NICE consults on new treatment for advanced breast cancer
In draft guidance issued for public consultation, NICE has not been able to recommend eribulin (also known as Halaven and made by Eisai) for the treatment of locally advanced or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Commenting on the draft guidance NICE Chief Executive, Andrew Dillon said: "The majority of the evidence on the effectiveness of eribulin submitted by the manufacturer was based on one study that compared eribulin to a 'treatment of physician's choice'. Although the study indicated that eribulin could potentially help patients live for a little longer, it also caused more negative side effects than the other treatments and the effects on health-related quality of life had not been adequately assessed. The manufacturer and other stakeholders now have an opportunity to comment on the preliminary recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued."
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. The estimated cost per quality adjusted life year gained of eribulin compared with 'treatment of physician's choice' is thought to be in excess of £68,600.
Metastatic cancer is a cancer that has spread from the part of the body where it started (the primary site) to other parts of the body. Locally advanced cancer is cancer that has grown outside of the organ it started in but has not yet spread to distant parts of the body.
The committee heard from clinical experts that in current practice, palliative chemotherapy after anthracyclines and taxanes is usually sequential monotherapy with vinorelbine, capecitabine and, more rarely, gemcitabine. These experts also stressed that if eribulin were approved by NICE, it would be unlikely to replace capecitabine and vinorelbine in the established sequential pathway because of its toxicity profile and would only be offered as a third or fourth-line option after treatment with capecitabine and vinorelbine.
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 guidance
1. The guidance is available at: http://guidance.nice.org.uk/TA/Wave23/13
2. Eribulin was found to potentially extend life by 2.7 months compared with 'treatment of physician's choice'.
3. The most common adverse effects of eribulin are fatigue, alopecia, peripheral neuropathy, nausea, neutropenia, leukopenia and anaemia.
4. 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.
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 Clinical 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 sectorhealth technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHSclinical 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 servicesQuality 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: 19 July 2011