November 06, 2014
By Natalie Huet
PARIS - French medicine agency ANSM has written to Roche asking the Swiss drugmaker for information on off-label uses of its cancer drug Avastin, which ANSM wants to let doctors prescribe as a cheap alternative eye treatment.
French lawmakers voted in July to allow such a use of Avastin instead of Novartis and Roche's much more expensive Lucentis, a budget-minded move that critics fear could put patients' health - and company profits - at risk.
French regulators are now in the process of gathering more data on the benefits and risks of using Avastin instead of Lucentis to treat wet age-related macular degeneration (wAMD)- a leading cause of blindness among the elderly.
ANSM said the letter had been sent to Roche on Oct. 21 and that the company had three months to reply.
The information provided by Roche, combined with ANSM's own research, will be examined early next year by an ANSM "risk-benefit committee" that is expected to make its recommendations public in the first half of 2015.
Roche's Avastin is not approved by health regulators as a treatment for wAMD, but works in a similar way to the drugs currently authorized for the condition - Lucentis, marketed by Novartis and Roche, and Eylea, from Germany's Bayer and Regeneron.
France argues that encouraging the use of Avastin, which costs around 30 times less than those rival treatments, could save some 200 million euros ($250 million) annually. The move may also prompt others in Europe to follow suit.
But drugmakers and some medical experts worry that allowing such off-label uses of a drug without adequate clinical trials could raise health risks, including infections.
Novartis and Roche have always discouraged the substitution of Avastin for Lucentis, saying that the two drugs were developed for different therapeutic purposes.
"We have received the letter regarding the evaluation process in wet AMD to be started and we will of course fully cooperate with the authorities," a Roche spokeswoman said on Thursday. "Our position regarding the use of Avastin in wet AMD has not changed."
SPARKING A TREND?
In its letter, made public on its website, ANSM asks Roche for any data the drugmaker has on the safety and efficacy of Avastin in wAMD or the detail of ongoing studies on the topic. It also asks Roche how it plans to monitor patients being administered Avastin for such an off-label use.
ANSM chief Dominique Martin told reporters that even if Roche chose to drag its feet in the process, ANSM experts already had plenty of research on the use of Avastin in wAMD that they could build their analysis upon.
An independent study published in September showed injecting Avastin into the eye did not appear to increase deaths or serious side effects and that there was no evidence to support current policies favouring Lucentis.
Industry observers reckon that France's move may spark a trend across Europe, as cash-strapped governments seek ways to contain their healthcare costs.
Some doctors in the United States and Europe already use Avastin in wAMD on an unapproved basis and some pharmacies offer to split the cancer medicine into smaller doses for eye injections.
Lucentis, for which a single injection can cost as much as 900 euros, was a leading reimbursement charge in France's healthcare budget last year.
If ANSM eventually decides to issue a temporary authorization to use Avastin in AMD, that authorization, called an RTU, will be valid for an extendable three-year period.
Lucentis is marketed by Novartis outside the United States and is the company's third-biggest seller, with $2.4 billion in sales last year.
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