Recently, the French Competition Authority concluded its investigation into Roche and Novartis for Lucentis marketing missteps, fining Roche and Novartis a collective $526 million ($455 million levied against Novartis and $71 million against Roche). The investigation started in 2014, when the French Competition Authority raided the local offices of Roche and Novartis searching for evidence of missteps the companies made while marketing Lucentis for age-related macular degeneration (AMD).
Roche, through its subsidiary Genentech, developed Lucentis and partnered with Novartis to commercialize the drug. Roche sells the drug the US while Novartis markets it in the European countries. The Authority believes that Novartis, Roche, and Genentech should be regarded as forming a “collective entity” based on the cross capitalistic links and the contractual links that exist between the three of them.
The Authority found that Novartis and Roche allegedly engaged in anti-competitive practices by promoting Lucentis over Roche’s less expensive cancer drug Avastin, which can be used off-label to treat AMD. As there was a significant difference in treatment cost for patients using Lucentis versus Avastin, any use of Avastin instead of Lucentis would likely lead to a significant loss of earnings for each of the three companies involved.
Novartis sought to stop ophthalmologists who decided to prescribe Avastin “off-label” in ophthalmology by disseminating a disparaging speech which exaggerated the risks associated with the “off-label” use of Avastin for the treatment of AMD, and more generally in ophthalmology, in comparison with the safety and tolerance of Lucentis for the same use.
This practice limited the prescriptions of Avastin “off-label” for the treatment of AMD and, more generally in ophthalmology. It also had the indirect consequence of maintaining Lucentis at a particularly high price, which led to the fixing of the price of Eylea (a competing specialty which entered the market in November 2013) at an artificially high level.
Not the First Time
These fines follow 2014 fines levied by the Italian authorities, totaling €180 million, in response to similar allegations. In that case, Roche and Novartis attempted to fight the fines, but an Italian court upheld the charges and punishment.
Company Responses
In response to the announcement, Novartis has noted that the company is planning an appeal, stating it is “very disappointed” and “strongly refutes” the allegations of anti-competitive practices. The statement read, “Novartis believes that this decision relies on a gross misinterpretation of the facts and a distortion of previous case law that is not intended to cover the situation in this case.”
Roche also seems to disagree with the Authority’s finding, saying it does believe it was in compliance with local health regulations, but stopped short of calling for an appeal, instead indicating they are “assess[ing] our next steps.”