NICE is appraising rifaximin as a treatment for reducing the recurrence of episodes of hepatic encephalopathy in adults. This is when people become confused, lose consciousness or, in more serious cases, fall into a coma, as a result of problems with their liver. It is thought to be caused by a build-up of toxic substances in the body that are normally removed by the liver. The independent Appraisal Committee, which develops the guidance on behalf of NICE, considered evidence from the company, clinical experts, patient experts and an independent critique of the company’s submission.

Commenting on the draft guidance Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “We are pleased that new evidence became available which allowed us to recommend rifaximin as a treatment option for people with hepatic encephalopathy.

“This serious brain condition has far-reaching effects on people with the condition and their families and carers. It can be serious, even fatal. People affected may have to go into hospital regularly. Rifaximin can prevent these life-threatening episodes and improve people’s quality of life.”

Final guidance on the use of rifaximin for reducing the recurrence of episodes of hepatic encephalopathy is expected to be published in spring 2015. Until then, NHS bodies should make decisions locally on the funding of specific treatments. 

Ends

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

Notes to Editors

The draft guideline (Final Appraisal Document/FAD) can be found from 00:01hrs on Thursday 19 February 2014 on the Hepatic encephalopathy - rifaximin (maintenance) [ID496].
Embargoed copies are available on request from the press office.

1. 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.
2. The summary of product characteristics lists the following common adverse reactions for rifaximin: 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.
3. 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.