Novartis is "fundamentally right" to be taking action against a primary care trust cluster that endorsed the off-label prescribing of bevacizumab, and is destined to win the legal challenge, according to Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry.
Novartis is seeking a judicial review of Southampton City, Hampshire, Isle of Wight and Portsmouth City (SHIP) PCT cluster’s decision to allow bevacizumab (Avastin; Roche) to be prescribed for the treatment of wet age-related macular degeneration — an indication for which it is not licensed, but works out ten times cheaper than the licensed alternative, ranibizumab (Lucentis; Novartis).
Speaking at the ABPI conference last week (26 April 2012), Mr Whitehead said: "I think Novartis’s action is absolutely, fundamentally right. There is a National Institute for Health and Clinical Excellence recommendation behind [ranibizumab for wet AMD]."
NICE has advised the industry to pursue legal avenues if its recommendations are not being adopted, including using the media to draw attention to the issue and put pressure on, he said.
"The Lucentis issue is a complex issue. It’s not simply about not adopting a new medicine, it’s also substitution of off-label medicines, which is fundamentally dangerous and undermines the whole regulatory process," he added.
"Why go through clinical trials if healthcare professionals — or, more importantly, healthcare funders . . . — use medicines that are off-label and off-licence."
Asked what the implications will be if Novartis loses the judicial review, he said simply: "I don’t think Novartis will lose."
Case will prove intriguing, says NICE’s Sir Andrew
NICE chief executive Sir Andrew Dillon said he understands why individual clinicians might choose to prescribe off-label, and the logic behind SHIP PCT cluster’s decision to support the practice.
"Equally, it’s not without risk. It is unlicensed use, so the studies, though there are clinical trials under way, haven’t been through that formal evaluation," he said, stressing that the it’s a difficult and complex decision making process that factors in both safety and pricing issues.
Sir Andrew said NICE does not take a view on the ongoing legal battle, but said the case will prove an intriguing one.
"It’s actually a fascinating story, because it weaves together all sorts of interesting strands around drug development, the regulatory process, the origin of the ownership of individual molecules, the physical relationships between the pharmaceutical companies and the politics of the NHS.
"And the heart of it, of course, is what is the right thing to do for individual patients."
Thursday, May 03, 2012
Novartis action over off-label Avastin backed by ABPI | PJ Online