Cost regulators are looking favourably on the use of Roche’s MabThera on the National Health Service to treat patients with relapsed/refractory forms chronic lymphocytic leukaemia, the most common form of the blood disease.

The National Institute for Health and Clinical Excellence has published an appraisal consultation document in which it recommends the drug in combination with the chemotherapy regimen fludarabine and cyclophosphamide as an option for relapsed/refractory forms of the cancer.

However, the Institute has stipulated that Mabthera (rituximab) should not be used in patients who have previously failed to respond to fludarabine or those who have already had treatment with MabThera, 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 circumstances.

CLL is form of blood cancer caused by the uncontrolled division of abnormal B-cells, which play a key role in the body’s defence system. These altered B-cells are unable to function properly, and as their multiplication takes over that of their healthy counterparts the body’s ability to fight infection is compromised.

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

The Institute’s decision is based on an analysis by the Appraisal Committee which agreed that clinical data from the REACH trial showed that the addition of MabThera to fludarabine and cyclophosphamide improves progression-free survival and complete response rates. Furthermore, based on the cost of £174.63 for a 100mg vial, the QALY gained in the base case scenario was found to be £15,600, well under its cost-effectiveness threshold.

Green light for CLL
Earlier this year NICE published final guidance recommending MabThera as a first-line option for patients presenting with CLL for the first time on the back of clinical data which showed that adding MabThera to fludarabine/cyclophosphamide extended progression-free survival by 10.5 months versus chemotherapy alone (3.5 years vs 2.7 years), and that proportion of patients experiencing complete remission was more than twice that of chemotherapy alone (36% vs 17.2%).

Commenting at the time, Professor John Gribben, Consultant Haematologist and Medical Oncologist at Barts and The London NHS Trust, said the ability to add MabThera to chemotherapy is “a major advance” in the treatment of CLL, as “where previously our goal was just to improve symptoms, for the first time we now have a treatment combination that is capable of producing much higher remission rates and more durable responses”.