Supreme Court ends legal challenges over…

The long-running legal saga concerning the lawfulness of using compounded Avastin to treat wet AMD patients has finally ended. The Supreme Court has refused an application by Bayer to appeal against the decision of the Court of Appeal that a policy adopted by 12 CCGs in the North East of England promoting the use of compounded Avastin as the drug of choice for wet AMD patients was lawful.

Wet AMD is the commonest cause of blindness in the UK. There is no cure but anti-VEGF drugs injected into the eye at regular intervals can restrain the progress condition. Three anti-VEGF drugs can treat wet AMD, namely Lucentis, Eylea and Avastin. The intellectual property (IP) rights in Lucentis are owned by Roche but it is marketed in Europe by Novartis, under licence from Roche. It has EMA marketing authorisation, often mistakenly called a “drug licence”, which allows it to be marketed as a drug to treat ocular patients. The list price of Lucentis is over £500 per injection, subject to confidential NHS discounts. The IP rights in Eylea are owned by Bayer and this drug also has an EMA marketing authorisation which allows Bayer to market the drug within the EU. The price of Eylea is roughly the same as Lucentis.

Avastin is an anti-VEGF drug which was developed to treat various cancers. The IP rights in Avastin are owned by Roche, and it has a marketing authorisation from the EMA as a cancer drug. However, it has been shown to be equally clinically effective as Eylea and Lucentis and equally safe as a treatment for wet AMD patients. A single vial of Avastin can be compounded in an NHS pharmacy and sold to hospitals treating wet AMD patients for under £30 injection. The price difference between these drugs is accordingly huge. Estimates of the amounts that could be saved by the NHS in moving from using Eylea or Lucentis to Avastin range from £200M per year to £500M per year.

There were two potential difficulties with policies promoting Avastin. First, both Eylea and Lucentis have secured NICE Technology Appraisal Guidance which recommends the use as a cost-effective medicine within the NHS. However, but does not prevent NHS bodies offering Avastin as a third alternative and informing patients of the amount the NHS will save if this choice is made.

Secondly, Bayer and Novartis consistently asserted that any policy to promote the use of Avastin would be unlawful under both EU and UK law. That position was supported by the Department of Health, as set out in a letter in 2015 sent to CCGs who were pressing the Department to allow them to promote the use of Avastin. Despite the efforts of the Department to dissuade CCGs from promoting the use of Avastin, in 2018 12 CCGs in the North East adopted a policy to encourage their Trusts to use Avastin as a treatment of choice for wet AMD patients. The lawfulness of that policy was challenged by Bayer and Novartis. That challenge was decisively rejected by both the High Court and the Court of Appeal. The legal challenges now run out of road with the refusal of the Supreme Court to intervene. The policy is now being implemented.

This legal decision means that NHS bodies can lawfully offer patients a choice of being treated with Avastin at a fraction of the cost of either Eylea or Lucentis. It also means that NICE needs to conduct an urgent review of its TAG Guidance concerning Eylea and Lucentis because, in comparison to a now established legal alternative, neither of these drugs satisfy the cost effectiveness tests.