Rapid NICE assessments planned for single indication drugs
New drugs with a single indication, plus new indications for licensed drugs, will be put through a more rapid assessment process, the National Institute for Health and Clinical Excellence announced last week.
Providing further details of NICE’s plans to speed
up the appraisal process (PJ, 1 October, p397), Andrew Dillon, chief executive, said that
manufacturers will be asked to provide information on a standard template
and that the institute will also increase its horizon-scanning activity.
These single technology appraisals (STAs) will mean that guidance can
be issued as little as eight weeks after a drug receives its marketing
authorisation. This reduction from the 14 months that NICE’s first
95 assessments have, on average, taken has been achieved by running the
appraisal and licensing processes alongside one another to a much greater
degree.
The first five drugs to be assessed under the new process will be bortezomib
(Velcade) for multiple myeloma, docetaxel (Taxotere) for breast cancer,
paclitaxel (Taxol) for breast cancer, rituximab (MabThera) for non-Hodgkin’s
lymphoma and trastuzumab (Herceptin) for breast cancer. The first guidance
developed using the new process will appear in June 2006.
Following this first wave, NICE will be consulting patients, health care
professionals and the health care industry on the details of the process.
The system for more complicated assessments — now termed the multiple
technology assessment (MTA) process — will remain, Mr Dillon said,
recognising the difference between these and simple appraisals which
can be conducted more swiftly.
The Association of the British Pharmaceutical Industry welcomed the announcement,
but added that it is vital that the new process is properly funded and
that, once guidance is produced earlier for the NHS, it is implemented
without delay by NHS trusts. |
The
Pharmaceutical Journal
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