviolet radiation, which is the main cause of melanoma and other skin cancers, and accelerates skin aging.
Every year in Poland, melanoma is diagnosed in about 2,5 thousand. people, and over 1 thousand. because of him he dies. The risk of this disease increases when we have a lot of moles and freckles, a very fair complexion and a tendency to sunburn. In the risk group, therefore, there are blondes, people with red hair, blue eyes, and those who have suffered from skin cancer in the past or have someone like that in the family.
90 percent all melanomas are found on the skin. Their diagnosis does not require specialized devices. It is enough to examine them well, sometimes using a dermatoscope, i.e. a magnifying glass that allows you to see the details of skin changes. – If melanoma is suspected, a simple procedure under local anesthesia is performed, similar to the excision of each lesion on the skin – says Prof. Rutkowski.
Only that, unlike our western neighbors, where the incidence of melanomas is similar, in Poland they are detected at a much higher stage of advancement. – The problem in our country is that the average thickness of the excised melanoma is over 2 mm, while for example in Germany it is only 0,8 mm. And this translates into treatment results. In Germany, it is possible to cure 90 percent. patients with melanoma, and in Poland 60-70 percent – summarizes prof. Rutkowski.