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Defines medical necessity and prior authorization criteria for use of Follistim AQ (follitropin beta), Gonal-f/Gonal-f RFF (follitropin alfa), and Menopur (menotropins) for ovulation induction, ovarian stimulation, assisted reproductive technology (ART), and male hypogonadotropic hypogonadism under Optum Fertility Solutions for UnitedHealthcare Commercial Plans. Includes dosing limits, required ovarian reserve markers, exceptions, and authorization durations.
Effective Date set to 9/1/2025 and program number established.
6/2025 revision: Revised definition of infertility to correlate with ASRM and added bypass criteria for hypothalamic amenorrhea.
5/2024 revision: Added coverage criteria for fertility preservation for iatrogenic infertility and updated terminology from 'controlled ovarian stimulation' to 'ovarian stimulation'.
10/2022 revision: Added Assisted Reproductive Technology section and clarified when gonadotropins are indicated for endometrial lining preparation; updated ovarian reserve marker thresholds.
8/2019 revision: Changed step therapy to require trial of Follistim AQ before Gonal-f.
Policy 2025 P 2149-10 (Effective 2025-09-01, last reviewed 2025-06) defines prior authorization and medical necessity for gonadotropins (Follistim AQ, Gonal-f, Gonal-f RFF, Menopur) for UnitedHealthcare commercial plans managed through Optum Fertility Solutions. The policy subject is prior authorization/medical necessity for these agents and the program status is covered_with_criteria.
Covered indications include: Ovulation Induction (induction of ovulation in oligo-anovulatory or anovulatory women and related scenarios), Ovarian Stimulation (including ovarian stimulation for ART and a fertility preservation pathway for patients undergoing gonadotoxic therapy), Assisted Reproductive Technology (ART) (development of multiple follicles and use within ART cycles), and Male Hypogonadotropic Hypogonadism (induction of spermatogenesis in men with primary or secondary HH when infertility is not due to primary testicular failure).
Authorization duration: when criteria are met, prior authorizations will be issued for 3 months (applies to ovulation induction, ovarian stimulation including fertility preservation, ART, and male HH).
General Coverage Criteria (Section A)
Approved when ALL of the following are met:
ALL of the following
Adequate ovarian reserve (at least two of the following within previous 6 months):
within previous 6 months
within previous 6 months
within previous 6 months
Evidence of adequate ovarian response if previously monitored within previous 6 months
Agent-specific precondition for Gonal-f/Gonal-f RFF
Eligible indications (must be one of):
Ovulation Induction (Section B)
Follistim AQ, Gonal-f, Gonal-f RFF, or Menopur will be approved when ALL of the following are met:
ALL of the following
One of the following clinical situations
Ovarian Stimulation (Section C)
Follistim AQ, Gonal-f, Gonal-f RFF, or Menopur will be approved when ALL of the following are met:
Assisted Reproductive Technology (ART) (Section D)
Follistim AQ, Gonal-f, Gonal-f RFF, or Menopur will be approved when ALL of the following are met:
ALL of the following
Endometrial lining preparation exception
Male Hypogonadotropic Hypogonadism (Section E)
Approved when ALL of the following are met:
ALL of the following
Diagnosis
Prior authorization required
Prior authorization is required through Optum Fertility Solutions. When criteria are met, authorizations will be issued for 3 months for ovulation induction, ovarian stimulation (including fertility preservation), assisted reproductive technology (ART), and male hypogonadotropic hypogonadism.
Document ovarian reserve and response
Document prognosis for conception (≥ 5%), provide at least two ovarian reserve markers obtained within the previous 6 months (examples: FSH, AMH, antral follicle count, or documented embryo aneuploidy risk), and when applicable include evidence of prior ovarian response to stimulation (e.g., follicle sizes/counts such as one follicle ≥ 15 mm for IUI or minimum one follicle ≥ 15 mm for ART).
