NICE raises ‘uncertainties’ over Pixuvri

Pharma NICE Update Cell Therapeutics’ Pixuvri (pixantrone) has not been recommended by NICE in draft guidance as a treatment option for an aggressive form of non-Hodgkin’s lymphoma.

NICE’s independent appraisal committee decided there was insufficient evidence to show the drug works more effectively than existing options and raised question marks over its cost.

Sir Andrew Dillon, NICE Chief Executive, said that clinical trial evidence left NICE with a “number of uncertainties” and questioned how many people may actually benefit from the treatment.

Non-Hodgkin’s lymphoma is the sixth most common cancer in the UK. In 2010, around 12,000 people were diagnosed with the disease. However, Cell Therapeutics estimates that only around 1,650 people with an aggressive form of the disease would be eligible to receive the treatment, if recommended.

Pixuvri has a conditional licence to treat adults with aggressive non-Hodgkin B-cell lymphoma that has either returned after treatment or become resistant to current therapy in those who have received at least two previous types of treatment.

NICE was developing guidance for this specific group of people but was told by clinical experts that the analysis supplied by the manufacturer did not include comprehensive data in patients who had received MabThera (rituximab) – an integral part of first-line treatment and often used in second-line therapy.

Because of this, the committee concluded that differences between previous treatment between the trial population and current practice meant there was considerably uncertainty in determining the treatment’s clinical effectiveness for a UK population.

The recommendation is now open for consultation until 1 May 2013.