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Rome – La Repubblica tells the story in an article by Michele Bocci: in 2005 Roche began producing the Avastin, which is used for the colon cancer but it also works for an eye disease like macular degeneration. However, the manufacturer does not ask for the extension of use and the drug is used off label. Then comes the competition:
Since 2007, the Lucentis from Novartis, which until recently cost 1,044 euros per vial (now the price has dropped by 30%). On average, 6 vials per patient are made each year. With the other product, prepared by hospital pharmacies, an application costs 15-20 euros. According to Nicola Magrini, of the Emilian Health Agency, "Roche's decision not to place its drug on the market and the advantage for Novartis reveal the existence of agreements that limit competition and weigh economically on the community".
People with macular degeneration in Italy there are 90 thousand. A third are treated in the public system, now almost exclusively with Lucentis. The others are followed in private, not even Novartis knows with which product.
According to extensive scientific literature, ranibizumab and bevacizumab (the two active ingredients) are equivalent and in the US Avastin has about the 70% on the market. In our country the situation is very different. The drug was initially included by Aifa in the list of those usable "off label". Two years ago, Emilia decided that only that should be used in its hospitals.
Novartis has resorted to the Tar because only Lucentis is cleared for macular degeneration. The matter went to the Constitutional Court. More recently it was the turn of the Veneto region, which the Tar imposed to use the expensive drug on new patients. “We will call the Council of State into question – says the health councilor Luca Coletto – Avastin has never given us problems, why do we have to stop? ».
The turning point came recently, on October 27:
AIFA has removed Avastin from the list of drugs "payable by the Health Service" if used "for a therapeutic indication other than the authorized one" because the EMA, the European drug agency, has reported some adverse reactions, common to all "vegf inhibitors". Lucentis also belongs to this category but having the authorization for the trade for macular degeneration, it was enough to include the possible problems in the package insert.
