The National Institute for Health and Clinical Excellence has published final recommendations for the use of Roche’s MabThera as a treatment for leukaemia on the National Health Service.

The Institute’s Final Appraisal Determination, which will become its final guidelines for doctors if no appeals are lodged against its recommendations, back the use of MabThera (rituximab) as a cost-effective treatment for patients with relapsed/refractory forms chronic lymphocytic leukaemia (CLL).

CLL is form of blood cancer caused by the uncontrolled division of abnormal B-cells, which play a crucial part in the body’s defence system. In patients with CLL the body’s ability to fight infection is compromised, as the multiplication of these abnormal B-cells - which are unable to carry out their role properly - overtakes that of their normal counterparts.

MabThera is a monoclonal antibody that targets a specific protein on the surface of both healthy and malignant mature B-cells and then kills them, which allows a new generation of healthy B-cells to develop from stem cells without harming other ‘healthy’ cells nearby, as chemotherapy can.

Proven efficacy
Data from clinical trials have shown that the addition of MabThera to a chemotherapy regimen of fludarabine and cyclophosphamide improves progression-free survival and complete response rates in patients, and the Institute’s appraisal committee ruled that, at an incremental cost of £15,600 per QALY (quality-adjusted life year), the drug also offers the NHS value for money.

However, NICE has also stipulated that MabThera should not be used in patients who have previously failed to respond to the chemotherapy fludarabine, or those who have already had prior treatment with MabThera (unless for the purposes of research), and that it should not be given in combination with any other chemotherapy agents as it does not consider the drug to be a cost-effective use of NHS resources in these settings.