Now, Italy’s health ministry is seeking an additional euro 1.2 billion ($A1.72 billion) in damages.
The health ministry says the companies had a “horizontal agreent to restrict competition” and that the steep damages award it is seeking from th is justified by estimates of what Lucentis has cost the country’s health syst.
Paying for Lucentis rather than its alternative Avastin caused damages of euro 45 million ($61 million) in 2012, euro 540 million ($735 million) in 2013, and euro 615 million ($837 million) this year, the ministry says.
Roche developed Lucentis to treat age-related macular degeneration, which Novartis markets in Europe, but many ophthalmologists prefer to use the much-less-expensive cancer drug, Avastin, which is also effective against the disease but is off-label for treatment of AMD.
The two companies came under fire in Italy in February, when the Italian Competition Authority launched an investigation into allegations that Novartis and Roche had formed a cartel to restrict sales of Avastin to ophthalmologists. Both companies were fined in March.
In April, French authorities began their own probe, raiding local offices of Novartis and Roche. Then the European Union joined in, confirming in early May that it was “gathering information” on the question of whether the two companies colluded to protect Lucentis.
There are no results of those probes to date.
The two Swiss companies continue to deny the charges and did so again on 30 May. They both have said they plan to appeal.
The Avastin-vs-Lucentis controversy has been plaguing Roche and Novartis ever since Genentech (now a unit of Roche) won United States Food and Drug Administration approval to market Lucentis back in 2006.
Both drugs are known as VEGF inhibitors – they choke off the growth of harmful blood vessels – but many ophthalmologists around the world have chosen to use Avastin off-label because it is so much cheaper: in Italy, for example, a Lucentis injection costs the patient about euro 900 ($US1,230) compared with euro 81 ($US111) for Avastin, regulators there have estimated.
In Australia, a Lucentis injection costs the patient about $2,000 and an Avastin injection about $200.
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