The European Union’s antitrust chief said regulators are “gathering information” on whether Roche Holding AG (ROG) and Novartis AG (NOVN) colluded to prevent the use of Roche’s cancer drug Avastin to treat an eye disease.
The European Commission “will assess whether further action is needed in this area,” said Joaquin Almunia, the EU’s antitrust chief, in response to a question from an EU lawmaker dated yesterday. He declined to comment further on the “precise content of its current investigative activities.” The EU hasn’t opened a formal probe of the companies.
Roche and Novartis were fined 182.5 million euros ($254.4 million) by Italy for blocking sales of Avastin in favor of a more expensive drug, Lucentis, that the two companies market jointly for an eye malady known as wet age-related macular degeneration. Their actions cost Italy’s health system more than 45 million euros in 2012, the country’s antitrust authority said. Novartis is appealing the decision.
Italy’s conclusions aren’t “an indication of the existence, or not, of similar behavior in other member states,” Almunia said. The Italian case is “factually and legally, closely related to the Italian regulatory framework.”
Roche and Novartis described Avastin as “more dangerous” than Lucentis to sway doctors and health services, the Italian authority said in March. Italy only recently approved off-label use of a medicine where doctors may use a drug approved for one condition to treat another. This would allow them prescribe Avastin as an eye treatment.
Antoine Colombani, a spokesman for Almunia, declined to comment beyond Almunia’s response. He said in March that the Italian case was “very specific due to the local regulation concerning off-label use. Avastin doesn’t have EU-wide approval as an eye drug.
‘‘Roche confirms there is no agreement between Roche and Novartis that restricts competition,’’ Nicolas Dunant, a spokesman for the company, said in an e-mail. Novartis hasn’t been informed of any investigation into alleged anti-competitive practices between itself and Roche in relation to Lucentis and Avastin, Anja von Treskow, a spokeswoman for the company, said in an e-mail.
France is also probing Roche and Novartis and last month raided companies it didn’t name to seek evidence. Almunia said the EU was in close contact with France and other national competition authorities.
The European Consumer Organisation, a consumer advocacy group known as BEUC, has asked the EU to investigate, saying it is unacceptable that ‘‘unethical tactics” by the companies have blocked sales of a cheaper alternative treatment.
“This case undoubtedly requires an EU-wide investigation as both medicines have been approved” by the European regulator and “are available in most EU member states,” Ilaria Passarani, Senior Health Policy Officer at BEUC, said in an e-mail. “Consumers have the right to access cheaper medicines.”
European authorities are monitoring drug prices more closely as governments face ballooning health-care costs because of an aging population and as the number of patients suffering from chronic diseases such as diabetes rises.
A study in 2010 found that Avastin worked as well as Lucentis in treating the disease. Roche hasn’t sought regulatory approval for the use of Avastin in the eye malady and has fought efforts in the U.S. to expand the use of the drug for that purpose.
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