Today, the Court of Appeal handed down its judgment dismissing the appeals brought by Bayer Plc and Novartis Pharmaceuticals UK Ltd against a Judgment of Mrs Justice Whipple, which upheld as lawful a policy adopted by 12 Northern Clinical Commissioning Groups. The policy stated that Avastin should be the “preferred treatment option” for the treatment of wet-AMD, a common eye condition which can lead to blindness.
Avastin is licensed to treat certain cancers but is not licensed to treat wet-AMD, although NICE has concluded (whilst not recommending its use) that it is clinically effective and safe. The purpose of the policy is to save money for the NHS, because Avastin is cheaper than the products licensed to treat wet-AMD: Eylea (marketed by Bayer) and Lucentis (marketed by Novartis).
The policy was initially predicated on Avastin being “compounded” (i.e. divided up into smaller doses either in a commercial facility or in a pharmacy), which achieves the greatest cost-saving, although (after the claim was issued) the Defendants suggested that the policy could also be fulfilled by using whole vials of Avastin and discarding the surplus.
The Court of Appeal found that the policy was lawful because it could be implemented using compounded Avastin without breaching the requirements of the relevant legislation. It disagreed with Mrs Justice Whipple, however, by holding that a prior individual patient prescription would need to be in place for such supply to be lawful, which the policy had not envisaged but which Bayer and Novartis had argued was required. The Court of Appeal also found that using whole vials of Avastin would be lawful but that this was irrelevant to the lawfulness of the policy itself, as that was only directed to the use of compounded Avastin.
Roche Products Limited, which holds the marketing authorisation for Avastin, appeared as an interested party but neither supported nor resisted the claim.
The judgment is here.
Jemima Stratford QC and Emily MacKenzie appeared for Bayer Plc, instructed by Arnold & Porter.
Victoria Wakefield QC appeared for Roche Products Limited, instructed by Fieldfisher.