Background

Background

The manufacturer of decitabine (Janssen) was invited to submit evidence for this single technology appraisal in September 2012.

The manufacturer informed NICE that it had decided not to provide an evidence submission because it could not provide adequate evidence to appraise the technology in accordance with the methods and reference case employed by NICE. The manufacturer stated that the single randomised controlled trial of decitabine in acute myeloid leukaemia did not provide enough data for certain outcomes (for example, low completion rates for patient-reported health outcomes) and that the trial's design (with a mixed treatment comparator) meant there were several potential subgroups with the potential for confounding. The manufacturer also said that it would be challenging to develop an economic model to meet the decision problem because the clinical outcomes would be complicated by subsequent rescue treatments. The manufacturer said that it would therefore not be able to address the clinical and cost effectiveness of decitabine in people with acute myeloid leukaemia.

NICE has therefore terminated this single technology appraisal.

  • National Institute for Health and Care Excellence (NICE)