NICE publishes first off-label summary
pharmafile | October 18, 2012 | News story | Sales and Marketing | NICE, UK, prescribing
In a radical change to its modus operandi, NICE has published the first in an ongoing series of assessments of drugs which are not yet on the market.
The watchdog has previously reviewed medicines that have already received marketing authorisation: the idea behind the new initiative is to make life easier for doctors by giving them more information to meet off-label requests.
The best available evidence of safety, efficacy, cost and potential to improve outcomes for individual patients will be critically reviewed to create the new bulletins.
NICE says this will end duplication of effort as different NHS organisations no longer need to do their own assessments of such drugs.
The first ‘evidence summary: unlicensed or off-label medicine’ covers Pfizer’s Cyklokapron (tranexamic acid) for severe bleeding following trauma.
Healthcare research company Bazian has been contracted to put together the information which forms the basis of the final NICE summary – although the watchdog is at pains to make clear that these are not to be taken as formal NICE guidance.
However, it insists that there will be similar transparency, with pharma companies among the interested parties able to contribute to the development of the summaries, along with doctors, patients and carers.
Produced by the NICE Medicines and Prescribing Centre (formed after the transfer into NICE of the National Prescribing Centre in April 2011), the new service is also aimed at giving patients in England a better idea of available treatments.
“Up until now there has been a lack of nationally available, good quality information about using unlicensed and off-label medicines,” explained Professor Mark Baker, director of NICE’s Centre for Clinical Practice.
“Clinical situations will arise where the use of unlicensed medicines or the use of medicines to treat conditions for which they are not licensed may be judged by the prescriber to be in the best interest of the patient,” he added.
“This is particularly the case for certain rare diseases, where there are often not enough patients to enlist on the clinical trials that are needed to develop a drug,” Baker pointed out.
A number of off-label or unlicensed drugs are to be included in future summaries: two on Novo Nordisk’s new ultra long-acting basal insulin analogue insulin degludec, and one on Abbott’s Humira (adalimumab) in ulcerative colitis, are due to be published later this month.
An assessment of Roche’s Herceptin (trastuzumab) as a subcutaneous (neo) adjuvant for early breast and metastatic breast cancer is scheduled for January 2013.
Adam Hill
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