• Hepatitis C Trust loses legal challenge to NHS England’s decision to cap access to new drugs for the disease
  • Judge rules decision to roll out treatments via “monthly run rate” is “legitimate” and “rational”
  • Charity argued that capping therapy approved as cost effective went against NICE rules

The Hepatitis C Trust has lost its legal challenge to NHS England’s decision to cap access to new drugs for the disease.

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”.

Royal Courts of Justice

Royal Courts of Justice

Source: Freefoto

The judge said NHS England’s decision was ‘legitimate and rational’

In 2015, new oral treatments for hepatitis C were approved by the National Institute for Health and Care Excellence.

The drugs are extremely clinically effective. However, NHS England has identified them as a significant financial risk because of their high cost and the prevalence of the disease. It capped courses of treatment at around 10,000 in 2016-17.

The drugs are being rolled out via 22 “operational delivery networks” with each network working to a monthly run rate dictating how many courses of treatment it is allowed to administer.

The Hepatitis C Trust said capping a therapy approved as cost effective went against NICE rules, and applied for a judicial review of NHS England’s decision.

In his judgment refusing the application, the judge said: “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.”

He said he was “persuaded” by NHS England’s defence that this was 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’”.

“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,” the judgment added.

The charity applied for its liability to pay NHS England’s legal costs to be capped at £49,000.

However, Mr Justice Blake said there were “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 are listed as interested parties in the application for judicial review.

The judge said he was “not persuaded that the cap proposed is appropriate”, though he capped costs for the “permission stage” of the judicial review to £20,000.

“I consider that sum is proportionate having regard to the central legal point in dispute and the means of the respective parties,” he added.

An NHS England spokeswoman said 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 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’,” she said.

She said NHS England would “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”.

The Hepatitis C Trust declined to comment.