atients with a common form of leukaemia could soon get approved access to treatment with Roche’s MabThera, as the National Institute for Health and Clinical Excellence is recommending the drug for use on the NHS in England and Wales.
The Institute has this morning published a Final Appraisal Determination endorsing treatment with MabThera - but only alongside chemotherapy with fludarabine and cyclophosphamide - in patients with chronic lymphocytic leukaemia, after concluding that the regimen offers value for money for the NHS.
CLL is form of blood cancer caused by the uncontrolled division of abnormal B-cells, which are unable to carry out their ‘normal’ role in the body’s defence system. The current standard of treatment is chemotherapy, but as this is indiscriminate other healthy cells around the cancer are also damaged. MabThera is able to address this problem because it is a monoclonal antibody that only kills healthy and malignant mature B-cells, which enables a new generation of healthy cells to develop from stem cells without harming other tissues.
Clinical trials of the drug have demonstrated its survival benefit to patients, with the addition of MabThera to fludarabine/cyclophosphamide chemotherapy extending progression-free survival by 10.5 months versus chemotherapy alone (3.5 years vs 2.7 years). Furthermore, studies have shown that the number of patients achieving complete remission was more than twice that of chemotherapy alone (36% vs 17.2%).
A spokesperson for Roche previously told PharmaTimes UK News that a course of MabThera for the treatment of CLL will cost the NHS £9,000. But is estimated that more than 20,000 people in the UK are living with CLL and that there will be around 3,700 new cases every year, highlighting the urgent need for novel and more effective treatments.
NICE’s decision to approve the drug for NHS use in England and Wales closely follows that of its sister cost watchdog, the Scottish Medicines Consortium, which issued a green light for MabThera in CLL in Scotland earlier this month. The Institute says it expect to publish final guidance in August provided no appeals are received before June 29.