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European court approves off-label Avastin use for AMD following extended legal battle

The European Court of Justice (ECJ) has ruled the drug Avastin can be used off-label to treat eye disease, thwarting further attempts from competing drug company Novartis to block it from the European market.

The decision paves the way for Italy’s national health system to continue reimbursement for use of the Avastin (bevacizumab) in treating age-related macular degeneration (AMD), something it has done since 2014.

Avastin, which was developed by Roche, is marketed to treat certain cancers, but is often prescribed off-label for AMD in Italy at a much less expensive rate of €82 (AU$129.84) per dose, compared with Novartis’ Lucentis, which is around €900 (AU$1,425) per dose.

For ophthalmolmic purposes, Avastin is extracted from its original vial and divided into single-use syringes for intravitreal injection, leading to fears that repackaging could risk infection or dosing errors.

Novartis challenged Italy’s policy of allowing thee off-label use of Avastin in the Italian judicial system, which the Council of State, Italy, took to the ECJ.

In its judgement, the ECJ ruled against Novartis, stating the management of health services – including setting prices for products and deciding whether to include them on formularies – were the responsibility of EU member states themselves.

In addition, the court indicated repackaging of Avastin for intravitreal injections was not prohibited by EU law, and not an activity that requires a new marketing authorisation. It also noted that the “pharmaco-vigilance efforts” already in place for the drug were sufficient to cover its off-label use.

For Novartis, the defeat comes in the wake of another failed legal challenge last September, when it combined with Bayer to try and prevent doctors prescribing Avastin for AMD in the UK.

In this case, the High Court ruled that despite Avastin being unlicensed for eye disease treatment, it could be offered as an alternative to the Novartis and Bayer products.

The decision is expected to saved the UK’s National Health Service hundreds of million of pounds per year. However, both companies have appealed the UK ruling.

Younger Optics

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