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The Scottish Medicines Consortium (SMC) announced today that it does not recommend funding for Halaven® (eribulin), a new treatment for locally advanced or metastatic breast cancer.
The decision has led to criticism from Andrew Wilson, the Chief Executive of the UK Rarer Cancers Foundation, who believes seriously ill patients with very limited treatment options are being denied access to a drug that has demonstrated a significant improvement in overall survival.
Wilson suggested the decision was symptomatic of the overall failings of the Scottish regulatory body to afford Scottish patients the same treatment options as their neighbours in England.
“Scottish women with advanced breast cancer are currently prejudiced in Scotland as their chances of accessing a life-extending cancer drug are now much lower than their neighbours in England”, he said.
“Our recent report ‘Nations Divided’ uncovered a profound difference in the availability of new cancer medicines between Scotland and England.
“Following the implementation of the Cancer Drug Fund (CDF) in England, patients in Scotland are now three times less likely than patients in England to receive the drugs that their clinician wishes to prescribe.”
Eribulin is a novel monotherapy treatment indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease.
Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.
Launched in the UK in April 2011, it is the first single agent chemotherapy to demonstrate prolonged overall survival in women with metastatic breast cancer who have had prior anthracycline and taxane treatment.
The SMC guidance is based on the EMBRACE Phase III clinical trials, which showed a median overall survival benefit of 13.2 months for patients receiving eribulin compared to 10.5 months for patients receiving ‘treatment of physician’s choice’.
“The EMBRACE Phase III study showed clearly that eribulin prolonged overall survival,” said David Cameron, Professor of Oncology at the University of Edinburgh and Director of Cancer Services at NHS Lothian.
“Importantly, there were no unexpected side-effects in comparison with other treatment options in these heavily pre-treated patients with locally advanced or metastatic breast cancer, reflecting a predictable and manageable side effect profile.
“The main barrier to NHS use in Scotland is not related to the efficacy or safety of the drug, but to its cost-effectiveness as measured by the cost of treatment per quality adjusted life year or QALY.
“The price of eribulin is only one of the factors in this equation.”
The side-effect profile of eribulin was expected and manageable. The most commonly reported adverse reactions among patients were asthenia (fatigue), neutropenia, alopecia (hair loss), peripheral neuropathy (numbness and tingling in arms and legs), nausea and constipation.
Eribulin is approved in the European Union, USA, Switzerland,Japan, and Singapore. It is currently commercially available in Austria, Denmark, Finland, Germany, Netherlands, Norway, Portugal, Spain, Sweden, Singapore, Switzerland, United Kingdom, the USA and Japan.