Today, Mrs Justice Whipple handed down her judgment in two applications for judicial review brought by Bayer Plc and Novartis Pharmaceuticals UK Ltd, which challenged 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 Judge agreed with the Claimants that, based on guidance issued by the MHRA in 2011, the use of “compounded” Avastin is unlicensed, rather than merely off-label. Nevertheless, she found that its supply to fulfil the policy might be lawful under EU law and so the policy itself could not be unlawful; the lawfulness of any future implementation of it by an NHS Trust being a separate question.
The Judge also found that using a whole vial of Avastin was a lawful means of fulfilling the policy. Finding that such a use is off-label (rather than unlicensed), she rejected the Claimants’ arguments that a policy asking doctors to prefer an off-label medicine on grounds of cost, rather than clinical need, unlawfully circumvents the EU medicines regime and breaches General Medical Council Guidance applicable to doctors.
The Judge also rejected other grounds of challenge brought by the Claimants, including that the policy undermines patients’ rights of access to treatments recommended as cost-effective by NICE, namely Eylea and Lucentis, and that a Q&A document and a Patient Information Leaflet which accompany the policy are misleading and inaccurate.
Roche Products Limited, which holds the marketing authorisation for Avastin, appeared as an interested party but neither supported nor resisted the claim.
The parties have 21 days in which to decide whether or not to appeal to the Court of Appeal.
The judgment appears here.
Jemima Stratford QC and Emily MacKenzie appeared for Bayer Plc, instructed by Arnold & Porter.
Martin Chamberlain QC appeared for Roche Products Limited, instructed by Field Fisher.