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NICE recommends leukaemia drug for NHS use

Rituximab (MabThera, Roche Products) will now be routinely available to certain NHS patients with chronic lymphocytic leukaemia, thanks to final guidance published today (28 July). The NHS has three months to begin implementing this new guidance.

The National Institute for Health and Care Excellence (NICE) recommends rituximab, in combination with the chemotherapy drugs fludarabine and cyclophosphamide, for the treatment of relapsed or refractory chronic lymphocytic leukaemia except when the condition has not previously responded to fludarabine or has relapsed within 6 months of treatment, or has previously been treated with rituximab.

Following an appeal earlier this year, rituximab in combination with fludarabine and cyclophosphamide will also be available to patients who have already been treated with rituximab as part of a clinical trial but at a lower dose to the licensed amount, or who have previously received rituximab in combination with other chemotherapy drugs as part of a clinical trial.

For people who have previously received rituximab outside of clinical trials, or for whom fludarabine and cyclophosphamide are not considered appropriate, the drug, in combination with chemotherapy, is recommended in the context of research.

Professor Peter Littlejohns, Clinical and Public Health Director at NICE, said: “NICE received an appeal following the last stage of draft guidance and, as a result, the recommendations for this guidance have changed slightly. We want to ensure rituximab is routinely available in the NHS for those patients who may benefit most from it, including those who had already been treated with the drug during a clinical trial but at a lower dose than usual or in combination with other chemotherapy regimens.

“Where rituximab has been recommended in the context of research, this is because of a lack of evidence relating to the treatment's efficacy in those instances. Hopefully, there will be more research in these areas to help NICE develop firmer recommendations, when this guidance is updated.”

Chronic lymphocytic leukaemia is a cancer of the white blood cells and is the most common form of leukaemia in the UK. This type of cancer encourages a type of white blood cell called B lymphocytes to grow abnormally, causing anaemia and an increased susceptibility to infection. Rituximab works by targeting a protein called CD-20 that is found on B lymphocytes and cancer cells. It kills these cells, allowing normal lymphocytes to grow and replace those destroyed.

Ends

Notes to Editors

  • The guidance is available to view at: www.nice.org.uk/TA193. The full recommendations state:
    • 1.1 Rituximab in combination with fludarabine and cyclophosphamide is recommended as a treatment option for people with relapsed or refractory chronic lymphocytic leukaemia except when the condition:
      • is refractory to fludarabine (that is, it has not responded to fludarabine or has relapsed within 6 months of treatment) or
      • has previously been treated with rituximab, unless
      • in the context of a clinical trial, at a dose lower than the dose currently licensed for chronic lymphocytic leukaemia or
      • in the context of a clinical trial, in combination with chemotherapy other than fludarabine and cyclophosphamide.
    • 1.2 Rituximab in combination with fludarabine and cyclophosphamide is recommended only in the context of research for people with relapsed or refractory chronic lymphocytic leukaemia that has previously been treated with rituximab, unless rituximab has been given as specified in section 1.1.
    • 1.3 Rituximab in combination with chemotherapy other than fludarabine and cyclophosphamide is recommended only in the context of research for people with relapsed or refractory chronic lymphocytic leukaemia.
    • 1.4 People with chronic lymphocytic leukaemia that is refractory to fludarabine (as defined in section 1.1), who are currently receiving rituximab in combination with fludarabine and cyclophosphamide should have the option to continue treatment until they and their clinicians consider it appropriate to stop.
    • 1.5 People with chronic lymphocytic leukaemia that has previously been treated with rituximab other than as specified in section 1.1 who are currently receiving rituximab in combination with fludarabine and cyclophosphamide and people who are currently receiving rituximab in combination with other chemotherapy regimens that is not in the context of research, should have the option to continue treatment until they and their clinicians consider it appropriate to stop.
  • The Appraisal Committee considered that the most plausible incremental cost-effectiveness ratio (ICER) was likely to be at the upper end of the range of £20,000 to £30,000 per QALY gained.
  • Rituximab is administered directly into the bloodstream via a drip. It is given once every four weeks for a total of six cycles.
  • Optimal dosage is calculated according to a patient's body surface area, with a first dose of 375mg/m² followed by subsequent doses of 500mg/m². For a patient with a body surface area of 1.86m², the total cost for a full course of rituximab would be about £9,954.
  • Around 2,400 people are diagnosed with chronic lymphocytic leukaemia in the UK each year[1].
  • NICE has also published guidance on the use of rituximab as a first-line treatment for patients with chronic lymphocytic leukaemia: http://guidance.nice.org.uk/TA174

About NICE

1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance 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 and procedures within the NHS
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

[1] http://www.cancerhelp.org.uk/type/cll/treatment/statistics-and-outlook-for-chronic-lymphocytic-leukaemia#general

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This page was last updated: 27 July 2010

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.