Relugolix / Estradiol / Norethisteronacetat (2) – Ryeqo®
Endometriosis, after medical or surgical treatment
Characteristics
| Start date | 01.12.2023 – Marketing authorisation: 30.10.2023 |
|---|---|
| Resolution | 16.05.2024 |
| INN | Relugolix/Estradiol/Norethisteronacetat |
| Brand name | Ryeqo® |
| Pharm. company | Gedeon Richter Pharma GmbH Allgemeine |
| G-BA Procedure ID | D-997 |
| ATC code | H01CC54 Anti-gonadotropin-releasing hormones (H01CC) |
| ICD-10 codes (AIS) | N80.0Endometriosis of uterus, N80.1Endometriosis of ovary, N80.2Endometriosis of fallopian tube, N80.3Endometriosis of pelvic peritoneum, N80.4Endometriosis of rectovaginal septum and vagina, N80.5Endometriosis of intestine, N80.6Endometriosis in cutaneous scar, N80.8Endometriosis of thorax, N80.9Endometriosis, unspecified |
| Alpha-ID codes (AIS) | I21467Endometriosis vaginae, I23944Endometriosis, I6951Endometriosis genitalis externa, I7298Endometriosis uteri, I7303Endometriosis ovarii, I7307Endometriosis of the uterine tube, I7311Endometriosis of the pelvic peritoneum, I7315Intestinal endometriosis, I7318Skin scar endometriosis |
| Therapeutic area | Genitourinary system diseases Endometriosis |
| Reason for procedure | New therapeutic indication |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
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|
Ryeqo is used in adult women of childbearing age for the symptomatic treatment of endometriosis in women with previous medical or surgical treatment of their endometriosis |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Patients of childbearing age with endometriosis who have already been treated with medication or surgery; for symptomatic treatment | Patient-specific therapy taking into account previous therapy, possible organ destruction and the localization and extent of the endometriosis lesions with a choice of o Dienogest o GnRH analogues (goserelin or buserelin or leuprorelin or triptorelin or nafarelin), o Surgical measures |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + no ITC) |
| ACT change | 03.04.2023 – Änderung des Therapiestandards |
- Clinical trials
- The pharmaceutical manufacturer has submitted a meta-analysis of the two studies, SPIRIT 1 and SPIRIT 2, which have identical study designs. These are randomised, double-blind studies in which the efficacy and safety of the combination of relugolix and oestradiol (E2)/norethisterone acetate (NETA) were compared with placebo over a 24-week period.
Women of childbearing age with endometriosis who have already undergone medical or surgical treatment; for symptomatic treatment
- For women of childbearing age with endometriosis who have already received medical or surgical treatment (for symptomatic management), the additional benefit is not proven.
- Overall, the additional benefit for women of childbearing age with endometriosis who have already been treated with medication or surgery is not proven, as no suitable data are available for comparison with the specified appropriate comparator therapy.
- On balance, there are no suitable data available for comparison with the specified appropriate comparator therapy. The additional benefit for women of childbearing age with endometriosis who have already been treated with medication or surgery is therefore not proven.
- Overall assessment
- Overall, the additional benefit for women of childbearing age with endometriosis who have already been treated with medication or surgery is not proven, as there are no suitable data available for comparison with the established appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Relugolix / Estradiol / Norethisteronacetat (2) | Ryeqo® | Gedeon Richter Pharma GmbH Allgemeine | Endometriosis, after medical or surgical treatment | 8,200–13,900 | 100% additional benefit not proven | |
| Relugolix / Estradiol / Norethisteronacetat (1) | Ryeqo® | Gedeon Richter Pharma GmbH | Uterine myoma | 20,160–100,840 | 50% Hint for considerable additional benefit |
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