NHS wins legal fight with pharma over off-label Avastin

A group of NHS organisations have claimed a legal victory against Bayer and Novartis, which had sought to stop them using Avastin as a cheap, unlicensed substitute for their ophthalmology drugs.

The two pharma companies mounted the legal challenge to stop the 12 Clinical Commissioning Groups (CCGs) in the north east of England from using Avastin in place of Bayer’s Eylea and Novartis’ Lucentis  to treat wet AMD, claiming that it broke EU and UK laws governing medicines licensing.

However the judge, Mrs Justice Whipple DBE dismissed all of the claims, which could now open the door for other NHS organisations to follow suit – saving the health service millions of pounds and denting the revenues of the ophthalmology drugs, which are among the biggest earners in the UK.

The ruling comes after three years of legal manoeuvring and disagreement, and the decision has sharply divided UK pharma industry and NHS leaders.

Dr Sheuli Porkess, Deputy Chief Scientific Officer for the ABPI said: “We will consider this judgement carefully. Patients and doctors need total clarity on who determines whether medicines work and are safe to be used.

“This extraordinary judgement potentially undermines the regulation of all medicines and by doing that, neither patients nor doctors have clarity on what information to trust.

“As we exit the EU and the UK Government is looking for regulatory co-operation between the UK and the EU, this confusion is deeply unhelpful.”

Perhaps not surprisingly, there was a contrasting response from the NHS Clinical Commissioners, which represents the health service organisations that pay for care.

Responding to today’s ruling, Julie Wood, chief executive of NHS Clinical Commissioners said:

“We are delighted by today’s ruling that clearly shows the northern CCGs acted lawfully in introducing the preferred treatment option for Avastin. CCGs across the country have been thwarted in their various attempts to introduce the cheaper but equally effective drug Avastin for the treatment of wet AMD and the court rightly makes several findings about the legality of both CCGs and clinicians to determine whether Avastin is clinically effective and safe for ophthalmic use in local areas.”

The cost implications are clear, as the court judgement showed: it says Avastin’s list price is around £28 per injection; Eylea around £816 per injection; Lucentis around £551 per injection. It noted that actual prices will vary depending on a number of factors, including whether any confidential discount on price has been negotiated with a pharmaceutical company, but savings in each region will be substantial.

Julie Wood concluded by saying: “We are really pleased that the northern CCGs remained true to their belief that this was the right thing to do for their patients and populations in spending the NHS pound to best effect, and that it was lawful to do so.”

She said the savings, “with no impact on patient outcomes” would be huge, and called on the Department of Health and Social Care and NHS England to actively support other parts of the country to make these savings.

Bayer's Eylea (aflibercept) and Novartis' Lucentis (ranibizumab) are among the top selling drugs in England, number 2 and number 5 in the top ten medicines by spending in the 2016/17 year, according to NHS Digital data. The combined spending on the drugs last year was 477.3m - a total that could decline rapidly if CCGs in other parts of the country now follow the north east's lead.

Source: Prescribing Costs in Hospital and the Community, England 2016/17. NHS Digital

A number of technical factors helped tip the judgement in favour of the CCGs. After the challenge first arose in February 2015, NICE released guidance saying that Avastin was safe and effective in this setting, and the judge said this helped clarify the clinical case. The two pharmaceutical companies also argued that the ‘compounding’ or adaptation of Avastin for use in eye treatment was unlawful, but the judge found in favour of the defendants.

The case could not only open the door for more unlicensed use of Avastin, but also been seen as a precedent for similar cost-driven uses of unlicensed drugs. For that reason, Bayer and Novartis may decide to pursue the legal challenge further.

It remains to be seen if NHS England will encourage other parts of the country to follow suit, but is under huge budgetary pressure to find savings in medicines.

Read the verdict in full here.