Background

Background

Novartis Pharmaceuticals was invited to submit evidence for this single technology appraisal for ruxolitinib in March 2015.

The company informed NICE that the data used to support the marketing authorisation for ruxolitinib for treating polycythaemia vera were from a trial that only included people with splenomegaly. However, the marketing authorisation includes those with and without splenomegaly. The company stated that a trial comparing ruxolitinib with best supportive care is ongoing and includes people without splenomegaly. In addition this trial would capture the quality of life and resource data needed to better characterise the disease and the effect of ruxolitinib. The company explained that without data from this ongoing trial it would not be possible to develop a submission that would meet the standards necessary to ensure a proper appraisal.

NICE has therefore terminated this single technology appraisal.

  • National Institute for Health and Care Excellence (NICE)