Landmark NHS Legal Battle: High Court supports off-label use of Avastin

Landmark NHS Legal Battle: High Court supports off-label use of Avastin

Landmark NHS Legal Battle: High Court supports off-label use of Avastin

On 21 September 2018, the NHS won a landmark case against Bayer and Novartis, who were seeking to prevent the off-label use of Avastin to treat wet age-related macular degeneration (“wet AMD”), a leading cause of sight loss in the elderly. This High Court ruling will allow the National Health Service to save millions of pounds by prescribing Avastin as an alternative to other more expensive treatments.

What is the case about?

Wet AMD is the biggest cause of age related vision loss in the UK, first affecting people in their 50s and 60s. The condition damages the middle part of a person’s vision and can make everyday activities difficult. Currently in the UK, wet AMD is managed by anti-vascular endothelial growth factor (“anti-VEGF”) therapies, Lucentis and Eyela, which are reported to cost £561 and £800 respectively per injection.

However, 12 NHS clinical commissioning groups (“CCGs”) adopted a policy of prescribing Avastin as the “preferred treatment option” for wet AMD, despite it not having a Marketing Authorisation and being licensed for ophthalmic use. Although Avastin is only licensed for cancer treatment in the UK, it is used internationally to treat wet AMD “off-label” and reportedly costs a mere £28 per injection. This price is likely to decrease further as Avastin’s patent expires next year.

Bayer and Novartis, manufacturers of the more expensive licensed medicines, consequently brought a High Court action against the NHS, challenging the lawfulness of its policy of prescribing Avastin off-label and in conflict with MHRA guidance.

Nonetheless, Mrs Justice Whipple rejected the arguments put forward by the claimant pharmaceutical companies. She concluded that the policy adopted by the NHS groups was lawful and gave substantial weight to the “significant difference” in price between Avastin and the licensed medicines. In addition, guidance published by the National Institute for Health and Care Excellence in January 2018 had deemed Avastin to be as safe and effective as the licensed anti-VEGFs.

Implications of the case

As a consequence of this ruling, the NHS, which is under huge financial pressures, will save more than £13.5million per year for the 12 CCGs involved in this action alone and reportedly hundreds of millions of pounds across the UK. The Court’s decision demonstrates that, despite the MHRA’s stringent legal and regulatory framework, not all off-label policies adopted by the NHS to reduce cost will be unlawful. As such, this landmark decision is likely to be an unwelcome one for many pharmaceutical companies, who have laboured to obtain licences for specific treatments.

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