Wednesday, December 19, 2007

Novartis and NICE - strange bedfellows


Novartis, the Swiss pharmaceutical group, has cut a groundbreaking deal with the UK’s medicines advisory agency to jointly design a clinical trial to measure cost effectiveness as well as the efficacy of an experimental new drug.

The National Institute for Health and Clinical Excellence (NICE) will charge a consultancy fee to tell Novartis the information that it needs to determine whether to advise the National Health Service to buy the medicine once it is launched.

Novartis started talks with NICE last month on the design of the Phase III trial for the drug, which remains unidentified, and it aims to have a final protocol in place by next March.
The treatment will still have to meet the usual regulatory requirements of efficacy and safety, but it is thought that additional economic data will help speed up a decision on reimbursement, which often takes more than two years after a drug has been approved.

FT


Insider's view: Hmmm! Strange bedfellows indeed. Not sure about this "fee". Will it leave NICE exposed to accusations of conflicts of interest?

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