The Scottish Medicines Consortium (SMC) has turned down the use of Eisai's Halaven (eribulin) on the NHS for patients with locally-advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimes for advanced disease.

Halaven is the first of a new type of anticancer medicine which interferes with the growth of cancer cells. It is given by intravenous injection days one and eight of every 21-day cycle of treatment. 

A study showed that patients treated with the drug survived for 2.5 months longer than patients given another treatment chosen by their doctor. However, the quality of life that patients could expect during this time is not clear, says the SMC. Also, side effects were experienced more frequently by patients given Halaven compared with those given another treatment by their doctor; the side effects were fatigue, hair loss, damage to the nerves of the peripheral nervous system, nausea, constipation and low number of white blood cells.

The SMC says it did not accept Halaven for use in NHS Scotland "because the balance of costs and benefits was not favourable."

Responding, Eisai said the decision "denies seriously-ill patients with very limited options access to a drug that has demonstrated a significant improvement in overall survival," and described Halaven's side-effect profile as "expected and manageable." 

"We are hugely disappointed with the SMC decision as there is such a high unmet need in these women, and our drug eribulin has shown that it improves overall survival by an additional three months compared to existing treatments," said Nick Burgin, European director of market access at Eisai.

"We have tried to make eribulin affordable and offered a substantial discount on the price. In fact, the price of our drug in Scotland is at the lowest anywhere in the world,” he added.

EMBRACE - a global Phase III clinical study designed to compare overall survival in patients treated with eribulin versus a Treatment of Physician's Choice (TPC) arm - had showed clearly that eribulin prolonged overall survival, commented 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," said Prof Cameron.

He added: "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 [QALY]. The price of eribulin is only one of the factors in this equation.”

Mr Burgin said that Eisai is committed to improving the options available for patients with metastatic breast cancer and that the firm plans to re-submit to the SMC later this year “to try and reverse this unfair decision."

Halaven was launched in the UK on April 20 this year. It is approved in the European Union (EU), USA, Switzerland, Japan and Singapore.