Norgine B.V. announced that the Ministry of Health in the Netherlands , Ministry van Volksgezondheid, Welzijn en Sport , has approved the reimbursement of XIFAXAN ® 550 ( rifaximin- α 550mg ) when added to lactulose , for prophylaxis of the 3rd and following episodes of overt hepatic encephalopathy in patients ≥ 18 years.
The reimbursement approval is effective from 1 July 2016.[1] Hepatic encephalopathy is a potentially life-threatening neuropsychiatric condition associated with chronic liver disease.
There is currently no cure for hepatic encephalopathy apart from liver transplantation.
Peter Martin, Chief Operating Officer, Norgine said: “We know that hepatic encephalopathy has a huge impact on the lives of patients, their families and carers and healthcare systems. This decision further demonstrates the value of XIFAXAN® 550 by reducing the recurrence of episodes of hepatic encephalopathy which ultimately can help decrease the cost of care for these patients.”
XIFAXAN® 550 is reimbursed in Australia, England, Finland, Germany, Ireland, Luxembourg, New Zealand, Norway, Scotland, Sweden, Switzerland and Wales.It is estimated that 500,000 people in Europe are living with advanced chronic liver disease, of which 40% will go on to develop hepatic encephalopathy. [2], [3]
Norgine currently holds marketing rights for XIFAXAN® 550mg (known as TARGAXAN®▼ 550 in the UK and some other markets) in Australia, Belgium, Denmark, Finland, Germany, Luxembourg, Netherlands, New Zealand, Norway, Republic of Ireland, Sweden, United Kingdom and Switzerland. Norgine and Alfa Wassermann co-promote the product under the TIXTAR® brand name in France.
About Hepatic Encephalopathy (HE)
HE is a serious and potentially life-threatening neuropsychiatric condition associated with liver cirrhosis.[4] 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.[5] 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. 2, [6]
About Alfa Wassermann
Alfa Wassermann is a private pharmaceutical company wholly owned by and subject to the direction and coordination of Alfasigma S.p.A. Alfa Wassermann has its headquarters in Bologna, Italy with its own Research, Development and Manufacturing facilities. In 2015, Alfa Wassermann net sales were €429 million and the company employs over 1,500 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 28 years, under the trade names of NORMIX®, XIFAXAN® and others, in 47 countries, including the USA.. 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
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References
[1] Ministry van Volksgezondheid, Welzijn en Sport final decision for rifaximin-α 550mg: 14 June 2016
[2] European association for the study of the liver, The burden of liver disease in Europe: A review of available epidemiological data, 2013
[3] American Association for the Study of Liver Diseases; European Association for the Study of the Liver. Hepatic Encephalopathy in chronic liver diease: 2014 practice guideline by the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases. J Hepatol. 2014;61(3):642-59
[4] Morgan M. Chapter 8: Hepatic Encephalopathy in Patients with Cirrhosis. In: Dooley JS, Lok A, Burroughs A, Heathcote J, editors. Sherlock’s Diseases of the Liver and Biliary System. 12th ed: Blackwell Publishing Ltd; 2011.
[5] Poordad F. Review article: the burden of hepatic encephalopathy, Aliment Pharmacol Ther 2006;25 (S1):3-9.
[6] Mullen KD. Review of the final report of the 1998 Working Party on definition, nomenclature and diagnosis of hepatic encephalopathy. Aliment Pharmacol Ther. 2007 Feb;25 Suppl 1:11-6
