Iqirvo to treat PBC approved for public funding in England and Wales
NICE opinion bringing therapy to eligible patients at low or no cost
England’s National Institute for Health and Care Excellence (NICE) has recommended that Iqirvo (elafibranor) be covered by the country’s National Health Service (NHS) and provided at low or no cost to certain adults with primary biliary cholangitis (PBC).
The positive recommendation comes just a few weeks after Iqirvo was approved in the U.K. for adult PBC patients who cannot tolerate or have failed to respond to the first-line PBC treatment ursodeoxycholic acid (UDCA, sold as Urso and Actigall).
NHS coverage matches the approved indication in the U.K., with the therapy being indicated for use on its own in adult patients who cannot tolerate UDCA or in combination with UDCA when the first-line treatment isn’t effective.
“NICE’s decision comes at a pivotal time as currently available treatments do not effectively manage both PBC disease progression and life-impacting symptoms like itch and sleep disturbances,” David Montgomery, MD, medical director for the U.K. and Ireland at Ipsen, the company that sells Iqirvo, said in a company press release.
Iqirvo expected to arrive on NHS list of covered medicines within 3 months
Iqirvo will be the first PBC treatment covered by the NHS in nearly a decade, according to Ipsen. NICE’s recommendation is expected to be implemented by England’s NHS within three months, and until then, the treatment’s coverage in the country will continue to be provided by the Innovative Medicines Fund.
David Jones, a professor of liver immunology at Newcastle University, said that the NICE recommendation “represents an important step forward in the management of this potentially life-threatening rare liver condition.”
The NHS in Wales also follows NICE guidelines, while decisions about coverage of Iqirvo in other parts of the U.K. will be decided independently by local authorities.
The therapy is approved for the same indication in the U.S. and European Union.
Like other types of cholangitis, PBC is marked by inflammation in the tubes that transport bile, a digestive fluid, from the liver to the intestines. This can slow bile flow, a condition called cholestasis, causing bile to build in the liver and damage the organ, and leak into the bloodstream, resulting in itching and other disease symptoms.
“As a rare condition that primarily affects women around menopausal age, it is not uncommon for PBC to be diagnosed late or, in some cases, for these symptoms not to be taken seriously at all,” said Mo Christie, head of patient services at The PBC Foundation.
Iqirvo is an oral therapy designed to activate proteins involved in regulating liver inflammation, scarring, and bile processing to ultimately ease PBC symptoms.
Treatment found to ease markers of liver damage in a Phase 3 trial
Iqirvo’s approvals were based mainly on data from the Phase 3 clinical trial ELATIVE (NCT04526665), results of which showed that the therapy was better than a placebo at reducing markers of liver damage in adults with PBC.
Measures of itch and quality of life also tended to favor Iqirvo over the placebo, and the treatment was generally well tolerated.
“The availability of a new treatment option is a significant step forwards for people living with PBC and may help to raise awareness of the condition overall, leading to earlier diagnoses and improved disease management,” Christie said.
NICE is responsible for drafting recommendations about therapies to be listed for public reimbursement, and the patients eligible for them. Recommendations are based on a treatment’s potential benefits along with its cost, which is determined in negotiations between the NHS and the therapy’s developer.
Iqirvo is taken as a once daily 80 mg oral tablet. Its list price is £2,867 (about $3,737) for a pack of 30 tablets, NICE reported, which works out to about £96 ($125) per pill. Its listing on the NHS means the therapy will be available for free or with a minimal copay to eligible patients.
A commercial agreement between NHS England and Ipsen allows the health agency to purchase the medication at a discount, NICE reported. Details of the agreement have not been disclosed.
“This approval is an important step for us in improving outcomes for people living with PBC and further reinforces our commitment to addressing unmet medical needs in rare cholestatic liver diseases,” Montgomery said.
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