HEDS is part of the School of Health and Related Research (ScHARR) at the University of Sheffield. We undertake research, teaching, training and consultancy on all aspects of health related decision science, with a particular emphasis on health economics, HTA and evidence synthesis.

Thursday, 18 October 2012

NICE unlicensed or off-label appraisals

From the NICE website:

“Tranexamic acid (Cyklokapron, Pfizer) for significant haemorrhage (severe bleeding) following trauma is the first topic to be covered by NICE as part of its new service to provide high quality information to the NHS and patients in England about the use of unlicensed and off-label medicines.
Produced by NICE's Medicines and Prescribing Centre (which was formed following the transfer into NICE of the National Prescribing Centre in April 2011), these outputs provide a summary of the published evidence for selected unlicensed or off-label medicines that are considered to be of significance to the NHS, where there are no clinically appropriate licensed alternatives. They will provide information for clinicians and patients to inform their decision-making and support the construction and updating of local formularies.

Although the strengths and weaknesses of the relevant evidence of a drug's efficacy, safety and cost are critically reviewed within the NICE evidence summaries, the summaries do not constitute formal NICE guidance.”

So although it is clear that tranexamic acid reduces all cause mortality and the economic evaluation came up with an ICER of £43 per life year saved, NICE doesn’t formally recommend it.  But providers and commissioners across the world must surely sit up and take notice.

The following topics will form the first tranche of NICE evidence summaries for unlicensed or off-label medicines:
  • Melatonin - sleep disorders in children
  • Diltiazem cream 2% - anal fissure
  • Glyceryl trinitrate 0.2% ointment - anal fissure
  • Midodrine - postural hypotension
  • Metformin tablets - Polycystic ovary disease
  • Modafinil tablets - decreasing fatigue in MS
  • Magnesium glycerophosphate oral - hypomagnesaemia
  • Clonidine - ADHD as sole treatment and adjunct
  • Rituximab in mantle cell lymphoma