NICE unveils fast track process
pharmafile | November 3, 2005 | News story | Sales and Marketing |
Cancer drugs will be the first treatments to benefit from changes designed to speed up the way NICE makes its assessments.
The new Single Technology Appraisal fast track process could see guidance issued just eight weeks (instead of the current average time of 18 months) after drugs are approved and should help the Institute avoid some of the controversies that continue to damage its reputation.
NICE has been under sustained pressure in recent months to act faster and the way it appraises cancer drugs has been particularly contentious with a patient campaign for wider access to breast cancer drug Herceptin attracting nationwide media attention.
Only selected life-saving drugs will be appraised using the new process with the rest coming under the current system.
Herceptin will be among the first wave of life-saving drugs to be fast-tracked, along with another of Roche's cancer drugs, MabThera for non-Hodgkin's lymphoma.
Sanofi-Aventis' Taxotere (early breast cancer), Bristol-Myers Squibb's Taxol (early breast cancer) and Janssen-Cilag's Velcade (multiple myeloma) will also be included and the first guidance will appear in June next year.
Guidance for Herceptin will take a little longer because the drug is being assessed for early stage breast cancer, an indication for which it is not yet approved, and NICE won't issue its recommendation until the drug gains that indication.
Health secretary Patricia Hewitt said that with NICE approaching its seventh year of operation it was only right to look at speeding up the guidance process.
NICE chief executive Andrew Dillon said: "The proposals we have set out mean NICE can deal with the current backlog much quicker than planned and that we will be able to issue guidance to the NHS rapidly in the future, once a drug is licensed."
The new fast track process will operate alongside the standard NICE appraisal process and will assess single new drugs and existing drugs with new indications.
The Department of Health has been assured that NICE won't need extra money to accommodate the work generated by the new process.
Although the pharma industry was not initially consulted about the changes, NICE is planning to consult with them, as well as healthcare professionals and patient organisations, over the next three months.
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