Friday - September 21, 2018

Protecting patient access to licensed and NICE recommended treatments for wet age-related macular degeneration

Following a judicial review, the High Court has decided that, in certain circumstances, it is potentially lawful to offer patients bevacizumab injections for the treatment of wet age-related macular degeneration (wet AMD) in preference to approved licensed treatments, even though bevacizumab is not manufactured or licensed for use in the eye.

The judicial review followed a policy proposed by 12 Clinical Commissioning Groups* in the North of England to prefer use of bevacizumab over two licensed treatments solely for the purpose of saving costs. In her final judgement, the Judge stated that use of a single vial of bevacizumab for every injection would not be unlawful and “is a realistic method of meeting the Policy”. However she concluded that whether a policy, which involved compounded bevacizumab (rather than single vials) would be lawful, would depend on the facts of any given supply.


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. However, the cost implications of treating patients with wet AMD and preserving their sight extend far beyond the price of the medication. Bevacizumab, marketed as Avastin for the treatment of cancer, is not manufactured or licensed for use in the eye. 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. Bayer believes the ruling is a setback for public health. Physicians may potentially be required to encourage patients to choose a treatment which is unlicensed for use in the eye, over approved regulatory licensed treatments for this indication that have been assessed as cost-effective use of NHS resources by the National Institute for Health and Care Excellence (NICE).


Bayer applied for a judicial review of the policy that gives preference to treatment with bevacizumab which has not been licensed to treat eye conditions, including wet AMD, in order to defend important principles that protect patient access to licensed and NICE recommended treatments.


The needs of patients remain Bayer’s highest priority and we are committed to ensuring patients continue to have access to licensed medicines, adhering to regulatory frameworks that are designed to protect patient safety.


Following the judgement, Bayer is now considering all options available to us, including an appeal of the decision.