The National Institute for Health and Care Excellence (NICE) is calling on the pharmaceutical company Norgine to provide more information on its drug rifaximin (also called Xifaxan) to treat a brain disease caused by liver failure.

NICE is appraising rifaximin as a treatment for the condition known as hepatic encephalopathy. In draft guidance published for consultation, NICE has asked for more data to be submitted by the manufacturer.

This draft has now been issued for consultation: NICE has not yet published final guidance to the NHS.

NICE is appraising rifaximin as a treatment for adults to reduce the recurrence of episodes of overt hepatic encephalopathy. This is when people experience some degree of confusion, lose consciousness or, in more serious cases, fall into a coma. It is 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 manufacturer, clinical experts, patient representatives and an independent critique of the manufacturer's submission.

Professor Gillian Leng, NICE Deputy chief Executive and Director of Health and Social Care, said: “When reviewing the evidence for rifaximin, the Appraisal Committee concluded that there were still questions to be answered about the drug. This is why we have requested more details from the manufacturer; we want to ensure that we have sufficient information to make an informed final recommendation.”

The manufacturer has until Wednesday 18 December 2013 to submit this extra information to NICE. The committee will then review the extra evidence and develop further draft guidance.

Final guidance on the use of rifaximin for maintaining remission from episodes of hepatic encephalopathy is expected to be published in 2014. Until then, NHS bodies should make decisions locally on the funding of specific treatments.

Ends

Notes to Editors

The draft guideline (appraisal consultation document/ACD) can be found from 00:01hrs on Wednesday 27 November on the Hepatic encephalopathy - rifaximin (maintenance) [ID496] webpage.

1. Rifaximin (Targaxan, Norgine) is a semi-synthetic derivative of the antibiotic rifamycin, which inhibits ribonucleic acid (RNA). Rifaximin a 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 UK marketing authorisation ‘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 the patients 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, abdominal pain upper, abdominal distension, diarrhoea, nausea, vomiting, ascites, rashes, pruritus, muscle spasms, arthralgia, anaemia, oedema peripheral and pyrexia. 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; ‘Medicines Index of Medicinal Specialties [MIMS]). It is administered orally at a recommended dose of 550 mg twice daily. The manufacturer estimated an average cost of £1689.65 for 6 months of treatment. Costs may vary in different settings because of negotiated procurement discounts

NICE requests further clarification from the manufacturer, which should include the following:

• Estimates of utilities from SF-36 quality-of-life data collected from the RFHE3001 trial and mapped directly to the EQ-5D, using all observations in each relevant health state and adjusted for baseline utility
• Results of scenario analyses reflecting a clinically plausible diminishing mortality benefit with rifaximin over time and excluding mortality benefit in the remission state
• Use of a lifetime time horizon to capture all costs and benefits associated with rifaximin and lactulose
• Results of a full probabilistic sensitivity analysis for the revised analyses, including the incremental cost-effectiveness ratios.

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