Novartis UK cuts deal with the NICE for clinical trial design

In an effort to speed up market access for its new pharmaceutical products, the UK unit of Swiss drug major Novartis has entered into a ground-breaking agreement with the National Institute for Health and Clinical Excellence (NICE), which advises on which products can be provided under the National Health Service in England and Wales, reports the Financial Times.

The NICE's assessments come after a new drug is approved by the regulatory authorities on the basis of safety and efficacy, and takes into consideration cost-effectiveness. What Novartis is planning to do is, with the help of the agency, to design a clinical trial to measure efficacy as well as cost for an investigational drug, Joe Jimenez, head of pharmaceuticals at the company told the FT in an interview. He declined to identify the drug candidate, saying only it was code-named "Novartis 001," and that the aim was to have the trial in place by March 2008.

Under the deal, the NICE will charge Novartis a consultancy fee for telling it what information it needs to determine whether to advise that the drug be made available on the NHS once it is approved, a Novartis spokeswoman confirmed to the Marketletter .