Hepatitis C Trust Loses Legal Challenge

Following a legal challenge, the Hepatitis C Trust has lost on the issue of NHS England’s decision to cap access to new drugs for the disease.

The charity aims to increase awareness and testing, to provide services on a national and local level to people with, affected by, or at risk of contracting hepatitis C; and to campaign for greater public understanding of the impact of the condition.

But Mr Justice Blake ruled that NHS England’s decision to roll out access to the treatments via a “monthly run rate” was “legitimate” and “rational”.

A new oral treatment for hepatitis C had been approved by the National Institute for Health and Care Excellence back in 2015.

Despite the clinical efficacy of these drugs, NHS England believes them to be a financial risk owing to the high cost and prevalence of the disease.

The healthcare organisation capped two courses of treatment at 10,000 for the existing financial year.

Responding to this decision, the Hepatitis C Trust believes that capping such an effective treatment went against the rules laid out by NICE, ultimately requesting a judicial review on the matter.

But a judge has now thrown the case out of court, ultimately being persuaded by evidence provided by the defence for NHS England.

“In my view, the claim form focuses on a single point that the defendant’s decision is unlawful as it amounts to an arbitrary cap of 10,011 treatments a year that was not part of the NICE guidance and is unlawful”.

The judge also asserted that there had been a “mischaracterisation of the decision and that a monthly run rate is not an arbitrary cap but a legitimate way of giving effect to the guidance that the treatments must be available as an option for patients with qualifying conditions ‘to prioritise treatment for people with the highest unmet clinical need’”.

In concluding statements, the judge noted that “if prioritising need is legitimate then a monthly run rate is a rational way of implementing the duty whether it was a means foreseen by NICE or not”.

Responding to the decision, the Hepatitis C Trust requested that the legal cost for the case to be capped at £49,000.

A decision on this remains imminent, with Mr Justice Blake commenting that there are “uncertainties as to what the terms of the claimants lawyers’ retainer are, and the financial relationship between the claimant and the interested parties”.

The drug companies Gilead, Bristol-Myers Squibb and Abbvie were listed as interested parties in the application for judicial review.

NHS England warmly welcomed the verdict, with a spokeswoman commenting that hepatitis C medicines were the health service’s “single biggest new treatment investment over the past year” and worth about an extra £200m annually. We thus welcome the High Court’s decision that NHS England’s approach to prioritising treatment ‘for people with the highest unmet clinical need’ is both ‘rational’ and ‘legitimate’. NHS England will now focus on securing an improved deal for patients from pharmaceutical companies so as to expand access to hepatitis C treatments even further in future years”.

Formed in 2001 by Charles Gore, the Hepatitis C Trust was the first charity in the UK to be set up in response to hepatitis C.


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