France is the latest country to baulk at paying a premium for Roche and Novartis' eye therapy Lucentis and recommend use of Roche's cheaper cancer drug Avastin instead.
The French government said earlier this week it is planning to amend its social security budgets to allow prescribing of Avastin (bevacizumab) for wet age-related macular degeneration (AMD) – a leading cause of blindness – even though the drug is not approved for that indication.
Avastin and Lucentis (ranibizumab) both act by inhibiting vascular endothelial growth factor (VEGF), but the cancer drug costs a fraction of its ophthalmic cousin and France estimates switching patients will save some €200m a year, according to Reuters. The measure will be voted on by lawmakers next week.
Novartis and Roche insist that Avastin's formulation was not developed for use in the eye and is manufactured to a different production standard, with higher permissible levels of particulate matter, which means it is not suitable for administration into the eye.
The active ingredients in both medicines were developed by Roche subsidiary Genentech. Roche holds US rights to Lucentis and Novartis holds the European licence.
Statements from both companies said that France's action in reimbursing off-label use of a drug for cost reasons is not in the “interest of public health” and is in violation of EU law.
France's stand follows a similar decision by Italy, which said a few weeks ago it would also change its reimbursement policy to allow Avastin to be used in place of Lucentis.
In May Italy's Ministry of Health said it was seeking €1.2bn in damages from Roche and Novartis for colluding to prevent doctors using Avastin to treat wet AMD, taking the lead from an earlier antitrust investigation in the country that resulted in the levying of a €182.5m fine.
Italy's probe centred on allegations that the two companies joined forces to block doctors from buying Avastin for use in treating eye diseases. Meanwhile, France and the EU have both been making noises about pursuing their own investigations into the companies' Lucentis dealings.
Lucentis has been a big earner for both companies, featuring at number 19 in PMLiVE's Top 50 pharmaceutical products list with sales of $4.18bn last year. Novartis has rights to the drug outside the US and took $2.4bn of that total.
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