CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Oriahnn and Myfembree prior authorization for uterine fibroids and endometriosis

Policy governs prior authorization and coverage criteria for Oriahnn (elagolix/estradiol/norethindrone) and Myfembree (relugolix/estradiol/norethindrone) for treatment of heavy menstrual bleeding from uterine fibroids and pain from endometriosis for members under the payer's Medicaid scope.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOriahnn and Myfembree prior authorization for uterine fibroids and endometriosis

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date12/01/2020

Next Review DateN/A

Key ActionObtain prior authorization and document member is ≥18, premenopausal, meets bone health criteria, has required prior trials/intolerances, and shows clinical benefit after 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

24 monthsmaximum cumulative therapy duration allowed

6 monthsinitial authorization length

56 tabs/28dOriahnn quantity limit

28 tabs/28dMyfembree quantity limit

premenopausal

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Coverage Criteria

Initial Authorization

Authorization of 6 months may be granted when ALL of the following are met:

Age and prescriber: Member is 18 years of age and older AND prescribed by or in consultation with an obstetrics/gynecologist (OB/GYN) or reproductive endocrinologist

Bone health and prior therapy limit: Member has no history of osteoporosis or a bone mineral density T score of -1.5 or less at the lumbar spine, total hip or femoral neck AND member has not received more than 24 months of therapy with Oriahnn or Myfembree<=24 months cumulative

Indication - Uterine Fibroids: Member has a documented diagnosis of heavy menstrual bleeding associated with uterine fibroids AND documentation that member is premenopausal AND documentation that the member has tried and failed OR had an intolerance or contraindication to at least three formulary alternatives (e.g., tranexamic acid, norethindrone, NuvaRing) AND member has no history of pelvic inflammatory disease and/or persistent or complex ovarian cysts if requesting Oriahnn

Indication - Endometriosis pain: Member has diagnosis of moderate to severe pain associated with endometriosis AND documentation that member is premenopausal AND member has tried and failed OR had an intolerance or contraindication after a three month trial of two analgesics AND member has tried and failed OR had an intolerance or contraindication after a three month trial to one hormonal contraceptive or progestin (e.g., norethindrone)

Prior exposure limits specific: If member previously received elagolix- or relugolix-containing products, cumulative duration across products must not exceed 24 months, and member must not have received greater than six months of treatment with Orilissa 200 mg twice daily<=24 months cumulative across products; <=6 months Orilissa 200 mg BID

Continuation of Therapy

Authorization of 6 months may be granted for continuation when ALL of the following are met:

Meets initial criteria: Member continues to meet all initial criteria

Clinical response: Documentation of a positive clinical response after at least 6 months of therapy as evidenced by a decrease in heavy menstrual bleeding and/or pain associated with endometriosis and improvement in overall signs and symptoms>=6 months treatment with documented benefit

Exclusion: For requests involving Oriahnn for the treatment of heavy menstrual bleeding due to uterine fibroids, approval is excluded when the member has a history of pelvic inflammatory disease and/or persistent or complex ovarian cysts. This condition must be documented and will prevent coverage for Oriahnn for the uterine fibroid indication.

Therapy beyond a cumulative duration of 24 months is not covered. Prior exposure to elagolix- or relugolix-containing products must be included when calculating the cumulative duration; total therapy across these products must not exceed the 24 months maximum.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorization may be granted for up to 6 months when all listed clinical criteria are met. Providers must submit documentation supporting diagnosis, prior trials, prescriber specialty, and relevant bone density/osteoporosis history.

Initial authorization: up to 6 months
Maximum cumulative therapy: 24 months

Denial Risk

Triggers for Denial / High-Risk Conditions

Denial may be issued when exclusion or risk conditions are present. Confirm age, bone health, prior cumulative exposure, and required specialist involvement before submitting an authorization request.

Age < 18 years — not eligible
History of osteoporosis or BMD T-score ≤ -1.5 at lumbar spine, total hip, or femoral neck — denial risk

Background

Oriahnn (elagolix with estradiol and norethindrone) and Myfembree (relugolix with estradiol and norethindrone) are combination regimens that pair a gonadotropin-releasing hormone (GnRH) antagonist with hormonal add-back therapy to reduce heavy menstrual bleeding from uterine fibroids and to treat pain from endometriosis in premenopausal women. Use is time-limited because of safety concerns related to bone mineral density; consequently, initial authorizations are granted for a defined period and cumulative therapy is limited to a maximum of 24 months.

Definitions

Oriahnn — composition and key metadata

Drug nameOriahnn

Active ingredientselagolix; estradiol; norethindrone

Indications (policy scope)Treatment of heavy menstrual bleeding from uterine fibroids and pain from endometriosis in premenopausal women (Medicaid scope)

Effective date12/01/2020

Reviewed9/2020; 4/2021; 2/2022; 3/2023; 3/2024; 3/2025

Myfembree — composition and key metadata

Drug name