The drug ofatumumab (Arzerra, GlaxoSmithKline) is not recommended for NHS use in patients with chronic lymphocytic leukaemia that is refractory (does not respond) to the drugs, fludarabine and alemtuzumab, in draft guidance published today (16 September). The National Institute for Health and Clinical Excellence (NICE) is unable to recommend the treatment for this group of patients because the benefits that ofatumumab may provide patients compared with current NHS treatment does not justify the extra cost the Health Service is being asked to pay.
This draft guidance is now with consultees who have the opportunity to appeal against the proposed recommendations. NICE has not yet issued final guidance to the NHS.
As part of this appraisal, the manufacturer was asked to supply evidence of ofatumumab’s effectiveness compared with best supportive care but instead submitted data on a small subgroup of patients in an ongoing clinical trial where all participants received ofatumumab. Because of this, a direct comparison with best supportive care was not possible. The Appraisal Committee concluded that this evidence was not robust enough to demonstrate how much extra time the drug may give patients’ compared with best supportive care.
In a second meeting to discuss ofatumumab, the manufacturer responded to comments made by clinical experts who highlighted other studies that might contain data about patients in whom fludarabine and alemtuzumab no longer work, which could be used to help estimate the relative effectiveness of ofatumumab from the main trial that was originally submitted as evidence. This could, in effect, compare ofatumumab with best supportive care. The Appraisal Committee thought this may provide a more robust estimate of survival for best supportive care, but concluded that, because this new preliminary data indicated survival figures similar to the ones originally estimated by the manufacturer, the evidence would not change the Committee conclusions and would still not make ofatumumab an efficient use of NHS resources.
Sir Andrew Dillon, NICE Chief Executive, said: “Chronic lymphocytic leukaemia is the most common form of leukaemia in the UK and treatment can depend on a range of factors, which is why it’s important to have a variety of therapies available for this disease. However, NICE can only recommend a treatment when it works better than current NHS treatments and represents good value for money for the NHS for the amount of benefit it offers patients.
“The Appraisal Committee formed its recommendations after analysing all of the evidence presented to them by the manufacturer and clinical and patient representatives at two separate meetings. In this case, they concluded that the amount of benefit that ofatumumab might provide patients over and above currently available treatments does not justify the extra cost that the NHS would have to pay for the drug.”
Consultees now have until Thursday 30 September to appeal against the recommendations via the NICE website. Final guidance for ofatumumab for chronic lymphocytic leukaemia that is refractory to fludarabine and alemtuzumab is expected to be published later this year. Until then, NHS bodies should make decisions locally on the funding of specific treatments.