GVS advice to include the relugolix in combination with oestradiol and norethisteronacetate (Ryeqo®) combination
The National Health Care Institute has completed its assessment whether relugolix in combination with oestradiol and norethisteronacetate (Ryeqo®) can be included in the Medicine Reimbursement System (GVS). The combination preparations is used for the treatment of symptoms of uterine fibroids in adult women of reproductive age. The National Health Care Institute advises the Minister to include relugolix in combination with oestradiol and norethisteronacetate (Ryeqo®) in List 1B with reimbursement conditions as described below.
Indication for which reimbursement is requested
Relugolix in combination with oestradiol and norethisteronacetate (Ryeqo®) is registered for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. It is available as a tablet. Each tablet contains 40 mg relugolix, 1 mg oestradiol, and 0.5 mg norethisteronacetate. The first tablet must be taken within 5 days of the onset of menstrual bleeding to prevent irregular and/or heavy bleeding. Discontinuation should be considered when the patient enters menopause.
National Health Care Institute's advice
The National Health Care Institute advises the Minister to include relugolix in combination with oestradiol and norethisteronacetate (Ryeqo®) n in List 1B of the Rzv. The National Health Care Institute hereby recommends the following reimbursement conditions.
Conditions relugolix in combination with oestradiol and norethisteronacetate (Ryeqo®)
Only for adult insured persons in their childbearing years with severe menstrual blood loss due to uterine fibroids for whom menopause is expected to start within 2 to 3 years and where conservative primary line medication has failed and surgical treatment/invasive procedure is not desired or possible.