GVS advice on mifepristone (Mifegyne®) for the treatment of miscarriages
The National Health Care Institute has tested whether mifepristone (Mifegyne®) can be included in the Medicine Reimbursement System (GVS). A medicinal product is eligible for reimbursement once it is included in the GVS. Mifepristone can be used in the treatment of miscarriages. The National Health Care Institute advises the Minister of Health, Welfare and Sport (VWS) to include mifepristone in List 1B of the GVS under conditions.
The reason for this advisory report is the revised Guideline on Miscarriages
In 2020, the Dutch Society for Obstetrics and Gynaecology (NVOG) revised the 'Guideline on Miscarriages'. During this review, a recommendation was added about pharmaceutical treatment in a miscarriage (non-vital pregnancy). The recommendation is to prescribe a combination therapy of mifepristone and misoprostol, instead of only misoprostol. Mifepristone is not currently included in the GVS, while the other medicinal product, misoprostol (Cytotec®, tablet 200 mcg), is included in the GVS. Mifepristone is therefore currently not reimbursed from the basic health care package.
Condition for which the medicinal product can be applied
The revised NVOG Guideline on Miscarriages focuses on the treatment of patients with symptoms that may indicate a miscarriage or non-vital pregnancy. In a non-vital (=non-intact) pregnancy, it is clear that the foetus is not viable, but there are no signs of a miscarriage in progress.
The National Health Care Institute's advice
The National Health Care Institute advises the Minister of Health, Welfare and Sport to include mifepristone (Mifegyne®) in List 1B of the GVS. Our assessment only applies to a miscarriage or non-vital pregnancy. We therefore recommend that you set the following conditions for reimbursement.
(off-label) In combination with misoprostol for the medical management of a miscarriage or non-vital pregnancy up to and including 16 weeks of amenorrhea.
Medicine Reimbursement System (GVS)
Mifepriston 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.