Editor's Note: 28th September 2018 - Bayer has issued a statement saying it will appeal against the High Court ruling.
Twelve NHS clinical commissioning groups (CCGs) in the north east of England have fought off a High Court challenge to the prescribing of bevacizumab (Avastin, Roche) for wet age-related macular degeneration (AMD).
The pharmaceutical companies Bayer and Novartis, who manufacture other drugs for the condition, challenged the lawfulness under EU rules of a policy designed to save money as bevacizumab, which is significantly cheaper, isn’t specifically licenced for ophthalmic use for wet AMD.
Court papers show bevacizumab costing around £28 for every injection compared with aflibercept (Eylea, Bayer) at around £816, and ranibizumab (Lucentis, Novartis) at £551. The actual amounts could vary depending on any undisclosed discounts.
The prescribing was challenged due to a lack of a marketing authorisation for ophthalmic use of bevacizumab, undermining of the EU Medicines Directive, and denying patients access to the drugs aflibercept and ranibizumab despite them being recommended by the National Institute for Health and Care Excellence (NICE). A patient information leaflet about the bevacizumab policy was also alleged to be misleading and inaccurate.
Today, the judge, Mrs Justice Whipple, ruled that the grounds for challenging the policy had failed. The ruling said the protection given by the Medicines Directive was overstated, and patients were not excluded from access to the other drugs recommended by NICE.
'Great Day for the NHS and Patients'
The Royal College of Ophthalmologists (RCOphth) welcomed the ruling.
RCOphth Scientific Chair, Professor Andrew Lotery, said: "This is a great day for the NHS and patients. The ruling is extremely welcome as the Royal College has long petitioned on the use of Avastin as an effective treatment for wet AMD. Our members, ophthalmologists overseeing the treatment of patients with eye disease, can now feel assured that they can offer the best treatment for their patient’s individual needs. We expect that the release of funds in the use of Avastin will be secured to improve patient care within the hospital eye service."
Although bevacizumab offers a drug price advantage per injection, RCOphth cautions that clinical capacity planning will have to take account of the potential need for more injections per patient.
The College President Mike Burdon added: "It is important that the regulatory bodies such as the GMC and the MHRA now reflect on the best ophthalmic practice in the light of this ruling and the previous supporting guidance from NICE. Licensing laws are designed to protect patients from poorly regulated and unproven drugs. As recently as January, NICE guidance concluded that there was ‘no clinically significant differences in effectiveness and safety’ between Avastin and the current licenced drugs."
Appeal Planned
A week after the judgement, Bayer said it intends to seek permission to appeal against Mrs Justice Whipple's judgment at the Court of Appeal.
In a statement Bayer said it 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 statement continued, saying: "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."
Cite this: Tim Locke. NHS Wins High Court Case Over Avastin for Wet AMD - Medscape - Sep 21, 2018.
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