GlaxoSmithKline will be disappointed with news that the NHS cost regulator has turned down Arzerra for the treatment of chronic lymphocytic leukaemia, after ruling that the drug does not offer value for money.

Draft guidance published by the National Institute for Health and Clinical Excellence today has rejected Arzerra (ofatumumab) as an option for NHS patients with the disease who have failed to respond to fludarabine and Genzyme’s Campath (alemtuzumab), because the benefits it may provide patients compared with current therapy “does not justify the extra cost the Health Service is being asked to pay”.

According to the Appraisal Committee’s calculations, the best estimate for the base case incremental cost is between more than £60,500 and more than £81,500 per QALY gained, way over and above its cost-effectiveness threshold, and the decision comes despite a patient access scheme proposed by GSK under which it offered the drug at a discounted price.

Defending the decision, NICE chief executive Andrew Dillon said that while its important to have a variety of therapies on hand to battle the CLL, which is the most common form of leukaemia in the UK, the Institute “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”.

Arzerra was granted conditional approval in Europe in May this year, after regulators considered that the immediate availability of the drug outweighed the risks of not yet having garnered a full set of data needed for full approval.

Lack of data

As per the terms of conditional approval GSK is required to submit further data for Arzerra to the EMA as it becomes available. But the lack of data thus far has proven to be somewhat of a stumbling block for the drug’s inclusion on the National Health Service, as NICE says it has been unable to adequately pit the drug’s effectiveness against current therapies.

This is the second piece of bad news for the company in as many days; yesterday the Institute also said no to GSK’s Revolade (eltrombopag) as a treatment for the clotting disorder chronic immune (idiopathic) thrombocytopenic purpura.

Elsewhere, NICE has also turned down the use of 600mg and 800mg versions of Novartis’ cancer drug Glivec (imatinib) in patients with unresectable and/or metastatic gastrointestinal stromal tumours (GIST) whose disease has progressed after treatment with standard 400 mg form.

According to Dillon, Committee were unable to recommend the higher dose versions because of a lack of any new good quality clinical data proving their effectiveness following the failure of standard dose.