The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse odevixibat (Kayfanda®) from the basic healthcare package. This medicinal product can be used in certain patients with Alagille syndrome (ALGS). This is a serious liver disease. If the Minister adopts our advice, odevixibat will be included in the Medicine Reimbursement System (GVS). Only then will this medicinal product be reimbursed from the healthcare insurer's basic healthcare package. We do recommend additional conditions for reimbursement.
Current state of affairs: advisory report sent to the Minister
The National Health Care Institute has sent this advice to the Minister of VWS. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.
Odevixibat is intended for certain people with Alagille syndrome (ALGS)
Odevixibat is the active substance. The brand name is Kayfanda®. The medicinal product is a tablet.
The medicine can be used to treat (very) severe itching in patients aged 6 months or older with ALGS. ALGS is a rare hereditary disorder that leads to many different parts of the body being affected. These include the liver, heart, eyes, face, skeleton, blood vessels and kidneys. Someone who is affected by ALGS has too few small bile ducts in the liver. Bile ducts transport liquid bile from the liver to the gall bladder for storage. The deficiency in the number of small bile ducts means that too much bile remains in the liver and bile ducts; this is known as cholestasis. Bilirubin, the waste product that arises when red blood cells are broken down, is normally transported away from the liver along with the liquid bile and then excreted in the stools. By reducing the number and quality of bile ducts, less bilirubin is also disposed of. Because the amount of bilirubin in the blood increases, it can then damage the above-mentioned organs and parts of the body. This is accompanied by jaundice and severe itching. This severe itching is called cholestatic pruritus.
The National Health Care Institute's advice on the reimbursement of odevixibat (Kayfanda®)
The National Health Care Institute advises the Minister of VWS to reimburse odevixibat (Kayfanda®) from the basic healthcare package. The recommendation is to include the medicinal product in List 1A of the GVS. We also recommend that the additional conditions be adjusted and combined with the additional condition for maralixibat. Because both products are also registered for another prurient disease; i.e. PFIC, these conditions are also included. These are the so-called List 2 conditions.
For more information on the GVS and lists 1A, 1B and 2, see the page on ‘Reimbursement of outpatient medicines’.
The following conditions apply for reimbursement.
- Only for an insured person
- With genetically confirmed PFIC (except subtype BSEP3 of PFIC 2); and
- Who is being treated at a centre of expertise; or
- Only for an insured person
- With severe pruritus due to ALGS;
- Who is being treated at a centre of expertise; and
- Who is not experiencing therapeutically sufficient effect from other non-invasive, symptomatic treatment; and
- The treatment for PFIC and ALGS must be evaluated during the first months. If no clinically detectable symptomatic treatment benefit can be established after up to 6 months, treatment must be discontinued.
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
Odevixibat is an extramural medicinal product. ‘Extramural’ means medicines for home use that can be obtained at the pharmacy with a prescription from a physician. They are only reimbursed from the basic healthcare package if they are listed in the GVS.