Iqirvo (elafibranor), an orphan drug for the treatment of patients with primary biliary cholangitis (CBP), will be reimbursed.

At its extraordinary meeting on 10 April 2025, the Board of Directors of the Italian Medicines Agency decided that an orphan medicine and a new chemical molecule should be eligible for reimbursement by the National Health Service (NHS).

The orphan medicine that the NHS will reimburse is Iqirvo (indicated for the treatment of primary biliary cholangitis (CBP), a rare and progressive liver disease that can lead to liver failure, need for liver transplantation and death. It is an autoimmune disease that predominantly affects women between 45 and 65 years of age, with a prevalence in Italy estimated at around 28 cases per 100,000 inhabitants.

Iqirvo is indicated in combination with ursodesoxycholic acid (AUDC) in adults who show an inadequate response to AUDC, or as monotherapy in adults who cannot tolerate AUDC.

The new chemical entity that will be eligible for reimbursement is Orserdu (elacestrant), indicated as monotherapy for the treatment of postmenopausal women and men with locally advanced or metastatic breast cancer.