The Medicines and Healthcare products Regulatory Agency (MHRA) has clarified its position on the use of Roche's Avastin off-label as a treatment for wet age-related macular degeneration (wet AMD).
The watchdog has concluded that reformulating the drug into smaller vials for ophthalmic injection is a permissable off-label use of the product and does not constitute an unlicensed medicine.
The Agency was asked to review its published statements on the licensing status of Avastin when intended for intravitreal administration, in the context of the judicial review brought by Bayer and Novartis regarding the commissioning policy of 12 Clinical Commissioning Groups (CCGs) in the UK.
These CCGs favoured off-label use of Avastin over Novartis' Lucentis (ranibizumab) or Bayer's Eylea (aflibercept), also both anti-VEGF treatments but licensed specifically for the treatment of wet AMD.
Lucentis costs £551 per injection, Eylea £816 per injection, but Avastin’s price is much lower at just £28 per shot for use in wet AMD; an article published by the Guardian in 2017 argued that using the latter off-label to treat wet-AMD could save the NHS more than £84 million a year.
In 2018, concluding legal proceedings brought by Novartis and Bayer, the High Court ruled that, in certain circumstances, it is potentially lawful to offer patients Avastin injections for the treatment of wet AMD in preference to approved licensed treatments.
At the time, Bayer argued that the ruling “prioritises the cost of medication over doctors’ clinical judgement and expertise, as well as over the regulatory assessment of a medicine’s quality, efficacy and safety.”
Avastin is not manufactured or licensed for use in the eye, it stressed, adding that “a service using this product risks increasing the number of clinic visits and injections a patient needs for proper monitoring of their conditions and for sight-saving treatment, placing more strain on NHS services and the already stretched workload of NHS staff.”
Novartis and Bayer are currently appealing the High Court's decision.