Source: The NewYork Times
4 June 2014
PARIS — Italian antitrust authorities said on Wednesday that they had fined two Swiss pharmaceutical companies, Novartis and Roche Holdings, a total of $250 million for colluding to keep doctors from prescribing a relatively inexpensive eye treatment in favor of a more expensive drug.
The authorities said the two companies had sought to steer doctors away from Avastin, an anticancer drug developed by Genentech that has been used for years as an off-label treatment for common eye problems. Instead, they said, the companies had tried to “channel demand toward the much more expensive drug Lucentis, through an artificial distinction between the two products,” essentially by overstating the dangers of Avastin use.
It is not the first time such substitution efforts have brought an unwanted spotlight: Genentech got into trouble in the United States in 2010, when it was found to be offering doctors secret rebates to prescribe Lucentis over Avastin.
Novartis, which holds the rights to market the two drugs outside the United States, has been fined 92 million euros by the Italian regulators. And Roche, which acquired Genentech in 2009, was fined 90.5 million euros, for a total of about $250 million in the Italian case. Novartis and Roche strongly disputed the findings, stressing that Avastin had never been approved for use in the human eye, and said they would contest the fines in court.
“The charges are unfounded,” said Claudia Schmitt, a spokeswoman for Roche. “We will appeal the verdict.”
Novartis said in a statement that the Italian decision “openly encourages and promotes the widespread unlicensed intravitreal use of Avastin contrary to the requirements of European and Italian regulatory law,” and “undermines the European regulatory framework designed to protect patient safety.”
Genentech was not implicated in the Italian case.
The Italian case could have wider ramifications if other European Union member states or the union’s antitrust authorities began their own investigations. But European Union rules take into account only the on-label use of medicines, so such a case would presumably be outside of the bailiwick of the union’s antitrust officials.
Antoine Colombani, a spokesman for Joaquín Almunia, Europe’s top antitrust official, acknowledged the finding Wednesday, but said it was “very specific,” owing to Italy’s off-label regulations.
Avastin has never officially been approved for ophthalmic use, but doctors have been using it since the middle of the last decade to treat disorders like age-related macular degeneration, a common cause of blindness in the elderly.
Drug companies are not allowed to market their drugs for unapproved uses, but the law gives doctors wide discretion to use their own judgment.
Genentech began developing Avastin in 1997. The drug, also known by its generic name of bevacizumab, is now approved for treating cancers of the colon, lung, kidney and brain, and earned Roche about $7.2 billion last year.
Genentech began developing Lucentis, or ranibizumab, in 2000 as a treatment for age-related macular degeneration. Lucentis and Avantis are based on two different molecules, but both derive from the same mouse antibody and work according to a similar mechanism.
The Food and Drug Administration in the United States did not approve Lucentis for the eye condition until 2010 — by which time Avastin was already in wide use as an off-label treatment for macular degeneration.
Lucentis earned Roche about $1.9 billion last year.
Avastin and Lucentis are equivalent in treating age-related macular degeneration, according to tests sponsored by the United States government, and millions of patients worldwide have received Avastin in place of Lucentis with no ill effects. There have been, however, a handful of cases in which improper handling of Avastin led to contamination and serious side effects for some patients.
The Italian antitrust investigation, which dates to February 2013, started after complaints were filed by a group of private hospitals and the Italian Ophthalmologic Association.
A Lucentis injection costs about €900 in Italy, according to the antitrust authorities, while an off-label injection of Avastin costs €81 at most. The illegal agreement cost the Italian National Health Service more than €45 million in 2012, the authorities said, and could have cost as much as €600 million a year in the future.
They said the collusion might also “have hindered access to treatment for many patients.”
The Italian authorities discovered numerous messages between Roche and Novartis in which the two companies discussed what kinds of communications would be needed to induce doctors and hospitals to adopt the more expensive product.
According to one such message from early 2013, cited in documents in the case released Wednesday, growing cost pressure in Italy and France to use Avastin had “reinforced the political dimension of the debate,” and “further reinforcement of the Lucentis value proposition to all stakeholders is critical.”
Another message called for the companies to “work with diabetes patient groups to increase voiced concerns about safety risks of unlicensed therapies” — a reference to Avastin — for an eye condition known as diabetic macular edema.
Correction: March 7, 2014
A headline on a report in the Business Briefing on Thursday about two pharmaceutical companies’ being fined in Italy for colluding to steer doctors away from a lower-priced drug for a common eye problem misstated the relationship between the companies, Novartis and Roche, and the developer of the cheaper drug, Genentech. Roche acquired Genentech in 2009 and Novartis markets both Genentech’s drug, Avastin, and the more expensive alternative, Lucentis, outside of the United States. Genentech is not a “rival” of Roche and Novartis.