Limited coverage criteria – relugolix/estradiol/norethindrone acetate

Last updated on May 6, 2026

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Generic name		relugolix/estradiol/norethindrone acetate (RGX-E2-NETA)
Strength & form		40 mg/1 mg/0.5 mg oral tablet

Special Authority criteria	Approval period
Initial For the management of heavy menstrual bleeding (HMB) associated with uterine fibroids (UFs) in patients aged 18 years and older who are premenopausal when all the following criteria are met: Confirmed UF¹ and HMB AND Special Authority request is submitted by an obstetrician-gynecologist	12 months
Renewal Patients attain and maintain a reduction in menstrual blood loss (MBL), reduction in pain, or improvement in hemoglobin (in patients with anemia) AND Special Authority request is submitted by an obstetrician-gynecologist	12 months²

Special Authority criteria

Approval period

Initial

For the management of heavy menstrual bleeding (HMB) associated with uterine fibroids (UFs) in patients aged 18 years and older who are premenopausal when all the following criteria are met:

Confirmed UF¹ and HMB

AND

Special Authority request is submitted by an obstetrician-gynecologist

12 months

Renewal

Patients attain and maintain a reduction in menstrual blood loss (MBL), reduction in pain, or improvement in hemoglobin (in patients with anemia)

AND

Special Authority request is submitted by an obstetrician-gynecologist

12 months²

Practitioner exemptions

None

Special notes

¹Diagnosis of UFs confirmed by a transvaginal ultrasound; ≥ 1 UF must be verified to meet ≥ 1 of the following criteria:
- Subserosal, intramural, or < 50% intracavitary submucosal fibroid with a diameter ≥ 2 cm (longest diameter), or
- Multiple small fibroids with a total uterine volume of ≥ 130 cm³
²Treatment should not exceed a maximum duration of 24 months
Coverage for RGX-E2-NETA should be discontinued if the patient has any of the following: successful surgery or procedure, plans for pregnancy, menopause symptoms, or a meaningful decline in bone mineral density (BMD)
RGX-E2-NETA should not be used in combination with another gonadotropin-releasing hormone agonist or antagonist

Special Authority requests

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