CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Oriahnn (elagolix/estradiol/norethindrone) and Myfembree (relugolix/estradiol/norethindrone) coverage

Medicaid coverage policy governing prior authorization criteria, quantity limits, and duration for Oriahnn and Myfembree for treatment of heavy menstrual bleeding due to uterine fibroids and pain associated with endometriosis.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOriahnn (elagolix/estradiol/norethindrone) and Myfembree (relugolix/estradiol/norethindrone) coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2020

Next Review Date

Key ActionSubmit prior authorization documenting indication, prescriber specialty, age >=18, premenopausal status when required, prior therapy trials/intolerances, and prior cumulative exposure to elagolix/relugolix products.

POLICY UPDATE CHANGES

No material clinical/coverage changes.

2Covered indications

24 moMaximum therapy duration

56/28dOriahnn quantity limit

28/28dMyfembree quantity limit

Coverage Summary

Medicaid prior-authorization policy for Oriahnn (elagolix combination) and Myfembree (relugolix combination) covers treatment of heavy menstrual bleeding due to uterine fibroids and moderate to severe endometriosis-associated pain. Coverage is covered with criteria and requires documentation of indication, prescriber specialty, age, premenopausal status when relevant, prior therapy trials or intolerances, and limits on prior cumulative exposure. Quantity limits are Oriahnn: 56 tablets per 28 days and Myfembree: 28 tablets per 28 days, and the maximum covered therapy duration is 24 months.

Policy effective date: 12/01/2020. Last reviewed: 03/01/2025.

Surface thresholds and stats

Age>= 18 years

Maximum therapy duration24 months cumulative (Myfembree); Orilissa prior-use limit 6 months at 200 mg BID

Oriahnn quantity limit56 tablets per 28 days

Myfembree quantity limit28 tablets per 28 days

Covered indications2 (heavy menstrual bleeding due to uterine fibroids; moderate to severe endometriosis-associated pain)

Initial Therapy (6 months)

Initial approval (6 months)

An authorization of 6 months may be granted when all the following criteria are met:

ALL of the following

Prescribed by or in consultation with an obstetrics/gynecologist (OB/GYN) or reproductive endocrinologist
Member is 18 years of age and older
Member has no history of osteoporosis OR has a bone mineral density T score of -1.5 or less at the lumbar spine, total or femoral neck
Original source text is fragmented; preserved intent regarding osteoporosis and BMD threshold
Member has not received more than 24 months of therapy with Oriahnn or Myfembree
Indication-specific (ONE of)
- Uterine fibroids - heavy menstrual bleeding
  - Documented diagnosis of heavy menstrual bleeding associated with uterine fibroids
  - Documentation of trial and failure or intolerance/contraindication to at least three formulary alternatives (e.g., tranexamic acid, norethindrone, NuvaRing)
  - Documentation that member is premenopausal
  - Member has no history of pelvic inflammatory disease and/or persistent or complex ovarian cysts if requesting Oriahnn
- Pain associated with endometriosis
  - Member has diagnosis of moderate to severe pain associated with endometriosis

If member previously received treatment with an elagolix-containing product (e.g., Oriahnn, Orlissa) or a relugolix-containing product (e.g., Myfembree), the member has not already received more than 24 cumulative months of treatment with Myfembree or greater than six months of treatment with Orilissa 200 mg twice daily

Continuation Therapy / Clinical Response (Extension)

Continuation / clinical response for extension

Authorization of 6 months may be granted for members who meet all initial criteria and have documentation of clinical response after at least 6 months of therapy

ALL of the following

Member met initial approval criteria
Documentation of positive clinical response after at least 6 months of therapy with Oriahnn or Myfembree as evidenced by a decrease in heavy menstrual bleeding and/or improvement in endometriosis-associated pain and overall signs and symptoms

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization required with specialty prescribing

Submit a prior authorization that documents the clinical indication (heavy menstrual bleeding due to uterine fibroids OR moderate to severe pain associated with endometriosis), the prescribing or consulting specialty (obstetrics/gynecology or reproductive endocrinology), the member’s age (≥18 years), premenopausal status when required, prior trials/intolerances to specified alternatives, and prior cumulative exposure to elagolix- or relugolix-containing products.

Indication: specify uterine fibroid-related heavy menstrual bleeding OR endometriosis-associated pain.
Prescriber: note OB/GYN or reproductive endocrinologist involvement.
Age: confirm member is ≥18 years.
Premenopausal status: include documentation when required (per indication-specific criteria).
Prior exposure: document cumulative prior treatment with elagolix- or relugolix-containing products and confirm not exceeding allowed cumulative durations.

Documentation Required

Document prior therapy trials and intolerances

Provide documentation of trials, failures, intolerances, or contraindications as required by indication. For heavy menstrual bleeding due to uterine fibroids, document trials/failures or intolerances to at least three formulary alternatives. For endometriosis-associated pain, document a three‑month trial and failure/intolerance of two analgesics and a three‑month trial and failure/intolerance of one hormonal contraceptive or progestin.

Examples of formulary alternatives for heavy menstrual bleeding: tranexamic acid; norethindrone; NuvaRing.
Examples of analgesics for endometriosis pain trials: ibuprofen; meloxicam; naproxen.
Example hormonal contraceptive/progestin: norethindrone.

Billing Rule

Quantity limits

Adhere to the policy quantity limits when dispensing: Oriahnn is limited to 56 tablets per 28 days; Myfembree is limited to 28 tablets per 28 days.

Denial Risk

Prior treatment duration exclusion

Claims may be denied if the member has already received cumulative therapy beyond the policy limits. Specifically, denials may occur if the member has received more than 24 months cumulative treatment with Oriahnn or Myfembree, or has exceeded prior-use limits for Orilissa (greater than six months at 200 mg twice daily).

Background

Background: Policy covers elagolix- and relugolix-containing combination products (Oriahnn and Myfembree) for heavy menstrual bleeding due to uterine fibroids and moderate to severe endometriosis-associated pain. Prior authorization requires prescribing by or consultation with a specialist (OB/GYN or reproductive endocrinologist) and documentation of prior therapy trials, intolerances, or contraindications as specified, along with verification of premenopausal status and limits on cumulative prior exposure to elagolix/relugolix products.