CurrentUnitedHealthcarePolicy 2025 P 1143-12

Pa Notification Menopur

Defines UnitedHealthcare prior authorization/notification criteria for Menopur (menotropins) for ovarian stimulation (including ART and IUI), ovulation induction (off‑label), male hypogonadotropic hypogonadism (induction of spermatogenesis), fertility preservation related to gonadotoxic therapy, authorization durations, and program notes.

Policy Summary

PayerUnitedHealthcare

PolicyPa Notification Menopur

Policy CodePolicy 2025 P 1143-12

Change Typerevised

Effective DateSep 1, 2025

Next Review Date

Key ActionMenopur requires prior authorization/notification; authorization will be issued for 2 months for approved indications.

SourceLink

POLICY UPDATE CHANGES

Effective date set to 9/1/2025 and P&T approval dates updated through 6/2025; revised definition of infertility in background to correlate with ASRM and updated fertility preservation criteria to include prolonged hormonal ovarian suppression.

3Primary covered indications (Ovarian stimulation; Ovulation induction; Male hypogonadotropic hypogonadism)

2 monthsAuthorization duration for approved indications

450/225/150 IU/dayMaximum dosing scenarios listed

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Defines UnitedHealthcare prior authorization/notification criteria for Menopur (menotropins) for ovarian stimulation (including ART and IUI), ovulation induction (off‑label), male hypogonadotropic hypogonadism (induction of spermatogenesis), and fertility preservation related to gonadotoxic therapy. Program notes: prior authorization/notification is required; authorization will be issued for 2 months for approved indications, and supply/authorization limits or automated approval processes may be used per program and benefit plan.

Maximum dosing (ART cycle without FSH)450 IU/day for not more than 14 days

Maximum dosing (mixed stimulation protocol hMG + FSH)225 IU/day

Maximum dosing (used alone for ovulation induction or ovarian stimulation)150 IU/day

Authorization duration2 months

Initial Therapy Criteria — Ovarian Stimulation

A. Ovarian Stimulation - Covered Criteria

Menopur will be approved based on one of the following criteria:

a. Option A

ALL of the following
- Diagnosis of infertility
- For the development of multiple follicles (ovarian stimulation)
- ONE of
  - (a) Both of the following
    i. One of the following exists
    Diminished ovarian reserve
    Endometriosis
    Male factor infertility
    Tubal factor infertility
    Unexplained infertility
    Uterine factor infertility
    Ovulatory dysfunction
    Recurrent pregnancy loss
    Failure to achieve conception with other treatment modalities
    Will be used in conjunction with assisted reproductive technology (ART)
  - (b) Both of the following
    i. One of the following exists
    Diminished ovarian reserve
    Mild to moderate male factor infertility
    Minimal to mild endometriosis
    Unilateral tubal factor infertility
    Unexplained infertility
    Will be used in conjunction with intrauterine insemination (IUI)
- b. Fertility preservation
  - Used for fertility preservation
  - The individual will undergo gonadotoxic therapy (e.g., exposure to cytotoxic agents, invasive surgery, prolonged hormonal ovarian suppression, radiation therapy)
  - Will be used as part of an assisted reproductive technology (e.g., in vitro fertilization) procedure

Initial Therapy Criteria — Ovulation Induction (Off-Label)

B. Ovulation Induction (Off-Label) - Covered Criteria

Menopur will be approved based on all of the following criteria:

ALL of the following

Diagnosis of ovulatory dysfunction
b. One of the following exists
- Anovulation
- Oligo-ovulation
- Amenorrhea
Other specific causative factors (e.g., thyroid disease, hyperprolactinemia) have been excluded or treated
Infertility is not due to primary ovarian failure
For induction of ovulation

Initial Therapy Criteria — Male Hypogonadotropic Hypogonadism

C. Male Hypogonadotropic Hypogonadism - Covered Criteria

Menopur will be approved based on all of the following criteria:

ALL of the following

a. One of the following diagnoses
- Diagnosis of male primary hypogonadotropic hypogonadism
- Diagnosis of male secondary hypogonadotropic hypogonadism
For induction of spermatogenesis
Infertility is not due to primary testicular failure

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization/notification required

Menopur requires prior authorization/notification. Authorization will be issued for 2 months for approved indications (ovarian stimulation, ovulation induction, male hypogonadotropic hypogonadism, fertility preservation).

Documentation Required

Documentation of diagnosis and treatment intent

Providers must document the diagnosis (infertility, ovulatory dysfunction, or hypogonadotropic hypogonadism), specific supporting factors when applicable (for example diminished ovarian reserve, male factor infertility, endometriosis, tubal factor, unexplained infertility, ovulatory dysfunction), the planned use with ART or IUI when required, and exclusion or treatment of other causative factors for ovulation induction (e.g., thyroid disease, hyperprolactinemia).

Diagnosis (infertility, ovulatory dysfunction, or hypogonadotropic hypogonadism)
Supporting factors (e.g., diminished ovarian reserve, male factor, endometriosis, tubal factor, unexplained infertility, ovulatory dysfunction)
Planned use with ART or IUI when required
Exclusion/management of other causative factors (e.g., thyroid disease, hyperprolactinemia)

Billing Rule

Supply/authorization limits

Supply limits may be in place. UnitedHealthcare may approve initial and re‑authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic, and may use automated approval and re-approval processes.

Background and Definitions

Background: Menopur (menotropins) is an hMG product used for development of multiple follicles and pregnancy in ovulatory women participating in an assisted reproductive technology (ART) program, for ovulation induction in women with ovulatory dysfunction (including PCOS after clomiphene failure), and for induction of spermatogenesis in men with hypogonadotropic hypogonadism when infertility is not due to primary testicular failure. Infertility definitions align with ASRM/WHO guidance and are defined as inability to achieve a successful pregnancy due to medical/sexual/reproductive history or failure to achieve pregnancy after 12 months (<35 years) or 6 months (≥35 years) of regular unprotected intercourse. Clinically appropriate dosing limits are: 450 IU/day for not more than 14 days when used in an ART cycle without an FSH product; 225 IU/day when used as part of a mixed stimulation protocol (hMG + FSH); and 150 IU/day when used alone for ovulation induction or ovarian stimulation.

Definitions

Infertility: Unable to achieve a successful pregnancy due to medical/sexual/reproductive history or failure to achieve pregnancy after 12 months (<35 years) or 6 months (>=35 years) of regular unprotected intercourse.

Clinical Evidence & Policy History

Evidence: P&T approval history — Approved/reviewed annually with P&T dates from 8/2014 through 6/2025. Annual review note: the policy is reviewed annually with updates recorded 8/2014 through 6/2025; the 6/2025 review revised the definition of infertility to align with ASRM and updated fertility preservation examples, and the effective date is set to 9/1/2025.

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