Advice - Reimburse bulevirtide (Hepcludex®) for the treatment of chronic hepatitis delta virus (HDV) infection in certain patients
The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse bulevirtide (Hepcludex®) from the basic health care package. This medicinal product can be used in certain patients with chronic hepatitis delta virus (HDV) infection. If the Minister adopts our advice, bulevirtide will be included in the Medicine Reimbursement System (GVS). Only then will this medicinal product be reimbursed from the health care insurer's basic health care package.
Bulevirtide is intended for certain people with chronic hepatitis delta virus (HDV) infection
Bulevirtide is the active substance. The brand name is Hepcludex®. The medicinal product is an injection that should be given under the skin (subcutaneously) every day.
The medicinal product can be used for the treatment of chronic hepatitis delta virus (HDV) infection in certain patients with compensated liver disease. In compensated liver disease, the liver is damaged, but it still works. People can only be infected with HDV if they are also infected with the hepatitis B virus (HBV). HDV and HBV are passed on through blood contact and sexual contact. Blood contact and careless use of drug syringes are the main causes. Symptoms that may occur with HDV infection include fatigue, mild fever, sometimes upper abdominal pain and nausea. Long-term HDV infection may cause liver cirrhosis. In liver cirrhosis, liver function is impaired by the presence of scar tissue. Liver cirrhosis can even lead to death.
Advice from the National Health Care Institute on reimbursement of bulevirtide
The National Health Care Institute advises the Minister of VWS to reimburse bulevirtide (Hepcludex®) from the basic health care package. The recommendation 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 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.