CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Follitropin (Follistim AQ, Gonal‑f) — Medical Benefit Prior Authorization Criteria

Covers medical benefit prior authorization criteria for follitropin products (Follistim AQ, Gonal-f) used for follicle stimulation/ovulation induction, ART cycles, and induction of spermatogenesis for hypogonadotropic hypogonadism for members of Neighborhood Health Plan of Rhode Island under Medical Benefit alignment rules.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFollitropin (Follistim AQ, Gonal‑f) — Medical Benefit Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit testosterone, FSH, and LH levels and confirm prior use of clomiphene/letrozole (or applicable exemptions) when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration for eligible indications

3minimum prior clomiphene/letrozole cycles

≥37age criterion for follicle stimulation

FSH, LH, Trequired lab documentation

Coverage Criteria for Follitropin Products

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Initial authorization — follicle stimulation and ART

Authorization for follicle stimulation/ovulation induction and ART-related follicle development may be granted when ANY of the FDA‑approved indications or the criteria below are met:

FDA-approved indications (women and men): Include: induction of ovulation and pregnancy in anovulatory/oligio-anovulatory women when the cause is functional and not primary ovarian failure; development of multiple follicles in ovulatory women as part of ART/IVF/ICSI; and induction of spermatogenesis in men with primary or secondary hypogonadotropic hypogonadism when infertility is not due to primary testicular failure.

All other indications are considered experimental/investigational and not medically necessary.

Authorization criteria for follicle stimulation (12-month): One of the following must be met: (1) member has completed three or more prior cycles of clomiphene or letrozole; (2) member has a risk factor for poor ovarian response to clomiphene/letrozole; (3) member has a contraindication or exclusion to clomiphene/letrozole; (4) member is 37 years of age or older.

Authorization of 12 months may be granted when any single criterion is met.

Initial authorization — hypogonadotropic hypogonadism

Authorization for treatment of hypogonadotropic hypogonadism may be granted when ALL of the following are met:

Hypogonadotropic hypogonadism treatment criteria: (1) Member has low pretreatment testosterone levels; AND (2) Member has low or low-to-normal follicle stimulating hormone (FSH) or luteinizing hormone (LH) levels.

Required laboratory documentation includes testosterone, FSH, and LH levels.

Continuation criteria

Continuation of therapy: All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.

All uses of follitropin products that are not listed in the FDA‑approved indications are considered experimental/investigational and not medically necessary. The FDA‑approved indications include induction of ovulation and pregnancy in oligio‑anovulatory women when the cause is functional (not primary ovarian failure), development of multiple follicles in ovulatory women as part of an ART cycle, and induction of spermatogenesis in men with hypogonadotropic hypogonadism not due to primary testicular failure.

Requests for follitropin (Gonal‑f, Follistim AQ) for indications outside the specified FDA‑approved uses are prohibited under this policy. Such non‑FDA or non‑compendial uses will be treated as experimental/investigational and therefore not covered.

Provider Requirements and Authorization Details

Prior Authorization

Prior Authorization Duration and Continuation

Authorization of 12 months may be granted for members undergoing ovulation induction or assisted reproductive technology (ART) who meet any of the following: member has completed three or more previous cycles of clomiphene or letrozole; member has a risk factor for poor ovarian response to clomiphene or letrozole; member has a contraindication or exclusion to clomiphene or letrozole; or member is 37 years of age or older. Authorization of 12 months may also be granted for treatment of hypogonadotropic hypogonadism when both of the following are met: member has low pretreatment testosterone levels and member has low or low-to-normal follicle stimulating hormone (FSH) or luteinizing hormone (LH) levels. All members (including new members) requesting continuation of therapy must meet all initial authorization criteria.

Prior authorization duration: up to 12 months for qualifying follicle stimulation or hypogonadotropic hypogonadism indications.
Continuation requirement: continuation requests (including new members) must meet all initial authorization criteria.

Documentation Required

Medical Benefit Alignment Documentation

Specialty Guideline Management coverage review will be bypassed when the drug(s) requested are for a procedure already approved under the member's medical benefit plan. When bypass applies, provide the medical authorization number and confirmation of the approved procedure(s) with the prior authorization request. Note that some plans may opt out of medical benefit alignment; members on those plans must meet standard prior authorization requirements.

Provide the medical authorization number and confirmation of the approved procedure(s) when requested.
If the member's plan has opted out of medical benefit alignment, submit full prior authorization documentation per policy.

Definitions

Follitropin — definition and products

TermFollitropin

Includes (products)Follitropin alfa (Gonal-f) and follitropin beta (Follistim AQ)

Class/descriptionRecombinant follicle-stimulating hormone (rFSH) used to induce ovulation, stimulate multiple follicle development for ART/IVF/ICSI, and to induce spermatogenesis in men with hypogonadotropic hypogonadism when primary testicular failure is not the cause.

Regulatory referenceDocument references Follistim AQ and Gonal-f as the follitropin products covered.

Hypogonadotropic hypogonadism — definition and markers

TermHypogonadotropic hypogonadism (HH)

Key clinical featuresCharacterized by low gonadotropin (FSH and LH) levels with low sex steroid levels (e.g., testosterone), leading to impaired spermatogenesis or ovulation.

Treatment contextTherapy with follitropin is appropriate when infertility is due to central (hypothalamic or pituitary) failure rather than primary gonadal/testicular failure.

Required documentationPretreatment laboratory evidence of low testosterone and low or low‑to‑normal FSH or LH levels is required for authorization.

Background

Follitropin products (follitropin alfa and follitropin beta) are recombinant follicle‑stimulating hormone preparations used clinically to: (1) induce ovulation and pregnancy in anovulatory or oligio‑anovulatory women when the cause is functional rather than primary ovarian failure; (2) stimulate development of multiple follicles in ovulatory women as part of Assisted Reproductive Technology (ART) cycles such as IVF/ICSI; and (3) induce spermatogenesis in men with primary or secondary hypogonadotropic hypogonadism when infertility is not due to primary testicular failure.