Bayer has said it will appeal a High Court ruling allowing a drug that is normally used to treat cancer to be given to patients suffering from a degenerative eye condition after insisting the decision was “a setback for public health.”
The pharmaceutical company, the makers of Eylea which is 30 times more expensive than Avastin, also known as bevacizumab and which was ruled by the court this month as suitable in certain circumstances to treat patients with age-related macular degeneration (Wet AMD), said Mrs Justice Whipple’s ruling was “wrong in a number of key respects.”
The court had backed a case brought by 12 clinical commissioning groups (CCGs) in the North-East of England to make the treatment available for patients with Wet AMD, a case Bayer maintained was based “solely for the purpose of saving costs.”
The company said its appeal will focus on two key issues; that the supply of unlicensed bevacizumab is unlawful and its belief the CCGs’ case “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).”
“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,” Bayer said.
“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.”