Novartis & UK’s NICE Strike Deal To Design Trials

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clinicaltrials1.jpgThis is part of the drugmaker’s effort to work closely with so-called large customers to find ways to ensure its meds gain approval. In this case, Novartis has made an arrangement with the UK’s medicine advisory agency to jointly design a clinical trial in order to measure cost effectiveness and efficacy of an experimental new drug, according to The Financial Times.

Last week, Novartis also disclosed plans to increasingly involve payers in new-drug development by asking for feedback on experimental meds to see what sort of evidence of efficacy and value the payer would need in order to cover the drug. In the US, for instance, this would involve insurers and pharmacy benefit managers.

In this deal, the UK’s National Institute for Health and Clinical Excellence, or NICE, will charge a consultancy fee to tell Novartis the info it needs to determine whether to advise the National Health Service to buy a med once it is launched, the Times writes, and notes that this follows a UK government-commissioned report on speeding the launch of new meds.

“We are interested in how new medicines can have a serious impact,” Joe Jiminez, the newly named head of the Novartis pharma biz, tells the Times. “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. We’re looking at more innovative ways to stand behind our drugs.”

Novartis opened talks with NICE last month on the design of its late-stage Phase III clinical trial for an undisclosed medicine, code-named “Novartis 001,” and the drugmaker hopes to have a final protocol in place by next March, with results within about a year. The drug will still have to meet the normal regulatory requirements of efficacy and safety, but the additional economic data will help speed up a decision on reimbursement, which often takes more than two years after a drug is launched, the Times reports.

Jimenez says he was talking to NICE’s counterparts in Sweden and the Netherlands about similar approaches to closer collaboration and developing trials with the data they need to make their decisions.

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