CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Follitropin (Follistim AQ, Gonal-f) coverage for ovulation induction, ART, and hypogonadotropic hypogonadism

This policy governs prior authorization and medical necessity criteria for follitropin products (Follistim AQ, Gonal-f) for ovulation induction, assisted reproductive technology (ART), and induction of spermatogenesis in hypogonadotropic hypogonadism for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFollitropin (Follistim AQ, Gonal-f) coverage for ovulation induction, ART, and hypogonadotropic hypogonadism

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit pretreatment testosterone, FSH, and LH levels to initiate prior authorization for hypogonadotropic hypogonadism.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration for eligible indications

3minimum prior cycles for follicle stimulation

≥37age threshold for follicle stimulation

T, FSH, LHrequired labs for HH

FDA-approved

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Coverage and Medical Necessity Criteria

Initial authorization criteria

Covered when ALL of the following are met for each indication group

FDA-approved female ovulation induction (anovulatory/oligo-anovulatory): Member has anovulatory or oligo-anovulatory infertility where the cause is functional and not due to primary ovarian failure (Follistim AQ/Gonal-f).

From FDA indications

Controlled ovarian stimulation for ART/IVF/ICSI: Member is a normal ovulatory woman undergoing controlled ovarian stimulation as part of an IVF/ICSI or ART cycle (Gonal-f and Follistim AQ per indications).

From FDA indications

Induction of spermatogenesis in men with hypogonadotropic hypogonadism: Member has primary or secondary hypogonadotropic hypogonadism where infertility is not due to primary testicular failure; pretreatment labs must show low testosterone and low or low-to-normal FSH or LH.

Lab requirements referenced in documentation and hypogonadotropic hypogonadism indications

Authorization eligibility for follicle stimulation: Member meets ANY of: (1) completed ≥3 prior cycles of clomiphene or letrozole; (2) has a risk factor for poor ovarian response to clomiphene/letrozole; (3) has a contraindication or exclusion to clomiphene/letrozole; (4) is age ≥37 years.

Authorization of 12 months may be granted if any condition met

Any indication for follitropin products (Follistim AQ, Gonal‑f) that is not listed in the FDA‑approved indications for these products is considered experimental/investigational and is not covered under this policy.

Use of follitropins for indications other than the FDA‑approved indications listed for Gonal‑f (and Follistim AQ) is considered not medically necessary and will be denied.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization duration and continuation

Authorization may be granted for up to 12 months when members meet the specified criteria for the requested indication. For follicle stimulation (ovulation induction or ART) and for hypogonadotropic hypogonadism, refer to the specific criteria for eligibility. Continuation requests (including for new members) must meet all initial authorization criteria.

Authorization duration: up to 12 months when criteria met
Continuation of therapy: all members (including new members) must meet initial authorization criteria

Step Therapy

Step therapy for follicle stimulation

For follicle stimulation (ovulation induction or ART), step therapy requires that the member has completed three or more prior cycles of clomiphene or letrozole unless the member meets one of the listed exceptions (risk factor for poor ovarian response, contraindication/exclusion to clomiphene or letrozole, or age ≥ 37).

Step requirement: ≥ 3 prior cycles of clomiphene or letrozole

Key Terms and Definitions

Follitropin

Defines follitropinRefers to Follistim AQ (follitropin beta) and Gonal‑f (follitropin alfa)

Product examplesFollistim AQ = follitropin beta injection; Gonal‑f = follitropin alfa injection

Reference notationPolicy uses the term ‘follitropin’ to describe both products

Hypogonadotropic hypogonadism (HH)

DefinitionHypogonadotropic hypogonadism (HH): condition of low gonadotropins (FSH/LH) leading to impaired gonadal function

Authorization lab requirementPolicy requires submission of pretreatment testosterone and FSH or LH levels for authorization in men with HH

Clinical Background

Follitropins (recombinant follicle‑stimulating hormones such as Follistim AQ [follitropin beta] and Gonal‑f [follitropin alfa]) are used to induce ovulation in anovulatory or oligo‑anovulatory women, to stimulate development of multiple follicles in ovulatory women as part of Assisted Reproductive Technology (ART) cycles, and to induce spermatogenesis in men with primary or secondary hypogonadotropic hypogonadism when infertility is not due to primary testicular failure.

Policy Revision History

2024-05-14reference_update

References and source access date updated (IBM Micromedex access noted).

2024-05document_reference

Gonal-f Multi-Dose and related Gonal-f RFF references updated with 2023–2024 package insert dates; Gonal-f RFF Redi-ject referenced May 2024.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFollitropin (Follistim AQ, Gonal-f) coverage for ovulation induction, ART, and hypogonadotropic hypogonadism

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit pretreatment testosterone, FSH, and LH levels to initiate prior authorization for hypogonadotropic hypogonadism.

SourceLink

On This Page

Exceptions: poor ovarian response risk factor; contraindication/exclusion to clomiphene/letrozole; age ≥ 37

Documentation Required

Medical benefit alignment documentation

When a drug is being requested for a procedure already approved under the member's medical benefit, the Specialty Guideline Management review will be bypassed. In these cases, provide the medical authorization number and confirmation of the approved procedure(s). Note that some plans may opt out of medical benefit alignment — members covered under such plans must meet the standard prior authorization requirements.

Provide medical authorization number and confirmation of approved procedure(s) when drug is for a procedure under medical benefit
Some plans may opt-out; if so, member must meet Sections IV requirements

Denial Risk

Experimental/Investigational exclusions

All indications not listed among the approved uses (e.g., induction of ovulation in oligo‑anovulatory women, development of multiple follicles for ART, induction of spermatogenesis in men with hypogonadotropic hypogonadism, and treatment of hypogonadotropic hypogonadism with supporting labs) are considered experimental/investigational and not medically necessary.

All other indications outside the listed FDA‑approved/covered indications are experimental/investigational and not medically necessary

Indication contextFollitropins are indicated for induction of spermatogenesis in men with primary or secondary HH when infertility is not due to primary testicular failure