Maximulta of the Antitrust against Roche and Novartis. The two large pharmaceutical companies will have to pay 92 and 90,5 million euros respectively for having set up a cartel that has influenced the sales of some medicines intended for vision care.
According to the Authority, "the two groups illicitly agreed to hinder the spread of a very cheap drug for the treatment of the most widespread eye disease among the elderly and other serious eye diseases (Avastin), to the advantage of a product much more expensive (Lucentis), artificially differentiating the two products”.
The Antitrust also underlines that "for the national health system, the agreement led to an additional outlay estimated at over 45 million euros in 2012 alone, with possible higher future costs of up to over 600 million euros a year".
Among the diseases affected by the investigation, senile macular degeneration stands out, the leading cause of blindness in industrialized countries and of which one million people are at risk in Italy alone. According to the Antitrust, the agreement had as possible consequence, among other things, a greater difficulty in the possibility of treatment for many patients.
The investigation was launched in February 2013 after reports received from Aiudapds, an association of private clinics, and the SOI-Italian Ophthalmological Society. The Emilia-Romagna Region and the consumer association Altroconsumo also requested and obtained participation in the proceeding.
NOVARTIS REPLICA…
Novartis has already announced that it intends to appeal the Authority's decision to the Tar. The pharmaceutical company "strongly rejects the allegations relating to anti-competitive practices implemented between Novartis and Roche in Italy - reads a note - and will exercise its rights of defense by appealing before the competent Court. The risks from unauthorized drug use are a critical issue and this decision by the Authority openly encourages the widespread unauthorized intravitreal use of Avastin. This is strongly in contrast with the European and Italian reference regulatory context, which aims to protect patient safety and which now risks being compromised. Roche's decision whether or not to request marketing authorization for Avastin for the ophthalmic indication, which it currently does not have, was taken in an absolutely unilateral manner. The factors that prevent or limit the off-label ocular use of Avastin in Italy have nothing to do with Novartis."
…AND ROCHE'S
Roche also "firmly rejects" the conclusions of the proceeding conducted by the Authority, stating in a press release that "the accusations are without any foundation" and that "it will appeal to all the designated offices, to protect its image and rights, certain of one's reasons".
In confirming "that there has been no anti-competitive agreement with Novartis", the company specifies "that Avastin (bevacizumab) and Lucentis (ranibizumab) are different drugs - in terms of composition, structure and method of administration - developed for different therapeutic purposes: Avastin (bevacizumab) is an oncological drug, while Lucentis (ranibizumab) is an ophthalmic drug”.
