GVS advice odevixibat (Bylvay®) for the treatment of progressive familial intrahepatic cholestasis
The National Health Care Institute has assessed whether odevixibat (Bylvay®) can be included in the Medicine Reimbursement System (GVS). This medicine can be used in the treatment of progressive familial intrahepatic cholestasis (PFIC). This is the medical term for a rare condition in which the transport of bile acids from the liver cells to the bile ducts is disrupted. As a result, bile acids accumulate in the liver cells. This can lead to liver damage. The National Health Care Institute advises the Minister for Health, Welfare and Sport (VWS) to include odevixibat on List 1B of the GVS under certain conditions.
Indication for which reimbursement is requested
Odevixibat (Bylvay®) is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older. PFIC is a group of rare, autosomal recessive (liver) disorders in which the transport of bile acids from liver cells to bile ducts is disrupted. As a result, bile acids accumulate in the liver cells. This can lead to liver damage. Itching is the most burdensome symptom of PFIC and often leads to scratching, which can cause severe skin mutilation. This can have an impact on daily activities and lead to sleep deprivation, irritability, concentration disorders and reduced school results. Treatment with odevixibat results in less itching in certain patients.
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Minister of Health, Welfare and Sport to include odevixibat, under conditions, in List 1B of the Health Insurance Regulation.
Medicine Reimbursement System (GVS)
Odevixibat is an extramural drug. Extramural drugs are medicinal products for home use, available at the pharmacy on prescription from a physician. They will only be reimbursed from the basic health care package if they are listed in the GVS. The amount of the reimbursement depends on the list the product is on. Interchangeable medicinal products are clustered in List 1A. These may be subject to a reimbursement limit. Unique medicinal products are listed in List 1B. There is no reimbursement limit for these products. Additional conditions may apply for reimbursement. In that case, a medicinal product is also listed on List 2.
The Scientific Advisory Board (WAR) advises the National Health Care Institute about the assessment. Based on the assessment, the National Health Care Institute sends an advisory report to the Minister of Health, Welfare and Sport. The Minister makes the final decision whether or not to reimburse the medication from the basic health care package.