Fast-track ‘not a soft option’ says NICE
pharmafile | January 19, 2007 | News story | |Â Â Â
The head of NICE's drug appraisal process has said the institute's new fast-track system is not a "soft option" through which new products can gain recommendation more easily.
The single technology appraisal process - otherwise known as the'fast-track' approval – was launched in 2006 to speed-up reviews of drugs which have been prioritised.
Herceptin was the first drug to be appraised through the new system, and was approved. Unlike the existing multiple technology appraisal system (MTA) the fast-track route is based largely on a manufacturer's data.
A fast-track appraisal could take just eight months, compared to the 12-24 months for MTAs in the past, but Prof David Barnett, the chairman of NICE's technology appraisal committee says this does not make for a less rigorous appraisal.
Explaining the new process to a meeting at the NICE conference in December Barnett said: "A quicker process and timely decision-making does not mean a less restrictive outcome." He added that the burden of proof was still on the manufacturer.
Each fast-track appraisal has four possible outcomes ' No', 'Minded No', 'Yes' and 'Yes, but with restrictions'.
Minded No is a new idea, intended to give manufacturers a chance to remedy technical queries which do not require new research or in-depth work.
Prof Barnett described the Minded No option as a kind of "release valve" but warned: "There might be slightly more Minded Nos than some people will be happy with."
Addressing an audience largely made up of pharma industry executives, Barnett said: "The assumption is that we should take a more lenient approach to this situation because the evidence base is immature. We have done our best to counteract that view. The NHS wants fast guidance on drugs, yes, that's true, but I dont think the NHS would wish us to lower our standards."
Barnett admitted that some appraisal committee members felt outside their comfort zone when told they had to use an abbreviated system, having concerns that they could not maintain quality standards. A number of refinements, including the use of a non-NICE expert for each appraisal has been introduced, reassuring committee members the process is robust.
