CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Follitropin (Follistim AQ, Gonal‑f) coverage — Prior authorization and coverage criteria

Coverage criteria and prior authorization requirements for follitropin products (Follistim AQ, Gonal‑f) for reproductive indications including ovulation induction, ART, and treatment of 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 — Prior authorization and coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit required labs (testosterone, FSH, LH) and supporting documentation to initiate prior authorization; prior authorization may be granted for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration when criteria met

3+prior oral induction cycles required

37 yrsage threshold

testosterone, FSH, LHrequired labs for HH

Coverage Criteria

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Follicle stimulation (ovulation induction / ART)

Authorization of 12 months may be granted for members undergoing ovulation induction or assisted reproductive technology (ART) who meet ANY of the following:

Follicle stimulation criteria

Prior cycles: Member has completed three or more previous cycles of clomiphene or letrozole.>=3 cycles
Risk factor for poor response: Member has a risk factor for poor ovarian response to clomiphene or letrozole.
Contraindication to oral agents: Member has a contraindication or exclusion to clomiphene or letrozole.
Age threshold: Member is 37 years of age or older.>=37 years

Hypogonadotropic hypogonadism

Authorization of 12 months may be granted for treatment of hypogonadotropic hypogonadism when ALL of the following are met:

Hypogonadotropic hypogonadism criteria

Testosterone: Member has low pretreatment testosterone levels.low testosterone per lab
Gonadotropins: Member has low or low-to-normal follicle stimulating hormone (FSH) or luteinizing hormone (LH) levels.low or low-normal

Requests for follicle-stimulating agents (follitropin products) for indications other than the FDA-labeled uses listed below are considered experimental/investigational and not medically necessary. Examples of noncovered uses include any indication beyond induction of ovulation, stimulation of follicle development for ART, or induction of spermatogenesis in hypogonadotropic hypogonadism.

Use of Gonal-f or other follitropin products for indications not specifically listed in the FDA-approved indications (induction of ovulation, development of multiple follicles for ART, or induction of spermatogenesis in appropriate hypogonadotropic hypogonadism patients) is considered not medically necessary and will be treated as experimental/investigational for coverage decisions.

Coding and Billing

Policy reference codesmixed

1914-A	Reference number for Follitropins (SGM P2024)
1915-A	Reference number for Follitropins (SGM P2024)

Prior oral induction cycles

RequirementMember has completed three or more previous cycles of clomiphene or letrozole.

Threshold detail>= 3 cycles of clomiphene or letrozole.

ContextThis is one of the qualifying criteria for follicle stimulation (ovulation induction/ART) prior authorization.

Age threshold

RequirementMember is 37 years of age or older.

Threshold detail>= 37 years.

ContextAge ≥37 is an alternative qualifying criterion for follicle stimulation (ovulation induction/ART) prior authorization.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization requirements and duration

Authorization of 12 months may be granted when members meet specified criteria for follicle stimulation or for hypogonadotropic hypogonadism. For follicle stimulation, examples of qualifying criteria include completion of three or more prior cycles of clomiphene or letrozole, risk factors for poor ovarian response, contraindication or exclusion to clomiphene/letrozole, or age ≥ 37. For hypogonadotropic hypogonadism, qualifying documentation includes low pretreatment testosterone and low or low-to-normal FSH or LH.

Authorization duration: up to 12 months when criteria met
Follicle stimulation qualifying examples: • ≥3 prior cycles of clomiphene or letrozole • Risk factor for poor ovarian response • Contraindication to clomiphene/letrozole • Age ≥ 37
Hypogonadotropic hypogonadism qualifying labs: low testosterone AND low or low-to-normal FSH/LH

Step Therapy

Prior medication trials for ovulation induction

Authorization generally expects that members have completed prior medication trials for ovulation induction. Specifically, requests for follicle stimulation typically require documentation of completion of three or more cycles of clomiphene or letrozole, unless an exception applies (e.g., documented contraindication, exclusion, or risk factors for poor ovarian response).

Prior medication trial expected: completion of ≥3 cycles of clomiphene or letrozole
Exceptions: documented contraindication/exclusion to clomiphene/letrozole or clinical risk factors for poor response

Documentation Required

Required laboratory documentation

Submit laboratory documentation to initiate prior authorization review for hypogonadotropic hypogonadism. Required labs include testosterone, follicle stimulating hormone (FSH), and luteinizing hormone (LH). These results should demonstrate low pretreatment testosterone and low or low-to-normal FSH/LH as applicable to meet clinical criteria.

Required labs: testosterone, FSH, LH
Lab interpretation: documentation that supports low testosterone and low or low-to-normal FSH/LH

Documentation Required

Medical benefit alignment documentation

If the requested drug is for a procedure that already has an approved medical benefit authorization, Specialty Guideline Management review may be bypassed. Provide the medical authorization number and confirmation of the approved procedure(s). Note that some plans may opt out of medical benefit alignment; members under those plans must meet the written criteria for drug coverage.

Provide medical authorization number and confirmation of approved procedure(s) when drug is tied to an approved medical-benefit procedure
If plan has opted out of medical benefit alignment, member must meet standard drug criteria

Background

Follitropin products (including follitropin alfa — Gonal-f) are indicated to: 1) induce ovulation and pregnancy in oligio‑anovulatory women when infertility is functional rather than due to primary ovarian failure; 2) develop multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle; and 3) induce spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism when infertility is not due to primary testicular failure. Uses outside these FDA‑labeled indications are considered experimental/investigational and are not covered.

OpenPayer

Follitropin (Follistim AQ, Gonal‑f) coverage — Prior authorization and coverage criteria

Coverage Criteria

Coding and Billing

Provider Actions & Prior Authorization

Definitions

Background