Scotland to cover Iqirvo for eligible primary biliary cholangitis patients
Decision follows a similar one in England and Wales
The Scottish Medicines Consortium (SMC) has agreed that Ipsen’s Iqirvo (elafibranor) be covered by the country’s public National Health Service (NHS), making the therapy available at little to no cost for eligible adults with primary biliary cholangitis (PBC).
The decision, which follows a similar one in England and Wales, makes Iqirvo the first medication in its class to be covered by NHS Scotland and the first new PBC medication to be covered in nearly a decade.
NHS Scotland coverage for Iqirvo aligns with the therapy’s approved indications in the U.K., and in the U.S. and European Union. Iqirvo can be used for adults with PBC either in combination with the first-line treatment ursodeoxycholic acid (UDCA) for those who haven’t responded adequately to UDCA, or alone in those who didn’t tolerate UDCA.
“The SMC acceptance offers a significant option to patients and healthcare teams who may have been unable to slow the progression of PBC with existing treatments,” John Dillon, MD, a liver specialist and professor at the University of Dundee, in Scotland, said in a press release from Ipsen. “It is an important new therapeutic agent and a welcome addition in managing a condition that is often debilitating for patients and life threatening for some.”
PBC is a chronic liver disease marked by inflammation in the bile ducts, or the series of tubes that carry the digestive fluid bile to the small intestine. Known as cholangitis, this inflammation can harm the ducts and lead to stalled bile flow, or cholestasis, with bile accumulating in the liver and damaging it, and backing up into the bloodstream to cause symptoms such as intense itching, or pruritus
New treatment access
Taken as a once-daily 80 mg oral tablet, Iqirvo is designed to ease PBC symptoms by activating PPAR alpha and PPAR delta, two proteins that regulate PBC-related processes such as inflammation, scarring, and bile processing.
Data backing its approvals largely come from the Phase 3 ELATIVE clinical trial (NCT04526665), where Iqirvo outperformed a placebo in reducing markers of liver damage and cholestasis among adults with PBC, with evidence showing it may also ease pruritus and improve life quality.
Iqirvo’s NHS coverage will offer new treatment access for PBC patients in Scotland where the rare disease is estimated to affect about 1,900 people, disproportionately impacting middle-aged women.
A recent report from the PBC Foundation and Ipsen found disparities in diagnosis and support for people with PBC in Scotland. In some cases, early symptoms are mistaken for aging or menopause. The report indicated a need for a national consensus on PBC care.
“PBC can have a massive impact on the lives of people living with the condition, but in some cases the symptoms aren’t being taken seriously,” said Mo Christie, head of patient services at the PBC Foundation. Christie said people with liver diseases often face stigma, with the common belief that such conditions are associated with alcohol abuse, which is not the case with PBC.
“Our report into the PBC care pathway in Scotland calls for all patients to receive NHS-endorsed information at the point of diagnosis, to help tackle this misunderstanding and stigma,” Christie said.
Meanwhile, Cabometyx (cabozantinib), a therapy that Ipsen markets outside the U.S. and Japan, has also been recommended for coverage by the SMC to treat hepatocellular carcinoma, the most common form of liver cancer.
“The SMC’s recommendation of both [Iqirvo] and [Cabometyx] demonstrates Ipsen’s commitment to bringing high value medicines to the U.K. to address unmet clinical and patient needs in rare liver diseases,” said David Montgomery, Ipsen’s medical director in the U.K. and Ireland. “These approvals are an important step in improving outcomes for patients and bringing parity of access across the U.K.”
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