The National Health Service’s cost watchdog has issued final guidance saying that Roche’s MabThera will now be routinely available to certain patients with chronic lymphocytic leukaemia.

The National Institute for Health and Clinical Excellence has recommended that MabThera (rituximab) can be used in combination with the chemotherapy drugs fludarabine and cyclophosphamide, for the treatment of relapsed or refractory CLL. The exceptions are when the condition hasn't previously responded to fludarabine or has relapsed within six months of treatment, or has previously been treated with MabThera.

NICE noted that 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 the Roche drug as part of a clinical trial but at a lower dose to the licensed amount, or who have previously received MabThera in combination with other chemotherapies in clinical trials.

Peter Littlejohns, NICE’s clinical and public health director, said that the agency received an appeal following the last stage of draft guidance “and, as a result, the recommendations for this guidance have changed slightly”. He added that “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”.

Prof Littlejohns concluded by saying “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”. He went on to say that “hopefully, there will be more research in these areas to help NICE develop firmer recommendations, when this guidance is updated.”

Around 2,400 people are diagnosed with CLL in the UK each year and MabThera is administered directly into the bloodstream via a drip once every four weeks for a total of six cycles. Institute’s appraisal committee considered that the cost-effectiveness of the drug was likely to be at the upper end of the range of £20,000 to £30,000 per QALY (quality-adjusted life year) gained and for a patient with a body surface area of 1.86m², the total cost for a full course of MabThera would be about £9,954.

Last month, NICE also proposed that MabThera, in combination with methotrexate, can be used for the treatment of adult patients with severe active rheumatoid arthritis that have failed to responded to other disease-modifying anti-rheumatic drugs (DMARDs), including at least one tumour necrosis factor inhibitor, or when patients are unable to tolerate other DMARDs.

Xeloda, Iressa thumbs-up
Meantime, NICE has also issued final guidance and recommended two other oncology treatments – Roche’s Xeloda (capecitabine) for stomach cancer and AstraZeneca’s Iressa (gefitinib) for non-small-cell lung cancer.

Xeloda is recommended, in combination with a platinum-based regimen, for the first-line treatment of inoperable advanced gastric cancer, while NICE has backed Iressa for the first-line treatment of people with locally advanced or metastatic NSCLC if they test positive for the epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation.

Carole Longson, health technology evaluation centre director at NICE, noted that Iressa has now been added to the list of treatment options for NSCLC, helped by the fact that it is taken in tablet form, “meaning it can be taken at home and would allow patients to carry on with normal daily activities”. She added that patients with inoperable advanced gastric cancer have generally been treated with fluorouracil via an infusion pump. However, “capecitabine-based regimens work as well…and because the treatment is with tablets, rather than an infusion pump, patients will spend less time in hospital.”