· The average cost of care in Belgian patients using real world evidence was shown to be €31,262 for rifaximin-α 550mg plus lactulose versus €44,190 for lactulose alone 1
· In a Dutch societal framework rifaximin-α 550mg has demonstrated an incremental cost-effectiveness ratio of €31,897 2
LONDON, UK, Thursday 19 November, 07.00 GMT. Norgine B.V. has presented new analyses demonstrating the cost effectiveness of XIFAXAN® / TARGAXAN® 550 (rifaximin-α 550mg) treatment in Belgian and Dutch cirrhotic patients with recurrent hepatic encephalopathy with standard of care (lactulose) versus standard of care alone.1, [2] These data were presented at the ISPOR Annual Congress 2015, Milan, Italy.
The Belgian analyses demonstrate that over a five-year time horizon, treatment with rifaximin-α 550mg plus lactulose was both less costly and more effective than with lactulose alone. The analysis was derived from estimates of cost and quality adjusted life year (QALY) measures, which were based on key parameters, including length of hospital stay and number of hospital admissions.
In Dutch patients, the data show use of rifaximin-α 550mg plus lactulose represented good use of economic resource and was cost-effective compared with lactulose alone. Outcome metrics were incremental cost effectiveness ratios (ICERs) derived from QALY estimates and estimates of impact of work productivity loss upon patient/carer using a friction cost method reflecting patient and societal considerations in the model.
Both studies showed positive data for rifaximin-α 550mg, demonstrating a cost saving in Belgium of €12,927 per person over a 5 year time horizon. In the Netherlands, a cost effective base-case ICER of €31,897 over a lifetime horizon was demonstrated. 1, [2]
Peter Martin, Chief Operating Officer at Norgine said “These new analyses are significant because they further demonstrate the value of XIFAXAN® / TARGAXAN® 550 as an effective treatment to manage hepatic encephalopathy, a debilitating condition that currently has no cure apart from liver transplantation.”
XIFAXAN® / TARGAXAN® 550 is reimbursed in Australia, Finland, Germany, Ireland, Luxembourg, Norway, Sweden, Switzerland and United Kingdom.
Norgine currently holds marketing rights for XIFAXAN® 550mg (known as TARGAXAN®? 550 in the UK and some other markets) in Australia, Belgium, Denmark, Finland, France, Germany, Luxembourg, Netherlands, New Zealand, Norway, Republic of Ireland, Sweden, United Kingdom and Switzerland. The product is reimbursed in Australia, England, Germany, Ireland, Luxembourg, New Zealand, Norway, Scotland, Sweden, Switzerland and Wales.
Ends
Notes to Editors
About Hepatic Encephalopathy (HE)
HE is a serious and potentially life-threatening neuropsychiatric condition associated with liver cirrhosis.[3] 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.[4] 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. 3, [5]
Evaluation of the cost effectiveness of rifaximin-α 550mg in the reduction of recurrence of overt hepatic encephalopathy in Belgium
This economic evaluation used a Markov state transition model. The outcome metric was the incremental cost effectiveness ratio (ICER), derived from estimates of the cost/quality adjusted life years (QALYs). The payer perspective was that of the Belgian healthcare system. Outcome data were from two trials of rifaximin-α. Belgian costs data (2010) were derived from published sources. Health-related utility was estimated indirectly from disease-specific quality of life RCT data. The time horizon was five years. Costs and benefits were discounted at 3% and 1.5%, respectively. Real world data were also applied into the model for length of hospital stay (LOHS) and number of admissions.
Evaluation of the cost effectiveness and societal impact of rifaximin-α 550mg in the reduction of recurrence of overt hepatic encephalopathy in the Netherlands
A Markov state transition model was used. Outcome metrics were incremental cost effectiveness ratios (ICERs), derived from cost/quality adjusted life years (QALYs) estimates and estimates of impact of work productivity loss upon patient/carer using a friction cost method reflecting patient and societal considerations in the model. Outcomes data were from two trials of rifaximin-α 550mg. Dutch costs data were derived from published sources and societal cost estimates were from the Dutch costing manual (2010) inflated to 2015 prices. The time horizon was lifetime. Costs and benefits were discounted at 4% and 1.5%, respectively.
Quality-adjusted life year (QALY)
A measure of the state of health of a person or group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health.
QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality of life score (on a zero to 1 scale). It is often measured in terms of the person's ability to perform the activities of daily life, freedom from pain and mental disturbance.
Incremental cost effectiveness ratio (ICER)
The incremental cost-effectiveness ratio (ICER) is a statistic used in cost-effectiveness analysis to summarise the cost-effectiveness of a health care intervention. It is defined by the difference in cost between two possible interventions, divided by the difference in their effect.
About XIFAXAN® / TARGAXAN®? 550mg film-coated tablets
XIFAXAN® / TARGAXAN®? 550mg is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥18 years of age. TARGAXAN®?/ XIFAXAN® 550mg 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 European specialist pharmaceutical company that has been established for over 100 years. In 2014, Norgine’s total revenue was €296 million and the company employs over 1,000 people.
Norgine provides expertise and ‘know how’ in Europe to develop, manufacture and market products that offer real value to healthcare professionals, payers and patients. Norgine’s approach and infrastructure is integrated and focused upon ensuring that Norgine wins partnership opportunities for growth.
Norgine is headquartered in the Netherlands and its global operations are based in Amsterdam and in Harefield, UK. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites, one in Hengoed, Wales and one in Dreux, France.
For more information, please visit www.norgine.com
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.norgineventures.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 2014, Alfa Wassermann net sales were above €430million 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 28 years, under the trade names of NORMIX®, XIFAXAN® and others, in 47 countries, including the USA where Valeant / 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.
Media Contacts:
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Charlotte Andrews, T: +44 (0)1895 453607
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GL/XIF/1115/0128
November 2015
References
1 Evaluation of the cost effectiveness of rifaximin-α 550mg in the reduction of recurrence of overt hepatic encephalopathy in Belgium. ISPOR Annual Congress 2015, Abstract PGI25.
[2] Evaluation of the cost effectiveness and societal impact of rifaximin-α 550mg in the reduction of recurrence of overt hepatic encephalopathy in the Netherlands. ISPOR Annual Congress 2015, Abstract PGI38.
[3] 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.
[4] Poordad F. Review article: the burden of hepatic encephalopathy, Aliment Pharmacol Ther 2006;25 (S1):3-9.
[5] 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.
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