Friday - September 28, 2018

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

Following the judicial review judgment on 21 September, the High Court has decided that in certain circumstances it is 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.

This follows a policy proposed by 12 Clinical Commissioning Groups in the North of England, solely for the purpose of saving costs.


Bayer considers that Mrs Justice Whipple’s conclusions are wrong in a number of key respects and, accordingly, intends to seek permission to appeal her judgment to the Court of Appeal. Bayer’s appeal will focus on two principal issues: our firm view that supply of unlicensed bevacizumab as envisaged by the policy, is unlawful; and our belief that the policy undermines the comprehensive licensing regime for medicines across the EU, which is designed to protect patients from harm, and the role of the EMA and the MHRA (duty of sincere co-operation).


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 wet AMD, that have been assessed as cost-effective use of NHS resources by the National Institute for Health and Care Excellence (NICE). This has the potential to set a worrying precedent that denies patients the protection afforded by the regulatory process.


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.



* *NHS Northumberland CCG; NHS Newcastle Gateshead CCG; NHS North Tyneside CCG: NHS South Tyneside CCG; NHS Darlington CCG; NHS Durham Dales, Easington and Sedgefield CCG; NHS North Durham CCG; NHS Hartlepool and Stockton CCG; NHS North Cumbria CCG; NHS Sunderland CCG; NHS Hambleton, Richmondshire and Whitby CCG; NHS South Tees CCG.




UKBAY09180367 / September 2018