France ‘to approve’ Avastin use
pharmafile | July 3, 2014 | News story | Sales and Marketing | AMD, France, Lucentis, Novartis, Roche, avastin, off label, off-label, wet AMD
The French government is planning to allow Roche’s cancer drug Avastin to be prescribed off-label to treat wet age-related macular degeneration (AMD).
In a move which has infuriated Novartis, Reuters reports that the government has introduced an amendment to its social security budget bill – which has not yet been voted on – allowing doctors to use Avastin (bevacizumab) as a treatment for the eye condition.
Off-label prescribing of Avastin in this therapy area has been relatively common, but Novartis’ issue with this is that its own drug Lucentis (ranibuzimab) is actually licensed for wet AMD, works in a similar way to it – but is considerably more expensive.
Lucentis was developed by Roche subsidiary Genentech and Novartis. Genentech holds the rights to the drug in the US, while Novartis has exclusivity in the rest of the world.
Novartis has no rights to Avastin, which is marketed by Roche as a treatment for several cancers.
In a statement, Novartis warned that patients could be exposed to safety issues if Avastin is used for wet AMD. “Bevacizumab was designed and is approved for the treatment of patients with certain forms of cancer and is not manufactured or approved by health authorities for use in the eye,” it said.
“There is a growing body of evidence suggesting safety concerns associated with the unlicensed use of bevacizumab in the eye,” the company went on. “There are retrospective database analyses pointing to systemic and ocular safety issues with unlicensed intravitreal bevacizumab compared to Lucentis, as well as clinical studies and reports of clusters of ocular safety events with unlicensed intravitreal bevacizumab.”
On the vexed issue of price, Novartis insists it has an “excellent track record of working with health authorities and reimbursement agencies across the world to secure statutory access to medicines for patients.
“We take great care to price medicines fairly based on the value they deliver to patients, the scientific innovation they represent, the cost of the current therapies and the associated costs of research and development,” the Basel-based firm added.
Novartis also suggests that the European Court of Justice has said that cost or economic grounds are not valid reasons to justify prescribing an off-label drug.
The situation is further complicated by the fact that Novartis and Roche have been under investigation over claims that the companies colluded to stop Avastin from being used by doctors to treat wet AMD.
French competition authorities have already began their own investigation into the claims, with the Authorite de la Concurrence making unannounced visits in April to unnamed companies in France suspected of being involved in ‘anti-competitive activities’.
And in May Italy’s health ministry said it was looking for €1.2 billion in damages from the companies. Both firms have consistently said that there is no such agreement between them but in March, Italy’s antitrust authority fined them €182.5 million nonetheless.
European Union regulators have also been considering whether they need to take any action over the allegations.
There has been no formal move by the European Commission, but Joaquin Almunia, vice president of the EC in charge of competition issues, has been quoted as saying regulators were ‘gathering information’.
Adam Hill
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