ModifiedUnitedHealthcarePolicy 2025 P 2216-7

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

Defines UnitedHealthcare prior authorization and medical necessity criteria for Oriahnn (elagolix with estradiol/norethindrone) and MyFembree (relugolix with estradiol hemihydrate/norethindrone) for treatment of heavy menstrual bleeding due to uterine fibroids and (MyFembree only) moderate to severe endometriosis pain, including initial and reauthorization requirements and treatment-duration limits.

Policy Summary

PayerUnitedHealthcare

PolicyUnitedHealthcare Pharmacy Clinical Pharmacy Programs

Policy CodePolicy 2025 P 2216-7

Change TypeMODIFIED

Effective DateMay 1, 2025

Next Review Date

Key ActionPrior authorization/medical necessity program applies; approvals issued when criteria met.

POLICY UPDATE CHANGES

Program established for Oriahnn and MyFembree with prior authorization/medical necessity.

MyFembree added to program and new indication for endometriosis pain added.

Tranexamic acid requirement was removed from criteria.

Removed premenopausal requirement and updated failure language, state mandate language, and authorization duration.

State-specific trial duration exception for Connecticut, Kentucky, and Mississippi (30 days).

2Covered Indications

24Maximum Treatment Duration (months)

12Authorization Duration Per Approval

30dState-specific trial length (CT/KY/MS)

Coverage Summary & Scope

Defines UnitedHealthcare prior authorization and medical necessity criteria for Oriahnn (elagolix with estradiol/norethindrone) and MyFembree (relugolix with estradiol hemihydrate/norethindrone) for treatment of heavy menstrual bleeding due to uterine fibroids. Also covers the MyFembree-only indication for moderate to severe endometriosis-related pain. Overall coverage stance: covered_with_criteria. Effective date: 2025-05-01. Policy number: 2025 P 2216-7.

Thresholds

Treatment durationMaximum total 24 months

Authorization per approvalIssued for 12 months

Analgesic trial (endometriosis)Failure after a 3-month trial of two analgesics

Analgesic trial - CT/KY/MS30-day trial acceptable for Connecticut, Kentucky, Mississippi

Contraceptive/progestin trialFailure after a 3-month trial of hormonal contraceptive or progestin

Contraceptive/progestin trial - CT/KY/MS30-day trial acceptable for Connecticut, Kentucky, Mississippi

Initial Therapy Criteria

Initial Authorization - Heavy Menstrual Bleeding due to Uterine Fibroids (Oriahnn and MyFembree)

Approved when ALL of the following are met:

ALL of the following

Diagnosis of uterine fibroids (leiomyomas)
Used for the management of heavy menstrual bleeding
ALL of the following
- ONE of
  - Estrogen/progestin contraceptive (e.g., Loestrin FE)

Reauthorization / Continuation Criteria

Reauthorization - Heavy Menstrual Bleeding due to Uterine Fibroids (Oriahnn and MyFembree)

Approved when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to therapy
Impact to bone mineral density has been considered
Treatment duration has not exceeded a total of 24 monthsMaximum total 24 months; authorizations issued for 12 months
Authorization will be issued for 12 months up to a maximum treatment duration of 24 months

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Exclusions / Limitations

Policy-level exclusions/limits: coverage limited to the specified indications — MyFembree-only for moderate to severe endometriosis pain; no other indications are covered. Treatment duration is limited to a maximum total of 24 months with authorizations issued for up to 12 months. Note: the prior requirement for tranexamic acid was removed in 1/2022.

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization/medical necessity program applies; approvals issued when criteria met. Effective date for program: 2025-05-01.

Documentation Required

Document prior therapy failures

Providers must document prior trials of specified contraceptives, IUDs, progestin-only methods, or analgesics including duration and reason for failure/contraindication/intolerance.

Referenced Drugs / Comparison Products

Referenced example drug/comparison productsmixed

Micronor	norethindrone (example progestin-only contraceptive)
Mirena	progestin-releasing IUD example
Loestrin FE	estrogen/progestin contraceptive example
Aygestin	norethindrone example for progestins

Clinical Evidence & References

Evidence and administrative references: P&T approval dates include 9/2020; 8/2021; 1/2022; 9/2022; 2/2023; 2/2024; 2/2025. Key references include the Oriahnn package insert (June 2023), the MyFembree package insert (July 2024), and ACOG Practice Bulletins 228 (Management of Symptomatic Uterine Leiomyomas) and 114 (Management of Endometriosis).

