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Bayer to challenge Avastin legal ruling

Both sides claim to be acting in patients' best interest

Avastin

Bayer is looking to protect earnings from its top selling drug in the UK after a court ruled that NHS organisations could use a cheap off-licence substitute in its place.

A week ago the UK’s High Court ruled that it was lawful for local NHS Clinical Commissioning Groups (CCGs) to offer patients Avastin (bevacizumab) injections for the treatment of wet age-related macular degeneration (wet AMD) in place of two licensed but much more expensive treatments, Bayer’s Eylea and Novartis’ Lucentis.

The ruling was a blow to the two pharma companies, who had applied for a judicial review against the action of 12 CCGs in the north east of England after years of rows over unlicensed use of Avastin in AMD.

England’s use of Avastin is not an isolated one. Health systems in other countries, including France, have also promoted its off-licence use, with a number of publicly-funded trials carried out to establish its equivalence in safety and efficacy with Lucentis in particular.

The case has huge implications for the NHS medicines budget, and for Bayer’s UK earnings.

The NHS in England spends around £500m on licensed wet AMD treatments every year, with around £300m being spent on Eylea, and the rest on Novartis’ drug.

Switching to off-licence Avastin would save £100m or more, if applied across the whole of England. Avastin costs around £28 per injection, while the list prices of Eylea and Lucentis are around £816 and £551 per injection respectively.

One week on from the ruling, Bayer has now announced that it believes that the conclusions of the judge, Mrs Justice Whipple, are “wrong in a number of key respects”, and will now seek to challenge the ruling at the Court of Appeal.

Bayer says its appeal will focus on two principal issues, firstly that supplying unlicensed bevacizumab for this use is unlawful and secondly that the policy undermines the comprehensive licensing regime for medicines across the EU, which is designed to protect patients from harm.

The company says it believes the ruling is “a setback for public health” and that using adapted or ‘compounded’ bevacizumab could result in patients needing more clinic visits and injections than they would otherwise with the licensed drugs.

It added: “This has the potential to set a worrying precedent that denies patients the protection afforded by the regulatory process.”

Both Bayer and the CCGs say they have the best interests of patients at heart, and the case has added to a souring of relations between the NHS and pharma.

Neither NHS England nor the Department of Health and Social Care have commented on the legal ruling as yet, and are now likely to wait and see if Bayer is granted an appeal before directing CCGs nationally.

The row has erupted at a crucial juncture: The UK industry organisation the ABPI is in the midst of an all-important renegotiation of the PPRS pricing agreement, with the deadline for a new agreement just two months away - and with business disruption caused by Brexit less than six months away.

Article by
Andrew McConaghie

28th September 2018

From: Healthcare

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