Roche and Novartis fined $251m for Avastin collusion in Italy

Novartis and Roche have been fined €182.5 million ($251 million) in Italy for colluding to block use of Roche’s Avastin in eye disease.

Italy’s anti-trust regulator AGCM announced the fine after concluding the companies worked together to block distribution of Avastin in favour of Lucentis for wet age-related macular degeneration.

The drugs are very closely related, and were both developed by Roche’s biologics arm Genentech, but Lucentis is much more expensive when used to treat the serious eye condition wet age-related macular degeneration (wet AMD).

Avastin is not licensed to treat wet AMD, but ophthalmologists and healthcare systems around the world have been using it off-label in order to save money for a number of years.

The Italian regulator calculated that the collusion had cost its national health service an estimated €45 million in 2012 alone, with further future annual costs in excess of more than €600 million.

Novartis has been ordered to pay €92 million and Roche €90.5 million, but both say they have no agreement to restrict competition, and will appeal the verdict.

The investigation concluded that both companies had portrayed Avastin as being dangerous for use in the off-label use in wet AMD, thus influencing doctors and health services. The regulator said there was a huge difference in cost in these patients – Avastin costs up to €81 euros, compared with around €900 for Lucentis, it said.

BEUC, the European Consumer Organisation is a consumer advocacy group, and condemned the two companies for having blocked cheaper medicines.

“The unethical tactics of Roche and Novartis to block the cheaper alternative at the expense of consumers are unacceptable,” Monique Goyens, the group’s director general, said in a statement.

Goyens called for the European Commission to launch an investigation at the EU level to determine if the companies had had a similar impact in other member states.

Novartis challenged the AGCM ruling, saying patient safety and risks associated with using off-label medicines was a ‘critical issue’ and said its decision encourages the widespread use of Avastin outside its licensed use.

Italy is not the only country to have challenged the companies over the price difference, with skirmishes with healthcare systems across Europe and in the US. A number of academic groups have undertaken trials to determine Avastin’s safety and efficacy in wet AMD, with one 2010 study concluding that Avastin worked as well as Lucentis in treating the disease.

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Novartis’ Lucentis granted new EU indication

 

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