23 February 2011

New treatment to benefit certain patients with leukaemia thanks to new NICE guidance~

On 23 February the National Institute for Health and Clinical Excellence (NICE) published final guidance to the NHS recommending the use of a new treatment that can help extend the lives of certain people with the most common form of leukaemia. The guidance recommends bendamustine (Levact, Napp Pharmaceuticals) as a first-line treatment for patients with chronic lymphocytic leukaemia (Binet stage B or C) for whom a type of intensive treatment called fludarabine combination chemotherapy is not appropriate.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said:

“The strong evidence for bendamustine has meant that, not only have we been able to recommend this treatment but we have been able to fast track the publication of this guidance so that it can benefit as many people as quickly as possible.

”Most patients with chronic lymphocytic leukaemia are given an intensive treatment called fludarabine combination chemotherapy, but this may not be suitable for everyone. Bendamustine will be a welcome addition to the treatment options available for those patients who can't receive this type of treatment and the evidence showed it can slow the growth and spread of the cancer by, on average, 13 months more than chlorambucil, the alternative drug available.”

Tony Gavin, Director of Cancer Campaigning and Patient Advocacy at Leukaemia CARE, said:

“We at Leukaemia CARE are very pleased by this positive recommendation by NICE. It is great news for patients with chronic lymphocytic leukaemia (CLL); particularly since the current treatment options for patients with this disease are very limited. This positive guidance from NICE will mean that bendamustine can now help to make a real difference to the lives of people diagnosed with CLL. We are looking forward to the recommendations in this guidance being taken on board by doctors as soon as possible, so that patients who are in a position to benefit from bendamustine can start receiving their treatment sooner rather than later.”

Jane Barnard, Chairman of the Chronic Lymphocytic Leukaemia Support Association (CLSSA), said:

“We welcome this development, which means that bendamustine will be available to patients with chronic lymphocytic leukaemia. This will have a very positive impact on those patients who can't be treated with fludarabine, as well as on their carers  and families.”

Chronic lymphocytic leukaemia is a cancer of the white blood cells and mainly affects those over the age of 60. Around 2,400 people are diagnosed with chronic lymphocytic leukaemia in the UK each year and it is estimated that around 1,000 of these patients a year will be able to benefit from bendamustine.

Notes

  • The guidance for bendamustine for chronic lymphocytic leukaemia is available to view at: http://guidance.nice.org.uk/TA216
  • This guidance was developed after an independent Appraisal Committee considered evidence from the manufacturer, clinical experts and patient representatives. The committee concluded that bendamustine can delay the growth and spread of the cancer for, on average, 13 months more than chlorambucil, the only other drug for people with chronic lymphocytic leukaemia who are unable to have fludarabine combination chemotherapy. The committee agreed assumptions for the cost-effectiveness of bendamustine which gave an incremental cost-effectiveness ratio (ICER) of £9,400 per quality-adjusted life year (QALY), compared with the manufacturer's basecase estimate of £11,960 per QALY gained.
  • The cost of bendamustine is calculated according to a patient's body surface area. According to the manufacturer, bendamustine costs, on average, about £4,742 per patient. This is assuming that the patient's body surface area is 1.72m² and they receive an average of 4.9 treatment cycles.
  • Due to the strength of evidence for bendamustine, this guidance has been published after only one committee meeting (there are normally two) and bypassed the consultation stage of guidance development. This was designed to speed up the process of publishing positive guidance to the NHS so that patients can receive new treatments quicker.

About NICE

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 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.