NICE and Novartis work on groundbreaking pilot
pharmafile | December 18, 2007 | News story | Sales and Marketing |Â Â Â
NICE could provide early advice to pharma companies on the data it requires for its appraisals, if a new pilot project between the Institute and Novartis proves a success.
NICE's chief executive Andrew Dillon has revealed that it has given advice to Novartis on one of its drugs now entering phase III studies, and provided guidance on what sort of health outcomes data would NICE would want to see.
Dillon declined to name the drug in question, but was upbeat about the pilot project becoming a regular service for the industry, and believes the scheme will benefit both patients and pharma.
He said: "The industry is as keen as we are to make sure the right advice is out there in the health service."
The scheme could be a major breakthrough in relations between NICE and the industry, and the early discussions could help prevent drugs being rejected because of inadequate clinical trials data.
The cost effectiveness watchdog regularly concludes that the trials data pharma companies submit is either insufficient or flawed, and the problem has been highlighted in the Health Select Committees ongoing NICE inquiry.
The new service could avoid the delays when the NICE appraisal committees feel the need to request further clinical data during the process.
Early talks before appraisal will make clearer what NICE expects to see in order to make an approval, but exact details of how the system will work have not yet been disclosed.
NICE envisages companies will seek this type of advice as they prepare their phase III studies, although in principle they could approach NICE at any stage in the product development.
It is understood the pilot is now complete and is being assessed, but NICE has declined to give any further details until the pilot has been completed.
What is certain is that the advice is seen as a service provided by NICE to the industry, and companies will have to pay for the consultation.
"If it is found useful by Novartis, we will offer the service and we will be putting a price on it," said Dillon.
Asked about potential fears that the scheme could represent a conflict of interest, in that taking fees from the industry might compromise NICE's impartiality, Dillon said this would not be a concern.
He pointed to similar paid-for services already offered by the FDA or EMEA prior to a drug being filed.
"Even with this advice, there would be no guarantee that NICE's appraisal committees would recommend the drug, so I don't think that is a concern."
The next stage is for the pilot scheme to be reviewed by NICE's board at the end of March 2008. If approved, the service could then be offered to other pharmaceutical companies as early as next summer.
