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NHS England agrees funding for life-saving hepatitis C drugs
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"NHS England will commission Sofosbuvir + Daclatasvir/Ledipasvir +/-Ribivirin for the treatment of Hepatitis C in adults in accordance with the criteria outlined in this document. This policy outlines the arrangements for funding of this treatment for the population in England."
"Combining Sofosbuvir and ribavirin with either Daclatasvir or Ledipasvir (NS5A Direct Acting Antivirals) has demonstrated high efficacy and good tolerability and safety in 12 week oral only regimens. These NS5A DAAs are in phase 3 development and are to be available, cost-free, for compassionate use in combination with Sofosbuvir. Such Sofosbuvir, ribavirin and NS5A combinations are recommended for use in such patients by the European Medicines Agency.
Early access to DAA combinations prior to NICE recommendation offers the chance to cure a cohort of HCV infection patients who may otherwise die or progress to liver transplantation. Treatment of such patients will reduce mortality and may prevent the need for liver transplantation."
NHS England agrees funding for life-saving hepatitis C drug
16 April 2014 - 17:37
NHS England has approved an 18.7 million investment in a new drug for the treatment of hepatitis C.
Around 500 patients with acute liver failure, and/or awaiting liver transplantation, are expected to benefit from the decision to fund Sofosbuvir. The hepatitis C virus causes inflammation of the liver, affecting its ability to function. Whilst many sufferers naturally clear their infections within six months, others develop chronic hepatitis which is usually life-long without therapy.
Current estimates indicate that around 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 whilst not yet NICE-approved, Sofosbuvir will be funded for those patients at significant risk of mortality or who require transplantation.
View NHS England's policy statement on the funding of Sofosbuvir. The drug, which will be available as an oral formulation, will be used in combination with another antiviral agent.
James Palmer, Clinical Director, Specialised 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 centre, and we will ensure that clinicians are aware of this policy, so that all eligible patients have the opportunity to access this drug".
Professor Graham Foster, Professor of Hepatology and co-Chair of the Hepatitis C Clinical Reference Group sub-group welcomed the news. He said:
"The recently licensed, new, direct-ac ting antiviral drugs for hepatitis C may be life-saving for infected patients with advanced cirrhosis. I am delighted that NHS England will make these drugs available for these patients and allow us to treat those in urgent need.
"The availability of these drugs will ensure that NHS patients are among the first in Europe to benefit from these revolutionary new drugs".
NICE is currently 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.
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