CurrentUnitedHealthcarePolicy 2025 P 2216-7

Oriahnn (elagolix) and MyFembree (relugolix) — Prior Authorization and Coverage Criteria

Coverage and prior authorization criteria for Oriahnn and MyFembree for heavy menstrual bleeding due to uterine fibroids and endometriosis pain in premenopausal women; applies to UnitedHealthcare pharmacy clinical programs.

Policy Summary

PayerUnitedHealthcare

PolicyOriahnn (elagolix) and MyFembree (relugolix) prior authorization

Policy CodePolicy 2025 P 2216-7

Change TypeRoutine review — no material changes

Effective DateMay 1, 2025

Next Review DateFeb 1, 2025

Key ActionObtain prior authorization with documented diagnosis and required prior therapy trials; prescriber should be or consult an OB/GYN or reproductive endocrinologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

24 monthsmaximum treatment duration

12 monthsauthorization issuance period

3 monthsstandard trial duration

30 daysalternate trial (CT/KY/MS)

2failed analgesic trials

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Coverage and Authorization Criteria

Initial Therapy — Uterine Fibroids (Oriahnn, MyFembree)

Covered for uterine fibroids when ALL of the following are met:

Fibroids initial authorization: 1) Diagnosis of uterine fibroids (leiomyomas). 2) Used for the management of heavy menstrual bleeding. 3) Failure after a three-month trial, contraindication, or intolerance to one of the following: (a) estrogen/progestin contraceptive (e.g., Loestrin FE), (b) progestin-releasing intrauterine device (e.g., Mirena), (c) progestin-only contraceptive (e.g., norethindrone). 4) Prescribed by or in consultation with an Obstetrics/Gynecologist (OB/GYN) or a reproductive endocrinologist.3-month trial (30 days for CT, KY, MS business)

Authorization will be issued for 12 months; maximum treatment duration 24 months.

Initial Therapy — Endometriosis Pain (MyFembree)

Covered for endometriosis-related pain (MyFembree) when ALL of the following are met:

Endometriosis initial authorization: 1) Diagnosis of moderate to severe pain associated with endometriosis. 2) Failure after a three-month trial (e.g., inadequate pain relief), contraindication, or intolerance of two analgesics (e.g., ibuprofen, meloxicam, naproxen). 3) Failure after a three-month trial, contraindication, or intolerance to one of the following: (a) hormonal contraceptives, (b) progestins (e.g., norethindrone). 4) Prescribed by or in consultation with an Obstetrics/Gynecologist (OB/GYN) or a reproductive endocrinologist.3-month trial (30 days for CT, KY, MS business)

Authorization will be issued for 12 months; total treatment duration not to exceed 24 months.

Reauthorization — MyFembree and Oriahnn

Reauthorization criteria (both agents):

Reauthorization: 1) Documentation of positive clinical response to therapy. 2) Impact to bone mineral density has been considered. 3) Treatment duration has not exceeded a total of 24 months.

Authorization issued for 12 months up to a maximum treatment duration of 24 months.

Treatment with Oriahnn (elagolix with estradiol/norethindrone) or MyFembree (relugolix with estradiol hemihydrate/norethindrone) must not exceed a total duration of 24 months. Both products are indicated for a maximum treatment duration of 24 months, and requests that would result in cumulative therapy beyond this limit are not eligible for authorization.

Reauthorization is contingent on documentation that the member has had a positive clinical response and that the impact on bone mineral density has been considered; authorizations are issued for 12 months up to the 24-month lifetime maximum.

Provider Requirements and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial approval requires documented diagnosis and prior therapy failures as specified per indication; see indication-specific criteria for required trials and prescriber requirements.

Initial and re-authorization decisions may be based on submitted documentation or claims history (see below).
Authorization duration and specific prior-therapy requirements vary by indication; refer to indication criteria.

Step Therapy

Required Prior Therapy Trials

Trials of specified alternative therapies are required prior to approval as indicated in the clinical criteria. Typical trial duration is three months unless a contraindication or intolerance is documented.

Required alternatives include, but are not limited to, estrogen/progestin contraceptives, progestin-releasing IUDs, progestin-only contraceptives, hormonal contraceptives and trial of two analgesics for endometriosis pain.
Documented contraindication or intolerance to required therapies may substitute for trial requirements.

Initial Authorization Rules

Initial Therapy Rules

Initial authorization rules per indication:

Fibroids initial: See coverage criteria set: diagnosis of uterine fibroids with heavy menstrual bleeding; prior trial/failure of specified contraceptive or progestin therapies as listed; prescriber must be or consult with an OB/GYN or reproductive endocrinologist.3-month trial (30 days for CT, KY, MS business)

Authorization will be issued for 12 months.

Endometriosis initial: See coverage criteria set: diagnosis of moderate to severe endometriosis-related pain; failure of two analgesics and failure of specified hormonal therapies/progestins as listed; prescriber must be or consult with an OB/GYN or reproductive endocrinologist.3-month trial (30 days for CT, KY, MS business)

Authorization will be issued for 12 months.

Continuation and Reauthorization Rules

Continuation / Reauthorization

Continuation/Reauthorization for both agents requires:

Continuation nodes: Positive clinical response documented; consideration of impact to bone mineral density; total treatment duration ≤ 24 months.

Authorization issued for 12 months up to a maximum treatment duration of 24 months.

Step Therapy and Required Failures

Indication	Required prior trials	Trial duration / notes
Endometriosis-related moderate to severe pain (MyFembree only)
Failure, contraindication, or intolerance to: (1) two analgesics (e.g., ibuprofen, meloxicam, naproxen) AND (2) one hormonal therapy: hormonal contraceptives or progestins (e.g., norethindrone/Aygestin)
Three-month trial standard for each required therapy (30 days for CT, KY, MS business); prescriber must be or consult with an OB/GYN or reproductive endocrinologist. Authorization issued for 12 months; maximum treatment duration 24 months.

Drug Class and Definitions

Oriahnn / MyFembree class

Class nameGonadotropin-releasing hormone (GnRH) receptor antagonists co-packaged with a combined oral contraceptive

Example productsOriahnn (elagolix with estradiol/norethindrone); MyFembree (relugolix with estradiol hemihydrate/norethindrone)

Primary indicationManagement of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women

Additional indication (MyFembree)Management of moderate to severe pain associated with endometriosis in premenopausal women

Drug formulation noteOral GnRH receptor antagonist co-packaged with an estrogen/progestin combined oral contraceptive

Background and Clinical Context

Oriahnn (elagolix with estradiol/norethindrone) and MyFembree (relugolix with estradiol hemihydrate/norethindrone) are gonadotropin-releasing hormone (GnRH) receptor antagonists co-packaged with an estrogen/progestin formulation used to manage heavy menstrual bleeding due to uterine fibroids in premenopausal women; MyFembree additionally is indicated for moderate to severe endometriosis-related pain.

Prior authorization is required for both agents. Initial approval requires a documented qualifying diagnosis, applicable prior therapy trials or documented contraindications/intolerances per indication, and that the prescriber is an OB/GYN or reproductive endocrinologist or the request documents consultation with one. Typical prior therapy trial durations are 3 months (reduced to 30 days for Connecticut, Kentucky, and Mississippi business) as specified in the coverage criteria.