NICE has published final guidance recommending the drug rifaximin (also called Targaxan and manufactured by Norgine) as a treatment option for preventing recurrent episodes of overt hepatic encephalopathy in adults. This is when people become confused, lose consciousness or, in more serious cases, fall into a coma due to problems with their liver.

Hepatic encephalopathy, which is estimated to affect around 12,000 people in England, is thought to be caused by a build-up of toxic substances in the body that are normally removed by the liver. It is most commonly seen in people with cirrhosis of the liver.

Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said:  “We are very pleased to recommend rifaximin for hepatic encephalopathy. This brain disease can have far-reaching effects on people and their families and carers. It can be serious, even fatal, and those with the condition may have to go into hospital regularly.

“Studies show that rifaximin can prevent these life-threatening episodes, is generally better tolerated than other treatments and can improve a patient’s quality of life.”

Following the positive NICE recommendation, the NHS now has a legal obligation to begin providing the treatment to eligible patients within the next 3 months.

Ends

For more information call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.

Notes to Editors

About the guidance

• Rifaximin (Targaxan, Norgine) is a semi-synthetic derivative of the antibiotic rifamycin. Rifaximin decreases intestinal production and absorption of ammonia, which is thought to be responsible for the neurocognitive symptoms of hepatic encephalopathy, thereby delaying the recurrence of acute episodes.
• Rifaximin has a marketing authorisation in the UK ‘for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients aged 18 years or older’. The summary of product characteristics highlights that 91% of people in the pivotal study were using concomitant lactulose.
• Side effects for rifaximin can include: depression, dizziness, headache, dyspnoea (shortness of breath), upper abdominal pain, abdominal distension, diarrhoea, nausea, vomiting, ascites (accumulation of fluid in the abdominal cavity), rashes, pruritus (itching), muscle spasms, arthralgia (joint pain), and peripheral oedema (swelling). For full details of adverse reactions and contraindications, see the summary of product characteristics.
• Rifaximin is available as 550 mg film-coated tablets at a net price of £259.23 per 56-tablet pack (excluding VAT; British national formulary online [accessed December 2014]). It is administered orally at a recommended dose of 550 mg twice daily. The company estimated an average cost of £1689.65 for 6 months of treatment. Costs may vary in different settings because of negotiated procurement discounts.