EU Court Backs Reimbursement Scheme for Off-Label Drug

(CN) – The European Court of Justice refused to stand in the way Wednesday of Italy’s reimbursement of the cancer drug Avastin for an off-label use: the treatment of age-related macular degeneration.

In Italy the undertaking Roche Italia holds the marketing authorization for Avastin, and the country’s National Health Service offers reimbursement for the product as an ARMD treatment so long as it is repackaged in authorized pharmacies. Specifically for ophthalmological purposes, pharmacies must divide Avastin from its original vial into single-use syringes for intravitreal injection.

ARMD patients can use the authorized treatment Lucentis instead, but the product by Novartis Farma is significantly more expensive than Roche’s Avastin. Whereas Avastin repackaged for ophthalmological uses costs National Health Service 82 euros per dose, Lucentis costs it 902 euros.

Novartis in turn urged Italy’s Council of State to overrule its competitor’s reimbursement scheme, alleging that it is incompatible with EU pharmaceutical law.

This challenge led the Council of State to put the case on hold and seek input in Luxembourg from the European Court of Justice.

Rejecting the allegations by Novartis on Wednesday, that body’s First Chamber found that nothing about Avastin’s ophthalmological preparation involves “transformations” not covered by the terms of its marketing authorization.

“The processes for repackaging Avastin undertaken in accordance with the national measures at issue in the main proceedings do not significantly change the composition, form or other fundamental characteristics of that medicinal product,” the ruling from the five-judge panel states. “Those repackaging processes cannot be regarded as the ‘preparation’ of a new medicinal product derived from Avastin by means of a magistral formula or an officinal formula.”

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