NICE is recommending that Norgine’s new hepatic encephalopathy drug Targaxan should be funded by the NHS in England in final draft guidance.
The drug-pricing watchdog is recommending that Norgine’s Targaxan (rifaximin) be funded as a treatment option for preventing recurrent episodes of hepatic encephalopathy, a brain condition caused by liver failure.
The disorder causes patients to become confused, lose consciousness or, in more serious cases, fall into a coma, as a result of problems with their liver. It affects around 10,000 people in the UK.
It is believed to be caused by a build-up of toxic substances in the body that are normally removed by the liver.
NICE had originally been minded not to recommend the drug, saying it needed new information on a number of areas for the application to be assessed.
Norgine has since come back to the Institute with the updated data, and NICE says it is now prepared to green light the pill.
Commenting on the draft guidance Professor Carole Longson, director of the NICE centre for health technology evaluation, said: “We are pleased that new evidence became available which allowed us to recommend rifaximin as a treatment option for people with hepatic encephalopathy.
“This serious brain condition has far-reaching effects on people with the condition and their families and carers. It can be serious, even fatal. People affected may have to go into hospital regularly. Rifaximin can prevent these life-threatening episodes and improve people’s quality of life.”
Final guidance on the use of the treatment in hepatic encephalopathy will be published in the spring, according to NICE.
Peter Martin, chief operating officer at Norgine, said: “Norgine is very pleased that the true value of Targaxan has been recognised. It is a reflection of the value this medicine brings to patients, carers and the healthcare system, as demonstrated in the real world data that was submitted.
“It is critical to have additional treatment options for hepatic encephalopathy as liver disease is increasing and there is currently no cure for HE apart from liver transplantation.”
The drug is a semi-synthetic derivative of the antibiotic rifamycin and works by decreasing intestinal production and absorption of ammonia.
This is thought to be responsible for the neurocognitive symptoms of hepatic encephalopathy, thereby delaying the recurrence of acute episodes.
Targaxan comes in a 550mg tablet form and costs £259.23 per 56-tablet pack, according to the British National Formulary, and is taken twice a day.
Norgine says the average cost of its medicines is £1,689 for six months of treatment – a price NICE has deemed cost-effective. The drug has already been approved by the Scottish NHS. This followed a positive ruling from the country’s NICE equivalent, the Scottish Medicines Consortium, in September 2013.