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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsHMSA Gonal-f Coverage & Prior Auth | OpenPayer
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    CurrentHawaii Medical Service Association (HMSA)Policy N/A

    Gonal-f (follitropin alfa) Coverage Criteria

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    This policy governs HMSA coverage and precertification requirements for Gonal-f in fertility treatment for HMO and PPO members when eligible indications, preferred-product exception documentation, and related infertility benefit requirements are satisfied.

    Policy Summary
    PayerHawaii Medical Service Association (HMSA)
    PolicyGonal-f (follitropin alfa) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateDec 19, 2025
    Last ReviewSep 1, 2025
    Next Review DateN/A
    Key ActionSubmit precertification for Gonal-f with documentation of a clinical reason to avoid preferred Follistim AQ.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 monthsStandard authorization period
    3Covered indication categories

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Non-preferredProduct status
    PrecertificationUtilization management
    Follistim AQPreferred product

    Gonal-f Coverage Criteria

    Initial Gonal-f approval

    Authorization may be granted for Gonal-f for 12 months when all of the following are met.

    Gonal-f approval criteria

    • Eligible infertility indication

      • Female infertility with IVF: Infertility in females as part of an IVF procedure. Precertification is required, and medical benefit coverage for the IVF procedure and services must also be authorized by HMSA.
      • Female ovulation induction: Infertility in females for ovulation induction in conjunction with artificial insemination or timed intercourse.
      • Male hypogonadotropic hypogonadism: Infertility in males with hypogonadotropic hypogonadism.

    • Clinical reason to avoid Follistim AQ

      • Contraindication to Follistim AQ or any of its components.
      • Intolerance: History of intolerance to Follistim AQ.
      • Adverse event: Previous confirmed adverse event with Follistim AQ.

    Authorization and Documentation Requirements

    Prior Authorization

    Gonal-f Precertification Required

    Precertification is required for non-preferred Gonal-f. Approval may be granted when Gonal-f is requested for an eligible infertility indication and all applicable clinical and documentation requirements are met.

    • Covered indications include female infertility as part of IVF, female infertility for ovulation induction with artificial insemination or timed intercourse, and male infertility with hypogonadotropic hypogonadism.
    • Authorization may be granted for 12 months, subject to the applicable approval period for IVF.
    • Gonal-f is subject to quantity limits.
    Step Therapy

    Preferred Follistim AQ; Exception Required

    Follistim AQ is HMSA's preferred follitropin product. Requesting non-preferred Gonal-f requires documentation of an eligible clinical exception to preferred-product therapy.

    • Follistim AQ does not require precertification but is subject to quantity limits.

    Policy Background

    Gonal-f (follitropin alfa) is a follitropin product used in infertility treatment. This policy addresses its use for ovulation induction, assisted reproductive technology (including in vitro fertilization), and induction of spermatogenesis in males with hypogonadotropic hypogonadism.

    The policy applies to HMSA HMO and PPO members when the requested infertility indication is covered, related infertility services are covered under the member’s plan, and applicable approval requirements are met. Gonal-f is a non-preferred product; precertification and quantity limits apply, while Follistim AQ is the preferred follitropin product.

    Infertility Treatment Definitions

    Definitions
    TermART
    Full nameAssisted reproductive technology
    Policy contextIncludes assisted reproductive technology procedures such as IVF or ICSI.
    Definitions
    TermIVF
    Full nameIn vitro fertilization
    Policy contextIncludes controlled ovarian stimulation as part of an in vitro fertilization procedure.

    Initial Therapy

    Initial therapy criteria

    Authorization of 12 months may be granted when all of the following criteria are met.

    Initial Gonal-f therapy

    • Covered infertility indication

      • Female infertility with IVF: Infertility in females as part of an IVF procedure. Precertification is required, and medical benefit coverage for the IVF procedure and services must also be authorized by HMSA.
      • Female ovulation induction: Infertility in females for ovulation induction in conjunction with artificial insemination or timed intercourse.
      • Male hypogonadotropic hypogonadism: Infertility in males with hypogonadotropic hypogonadism.

