A United Kingdom court has ruled in favor of the National Health Service, allowing the health system to provide intravitreal injections of the anti–vascular endothelial growth factor agent bevacizumab to patients with age-related macular degeneration (AMD).
A United Kingdom court has ruled in favor of the National Health Service (NHS), allowing the health system to provide intravitreal injections of the anti—vascular endothelial growth factor (anti-VEGF) agent bevacizumab to patients with age-related macular degeneration (AMD).
Bayer, which markets aflibercept (Eylea), and Novartis, which markets ranibizumab (Lucentis) had jointly challenged the lawfulness of a policy adopted by 12 NHS Clinical Commissioning Groups in the northern region of England. The policy held that bevacizumab (Avastin) would be offered to patients as a preferred treatment option due to its cost-effectiveness for treating AMD.
According to Bayer and Novartis, because bevacizumab does not have a marketing authorization from the European Medicines Agency (EMA) for treating eye disorders—while the anti-VEGF agents aflibercept and ranibizumab both hold such marketing authorizations—using bevacizumab off-label to treat patients with these indications undermined patients’ rights to receive approved therapies for their disease.
The court ruled that the NHS’ policy was indeed lawful, saying that the EMA does not have the sole authority to determine whether bevacizumab is safe and effective for eye disorders; the UK health technology assessment body, the National Institute for Health and Care Excellence (NICE), also has such a role, said the court, and NICE has deemed bevacizumab appropriate for use in these indications.
Furthermore, the court held that the use of bevacizumab in this setting is not technically off-label, as bevacizumab must be compounded for ophthalmologic use. Thus, argued the court, bevacizumab is an unlicensed medication in this context, undermining Bayer and Novartis’ argument.
The ruling is a boon for the NHS, which stands to realize significant cost savings by using the cheaper bevacizumab to treat AMD. According to court documents, while aflibercept costs the health system £816 per injection (approximately $1073) and ranibizumab costs £551 (approximately $725), bevacizumab costs just £28 (approximately $37). Eventual marketing of Mvasi, a bevacizumab biosimilar approved in the European Union earlier this year, could drive the price point down even further.
Europe has been involved in a greater push to utilize cost-saving bevacizumab in the setting of AMD; a paper published in PLOS One earlier in 2018 demonstrated that the European Union is overspending on AMD therapy by relying on aflibercept and ranibizumab. Europe as a whole, argued the paper, could save €335 million (approximately $386 million) yearly by treating 80% of people with AMD with bevacizumab rather than aflibercept.