Step requirement for Gonal-f
For requests for Gonal-f or Gonal-f RFF, documentation must show prior failure, contraindication, or intolerance to Follistim AQ unless the patient has hypothalamic amenorrhea (in which case the step requirement is bypassed).
Denial if excluded situation
Claims will be denied when use falls into excluded situations listed in the criteria. Common denial triggers include doses or durations that exceed program thresholds (e.g., >225 IU/day for ovulation induction, >150 IU/day for ovarian stimulation, >450 IU/day or >14 days for ART), indications explicitly listed as not applicable (such as unexplained infertility or certain tubal/endometriosis scenarios depending on pathway), and prior ART failure scenarios noted in the policy.
Supply limits and automated approvals may apply
Supply limits and automated approval logic may apply. UnitedHealthcare/Optum Fertility Solutions may approve initial or reauthorization based on prior claim or medication history, diagnosis codes (ICD-10), and/or automated claim logic per program rules.
| No codes listed |
Gonadotropins (FSH and hMG) are used clinically to induce ovulation, stimulate follicle development for assisted reproductive techniques, and to induce spermatogenesis in men with hypogonadotropic hypogonadism; dosing and duration limits are set because clinical evidence indicates that exceeding specified daily IU thresholds or treatment days does not improve pregnancy outcomes. The policy notes specific maximums (e.g., 225 IU/day for ovulation induction, 150 IU/day for ovarian stimulation, and 450 IU/day for ART, each generally for no more than 14 days per cycle) and cites that exceeding these doses/durations has not been shown efficacious.
This is an optional program implemented for clients that elect fertility coverage and is managed through Optum Fertility Solutions; prior authorization and other utilization management (including possible supply limits, automated approvals based on claim history, and plan-specific exclusions) apply.
| Evidence / Source | Details |
|---|---|
| P&T approval history | |
| Multiple P&T dates: 7/2018, 11/2018, 5/2019, 8/2019, 8/2020, 9/2021, 10/2022, 10/2023, 5/2024, 6/2025; Effective Date 9/1/2025 | |
| References | |
| Package inserts (Gonal-F, Gonal-F RFF, Follistim AQ, Menopur) and professional society guidance and studies (ASRM/ESHRE guidance and multiple cited studies listed in references) |
| Term | Definition |
|---|---|
| Infertility | |
| Inability to achieve a successful pregnancy due to medical/sexual/reproductive history; failure to achieve pregnancy after 12 months of unprotected intercourse when female partner <35 years, or after 6 months when female partner ≥35 years | |
| ART | |
| Assisted reproductive technology; includes all fertility treatments in which eggs and embryos are handled, including in vitro fertilization and ICSI |
Program number 2025 P 2149-10 established; Effective Date set to 9/1/2025 and program managed by Optum Fertility Solutions with prior authorization/medical necessity requirements.
6/2025 revision: Revised definition of infertility to correlate with ASRM and added bypass criteria for hypothalamic amenorrhea (step requirement exception).
5/2024 revision: Added coverage criteria for fertility preservation for iatrogenic infertility and updated terminology from 'controlled ovarian stimulation' to 'ovarian stimulation'.
10/2022 revision: Added Assisted Reproductive Technology section and clarified when gonadotropins are indicated for endometrial lining preparation; updated ovarian reserve marker thresholds (FSH, AMH, antral follicle count, aneuploidy risk).
8/2019 revision: Changed step therapy to require trial of Follistim AQ before Gonal-f (later modified with bypass for hypothalamic amenorrhea).
7/2018 program inception: New prior authorization/medical necessity program created for Follistim AQ, Gonal-f, Gonal-f RFF, and Menopur.
longer than 14 days may be considered for hypothalamic amenorrhea
Dose and duration requirements (all):
Duration constraint
longer than 14 day stimulation may be considered in the setting of hypothalamic amenorrhea
Exclusions for ART
Agent-specific requirement for Gonal-f
applies if request is for Gonal-f