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France allows use of cheaper, unlicensed medicine in eye treatment

Out-Law News | 02 Apr 2015 | 11:58 am | 2 min. read

A French regulatory committee has recommended that doctors be given approval to prescribe an unlicensed drug for use in treating macular degeneration, despite a licensed alternative being available. 

The agence nationale de securité du médicament et des produits de santé (ANSM), the body responsible for assessing the risks of medical products, has recommended a 'temporary use recommendation' (RTU) to Roche's anticancer drug Avastin to treat the eye disease 'wet age-related macular degeneration' (AMD).

The ANSM announced that its risk/ benefit committee had recommended use of the drug, which is unlicensed for the treatment of AMD, despite the fact that two licensed treatments are on the market: Novartis' Lucentis and Bayer's Eylea.

Doctors have been engaging in the unlicensed prescribing of Avastin for AMD for some time, said Emmanuel Gougé of Pinsent Masons, the law firm behind Out-Law.com. The ANSM therefore contacted Roche last year to request information on the use of Avastin with a view to taking a decision on its use.

The use of Avastin instead of Lucentis, which costs up to 30 times more, could save the French state around €200 million (US$214 million), Reuters said in a report on the ANSM request last year.

Novartis owns one-third of the shares of Roche. Novartis and Roche have argued that Lucentis should be used over Avastin, Gougé said. Avastin is unlicensed, and has not been manufactured for ocular treatments, the companies say, and its use raises issues of product liability and health and safety. Large vials of the drug have to be broken down into smaller amounts, and this introduces a risk of infection, they said.

Gougé said he would advocate caution in swapping treatments for pure economic reasons.

"It is unwise to sidestep the regulatory process unless there are good reasons to do so for individual patients," he said. "In this case the potential health risk and liability issues associated with manipulating the product – splitting the Avastin vials into the smaller doses required to treat the eye – also needs to be considered."

"However, if the scientific evidence supports the use of one product as an interchangeable treatment over another more costly one and then what's needed is a change in the law so that an appropriate licence can be obtained for the cheaper alternative," Gougé said.

The French decision follows a similar move in Italy, where antitrust authorities fined Novartis and Roche a total of $250 million in early 2014 for preventing doctors from prescribing the cheaper drug, The New York Times reported.

In June 2014 Italy went on to change the rules on off-label (unlicensed) drugs, allowing them to be prescribed for different treatments than those they were originally intended for.

In the UK, too, there is a renewed call for an appraisal by NICE of the use of Avastin for wet age related macular degeneration and also for the General Medical Council to amend its current guidance, said UK life sciences expert Helen Cline of Pinsent Masons.   

"The GMC did consult previously about a change to its prescribing guidance but the legal advice at the time was against changing it and the legal position hasn't changed."

"Currently a physician can make a decision on prescribing a drug for an off label or unlicensed use when they consider it to be in a patient's interests and there is no licensed alternative," she said.