Being NICE?

NICE (National Institute for Health and Clinical Excellence) is to launch a new, rapid process for assessing drugs and other treatments to sit alongside its global standard process.

The Single Technology Appraisal (STA) process will initially be used to produce faster guidance on 'life-saving drugs' that have already been licenced and to enable new drugs and existing drugs with new indications to be rapidly assessed.

The new process will enable NICE to issue faster guidance, around six to 15 months earlier than the current situation allows, by:

Asking for a single submission of evidence from the drug's manufacturer;

Carrying out a faster independent assessment of this evidence;

Moving quickly to the final (appeal) stage of the process where the draft recommendations are in line with the licence.

NICE has already started work with manufacturers of numerous anti-cancer drugs, including docetaxel (Taxotere), paclitaxel (Taxol) and trastuzumab (Herceptin) for breast cancer and rituximab (MabTera) for non-Hodgkin's lymphoma, having told them that their products will be the first to be reviewed using the new process. The first guidance developed using the new process is expected to appear by June 2006, with guidance on trastuzumab (Herceptin) expected shortly after, providing it is granted a licence.

The Association of the British Pharmaceutical Industry (ABPI) has welcomed the changes, 'in view of the need to ensure that all patients have the fastest possible access to modern, innovative medicines'.

Andrew Curl, deputy director general, said: 'It is vital that, once the new process is in place and guidance is produced earlier for the NHS, this is properly funded and implemented without delay by NHS trusts. It should also give encouragement and confidence to doctors to prescribe modern medicines for the benefit of patients.'

However, the Association has also stated that there are 'sometimes limitations on what evidence is available for the evaluation of the clinical and cost effectiveness of a medicine at the time of launch', and is therefore eager to discuss the proposals' implementation with NICE to ensure the new process works 'achieves its objective of making innovative medicines available to patients as soon as possible after launch'.

The Institute is already consulting organisations representing patients, healthcare professionals and the healthcare industries about the process, and, furthermore, is examining proposals to speed up its current system for carrying out appraisals of more than one drug, the Multiple Technology Appraisal (MTA) process, investigating the possibility of looking at groups of drugs already on the market in order to compare them with one another.