NICE gives green light to leukaemia drug in draft guidance
A treatment that could help to extend the lives of patients with the most common form of leukaemia is a step closer to being made available in the NHS following the publication of positive draft guidance from the National Institute for Health and Care Excellence (NICE). Issued today (23 December), the draft guidance recommends the use of bendamustine (Levact, Napp Pharmaceuticals) as a first-line treatment for patients with chronic lymphocytic leukaemia (Binet stage B or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. This is in line with the drug's marketing authorisation.
Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: “Around 2,400 people are diagnosed with chronic lymphocytic leukaemia in the UK each year. Most patients will receive fludarabine combination chemotherapy but this is a very intensive treatment and is not suitable for everyone. For those who cannot receive this chemotherapy, there are very few treatment options left. Bendamustine was shown to slow the growth and spread of the cancer, on average, by over 13 months more than chlorambucil, which is the only other drug available for those unable to have fludarabine chemotherapy. This more than justifies the extra cost that the NHS will need to pay for the treatment, which in itself is low.”
Due to the strength of the evidence for bendamustine that was presented to the Appraisal Committee, it was deemed appropriate to proceed straight to the final stage of guidance development, which is to give consultees an opportunity to appeal against the proposed recommendation. This is designed to speed up the process of publishing positive guidance to the NHS so that patients can receive new treatments quicker.
Tony Gavin, Director of Cancer Campaigning and Patient Advocacy at Leukaemia CARE, said: “This positive recommendation by NICE is great news for patients, particularly since the treatment options for patients with CLL are very limited. Bendamustine can and will help to make a real difference to people's lives. We at Leukaemia CARE are looking forward to this guidance being published as soon as possible so that patients can start receiving this treatment as soon as their doctor thinks they need it.”
Final guidance for bendamustine for chronic lymphocytic leukaemia is expected to be published next year. Until then, NHS bodies should make decisions locally on the funding of specific treatments.
Notes to Editors
- The Final Appraisal Determination (FAD) is available to view at: http://guidance.nice.org.uk/TA/Wave23/16 (from Thursday 23 December 2010).
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: 22 December 2010