NHS sets aside £190m pot for hepatitis C in England

NHS England (NHSE) has earmarked £190 million to provide access to new therapies to the sickest hepatitis C virus (HCV) patients, in advance of funding decisions.

NHSE says the budget for HCV therapies will be increased to £190 million – up from £40 million last year – to provide stop-gap access to drugs such as AbbVie's on Viekirax (ombitasvir/paritaprevir/ritonavir) and Exviera (dasabuvir and Gilead's Harvoni (sofosbuvir/ledipasvir) to around 3,500 patients with cirrhosis.

NHSE's Clinical Priorities Advisory Group (CPAG) is recommending that Viekirax/Exviera should be offered to all patients in England with genotype 1a and 1b infection and compensated cirrhosis.

The therapy was approved by the EMA in January for wider use in HCV but still has not been given the go-ahead by the National Institute for Health and Care Excellence (NICE).

Similarly, Harvoni will also be provided under the early access scheme for HCV patients with cirrhosis.

The decision comes around a year after NHSE provided £18.7 million to fund Gilead Sciences' rival HCV therapy Sovaldi (sofosbuvir) for around 500 HCV patients at significant risk of death from the infection as a result of acute liver failure – including those awaiting a liver transplant – on the recommendation of the CPAG.

The funding block provided access to Sovaldi ahead of NICE guidance, which was eventually published earlier this year and controversially included a three-month delay in implementation that allowed NHSE to push the budget impact of including the almost £35,000-per-course drug into the next financial reporting period.

Charles Gore, chief executive of The Hepatitis C Trust, welcomed the CPAG's recommendations, saying: "Finally, the sickest HCV patients will have a chance to access these highly efficacious, curative therapies that are generally well tolerated.

"NHSE has been promising an interim commissioning policy ever since the implementation deadline for NICE guidance for [Sovaldi] was extended by three months earlier this year," he added.

"It's critical that this policy is now implemented swiftly to ensure that people with HCV, who have severe disease and are at risk of serious health issues or even death without treatment, can get rid of the virus."

Richard Jeavons, NHSE's director of specialised services, said: "At a time when funding is inevitably constrained across the NHS this is a huge new investment; in fact it'll be the NHS' single largest new treatment expansion this year."

The decision was also warmly received by HCV specialist Professor Geoffrey Dusheiko of UCL Institute of Liver and Digestive Health and Royal Free Hospital.

The policy "is long overdue but welcome, for those patients that have been waiting for what is now imperative treatment to prevent decompensated cirrhosis."

However, he noted also that there are "other people besides, who do not have cirrhosis, in whom the prevention of cirrhosis is equally important ... and they are not included in the interim commissioning policy."

In a statement, AbbVie noted that more than 200,000 people in the UK are chronically infected with HCV, but among these only an estimated 3 per cent are treated each year, despite the advent of treatments that can offer viral elimination.

Prior to the availability of effective oral therapies such as Viekirax/Exviera, Sovaldi and Gilead's dual combination Harvoni (sofosbuvir/ledipasvir), the only treatment options available were based on injections of pegylated interferon, which cause severe side effects, including flu-like symptoms and fatigue, and are less effective at clearing the virus.