Novartis has entered into an innovative deal with the National Institute for Health and Clinical Excellence, reports the Financial Times, which will see the Swiss firm and the agency jointly design a study that will look at the cost-effectiveness as well as the efficacy of a new drug.
The newspaper states that as part of the process, NICE will charge a consultancy fee to inform Novartis what type of data it requires in order to be able to recommend whether the treatment, if approved, should be made available on the National Health Service. The report suggested that while the drug will still need to meet standard efficacy and safety requirements, the additional economic data will help speed the decision-making process about whether the drug should be reimbursed.
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.
Joe Jimenez, the new head of pharmaceuticals at Novartis, told the FT that “this is about identifying the impact of the drug and the evidence of impact. Input at an early stage gives us the evidence to speed our drug to market”. He added that the firm is looking at “more innovative ways to stand behind our drugs” and noted that talks with NICE’s counterparts in Sweden and the Netherlands about a similar approach have begun.
