Italy moves to fund off-label use of drug; follow-on to $1.72bn damages

The legal action follows the Italian government’s decision to seek an extra $1.72 billion in damages from Rocher and Npovartis on top of the $251 million in fines already imposed on th by the government, with investigations in France and the European Union in train at present.
Italy’s approach, which may look appealing to other European countries, drew a sharp rebuke from both companies as well as ‘Big Pharma’ in general.
“Novartis strongly rejects the Italian law allowing reimbursent of Avastin to be used off-label in the eye for economic reason as it is against European law,” a spokesman for Novartis, Mr Eric Althoff, said. Novartis markets Lucentis in Europe.
“Patient safety is of the highest importance for Novartis, and we urge the Italian Medicines Agency to promptly implent clear protocols and procedures around the use of Avastin including monitoring.”
The Italian government will cover Avastin, used to treat AMD, instead of Lucentis, which is approved for that condition. Ophthalmologists have long used Avastin off-label for treating the eye disease.
Both companies deny wrongdoing saying they have an obligation to let ophthalmologists know the perils of substituting one drug for another.
The economics of the situation are compelling. A recent study found that the United States Medicare syst could save $3 billion a year if Avastin was substituted for the $2,000-plus-per-dose Lucentis.
They are compelling for Roche as well. Avastin, first approved for colon cancer, is approved for multiple indications and generated $6.751 billion last year for the company, up 13%, but Lucentis, used only for eye conditions, generated nearly $1.9 billion with 15% growth last year. It is even more important for Novartis, which markets it outside the US. Novartis reported Lucentis sales of $2.38 billion last year.
The pharmaceutical industry, which stands to lose more revenue if drug substitution becomes a trend, has spoken out against Italy’s decision as well. The industry has seen little growth in the European Union in recent years as governments have already been cutting reimbursents and been slow to approve new drugs.
“We are concerned about efforts by European Union mber states creating secondary, national marketing authorizations for economic reasons that undermine the EU regulatory framework and could potentially put patients at risk,” Mr Richard Bergstro told Bloomberg in a statent. He is director general of the European Federation of Pharmaceutical Industries and Associations, a trade group that represents ‘Big Pharma’.