New advanced breast cancer treatment not recommended
In final draft guidance NICE has not been able to recommend eribulin (also known as Halaven and made by Eisai) for the treatment of locally advanced or metastatic breast cancer in people whose disease has progressed after at least two chemotherapeutic regimens for advanced disease.
Commenting on the draft guidance NICE Chief Executive, Sir Andrew Dillon said: "Although the evidence presented to the independent advisory committee indicated that eribulin may help some patients live for a little longer, it also caused more undesirable side effects than other treatments already available, and the effects on health-related quality of life had not been adequately assessed.
"The advisory committee heard from clinical experts that in current practice, patients at this stage usually receive sequential treatment of vinorelbine, capecitabine and, more rarely, gemcitabine. The experts also stressed that even if eribulin were approved by NICE, it would be unlikely to replace capecitabine and vinorelbine in the established sequential pathway because of its related side effects."
The manufacturer provided additional analyses following the consultation period for the subgroup of people previously treated with capecitabine. However, the assessment of survival advantage in this subgroup was not thought to be robust, and given this uncertainty, the Committee concluded that no convincing cost effectiveness estimate had been presented for this subgroup.
The manufacturer has agreed a patient access scheme with the Department of Health which makes eribulin available at a discounted price. The size of the discount is currently confidential. However, even with this discount, NICE's independent Appraisal Committee decided that eribulin was not cost effective enough to justify diverting money from elsewhere in the NHS in order to fund its use.
The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. People who are currently receiving eribulin should have the option to continue therapy until they and their clinicians consider it appropriate to stop.
Notes to Editors
About the final draft guidance
1. The draft guidance is available at: http://guidance.nice.org.uk/TA/Wave23/32
2. Eribulin was found to potentially extend life by 2.7 months compared with 'treatment of physician's choice'.
3. Eribulin did not fulfil all the end-of-life criteria.
The Committee had not seen sufficient evidence to indicate that eribulin offers an extension to life of at least 3 months; the only plausible estimate presented for the mean overall survival gain was 2.7 months from the overall ITT population. .
4. The most common adverse effects of eribulin are fatigue, alopecia, peripheral neuropathy, nausea, neutropenia, leukopenia and anaemia.
5. The most plausible cost per quality adjusted life year gained of eribulin compared with 'treatment of physician's choice' is estimated to be in excess of £68,600.
6. The cost of a vial of a 1.0 mg of eribulin mesylate (equivalent to 0.88 mg eribulin) is £313. The manufacturer has agreed a patient access scheme with the Department of Health which makes eribulin available at a discounted price. The size of the discount is currently confidential.
7. The recommended dose of eribulin as the ready to use solution is 1.23 mg/m2 (equivalent to 1.4 mg/m2 eribulin mesylate), which is administered intravenously over 2-5 minutes on days 1 and 8 of every 21-day cycle.
1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health
2. NICE produces guidance in three areas of health:
- public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
- health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.
3. NICE produces standards for patient care:
- quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
- Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.
This page was last updated: 16 November 2011