CurrentUnitedHealthcarePolicy 2025 P 2149-10

Gonadotropins for fertility (Follistim AQ, Gonal-f, Gonal-f RFF, Menopur)

Prior authorization/medical necessity policy for coverage of gonadotropin medications (follitropin beta/alpha and menotropins) managed via Optum Fertility Solutions for ovarian stimulation, ovulation induction, assisted reproductive technology (ART), and male hypogonadotropic hypogonadism. Defines clinical criteria, dosing limits, exclusions, authorization durations, and program applicability.

Policy Summary

PayerUnitedHealthcare

PolicyGonadotropins for fertility (Follistim AQ, Gonal-f, Gonal-f RFF, Menopur)

Policy CodePolicy 2025 P 2149-10

Change TypeClinical criteria updates; terminology and fertility preservation additions

Effective DateSep 1, 2025

Next Review Date

Key ActionRequests for Follistim AQ, Gonal-f, Gonal-f RFF, or Menopur must be authorized through Optum Fertility Solutions and meet the clinical criteria in the policy; authorizations are generally issued for 3 months.

POLICY UPDATE CHANGES

6/2025: Revised definition of infertility in background to correlate with ASRM; added criteria bypassing step requirement for patients diagnosed with hypothalamic amenorrhea; clarified situations to which the use of gonadotropins applies; removed criterion for initial treatment of diminished ovarian reserve; updated fertility preservation criteria and references.

5/2024: Added coverage criteria for fertility preservation for iatrogenic infertility and updated terminology.

11/2018: Corrected maximum dosing for ovulation induction to 225 IU/day and controlled ovarian stimulation to 150 IU/day; added definition of ART.

Multiple annual reviews listed (2019, 2020, 2021, 2022, 2023) with periodic updates to criteria and references; some reviews noted 'no changes to coverage criteria'.

4Medications covered (by name)

14Max days per cycle

225/150/450Dose caps (IU/day) Ov/Stim/ART

Coverage Summary

This policy is a prior authorization/medical necessity program for gonadotropin medications (Follistim AQ, Gonal-f, Gonal-f RFF, Menopur) used for ovulation induction, ovarian stimulation, assisted reproductive technology (ART), and male hypogonadotropic hypogonadism. It is managed through Optum Fertility Solutions when a client elects fertility coverage and is optional depending on employer/state/member benefits. (Program number 2025 P 2149-10; effective 9/1/2025; P&T reviews through 6/2025).

Coverage under this policy is covered_with_criteria: medications are approved only when the policy’s clinical criteria are met (including documented prognosis for conception ≥ 5%, ovarian reserve markers, prior monitored response when applicable) and when dosing/duration limits by indication are not exceeded. UnitedHealthcare may also apply automated approval/re-authorization based on claims history and member-specific plans/state mandates may affect coverage.

Policy status: CURRENT (effective 2025-09-01; last review 2025-06-01). P&T approval history includes multiple approvals/reviews from 7/2018 through 6/2025.

Thresholds

Prognosis for conception≥ 5%

FSH (marker)≤ 15 mIU/mL

AMH (marker)≥ 0.2 ng/mL

Antral follicle count (marker)≥ 3

Maximum duration14 days per cycle (longer may be considered for hypothalamic amenorrhea)

Maximum dose - Ovulation induction225 IU/day

Maximum dose - Ovarian stimulation150 IU/day

Maximum dose - ART450 IU/day

General / Initial Approval Criteria

Indication-specific: Ovulation Induction

Indication-specific: Ovarian Stimulation

Indication-specific: Ovarian Stimulation (Section C)

Approval for ovarian stimulation requires section A criteria and additional criteria:

ALL of the following

Patient meets the coverage criteria in section A.
One of the following usage contexts
- All of the following when used alone or with IUI
  - And one of
    Treatment in individuals with diminished ovarian reserve that have not responded to clomiphene or letrozole.

