The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse hepatitis B immunoglobulin (Uman Big®) from the basic health care package. This medicinal product can be used to prevent hepatitis B virus infection or re-infection. The Minister has since adopted our advice and has included Uman Big® in the Medicine Reimbursement System (GVS). The reimbursement will take effect on 1 February 2025.

Hepatitis B immunoglobulin is intended for people with a high risk of being infected or re-infected with the hepatitis B virus

Hepatitis B immunoglobulin is the active substance. The brand name is Uman Big®. The medicinal product is an injection solution that is administered into a muscle.

The medicinal product is intended to prevent infection or re-infection with the hepatitis B virus. Hepatitis B is an inflammation of the liver caused by infection with the hepatitis B virus. Transmission can take place from mother to child at birth, through sexual contact or contact with blood. The symptoms of acute hepatitis B are fatigue, lack of appetite, muscle and joint pains, fever (feeling feverish), jaundice (discolouration of skin, whites of the eyes, stools and urine) and sometimes itching. Most people do not develop any symptoms. Hepatitis B immunoglobulin is given to people who have a high risk of becoming infected with the hepatitis B virus, such as those on dialysis and newborn babies from mothers who are hepatitis B virus carriers. It is also given to people who have a high risk of re-infection. These are people who have had a liver transplant after liver failure due to infection with the hepatitis B virus.

Advice from the National Health Care Institute on the reimbursement of hepatitis b immunoglobulin

The National Health Care Institute advises the Minister of Health, Welfare and Sport to reimburse hepatitis B immunoglobulin (Uman Big®) from the basic health care package. The advice is to include the medicinal product in List 1B of the GVS. 

For more information on the GVS and the Lists 1A, 1B and 2, see page ‘Reimbursement of extramural drugs (GVS)’.

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 National Health Care Institute advises the Minister after the assessment. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic health care package.

Explanation about the reimbursement of medicinal products

Uman Big® hepatitis B immunoglobulin is used as an intramural and extramural drug. Intramural means: medicines that are part of a hospital treatment. A hospital treatment consists of several actions that are charged as a package. The health insurance company will reimburse the cost of a hospital treatment directly to the hospital. 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 health care package if they are listed in the GVS.

This report is a summary of recommendations by the National Health Care Institute

The original text of this report is in Dutch.