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New HTA Decisions in Germany
December 2021
Drug name
RYEQO® (relugolix/estradiol/norethisterone acetate)
Company
Gedeon Richter Pharma GmbH
Decision date
01/12/2021
Therapeutic area
Gynaecological conditions
Therapeutic sub area
Gynaecological conditions: general and other
G-BA decision date
15/02/2022
Orphan Drug?
No
Decision
Considerable additional benefit
Indication
Adult patients of childbearing age with moderate to strong symptoms of uterine fibroids, for whom an observational approach is the best course of therapy. Appropriate comparator therapy: Patient-specific therapy depending on type and severity of symptoms as well as the burden on the patient. Selection of: observation, symptom orientated treatment such as, progestins taking into account the respective approval status (for patients where symptomatic treatment of the prolonged and/or heavy menstrual bleeding is sufficient), or ulipristal acetate (for patients who are have not reached menopause and those for which an embolisation of uterine fibroids and/or surgery has failed or is not suitable); or invasive treatment options.
Decision
No additional benefit
Indication
Adult patients of childbearing age with moderate to strong symptoms of uterine fibroids, for whom symptom-orientated treatment (with progestins or ulipristal acetate) or invasive treatment is the best course of therapy. Appropriate comparator therapy: Patient-specific therapy depending on type and severity of symptoms as well as the burden on the patient. Selection of: observation, symptom orientated treatment such as, progestins taking into account the respective approval status (for patients where symptomatic treatment of the prolonged and/or heavy menstrual bleeding is sufficient), or ulipristal acetate (for patients who are have not reached menopause and those for which an embolisation of uterine fibroids and/or surgery has failed or is not suitable); or invasive treatment options.
Decision Detail
Main studies: LIBERTY 1 and LIBERTY 2. Main driver of decision: There was an added benefit of treatment for the outcomes morbidity and health-related quality of life for indication 1. No data was provided for the benefit assessment of indication 2.
Summary
IQWIG concluded that there was a considerable added benefit for indication 1 and no added benefit for indication 2.