Definitions and Evidence Metrics

Definition — FailureLack of adequate clinical response after a specified trial period, or contraindication/intolerance to the therapy.

P&T Approval Dates9/2020; 8/2021; 1/2022; 9/2022; 2/2023; 2/2024; 2/2025

Background

Background: Oriahnn and MyFembree are gonadotropin-releasing hormone (GnRH) receptor antagonists co-packaged with a combined oral contraceptive. Oriahnn contains elagolix co-packaged with estradiol/norethindrone; MyFembree contains relugolix co-packaged with estradiol hemihydrate/norethindrone. Both are indicated for management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women; MyFembree is additionally indicated for management of moderate to severe endometriosis-related pain in premenopausal women.

Revision History

9/2020program_established

Program created as a Prior Authorization/Medical Necessity program for Oriahnn and MyFembree (new program).

8/2021added_product

MyFembree added to the program (annual review).

1/2022criteria_removed

Tranexamic acid requirement removed from the criteria; state mandate language updated.

Policy Summary

PayerUnitedHealthcare

PolicyUnitedHealthcare Pharmacy Clinical Pharmacy Programs

Policy CodePolicy 2025 P 2216-7

Change TypeMODIFIED

Effective DateMay 1, 2025

Next Review Date

Key ActionPrior authorization/medical necessity program applies; approvals issued when criteria met.

On This Page

Progestin-releasing intrauterine devices (IUDs) (e.g., Mirena)

Progestin-only contraceptive (e.g., norethindrone [Micronor])

ALL of the following

Obstetrics/Gynecologist (OB/GYN)
Reproductive endocrinologist

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Initial Authorization - Moderate to Severe Endometriosis Pain (MyFembree only)

Approved when ALL of the following are met:

ALL of the following

Diagnosis of moderate to severe pain associated with endometriosis
Failure after a three-month trial, contraindication, or intolerance of two analgesics (e.g., ibuprofen, meloxicam, naproxen)3 months (30 days for CT/KY/MS)
Three-month trial requirement modifies to 30 days for Connecticut, Kentucky, and Mississippi
ALL of the following
- ONE of
  - Hormonal contraceptives
  - Progestins (e.g., norethindrone [Aygestin])
ALL of the following
- Obstetrics/Gynecologist (OB/GYN)
- Reproductive endocrinologist

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ref_b1_1_title_should_match_ref_exactly__Initial Authorization - Moderate to Severe Endometriosis Pain (MyFembree only)

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Reauthorization - Moderate to Severe Endometriosis Pain (MyFembree only)

Approved when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to therapy
Impact to bone mineral density has been considered
Treatment duration has not exceeded a total of 24 monthsMaximum total 24 months; authorizations issued for 12 months
Authorization will be issued for 12 months up to a maximum treatment duration of 24 months

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Denial Risk

Duration limit enforcement

Claims will be denied or not reauthorized if cumulative treatment duration exceeds 24 months; reauthorizations are issued for up to 12 months only.

Maximum total 24 months
Authorization duration per approval: 12 months

Documentation Required

Specialty prescriber or consultation

Prescription must be by or in consultation with an OB/GYN or reproductive endocrinologist.

Billing Rule

Automated approvals may apply

UnitedHealthcare may approve initial and reauthorization based on previous claims/medication history, diagnosis codes, and claim logic; supply limits may apply.

9/2022added_indication

MyFembree indication expanded to include moderate to severe endometriosis-related pain; state mandate language updated to include Mississippi.

2/2024revised

Annual review revisions: removed premenopausal requirement and updated references.

2/2025revisedLatest

Annual review revisions with updated failure language, state mandate language, and authorization duration; effective date for the policy updated to 2025-05-01.

state-specific (CT/KY/MS)clarificationLatest

For Connecticut, Kentucky, and Mississippi only, trial length requirements (for contraceptive/progestin/analgesic trials) are reduced to 30 days instead of the standard three-month trial.