CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Follitropins (follitropin alfa/beta) coverage

Policy governs prior authorization, medical necessity criteria, and documentation requirements for follitropin products (Follistim AQ, Gonal-f) used for 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

PolicyFollitropins (follitropin alfa/beta) coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required labs; authorization up to 12 months may be granted when coverage criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

3+prior cycles required

testosterone + FSH/LHrequired labs

Follistim AQ, Gonal-fproducts referenced

Coverage Criteria for Follitropins

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Hypogonadotropic Hypogonadism

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

Hypogonadotropic Hypogonadism Eligibility: Member has a low pretreatment testosterone level AND has low or low-to-normal follicle stimulating hormone (FSH) or luteinizing hormone (LH) levels.laboratory-confirmed low testosterone and low/low-normal FSH or LH

Submit pretreatment testosterone and FSH or LH levels for prior authorization

All indications other than the FDA‑approved and compendial uses listed in this policy — specifically induction of ovulation and pregnancy in anovulatory or oligo‑anovulatory women, development of multiple follicles for assisted reproductive technology (ART), and induction of spermatogenesis in men with hypogonadotropic hypogonadism — are considered experimental/investigational and not medically necessary.

Requests for use of follitropin products outside of these FDA‑approved or compendial indications may be denied as not medically necessary.

Use of follitropins for any indication not explicitly listed among the FDA‑approved or compendial uses in this policy is not medically necessary.

Providers should request prior authorization only for the covered indications detailed elsewhere in this policy; requests for non‑listed uses are subject to denial.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization is required; authorization of up to 12 months may be granted when members meet the specified coverage criteria for follitropins.

Authorization up to 12 months may be granted for follicle stimulation (ovulation induction or ART) when member meets criteria (e.g., completed ≥3 cycles of clomiphene/letrozole, risk factor for poor ovarian response, contraindication to clomiphene/letrozole, or age ≥37).
Authorization up to 12 months may be granted for hypogonadotropic hypogonadism when member has low pretreatment testosterone and low or low‑to‑normal FSH or LH.

Documentation Required

Required Laboratory Documentation

For prior authorization of treatment for hypogonadotropic hypogonadism, submit pretreatment testosterone level and either follicle stimulating hormone (FSH) or luteinizing hormone (LH) levels.

Documentation Required

Medical Benefit Alignment Documentation

If the drug is being requested for a procedure approved under the member's medical benefit plan, the Specialty Guideline Management coverage review will be bypassed and the member is exempt from the coverage criteria requirements. Submit the medical authorization number and confirmation of the approved procedure(s). Note that some plans may opt out of medical benefit alignment; members in those plans must meet the coverage criteria.

Prior Authorization

Prior Medication Trials for Follicle Stimulation

For follicle stimulation, authorization may be granted if the member completed three or more prior cycles of clomiphene or letrozole, has a risk factor for poor ovarian response to those agents, has a contraindication to those agents, or is 37 years of age or older.

Denial Risk

Non‑approved Indications

Requests for indications not listed as FDA‑approved or compendial uses are considered experimental/investigational and not medically necessary.

Definitions and Terms

Follitropin — Recombinant follicle‑stimulating hormone products

DefinitionRecombinant follicle-stimulating hormone products (includes follitropin alfa and follitropin beta such as Gonal-f and Follistim AQ).

Common brand examplesGonal-f (follitropin alfa); Follistim AQ (follitropin beta).

Primary FDA‑approved usesInduction of ovulation in anovulatory/oligo‑anovulatory women; development of multiple follicles for ART (IVF/ICSI); induction of spermatogenesis in men with hypogonadotropic hypogonadism.

Not covered usesAll other indications are considered experimental/investigational and not medically necessary.

Medical benefit alignment — bypass of SGM review

DefinitionProcess where Specialty Guideline Management coverage review is bypassed when the drug is requested for a procedure already approved under the member's medical benefit plan.

Documentation requiredSubmit the medical authorization number and confirmation of the approved procedure(s) to qualify for bypass.

Scope noteMembers under plans that opt out of medical benefit alignment must still meet the coverage criteria requirements.

Background

Follitropins (recombinant follicle‑stimulating hormone products including follitropin alfa and follitropin beta such as Gonal‑f and Follistim AQ) are indicated for induction of ovulation and pregnancy in anovulatory or oligo‑anovulatory women, development of multiple follicles for ART cycles, and for induction of spermatogenesis in men with primary or secondary hypogonadotropic hypogonadism when infertility is not due to primary gonadal failure.

These FDA‑approved indications define the clinical situations in which prior authorization and coverage may be considered; uses outside these indications are considered experimental/investigational and not medically necessary.