CurrentCignaPolicy IP0205

Myfembree (relugolix/estradiol/norethindrone) drug coverage

Defines Cigna's prior authorization and medical necessity criteria for Myfembree for treatment of uterine fibroids (heavy menstrual bleeding) and endometriosis in premenopausal adults; applies to prescription benefit plans administered by Cigna Companies.

Policy Summary

PayerCigna

PolicyMyfembree (relugolix/estradiol/norethindrone) drug coverage

Policy CodePolicy IP0205

Change TypeRevised clinical criteria and duration

Effective DateJul 15, 2025

Next Review Date

Key ActionObtain prior authorization and ensure Myfembree is prescribed by or in consultation with an obstetrician-gynecologist or women's health specialist.

SourceLink

POLICY UPDATE CHANGES

Updated confirmation of uterine fibroids to specify imaging modalities: pelvic ultrasound (including transvaginal ultrasonography or sonohysterography), hysteroscopy, or MRI.

Increased authorization/approval duration from 12 months to 24 months for both uterine fibroids and endometriosis indications.

24 monthsMaximum approval duration per indication

≥ 18Minimum patient age for approval

PremenopausalRequired reproductive status

Not coveredNot covered for HMB not due to fibroids

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Coverage Criteria for Myfembree

Endometriosis (Initial/Duration criteria)

Approve for up to 24 months if ALL of the following are met:

Endometriosis criteria: A) Patient is >= 18 years of age; AND B) Patient is PREmenopausal (before menopause); AND C) Patient has previously tried ONE of the following, unless contraindicated: i) a contraceptive (e.g., combination oral contraceptives, levonorgestrel-releasing intrauterine system, depo-medroxyprogesterone injection) OR ii) an oral progesterone (e.g., norethindrone tablets). Exception: prior use of a gonadotropin-releasing hormone agonist (e.g., leuprolide depot) or elagolix (Orilissa) allows deviation from this requirement.

Duration limit: approve up to 24 months total (remaining duration if previously treated).

Use of Myfembree for any indication other than the specified uterine fibroids–associated heavy menstrual bleeding or moderate to severe endometriosis pain is not covered / considered not medically necessary.

Myfembree for heavy menstrual bleeding not associated with uterine fibroids is not medically necessary. Evidence of efficacy for reducing heavy menstrual bleeding has been demonstrated only in patients with uterine fibroids.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Prescriber Requirement

Prior Authorization Required: Prior Authorization is recommended for prescription benefit coverage of Myfembree. All approvals are provided for the duration noted in the policy (when authorized in months, 1 month = 30 days). Because of the specialized skills required for evaluation and diagnosis and monitoring for adverse events and long‑term efficacy, Myfembree must be prescribed by a physician who has consulted with or who specializes in the condition.

Approval durations follow the policy (e.g., up to 24 months for covered indications; remaining months are reduced by prior treatment time).
Prescriber limitation: Approval requires prescription by or in consultation with an obstetrician‑gynecologist or a clinician who specializes in women’s health.
Sample product: Receipt of sample product does not satisfy any prior therapy criteria.

Step Therapy

Required Prior Therapies for Endometriosis

Required prior therapies for endometriosis: For approval of Myfembree for endometriosis, the patient must have previously tried ONE of the following unless contraindicated. An exception may be made if the patient has previously used a gonadotropin‑releasing hormone (GnRH) agonist (e.g., leuprolide depot) or elagolix (Orilissa).

Definitions

inv-10: Uterine fibroids (leiomyomas) — brief definition and clinical impact

DefinitionBenign tumors of the uterus (leiomyomas) that may be asymptomatic or cause heavy menstrual bleeding, pelvic pain, or pressure; detectable in up to ~80% of women by age 50.

Clinical impactCan cause abnormal (heavy) uterine bleeding leading to complications such as iron deficiency anemia; may produce pelvic pain or pressure affecting quality of life.

Typical detection/epidemiologyFibroids are the most frequent benign gynecologic disease and may be detected in many women by age 50.

Relevance to policyMyfembree is indicated for management of heavy menstrual bleeding associated with uterine leiomyomas in premenopausal women; therapy limited to 24 months due to risk of progressive bone loss.

inv-11: Endometriosis — brief definition and clinical impact

Definition

Background

Myfembree is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist combined with estrogen and progestin that is indicated for treatment of heavy menstrual bleeding due to uterine leiomyomas (fibroids) and for moderate to severe endometriosis pain in premenopausal adults. Its mechanism involves suppression of gonadotropin signaling with add-back estrogen and progestin to mitigate hypoestrogenic effects. Use is limited because of risks such as progressive bone loss, and the policy authorizes therapy only for the labeled indications with a maximum approval duration of 24 months.

Policy Revision History

2025-07-15revisionLatest

Annual revision: clarified acceptable imaging modalities to confirm uterine fibroids (pelvic ultrasound including transvaginal ultrasonography or sonohysterography; hysteroscopy; or MRI) and increased authorization duration from 12 months to 24 months for uterine fibroids and endometriosis indications.

2024-08-01annual_review

Annual review noted updates to imaging confirmation wording for uterine fibroids and change in authorization duration to 24 months.

Documentation Required

Required Documentation and Denial Triggers

Required Documentation and Denial Triggers: Provide clear demographic and clinical documentation at the time of prior authorization request to avoid denials. Documentation must demonstrate the covered diagnosis and that all applicable criteria are met.

Age and menopausal status (patient ≥ 18 years and premenopausal) documented in the medical record.
Diagnosis documentation: for uterine fibroids, imaging confirmation (pelvic ultrasound — including transvaginal ultrasonography or sonohysterography — hysteroscopy, or MRI) confirming uterine fibroids.
Clinical indication: documentation of heavy menstrual bleeding associated with fibroids when applicable, or clinical rationale for endometriosis treatment.
Prior therapy records: documentation of trial and failure, intolerance, or contraindication to required prior therapies (e.g., contraceptives, oral progesterone) as specified in the criteria. Receipt of sample product does NOT satisfy prior therapy requirements.
Previous Myfembree/Oriahnn exposure: documentation that the patient has not previously received a continuous regimen of 24 months or longer of Myfembree or Oriahnn when requesting approval for fibroids.
Prescriber documentation: evidence that medication is prescribed by or in consultation with an OB‑GYN or specialist in women’s health.
Denial triggers (examples): claims or prior authorization requests will be denied if they lack a covered diagnosis or procedure code; if required documentation (age, premenopausal status, imaging confirmation for fibroids, prior therapy trial records, prescriber specialty/consultation) is missing; if required prior therapies for endometriosis are not documented or contraindication not justified; or if the patient previously completed a continuous 24‑month (or longer) regimen of Myfembree/Oriahnn for fibroids.
Operational note: Ensure submitted coding matches the coverage indication; claims billed without covered diagnosis/procedure codes will be denied as not covered.