Alleged damage of 200 million euros to the National Health System: investigation into Aifa executives

The investigations would have made it possible to ascertain that the Avastin and Lucentis drugs had the same therapeutic equivalence, as shown by a series of comparative studies. But despite this, the first was not included among the products reimbursable by the National Health Service until 2014 and a series of "unjustified limitations" were imposed on its use at least until 2017, causing an increase in spending for the State.

To the total of 200 million, the Gdf says, we have arrived by calculating the price difference between the drugs – between 600 and 730 euros per single dose – in relation to the number of treatments that have been carried out with Lucentis instead of Avastin . The AIFA executives and members of the Agency's technical scientific commission now have 60 days to provide their version to the Court of Auditors. On the sale of the two drugs, the Authority for the competition and the market has also ruled in the past: in 2014 the Authority in fact fined the two pharmaceutical manufacturers – Roche and Novartis – with a fine of over 180 million for having created a sort of 'cartel', deciding on a product differentiation that was actually artificial.

"The two groups have unlawfully agreed to hinder the spread of the use of a very cheap drug, Avastin, in the treatment of the more widespread eye disease among the elderly and other serious eye diseases, to the benefit of a much more expensive product , Lucentis, artificially differentiating the two products. For the National Health System the agreement entailed an additional outlay estimated at over 45 million euros in 2012 alone, with possible higher future costs up to over 600 million euros a year ", wrote the Authority in 2014.

"The conduct of the companies – added the Authority – find their economic explanation in the relations between the Roche and Novartis groups: Roche, in fact, has an interest in increasing Lucentis sales because through its subsidiary Genentech – which has developed both drugs – obtains relevant royalties from them from Novartis. The latter, for its part, in addition to gaining from the increase in sales of Lucentis, holds a significant stake in Roche of over 30% ". The Antitrust sanction was recently confirmed by a sentence of the Council of State, which rejected the appeal of the two pharmaceutical companies condemning them also to pay the costs.