Avastin-Lucentis: the Council of State confirms the sentences for Roche and Novartis

There is no longer any doubt regarding the matter: Roche and Novartis put an anti-competitive agreement in place to artificially favour the sale of Lucentis (Novartis) to the detriment of Avastin (Roche), both effective drugs in treating exudative maculophaty, but one (Lucentis) considerably more expensive than the other (Avastin).

“It took 10 years and 4 different levels of judgement – declared Ivo Tarantino, Altroconsumo External Relations Manager – but in the end the tireless commitment that saw us set to work straight away to protect consumers has paid off. Over the past few years, there have been many attempts by the two companies to turn the tables on the matter, with extreme technicalities that had nothing to do with the heart of the issue in question: patients that were denied access to treatment for a disease as serious as maculopathy and the health service which had to pay tens of millions of euros due to the heinous unlawful collusion of the two pharmaceutical companies.”
 

These are the stages of the story, which Altroconsumo has followed closely in the interest of patients and consumers as a whole

Avastin and Lucentis are medicines developed by Genentech, a company belonging to the Roche group. Genentech entrusted the commercial exploitation of Lucentis to the Novartis group through a licence agreement. Roche marketed Avastin.

Lucentis is authorised for the treatment of ophthalmic diseases. As it costs less than Lucentis, Avastin, equally effective in retinal diseases, although only authorised for the treatment of tumours, was also widely used for the treatment of ophthalmic diseases (off label use):

• between 2009 and 2012, the Italian Medicines Agency (Aifa) gradually suspended all uses of Avastin permitted under the reimbursement regime. Prescriptions moved over to Lucentis. Roche and Novartis agreed, in fact, to artificially differentiate between the two drugs, mainly trying to prove that Avastin posed greater risks, against the evidence coming from clinical experience and from all independent studies;
• Avastin could no longer be reimbursed by the Health Service and patients no longer had a treatment. Or they were forced to pay for it privately out of their own pocket if they had the means;
• the additional cost for the National Health Service is calculated at €45 million for 2012 alone;
• ·on 5 May 2014, the Antitrust Authority fined the two pharmaceutical companies at the end of a proceeding initiated in 2013, also after petitions from the Society of Italian Ophthalmologists and other bodies and organisations, including Altroconsumo;
• the exemplary fine (over €90 million to both pharmaceutical companies) is the first of several pieces in the puzzle to achieve transparency on the matter and to ascertain the responsibilities of those who took advantage of the health of particularly weak and needy consumers. Altroconsumo also sent a petition to the Public Prosecutor’s Office in Rome, in Turin, and to the Court of Auditors;
• the two companies immediately filed an appeal with the Regional Administrative Court (TAR) in Lazio, which however rejected it in November 2014;

• Roche and Novartis then involved the Council of State which referred the case to the European Court of Justice. On 23 January 2018, the Court of Luxembourg responded to the preliminary questions presented by the Council of State, essentially confirming the validity of the Antitrust Authority’s findings and conclusions and referring the case back to the Italian judicial system for the final act of this long process.
   

Today, the final act has been played out and does justice to one of the most blatant cases of unlawful actions to the detriment of consumers, even more serious if we consider that the two pharmaceutical companies took advantage of the health of particularly weak and needy consumers. “We are obviously satisfied with the sentence and proud of having in some way acted as one of the instigators, but this isn’t the end of the road for us – concludes Ivo Tarantino. Altroconsumo in fact reaffirms the right/duty of the Regions, now that the sentence is final, to request compensation for the greater expense incurred over the years for the purchase of the more expensive drug.”