NICE unveils fast track plans
pharmafile | November 10, 2005 | News story | |
NICE has unveiled plans to fast-track key new cancer drugs and other medicines through a new simplified appraisal process.
The Institute has been heavily criticised for being too slow in its decision-making, but the new plans means some breakthrough drugs will be appraised within eight weeks of gaining a licence.
The ongoing row over access to Roche's Herceptin has been the driving force behind the new plans, and the breast cancer drug is one of the first products to be fast-tracked. The first drugs to be fast-tracked, with guidance expected in June 2006, are:
- Roche's Herceptin (early stage breast cancer)
- Roche's MabThera (non-Hodgkins lymphoma).
- Sanofi-Aventis' Taxotere (early breast cancer)
- Bristol-Myers Squibb's Taxol (early breast cancer)
- Janssen-Cilag's Velcade (multiple myeloma)
NICE's chief executive Andrew Dillon said the drugs selected for quick assessment were all potential breakthrough treatments, but also had to fulfil other criteria.
"We have looked at those drugs that we believe are suitable for this process. These are single drugs with a single indication and a very narrowly defined evidence base. We have also looked at those drugs which have been waiting the longest since licence," commented Dillon.
NICE's current system attempts to be a comprehensive review of all available data, ranging from manufacturer data to meta-analyses and other reviews in the public domain.
The new Single Technology Assessment (STA) will cut out the wide-ranging consultation and review of all evidence in the public domain and consider only data from the manufacturers, its decision then scrutinised by an independent academic body before a final decision is reached.
The new system should cut the average appraisal time from eighteen to six months and will run in parallel with the application for a licence wherever possible.
No new funds will be made available to NICE to introduce the system, which will run alongside a system for more complicated reviews – the Multiple Technology Appraisal (MTA) process.
Wary of creating a 'two speed' NICE, the body says it is also looking at ways of cutting decision-making times for the MTA process as well.
NICE says the new process will include "at least one" round of consultation – as opposed to the current system of two separate consultation periods which lengthen the review time.
The Institute will also call on academic experts at six UK universities (Aberdeen, Liverpool, York, Sheffield, Birmingham and Exeter/Plymouth) to give an independent review of its decisions.
Appraisals of nine further drugs will begin in early 2006:
- Lilly's Gemzar (advanced/metastatic breast cancer)
- Schering's Fludara (first-line lymphocytic leukaemia)
- Roche's Tarceva (non-small cell lung cancer)
- Pfizer's Campto (adjuvant advanced colorectal cancer, subject to licensing)
- Lilly's Alimta (non-small cell lung cancer)
- SuperGen's rubetican (pancreatic cancer, subject to licensing)
- Merck Pharmaceutical's Erbitux (locally advanced colorectal cancer, subject to licensing)
- Abbott's atrasentan (hormone refractory prostate cancer, subject to licensing)
- Schering-Plough's Ezetrol (hypercholesterolaemia)
The ABPI says it welcomes the move but has warned that NICE could be assessing some drugs too early under the new system.
"The full clinical potential of new drugs will sometimes only become apparent once they have been out in the general public for a while. Drugs can then reveal potential for new indications and this is something an early appraisal will miss out on," said an ABPI spokesman.
The industry body – which is keen to discuss the new system with NICE – is also concerned that doctors may not follow the guidance, a problem which has undermined NICE's authority.
PCTs are legally obliged to consider NICE guidance but inequalities in accessing NICE approved drugs, so-called postcode prescribing, remains a problem.
Related articles:
NICE seeks urgent fix for slow appraisals
Monday , October 03, 2005
