May 24 2013
Norgine today announced that the Australian assessment body the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended the use of XIFAXAN 550 mg in the prevention of the recurrence of hepatic encephalopathy (HE) where other treatments have failed or are contraindicated; a potentially life-threatening neuropsychiatric condition associated with liver disease.
XIFAXAN 550 mg is the only treatment that has demonstrated a reduction in the recurrence of episodes of overt HE and hospitalisation due to HE compared with placebo in a 6-month randomised, double blind, placebo-controlled study in which ~91% patients were taking concomitant lactulose in both arms, in patients who were in remission from HE, resulting from chronic liver disease.
The PBAC announced its final decision as follows:
The PBAC recommended listing of rifaximin on the basis of high clinical need, improved clinical benefit over the existing treatments and acceptable cost effectiveness.
On the basis of the information available to it at the April 2013 meeting, the PBAC considered that there was no longer a requirement for a managed entry scheme approach.
This outcome represents the first acceptance for use made by a health technology assessment (HTA) process for XIFAXAN 550 mg in their healthcare system based on cost effectiveness review. Norgine and Alfa Wassermann are working closely with other HTA bodies across Europe including the National Institute for Health and Care Excellence (NICE) and The Scottish Medicines Consortium (SMC) to ensure patients have appropriate access to this important medicine. The review processes are currently underway and Norgine expects these bodies to make their decision in the second half of 2013.
'It's critical that we deliver medicines that treat serious conditions and improve quality-of-life as well as alleviate the cost burden on healthcare systems caused by hospital admissions," said Peter Martin , Norgine Chief Operating Officer.
"XIFAXAN 550 mg provides healthcare professionals with a world-leading treatment option for patients with hepatic encephalopathy, which is a recognised growing problem that may lead to premature death," added Peter Martin .
Norgine currently holds marketing rights for XIFAXAN 550 in: Australia, Belgium, Denmark, Egypt, Finland, France, Germany, Ireland, Luxembourg, the Netherlands, New Zealand, Norway, Switzerland, Sweden and the UK.
In Europe, XIFAXAN® 550 mg /TARGAXAN® 550 mg is already available in Denmark, Germany and in the UK for healthcare professionals to prescribe in accordance with local guidance.