* Italian regulator fines Novartis, Roche 182.5 mln euros
* Says drugmakers colluded to obstruct use of Avastin
* Both firms will appeal the verdict
* Rome prosecutors open a file on the companies - sources (Adds statement from Italian health ministry)
By Katharina Bart and Silvia Aloisi
ZURICH/MILAN, March 5 (Reuters) - Italy’s antitrust authorities said Swiss drugmakers Novartis and Roche colluded to try to stop cancer drug Avastin being used to treat a serious eye disease, and fined the companies 182.5 million euros ($251 million).
In a statement on Wednesday, Italy’s regulator accused the two Basel-based firms of striking an alliance to prevent distribution of Roche’s Avastin as a treatment for wet age-related macular degeneration (AMD) in favour of the more expensive drug Lucentis made by Novartis.
It fined Novartis 92 million euros ($126.4 million) and Roche 90.5 million euros.
Prosecutors in Rome opened a file on the two companies following the Italian antitrust regulator’s move, judicial sources said later on Wednesday.
However they said no formal investigation was underway and there was no suspicion of any criminal practice.
Novartis and Roche strongly denied the regulator’s assertions and said they would appeal.
Although the fines are relatively small, they underline how cash-strapped governments are scrutinising more closely the way drug companies sell their products.
The authority said it estimated that the alleged collusion has cost the Italian health service an additional 45 million euros in 2012, and said that figure could possibly exceed 600 million euros a year in the future.
Italian Health Minister Beatrice Lorenzin said she had asked her ministry’s top scientific officials to verify whether there were any risks to eye patients from using Avastin.
She also asked officials whether there were any grounds for reviewing a 2012 decision by the Italian Pharmaceutical Agency (AIFA) to exclude the drug from a list of treatments reimbursable by national health authorities.
Although Avastin is not licensed for AMD, it works in a similar way to Lucentis and is widely prescribed on a so-called “off label” basis. A 2011 study concluded that the drug worked as well as Lucentis in treating vision loss from AMD but that it had more adverse side effects.
Lucentis is marketed by Novartis outside of the United States and is an important drug for the company with sales of $2.38 billion last year, making it its third-biggest seller.
Sales of Lucentis for Roche, which markets the drug in the United States, were 1.69 billion Swiss francs in 2013.
$1 = 0.7277 euros Reporting by Katharina Bart and Caroline Copley in Zurich, Silvia Aloisi in Milan, James Mackenzie and Mario Sarzanini in Rome; editing by David Holmes, Tom Pfeiffer and Tom Heneghan