NEW DATA SHOW HOW HEPATIC ENCEPHALOPATHY CONTRIBUTES TO BURDEN OF LIVER DISEASE

• Hepatic encephalopathy (HE) is associated with a significant increase in mortality (58.1% vs. 32.4%), as well as longer hospital stays (8 days vs. 6.8 days) and more primary care visits (18.2 vs. 8.7 contacts per patient year) compared to similar liver patients without HE^1,2

• XIFAXAN^® 550 (rifaximin-α) is a cost-effective treatment option for the reduction of recurrent hepatic encephalopathy as shown over a number of different time horizons and plausible scenarios⁴

LONDON, UK, Friday 11 April 2014, 06.00 BST – New data presented today at the International Liver Congress (ILC), 2014 show the impact of hepatic encephalopathy on liver disease patients and healthcare systems. 

Data show that liver disease patients who develop HE have almost double the risk of dying compared with similar liver disease patients without HE over the same time period (mortality rate of 58.1% vs. 32.4% respectively).^[1]

A further analysis demonstrates that liver disease patients with HE are admitted to hospital three times more often for illnesses directly related to their liver disease, compared with liver disease patients without HE (admission ratio of 3.588:1 for HE patients vs. control group) and are admitted to hospital one and a half times more often for unrelated illnesses (admission ratio of 1.488:1 for HE patients vs. control group). Liver disease patients with HE will consult primary care more often following initial diagnosis (18.2 vs. 8.7 primary care contacts per patient year) and stay in hospital longer (8 days vs. 6.8 days)^[2] than those without HE, collectively representing a substantial increased use of healthcare resources.

There is currently no cure for HE other than liver transplant. However, XIFAXAN^®550 (rifaximin-α) significantly reduces the risk of further HE episodes.^[3] Data demonstrate that treatment with XIFAXAN^® 550 versus standard care (lactulose) offers a cost-effective treatment option for reduction of recurrence of overt HE over a number of different time periods and plausible scenarios, e.g. incremental cost-effectiveness ratios ranged from £13,919 to £21,425 for each year of perfect health gained through treatment with XIFAXAN^® 550 (Quality Adjusted Life Year) over a five year period.^[4]

“Hepatic encephalopathy is a serious but largely un-recognised condition that must be considered as part of the overall burden of liver disease.” commented study investigator Dr Mark Hudson, Consultant Hepatologist, Freeman Hospital, UK.

He added: “These new data demonstrate that hepatic encephalopathy both significantly increases mortality risk in patients with chronic liver disease and places a substantial additional burden on already-stretched healthcare systems in both primary and secondary care. XIFAXAN^® 550 is an important new medicine in the management of hepatic encephalopathy, and the cost-effectiveness data presented today support its benefits in terms of potential cost savings versus current practice.”

Ends

Notes to Editors

About the studies presented at ILC

Mortality associated with hepatic encephalopathy in patients with severe liver disease¹

The aim of the study was to characterise mortality risk for patients with HE using data from the Clinical Practice Research Datalink (CPRD).  17,030 patients were identified with a diagnosis of liver disease, of whom 551 (3.2%) had a HE diagnosis. Of all patients identified with HE, 304 (55.2%) died during the follow-up period compared with 6,693 (40.6%) of those without HE (p< 0.001). In the matched patient population (where cases were matched to liver disease controls), 226 (58.1%) died during the follow-up period, compared with 126 (32.4%) of those without HE, over a two-fold increase (crude relative risk of 2.73 (2.20-3.41)). In the Cox Proportional Hazard model, the hazard ratio for death for cases versus controls was 2.28 (95%CI 1.82-2.87; p< 0.001).

