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NHS England sees off AbbVie's Hep C legal challenge

Claims of unfair process dismissed by High Court

NHS England has claimed a victory after a legal challenge by AbbVie was rejected by the High Court, and says plans to eliminate hepatitis C by 2025 are back on track.

The court victory - and NHS England's reaction to it - reflect its growing confidence in its use of tough negotiations and procurement to drive down drug prices and strike access deals with pharma.

AbbVie is one of several companies to market the new class of hepatitis C (HCV) treatments known as Maviret (glecaprevir/pibrentasvir), which can cure patients of the serious blood infection. Maviret is in contention with rival treatments such as Gilead’s Sovaldi, Harvoni and Epclusa, to name a few.

NHS England had initially been slow in its uptake of these new curative treatments, but then last year declared it would aim to be the first country in the world to eliminate HCV, with a target date of 2025, and spending £1bn over five years to achieve this goal.

However, in order to make this £1bn stretch to treat millions of HCV patients, NHS England aimed to achieve this via its largest ever procurement process – and called on pharma companies to offer unprecedented discounts to their prices.

This is said to involve cutting prices for a course of treatment from £35,000 to just £10,000 in return for an initial three year supply contract, with an option to extend by a further two years.

AbbVie accused NHS England of not treating all bidders fairly, however, and took its case to the High Court in November.

But on Friday NHS England announced it had seen off AbbVie’s challenge, issuing a triumphant press release which detailed how the judge had dismissed the case on all counts.

It was also critical of AbbVie’s challenge, saying it had caused an unnecessary six month delay to the start of the HCV elimination programme.

John Stewart

NHS England's John Stewart

John Stewart, director of specialised commissioning at NHS England, said: “Court cases such as this are a waste of NHS resources and taxpayers’ money, in this case resulting in an unavoidable delay in our efforts to tackle the threat of Hepatitis C, which disproportionately affects some of the most vulnerable and marginalised people in society.

“We remain committed to driving best value to help eliminate Hepatitis C in England by 2025 or sooner, and with this court case behind us, we can now get on with the job.”

More than 32,000 patients with HCV have been treated so far with around 95% being cured of the disease in England. The plans to eliminate the disease by 2025 would put England five years head of the goals proposed by the World Health Organisation.

NHS England also took the opportunity to underline how the Hep C procurement is part of a broader exercising of its purchasing muscle – what it calls a series of ‘smart deals’ to help the NHS provide value for the taxpayer and benefits patients.

Among these is another procurement drive where AbbVie has lost out – the recent launch of biosimilar versions of its inflammation blockbuster Humira (adalimumab).

NHS England says it will save £300m by negotiating deals with five manufacturers on low cost versions of adalimumab, which has been the single biggest drug cost for the health service for some time. AbbVie was critical of NHS England for declaring in October it would make savings from the tendering process – as negotiations were still ongoing at the time.

Within weeks however, the company had agreed an ‘interim commercial offer’. It says it believes patients who are stable on their biologic medicine should not be switched to another product for ‘non medical reasons’ – but had to also ensure that its Humira was also a ‘best value’ product by cutting its price.

NHS England also pointed to two other deals struck in 2018, which illustrate a combination of fast uptake enabled by tough price negotiations - the first full access deal in Europe for CAR-T therapy (Gilead/Kite’s Yescarta and Novartis’ Kymriah) and a deal to make the MSD’s groundbreaking Keytruda available for routine use for lung cancer patients on the NHS.

2019 will see at least one more high stakes and contentious court case reach its conclusion - Bayer and Novartis are appealing against a court ruling to allow Avastin to be prescribed off-licence in wet age-related macular degeneration.

Article by
Andrew McConaghie

20th January 2019

From: Healthcare

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