NHS England has approved a $13.5 million investment in Sofosbuvir for the treatment of hepatitis C. About 500 patients with acute liver failure, and/or awaiting liver transplantation, are expected to benefit from the decision to fund Gilead Sciences’ new drug.

The hepatitis C virus causes inflammation of the liver, affecting its ability to function. While many sufferers naturally clear their infections within six months, others develop chronic hepatitis, which is usually life-long without therapy. Current estimates indicate about 30% of people infected with chronic hepatitis C will develop cirrhosis of the liver which, in some cases, may prove fatal without a liver transplant.

The recommendation of NHS England’s Clinical Priorities Advisory Group (CPAG) means that while not yet NICE-approved, Sofosbuvir will be funded for those patients at significant risk of mortality or who require transplantation. The drug, which will be available as an oral formulation, will be used in combination with another antiviral agent.

James Palmer, clinical director, specialized services, said, “This is a major step forward for patients with this debilitating, and often life-threatening, disease, and is evidence of NHS England’s commitment to widen access to cutting edge drugs, treatments and therapies where both clinically appropriate and cost effective. The majority of these patients will already be under the care of a specialist treatment center, and we will ensure that clinicians are aware of this policy, so that all eligible patients have the opportunity to access this drug.”

Graham Foster, professor of Hepatology and co-chair of the Hepatitis C Clinical Reference Group sub-group, said, “The recently licensed, new, direct-acting antiviral drugs for hepatitis C may be lifesaving for infected patients with advanced cirrhosis. The availability of these drugs will ensure that NHS patients are among the first in Europe to benefit from these revolutionary new drugs.”

NICE currently is developing Technology Appraisal Guidance relating to Sofosbuvir, which is due to be published later this year. The NHS England policy position will be reviewed once NICE has published this guidance.