Italy: Use Avastin off-label

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Italy is giving the go-ahead for patients to use Roche's Avastin off-label to treat age-related macular degeneration, reports Bloomberg. The move means the Italian Medicines Agency is guiding patients away from Roche's costlier AMD-indicated Lucentis.

The decision follows Italy's earlier censure of the company over allegations that Roche and Novartis presented Avastin as a dangerous alternative to Lucentis, and assessed a $251 million fine over the allegations.

Bloomberg notes that Lucentis costs 40 times more than Avastin in the US, which means Roche and Novartis, which shares European sales with Roche, could lose a bundle if patients start using Avastin. Healthcare analyst Asthika Goonewardene told Bloomberg this could trigger other countries to follows suit.

Novartis told Bloomberg that Italy's decision runs up against European law. The European Federation of Pharmaceutical Industries and Associations—PhrMA's equivalent—told BioCentury the news means EU member states are creating “secondary, national marketing authorizations for reasons that undermine the EU regulatory framework and could potentially put patients at risk.”

The push for off-label consideration is not limited to Europe. Researchers noted in a study last week that migrating US patients to Avastin could save the Centers for Medicare and Medicaid $18 billion, a number that includes giving doctors the same level of reimbursement for the cheaper medication.

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