French lawmakers back Roche cancer drug as cheap eye treatment

Tue Jul 8, 2014 10:04am EDT

* Move could spark trend in budget-minded EU countries

* Experts say Avastin works well but poses some risks

* EU shift to Avastin a threat to Novartis, Bayer profits

By Natalie Huet

PARIS, July 8 (Reuters) - French lawmakers voted on Tuesday to allow the use of Roche's cancer drug Avastin as a cheap alternative eye treatment, in a budget-minded move critics fear could put patients' health - and company profits - at risk.

The French government amended its social security budget bill to allow doctors to use Avastin as a treatment for wet age-related macular degeneration (AMD)- a leading cause of blindness among the elderly. Lawmakers in France's lower house endorsed the new budget with 272 votes for and 234 against.

The decision opens a new front in a long-running battle over the unapproved use of Avastin in eye care and underscores how cash-strapped governments are finding creative ways to contain ballooning healthcare costs.

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.

Roche's Avastin is not approved by health regulators as a treatment for AMD, but works in a similar way to the treatments currently authorised for AMD - 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 bring annual savings of some 200 million euros ($273 million) - and the French move may prompt others in Europe to follow suit.

"The economic arguments are obvious," analysts at Berenberg wrote in a recent note. "If financial arguments prevail, this could put a big dent in these franchises for Novartis - and to a lesser extent Roche, which receives royalties - and Bayer, with implications for originator Regeneron, which receives royalties on European sales."

The analysts argue that there is a risk that France's move could spark a "Europe-wide contagion" that could, in a worst-case scenario, reduce both Novartis and Bayer's profits by around 3 to 4 percent.

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, costing the social security around 430 million euros.

Some doctors in the United States and Europe already prescribe the cheaper Avastin instead.

A closely watched U.S. government-sponsored study in 2011 concluded that Avastin worked as well as Lucentis in treating vision loss from wet AMD but had more adverse side effects.

Last week, Novartis strongly criticised France's plans which it said put patients at risk since Avastin is not safely formulated to be injected in the eye. Roche said that financial considerations by national healthcare bodies should not compromise patient safety and EU law.

In 2012, Novartis challenged the use of Avastin as a treatment for AMD in some British hospitals, saying doing so put cost savings ahead of patient needs.

Novartis and Roche have always discouraged substituting Avastin for Lucentis, saying the two drugs were developed for different therapeutic purposes. Both companies have in recent months faced regulatory scrutiny in France and Italy on suspicion of anti-competitive practices.

Italy said in May it was seeking 1.2 billion euros in damages from both companies, alleging they had colluded to try to stop Avastin from being used as an AMD treatment. The two companies have denied malpractice and said they would appeal the ruling.

Lucentis is marketed by Novartis outside the United States and is the company's third-biggest seller with sales of $2.4 billion last year. Sales of Lucentis for Roche, which markets the treatment in the United States, were $1.9 billion. ($1 = 0.7331 Euros) (Editing by Ben Hirschler)