Indication-specific: Assisted Reproductive Technology (ART)

Indication-specific: Male Hypogonadotropic Hypogonadism

Program & Administrative Notes

Provider Actions

Prior Authorization

Prior authorization required via Optum Fertility Solutions

Requests for Follistim AQ, Gonal-f, Gonal-f RFF, or Menopur must be authorized through Optum Fertility Solutions and meet the clinical criteria in the policy; authorizations are generally issued for 3 months.

Documentation Required

Document ovarian reserve and prior response

Provide documentation of prognosis for conception, at least two ovarian reserve markers within 6 months (FSH, AMH, antral follicle count), and evidence of prior monitored response if applicable.

Prognosis for conception (must be ≥ 5%)
At least two ovarian reserve markers within the previous 6 months: FSH ≤ 15 mIU/mL; AMH ≥ 0.2 ng/mL; antral follicle count ≥ 3
Evidence of prior monitored, medicated-stimulated response if applicable (e.g., follicle ≥ 15 mm for IUI or ART)

Applicable Codes

Drugs covered by policyNDCCovered

Follistim AQ	follitropin beta (refer to product labeling for NDCs)
Gonal-f	follitropin alfa (refer to product labeling for NDCs)
Gonal-f RFF	follitropin alfa - rapid reconstitution formulation (refer to product labeling for NDCs)
Menopur	menotropins (human menopausal gonadotropin, hMG) (refer to product labeling for NDCs)

Clinical Evidence & References

P&T approval history: multiple approvals and reviews are documented between 7/2018 and 6/2025, with substantive updates noted in 11/2018 (dose corrections, definition of ART), 10/2022 (ovarian reserve markers clarified), 5/2024 (fertility preservation criteria), and 6/2025 (infertility definition aligned with ASRM; step bypass for hypothalamic amenorrhea).

Key references supporting the policy include product labeling for Gonal-f, Follistim AQ, Gonal-f RFF, and Menopur (package inserts), and professional society guidance such as the American Society for Reproductive Medicine (ASRM) and European Society for Human Reproduction and Embryology (ESHRE) guidelines and literature cited in the reference list.

Definition note: Assisted Reproductive Technology (ART) is defined in the policy as fertility treatments in which eggs and embryos are handled, including in vitro fertilization; this term is used in the approval pathways and dosing limits for ART cycles.

Background

Background and clinical uses: Gonadotropins (FSH and hMG) are used to induce ovulation, support ovarian stimulation for ART (development of multiple follicles), and to induce spermatogenesis in men with primary or secondary hypogonadotropic hypogonadism when infertility is not due to primary testicular failure. Product indications in labeling mirror these uses.

Policy alignment with ovarian reserve markers and dosing limits: The policy requires a documented prognosis for conception (≥ 5%) and evidence of adequate ovarian reserve (at least two markers within the previous 6 months: FSH ≤ 15 mIU/mL, AMH ≥ 0.2 ng/mL, antral follicle count ≥ 3). Dosing caps are specified by indication: ovulation induction ≤ 225 IU/day, ovarian stimulation ≤ 150 IU/day, ART ≤ 450 IU/day, and maximum duration generally ≤ 14 days per cycle (longer stimulation may be considered for patients with hypothalamic amenorrhea).

Management when fertility coverage elected: This is an optional program managed through Optum Fertility Solutions; prior authorization requests for Follistim AQ, Gonal-f, Gonal-f RFF, or Menopur must be authorized through Optum Fertility Solutions and meet the policy’s clinical documentation requirements (prognosis, ovarian reserve markers, prior monitored response when applicable).

Supplemental definitions: ART — fertility treatments in which eggs and embryos are handled, including in vitro fertilization. Adequate ovarian reserve — presence of at least two markers within the previous 6 months: FSH ≤ 15 mIU/mL, AMH ≥ 0.2 ng/mL, antral follicle count ≥ 3.

Program applicability — quick facts

Revision History

6/2025revisedLatest

5/2024added

5/2024: Added coverage criteria for fertility preservation for iatrogenic infertility and updated terminology (changed 'controlled ovarian stimulation' to 'ovarian stimulation').