    Preferred Product Step Therapy

    StepPreferred productGonal-f requirement/status
    1Follistim AQNon-preferred; precertification is required. Use Gonal-f only when there is documented support for a contraindication to Follistim AQ or its components, a history of intolerance, or a previous confirmed adverse event.

    Quantity Limit References

    Quantity Limits
    Product statusGonal-f is a non-preferred product.
    Quantity limitsGonal-f is subject to quantity limits.
    Applicable policiesRefer to the HMSA Artificial Insemination Policy or HMSA In Vitro Fertilization Policy for applicable quantity limits.
    Policy Summary
    PayerHawaii Medical Service Association (HMSA)
    PolicyGonal-f (follitropin alfa) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateDec 19, 2025
    Last ReviewSep 1, 2025
    Next Review DateN/A
    Key ActionSubmit precertification for Gonal-f with documentation of a clinical reason to avoid preferred Follistim AQ.
    SourceLink
    On This Page
    Gonal-f Coverage CriteriaAuthorization and Documentation RequirementsPolicy BackgroundInfertility Treatment DefinitionsInitial TherapyPreferred Product Step TherapyQuantity Limit References
  1. A Gonal-f exception requires a documented contraindication, intolerance, or previous confirmed adverse event with Follistim AQ.
    2. Documentation Required

    Submit the HMSA IVF Procedure Approval Form

    For Gonal-f requested in connection with an IVF procedure, providers must submit the HMSA IVF procedure approval form for precertification review.

    • The IVF procedure approval form is required to initiate the Gonal-f precertification review.
    Documentation Required

    Document the Preferred-Product Exception

    When applicable, submit chart documentation supporting the clinical reason to avoid preferred Follistim AQ.

    • Contraindication to Follistim AQ or any of its components.
    • History of intolerance to Follistim AQ.
    • Previous confirmed adverse event with Follistim AQ.

    Unsupported block type: prior_auth

    Denial Risk

    Noncovered Indication May Result in Denial

    Gonal-f may be denied when it is not requested for one of HMSA's covered infertility indications.

    • Eligible indications are female infertility as part of IVF; female infertility for ovulation induction with artificial insemination or timed intercourse; or male infertility with hypogonadotropic hypogonadism.
    Denial Risk

    No Preferred-Product Exception May Result in Denial

    Gonal-f may be denied when there is no documented clinical reason to avoid preferred Follistim AQ.

    • Submit supportive documentation of a contraindication, intolerance, or previous confirmed adverse event with Follistim AQ.
    • A preference for Gonal-f alone does not establish an exception to preferred-product therapy.
    Prior Authorization

    Confirm IVF Authorization and Aligned Approval Periods

    For IVF requests, the IVF procedure and related services must also be authorized by HMSA. The Gonal-f authorization period will align with the approval period documented on HMSA's In Vitro Precertification form.

    • Drug coverage authorization does not replace authorization for the IVF procedure and related services.
    • For artificial insemination, no precertification is required for the artificial insemination procedure.
    Denial Risk

    Meet Precertification and Quantity-Limit Requirements

    Requests may be denied when utilization-management requirements are not met, including required precertification or applicable quantity limits.

    • Gonal-f is non-preferred, requires precertification, and is subject to quantity limits.
    • Refer to the HMSA Artificial Insemination or In Vitro Fertilization policy for applicable quantity limits.
    • Use the HMSA medical specialty drug policy website fax form for precertification.
    Definitions
    TermICSI
    Full nameIntracytoplasmic sperm injection
    Related treatment contextWomen may undergo controlled ovarian stimulation as part of IVF or ICSI.

  2. Follistim AQ exception

    • Contraindication to Follistim AQ or any of its components.
    • Intolerance: History of intolerance to Follistim AQ.
    • Adverse event: Previous confirmed adverse event with Follistim AQ.