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September 21, 2018

NHS wins landmark ruling against pharma companies over AMD drug

The UK High Court has ruled in favour of the NHS regarding the use of a cheaper, unlicensed drug for common eye condition wet age-related macular degeneration (AMD) over the much more expensive treatments from Novartis and Bayer.

By Allie Nawrat

The UK High Court has ruled in favour of the NHS regarding the use of a cheaper, unlicensed drug for common eye condition wet age-related macular degeneration (AMD) over the much more expensive treatments from Novartis and Bayer.

The court also ordered the pharmaceutical companies to pay the NHS’s legal costs for the case.

Novartis and Bayer initiated a legal challenge against 12 NHS Clinical Commission Groups (CCGs) in the North East and North Cumbria CCG Forum for instituting a policy in November 2017. The policy told doctors that off-label Avastin was the preferred choice for wet AMD, but patients still had the option to choose Novartis’ Lucentis or Bayers’ Eylea.

Novartis and Bayer claimed that the CCGs were acting illegally because patients were denied their right to an approved drug. In addition, the companies argued that using an unlicensed medication rather than an approved option undermined the UK’s pharmaceutical regulatory framework. They also suggested that elderly patients may not have the mental capacity to make informed choices between the three drugs.

In January, the UK’s pricing regulator the National Institute of Health and Clinical Excellence (NICE) concluded that although Avastin is not approved in the UK for wet AMD, the treatment was considered as safe and effective as Novartis and Bayer’s drugs.

However, NICE’s guidance noted that Avastin should only be prescribed if no other licensed products met the treatment need of the patient and it cannot be used only because it is cheaper than the alternatives.

Avastin cost £28 per injection vial, compared to £561 for Lucentis and £800 for Eylea for similar doses. The NHS estimates that using Avastin saves the 12 CCGs £13.5m a year. Furthermore, if the drug was used throughout the NHS, then it could save the organisation a projected £500m annually.

High Court judge Philipa Whipple said in her ruling: “The CCGs have adopted this policy because of the significant difference in price between Avastin and the other two medicines. I have dismissed the claimant’s application on all grounds advanced. I find the defendants’ policy to be lawful.”

In response to the outcome, NHS South Tyneside CCG chief executive officer David Hambledon said: “We’ve always said we think that it’s important that patients should have the choice of a very effective treatment for wet AMD, and it’s actually a fraction of the cost of the other alternatives.

“So I think what we do now is offer patients that choice. We believe that they will support very strongly having a cost-effective, safe treatment and saving the NHS generally a lot of money. It is a victory for common sense over commercial interests.”

In a statement, Novartis said: “Novartis is deeply disappointed in this decision and remains of the opinion that the policy undermines the well-established legal and regulatory framework that is there to protect both patients’ safety and to ensure health care professionals can prescribe with confidence.”

It is not yet clear if Novartis and Bayer are going to appeal against the ruling.

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