11/2018revised

Policy Summary

PayerUnitedHealthcare

PolicyGonadotropins for fertility (Follistim AQ, Gonal-f, Gonal-f RFF, Menopur)

Policy CodePolicy 2025 P 2149-10

Change TypeClinical criteria updates; terminology and fertility preservation additions

Effective DateSep 1, 2025

Next Review Date

On This Page

Unilateral tubal disease in conjunction with IUI when no evidence of tubal compromise on patent side and at least 2 cycles of oral agents failed to yield a dominant follicle on patent side.

Dosing/duration limits for ovarian stimulation: Dose does not exceed 150 IU/day for no more than 14 days per cycle.150 IU/day; 14 days

Situations where use is NOT appropriate for ovarian stimulation

Treatment in individuals with unexplained infertility.
Endometriosis.
Bilateral tubal factor infertility.
Unilateral isthmic/ampullary/fimbrial or tubal compromise (e.g., loculated spill, dilatation, phimosis; occlusion).
Recurrent pregnancy loss.
Isolated male factor infertility.
An estradiol level < 100 pg/mL per follicle ≥ 15 mm diameter.< 100 pg/mL per follicle ≥ 15 mm
Failure to respond to ovarian stimulation (doses up to 150 IU/day and no follicles ≥ 15 mm diameter).150 IU/day
When there are ≥ 4 follicles ≥ 15 mm diameter from a previously gonadotropin-induced ovulation despite dosage adjustment.≥ 4 follicles ≥ 15 mm
Doses that exceed 150 IU/day for ovarian stimulation.>150 IU/day
Following ART cycles that fail due to poor ovarian response or poor-quality oocytes/embryos.
Duration of therapy that exceeds 14 days per cycle.>14 days
Beyond 3 cycles.>3 cycles

Permitted uses related to fertility preservation

Used for fertility preservation for individuals who 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 procedure.

Authorization will be issued for 3 months.3 months

Denial Risk

Denial risk for excluded indications or exceeding dosing/duration

Claims may be denied if used for excluded indications (see policy exclusions for ovulation induction, ovarian stimulation, and ART) or if dosing/duration limits (IU/day caps or >14 days per cycle) are exceeded.

Exclusions include specified situations for each indication (e.g., use alone for unexplained infertility, certain tubal disease, endometriosis, bilateral tubal factor, etc.)
Denial risk if dose caps exceeded (225 IU/day for ovulation induction; 150 IU/day for ovarian stimulation; 450 IU/day for ART)
Denial risk if duration exceeds 14 days per cycle (except hypothalamic amenorrhea may be considered for longer stimulation)

Billing Rule

Program and benefit verification required

Verify member-specific benefits and state mandates; coverage depends on client election to provide fertility benefits and may be denied if infertility is excluded under the member's plan.

This program is optional and applies only when the client/business elects fertility coverage and is managed through Optum Fertility Solutions
State mandates and member-specific benefit plans may impact coverage

Step Therapy

Step requirement bypass for hypothalamic amenorrhea

Step-therapy requirements (for example, trial of Follistim AQ before Gonal-f) may be bypassed for patients diagnosed with hypothalamic amenorrhea per policy revision.

Policy revision added criteria bypassing step requirement for hypothalamic amenorrhea

Managed via Optum Fertility Solutions (optional program for clients electing fertility coverage)

Client participationOptional — applies only to clients/businesses electing to provide gonadotropin coverage

Typical authorization length3 months (authorizations issued for 3 months)

Effective date2025-09-01

Last review2025-06-01

11/2018: Corrected maximum dosing for ovulation induction to 225 IU/day and controlled ovarian stimulation to 150 IU/day; added definition of ART; moved Follistim AQ criteria into general requirements sections.

Multiple (2019-2023)annual_review

Multiple annual reviews listed (2019, 2020, 2021, 2022, 2023) with periodic updates to criteria and references; some reviews noted 'no changes to coverage criteria'.