MHRA says Avastin can be used for AMD despite Bayer, Novartis objections

The UK drugs regulator has endorsed the use of Roche’s Avastin as a treatment for age-related macular degeneration, a leading cause of blindness, even though it isn’t approved for that use.

The Medicines and Healthcare products Regulatory Agency (MHRA) looked into off-label use of Avastin (bevacizumab) for AMD in the context of an ongoing judicial review requested by Bayer and Novartis, which sell authorised AMD drugs and have long-argued that Roche’s drug shouldn’t be used in this way.

The MHRA’s statement comes down on the side of 12 NHS Clinical Commissioning Groups which have implemented a policy of using diluted and repackaged Avastin as a low-cost alternative to the two approved treatments – Bayer’s Eylea (aflibercept) and Novartis’ Lucentis (ranibizumab).

All three drugs are VEGF inhibitors, blocking the growth of abnormal blood vessels in the back of the eye that are responsible for the progressive loss of vision in the wet form of AMD, but Avastin is approved only for cancer indications.

In its judgment, the MHRA has determined the process of compounding Avastin to produce multiple doses, usually in plastic syringes, doesn’t exceed what is allowed for off-label use of a drug as the medicines regulatory regime “does not legislate how medicines are to be prescribed and used by healthcare professionals once they have been placed on the market.”

Avastin costs around £28 per injection when used off-label as an intravitreal injection for AMD, which compares to a cost of £816 for Eylea and £551 for Lucentis, according to the judicial review documents.

The MHRA does note that if Avastin were to be made available in single-dose syringes intended for AMD treatment they would fall under the category of an unlicensed medicine and would need marketing authorisation. That may be relevant as biosimilars of Avastin become available in Europe.

Last year, the High Court ruled that it is lawful for the NHS to prescribe Avastin instead of the licensed drugs, a verdict which was subsequently challenged by Novartis and Bayer. A long-running bid to block off-label use of Roche’s drug in Italy was subsequently also rejected by the European Court of Justice.

Avastin is dosed at four to six-week intervals for AMD, while Eylea is given every four to eight weeks and Lucentis once a month. Novartis is developing a follow-on drug – brolucizumab – that could cut the dosing frequency to 12 weeks.