CurrentCignaPolicy N/A

Gonadotropin-Releasing Hormone Antagonists - Myfembree Prior Authorization Policy

Cigna coverage policy governing prior authorization requirements and medical necessity criteria for Myfembree for treatment of uterine fibroids (heavy menstrual bleeding) and endometriosis in premenopausal adults.

Policy Summary

PayerCigna

PolicyGonadotropin-Releasing Hormone Antagonists - Myfembree Prior Authorization Policy

Policy CodePolicy N/A

Change TypeRevised prior-therapy wording for endometriosis

Effective DateN/A

Next Review DateApr 29, 2026

Key ActionObtain prior authorization and document age, premenopausal status, diagnosis confirmation, prior therapies tried, and specialist prescribing when required.

SourceLink

POLICY UPDATE CHANGES

Endometriosis criteria wording changed from 'used' to 'tried' regarding previous therapies and the exception note was revised to reference prior use of a GnRH agonist or Orilissa.

24 monthsMaximum approved duration

≥18Minimum age

PremenopausalRequired status

HMB w/o fibroidsExcluded use

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Initial therapy — Endometriosis

Approve for up to 24 months if the patient meets ALL of the following (A through C):

Endometriosis criteria: A) Patient is ≥ 18 years of age; AND B) Patient is PREmenopausal; AND C) Patient has previously tried ONE of the following, unless contraindicated: i) a contraceptive (e.g., combination oral contraceptives, levonorgestrel-releasing intrauterine system such as Mirena or Liletta, or depot medroxyprogesterone injection); OR ii) an oral progesterone (e.g., norethindrone tablets). Exception: this prior-therapy requirement can be waived if the patient has previously used a gonadotropin-releasing hormone agonist (e.g., leuprolide depot) or Orilissa (elagolix).all 3 required

Policy wording changed from 'used' to 'tried' for prior therapies; exception clarified.

Use of Myfembree (relugolix/estradiol/norethindrone acetate) for heavy menstrual bleeding not associated with uterine fibroids is considered not medically necessary. The policy notes that Myfembree has demonstrated efficacy for reducing heavy menstrual bleeding only in women with uterine fibroids and does not support coverage for this non‑fibroid indication.

Myfembree is not medically necessary for any use(s) other than the specified indications. Specifically excluded is treatment of heavy menstrual bleeding not associated with uterine fibroids. The coverage rationale states Myfembree has shown efficacy in reducing heavy menstrual bleeding only in patients with uterine fibroids, and requests for the excluded use are therefore not covered.

Provider Actions and Documentation

Prior Authorization

Prior authorization required; approvals time-limited and may require specialist prescriber

Prior authorization is required for Myfembree; approvals are time-limited (examples: up to 24 months) and may require the medication to be prescribed by or in consultation with a specialist (obstetrician-gynecologist or women's health specialist). Approvals are provided for the duration noted (1 month = 30 days).

All approvals are provided for the duration noted; example: if patient already received 6 months, approve remaining 18 months.
Specialist prescribing or consultation required for certain diagnoses (obstetrician-gynecologist or clinician specializing in women's health).

Step Therapy

Prior therapy required before approval (fibroids and endometriosis)

For uterine fibroids, the patient must have tried at least one other medical therapy for management of heavy menstrual bleeding prior to approval. For endometriosis, the patient must have previously tried one of the specified therapies (contraceptive methods or an oral progesterone) unless contraindicated; the prior-therapy requirement may be waived if the patient has previously used a GnRH agonist (e.g., leuprolide depot) or Orilissa (elagolix).

Uterine fibroids: examples of prior therapies include combination estrogen–progestin contraceptives, levonorgestrel-releasing IUDs (e.g., Mirena, Liletta), oral progesterone, depot medroxyprogesterone, tranexamic acid.
Endometriosis: required prior therapy options include a contraceptive (combination oral contraceptives, levonorgestrel IUD, depot medroxyprogesterone) or an oral progesterone (e.g., norethindrone); exception if prior GnRH agonist or elagolix used.

Documentation Required

Required documentation to support prior authorization

Document age (patient ≥ 18 years), premenopausal status, confirmation of diagnosis, and prior therapies tried. For uterine fibroids, confirm fibroids by pelvic ultrasound (including transvaginal or sonohysterography), hysteroscopy, or MRI. When required, document that medication is prescribed by or in consultation with an obstetrician-gynecologist or women's health specialist.

Age ≥ 18 years and documentation that patient is premenopausal.
For fibroids: imaging or hysteroscopy/MRI documentation confirming uterine fibroids.
Records of prior therapies tried (as specified in policy).
Prescriber specialty or consultation note when required.

Denial Risk

Denial triggers: missing prior authorization or non-covered indication

Requests may be denied if prior authorization is not obtained or if treatment is requested for uses considered not medically necessary, specifically heavy menstrual bleeding not associated with uterine fibroids.

Myfembree is considered not medically necessary for heavy menstrual bleeding not associated with uterine fibroids.

Definitions

inv-12: Myfembree — definition/key facts

Generic componentsRelugolix (GnRH receptor antagonist) combined with estradiol and norethindrone acetate

IndicationsManagement of heavy menstrual bleeding associated with uterine fibroids and management of moderate to severe endometriosis pain in premenopausal women

FormulationOral combination tablet (Myfembree)

Use limitationUse should be limited to 24 months due to risk of progressive bone loss

inv-13: Premenopausal — definition

DefinitionPremenopausal — patient status before menopause; required for Myfembree coverage

Age requirementCovered patients must be ≥ 18 years of age (in addition to premenopausal status)

ApplicabilityPremenopausal status is required for both uterine fibroids and endometriosis indications

DocumentationPolicy requires documentation of premenopausal status as part of prior authorization

OpenPayer

Gonadotropin-Releasing Hormone Antagonists - Myfembree Prior Authorization Policy

Coverage Criteria

Coding and Duration

Provider Actions and Documentation

Definitions

Background