The National Institute for Health and Clinical Excellence (NICE) has today (4 March) issued final draft guidance recommending the drug rituximab(MabThera) as a treatment for certain patients with relapsed or refractory chronic lymphocytic leukaemia. This draft is now with consultees who have the opportunity to appeal against the proposed recommendations before final guidance is published later this year.

Chronic lymphocytic leukaemia is a cancer of the white blood cells and is the most common form of leukaemia in the UK. The draft guidance, which has been issued following a thorough review of all available evidence, recommends rituximab, in combination with fludarabine and cyclophosphamide, for the treatment of this disease 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.

When the condition has previously been treated with rituximab, the drug, in combination with fludarabine and cyclophosphamide, is recommended as a treatment but only in the context of research. Rituximab, in combination with chemotherapy agents other than fludarabine and cyclophosphamide, is also only recommended in the context of research.

Professor Peter Littlejohns, Clinical and Public Health Director at NICE said: "Treatment for chronic lymphocytic leukaemia can differ from patient to patient depending on factors such as whether a patient has any genetic abnormalities or received any previous treatment. Rituximab, in combination with fludarabine and cyclophosphamide, will offer another treatment option for those patients with relapsed or refractory disease who may benefit most from the drug.

"The independent committee also made some research recommendations for rituximab. This is because there is currently a lack of evidence of the treatment's efficacy when used in combination with other chemotherapy drugs, or when rituximab has already been used as a treatment. Recommendations can only be made according to the evidence that is available so we would welcome more research in these areas."

In line with the NICE technology appraisals process, this final draft of the guidance is now subject to an appeals process where consultees can register any concerns relating to the proposed recommendations. NICE has not yet issued final guidance to the NHS. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.

Source
NICE