The National Institute for Health and Care Excellence (NICE) has launched a second consultation on draft guidance on the use of Cell Therapeutics’ Pixuvri (pixantrone) in the treatment of an aggressive form of lymphoma.

This - the third version of NICE’s draft guidance - examines Pixuvri’s clinical and cost effectiveness as a treatment for adults with aggressive non-Hodgkin’s B-cell lymphoma whose cancer has either returned after treatment or become resistant to current therapy, and who have already received at least two lines of treatment.

The consultation comes after Cell Therapeutics submitted a patient access scheme (PAS) to NICE’s independent appraisal committee, which then considered how this might affect Pixuvri’s cost-effectiveness.

“Unfortunately, the committee concluded that this scheme - the details of which are confidential in accordance with the agreement between the company and the Department of Health - does not overcome the uncertainties in the evidence for the drug’s clinical effectiveness over and above current treatments for this disease,” said NICE’s chief executive, Sir Andrew Dillon.

In examining data on the drug from the PIX031 clinical trial submitted by the manufacturer, the appraisal committee noted a number of uncertainties, including that the trial had failed to recruit the planned number of patients and that its primary endpoint was complete or unconfirmed complete response to treatment, rather than a primary endpoint of overall survival or progression-free survival, which is preferred by European regulators.

The panel also found considerable uncertainty in determining Pixuvri’s clinical effectiveness for a UK population, and considerable doubt over its clinical benefit in patients who had previously received ritxuximab (Roche/Biogen Idec’s Rituxan) - this applied to virtually all patients with relapsed or refractory aggressive B-cell lymphoma in England and Wales.

Overall, the committee concluded that there was insufficient evidence to show that Pixuvri is more clinically effective than treatments currently used in clinical practice.

And in this third draft of guidance, the panel found that cost-effectiveness calculations including the PAS would most likely result in an incremental cost-effectiveness ratio (ICER) for the product of £30,700 per quality-adjusted life year (QALY) gained.

Because this was above the range normally considered cost-effective (usually £20,000-£30,000 per QALY gained), coupled with substantial uncertainty relating to Pixuvri’s effectiveness compared with other treatments, the appraisal committee concluded that Pixuvri is not recommended as a cost-effective use of NHS resources.

The consultation on this draft guidance is open until November 4.