Resource use associated with hepatic encephalopathy in patients with liver disease²

The study determined the association between HE status and resource use using data from the Clinical Practice Research Datalink (CPRD). Patients with a diagnosis of HE had a greater number of hospital admissions (crude admission ratio of 3.59 (95% CI 3.33―3.87, p< 0.001) for admissions with primary diagnoses of liver disease), with the mean length of stay 8.0 days (sd 11.6) compared to 6.8 days (sd 9.5) (p=0.148) in the non-HE group. In the HE group, a significantly greater proportion of liver-related admissions were through A&E (62.1% versus 50.0%, p< 0.001), and following the first HE event, patients had 18.2 primary care contacts per patient year compared with 8.7 for non-HE controls (p<0.001).

Cost effectiveness of rifaximin-α in the reduction of recurrence of overt hepatic encephalopathy⁴

The study aimed to characterise the cost effectiveness of rifaximin-α versus standard care (lactulose) in the treatment of hepatic encephalopathy. The study determined the incremental cost effectiveness ratio (ICER) derived from estimates of the cost/quality adjusted life years (QALY). Treatment with rifaximin-α versus standard care (lactulose) offered a cost-effective treatment option for reduction of recurrence of overt HE over a number of different time horizons and plausible scenarios. For example, incremental cost-effectiveness ratios ranged from £13,919 to £21,425 per Quality Adjusted Life Year over a five year time horizon.

About hepatic encephalopathy

HE is a serious and potentially life-threatening neuropsychiatric condition associated with liver cirrhosis.^[5] Severe HE has been estimated to affect 30-45 per cent of people with cirrhosis and symptoms include disorientation, confusion, inappropriate behaviour and personality change.^[6] Hepatic encephalopathy results from a damaged liver that is not able to detoxify the blood as efficiently as usual. Toxins build up in the bloodstream and eventually in the brain, which leads to neurological disorders.5^,[7]

To learn more about HE, please visit the New Insights into HE programme – available online atwww.hepaticencephalopathy.info

About XIFAXAN^® 550

XIFAXAN^® 550 mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥18 years of age.  XIFAXAN^® 550 is a broad spectrum antibiotic that targets commensal gut bacteria, acting on Gram-negative and Gram-positive aerobes and anaerobes, reducing the excess ammonia produced by the gut bacteria of patients with cirrhosis.

Product under licence from Alfa Wassermann S.p.A. XIFAXAN^® and TARGAXAN^® are registered trademarks of the Alfa Wassermann group of companies, licensed to the Norgine group of companies.

About Norgine

Norgine is a leading independent European specialty pharmaceutical company that has been established for over 100 years and has a presence in all major European markets. In 2013, Norgine’s total revenue was €274 million and the company employs over 1,000 people.

Norgine’s focus is the development and marketing of pharmaceutical products that address significant unmet clinical needs in therapeutic areas such as gastroenterology, hepatology , critical and supportive care. Norgine owns a manufacturing and development site in Hengoed, UK and a manufacturing site in Dreux, France.

In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US.

For more information, please visit www.norgine.com

NORGINE and the sail logo are trademarks of the Norgine group of companies.

About Alfa Wassermann

Alfa Wassermann is a private pharmaceutical group with headquarters in Bologna, Italy with its own Research, Development and Manufacturing facilities.  In 2013, Alfa Wassermann net sales were above €390million and the company employs over 1,400 people. It has a growing number of affiliate companies in both Europe as well as in emerging markets such as Russia, China and Mexico. Its main product rifaximin-α is a gut-selective antibiotic which has been prescribed for 24 years, under the trade names of NORMIX^®, XIFAXAN^® and others, in 33 countries, including the USA where Salix Pharmaceuticals is the exclusive licensee. Alfa Wassermann has also developed other important products: sulodexide (VESSEL^®), a heparinoid for thromboembolic diseases, and parnaparin (FLUXUM^®), a low molecular weight heparin for the treatment and prophylaxis of deep-vein thrombosis. For more information, please visit Alfa Wassermann’s website at www.alfawassermann.com.  

ALFA WASSERMANN^®, the ALFA WASSERMANN logo, NORMIX^®, XIFAXAN^® and TARGAXAN^® are registered trademarks of Alfa Wassermann group of companies.

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