The National Health Care Institute has advised the minister of Health, Welfare and Sport (hereinafter also “VWS”) to reimburse maralixibat (Livmarli®) through the basic healthcare package. This medicinal product can be used in certain patients with progressive familial intrahepatic cholestasis (PFIC). This is a rare and severe hereditary liver disease. The medicinal product is already in the Medicine Reimbursement System (GVS) for another severe liver disease. If the minister adopts our advice, this medicine will be reimbursed for the said PFIC patients as well.
Current state of affairs: advice adopted by the minister
The minister has now adopted our advice, meaning that maralixibat (Livmarli®) will also be reimbursed as of 1 July 2025 under the basic healthcare package for the said PFIC patients. However, additional conditions do apply to reimbursement.
Maralixibat is intended for certain people with a rare and severe hereditary liver disease
Maralixibat is the active substance; the brand name is Livmarli®. The medicine is a liquid formulation.
The product can be used in people with progressive familial intrahepatic cholestasis (PFIC). This is a rare and severe hereditary liver disease. In PFIC, the bile does not drain from the liver into the intestines properly. Because bile is not being excreted properly, certain substances accumulate in the body. This condition can lead to serious complications, such as liver damage or liver cancer, and can even be fatal in young children or teenagers. People with PFIC may suffer from severe itching. In some cases, the itching is so severe that a liver transplant is needed even before liver function is lost. Maralixibat inhibits the reabsorption of bile acids from the intestines into the bloodstream, leading to more bile acids being excreted and less accumulation in the body.
Advice from the National Health Care Institute on reimbursing maralixibat (Livmarli®)
The National Health Care Institute advises the Minister of Health, Welfare and Sport to reimburse maralixibat (Livmarli®) from the basic healthcare package. The medicinal product has already been included on List 1A of the GVS for treating cholestatic pruritus in patients aged 2 months and older with Alagille syndrome (ALGS), and is subject to additional reimbursement conditions on List 2.
The National Health Care Institute advises you to amend the additional List 2 conditions for maralixibat.
For more information on the GVS and Lists 1A, 1B and 2, see the page on ‘Reimbursement of outpatient medicines‘.
New conditions for reimbursing maralixibat (Livmarli®)
Only for an insured person:
- with severe cholestatic pruritus caused by ALGS, or
- with genetically confirmed PFIC (except PFIC2 subtype BSEP3);
- receiving treatment for it at a centre of expertise;
- and who has not yet started non-invasive, symptomatic treatment, or in whom it has not produced a lasting, therapeutically satisfactory result.
Treatment must be discontinued if no clinically demonstrable symptomatic treatment benefit can be determined after a maximum of four months of continuous treatment.
More information or questions
If you have any questions about this advice, please send your question to the National Health Care Institute via warcg@zinl.nl. If you have questions about the reimbursement of a medicinal product, the personal expenses or whether you should pay a contribution, please ask your health insurance provider.
How did the advice come about?
The Minister of VWS asks the National Health Care Institute to make an assessment. The minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.
Explanation about the reimbursement of medicinal products
Maralixibat is an extramural medicinal product. ‘Extramural’ means medicines for home use that can be obtained at a pharmacy with a prescription from a physician. They are only reimbursed from the basic healthcare package if they are listed in the GVS.