CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Follitropins (Follistim AQ, Gonal‑f) — Coverage Criteria and Prior Authorization

Policy governs prior authorization and medical necessity criteria for follitropin products (Follistim AQ, Gonal‑f) used for ovulation induction, assisted reproductive technology, and induction of spermatogenesis for hypogonadotropic hypogonadism; applies to members of Neighborhood Health Plan of Rhode Island subject to benefit exclusions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFollitropins (Follistim AQ, Gonal‑f) — Coverage Criteria and Prior Authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit pretreatment testosterone, FSH, and LH levels and documentation of prior clomiphene or letrozole trials (or contraindications) when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12max auth period (months)

3+required prior trials

≥37age criterion

T, FSH, LHrequired labs

Coverage and Medical Necessity Criteria

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Covered Indications and Authorization Criteria

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

Follistim AQ FDA indications: Induction of ovulation and pregnancy in anovulatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure; pregnancy in normal ovulatory women undergoing controlled ovarian stimulation as part of an IVF or ICSI cycle; induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.

Gonal-f FDA indications: Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure; development of multiple follicles in ovulatory women as part of an ART cycle; induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.

Follicle stimulation authorization criteria

ONE of
- 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.
- Member is 37 years of age or older.

Hypogonadotropic hypogonadism authorization criteria

BOTH of
- Member has low pretreatment testosterone levels.
- Member has low or low-to-normal follicle stimulating hormone (FSH) or luteinizing hormone (LH) levels.

All indications for follitropin products that are not listed among the approved FDA indications in this policy are considered experimental/investigational and not medically necessary.

Use of Gonal-f for any indication other than the specific FDA-approved uses listed in this policy is considered not medically necessary (experimental/investigational).

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization duration & continuation

Prior authorization may be granted for up to 12 months for members who meet the specified criteria for follicle stimulation or for treatment of hypogonadotropic hypogonadism. For follicle stimulation, 12‑month authorization may be granted when any of the following apply: completion of three or more prior cycles of clomiphene or letrozole; a risk factor for poor ovarian response to clomiphene or letrozole; a contraindication or exclusion to clomiphene or letrozole; or age 37 years or older. For hypogonadotropic hypogonadism, 12‑month authorization may be granted when both of the following are present: low pretreatment testosterone and low or low‑to‑normal FSH or LH.

Auth duration: up to 12 months for eligible members
Follicle stimulation criteria: ≥3 prior clomiphene/letrozole cycles OR risk factor for poor response OR contraindication to alternatives OR age ≥37
Hypogonadotropic hypogonadism criteria: low testosterone AND low/low‑normal FSH or LH
Continuation: All members requesting continuation must meet all initial authorization criteria

Billing Rule

Medical benefit alignment and authorization confirmation

If the requested drug is for a procedure that already has been approved and is billed to the member's medical benefit, providers must confirm medical benefit alignment and supply the medical authorization number and confirmation of the approved procedure(s). Members whose plans have opted out of medical benefit alignment remain subject to the prior authorization requirements in Section IV.

If medical‑benefit approved, submit the medical authorization number and confirmation of the approved procedure(s)
If the plan has opted out of medical benefit alignment, follow the standard prior authorization requirements

Terminology and Product Definitions

follitropin

DefinitionRecombinant follicle-stimulating hormone products (follitropin). Document uses 'follitropin' to describe all products including Follistim AQ (follitropin beta) and Gonal-f (follitropin alfa).

Included products (brand and generic)Follistim AQ — follitropin beta injection; Gonal-f — follitropin alfa injection.

Reference numbersReference number(s): 1914-A, 1915-A.

Primary clinical uses (summary)Induction of ovulation, controlled ovarian stimulation for ART/IVF/ICSI, and induction of spermatogenesis for hypogonadotropic hypogonadism.

Assisted Reproductive Technology (ART)

DefinitionAssisted Reproductive Technology (ART) refers to procedures involving controlled ovarian stimulation and techniques such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) to achieve pregnancy.

ART procedures citedIVF and ICSI are specifically referenced as ART procedures involving controlled ovarian stimulation and multiple follicle development.

Role of follitropin in ARTFollitropin (follitropin alfa or beta) is used for development of multiple follicles in ovulatory women as part of an ART cycle and for pregnancy in normal ovulatory women undergoing controlled ovarian stimulation as part of an IVF/ICSI cycle.

LimitationsUse of follitropin is limited to FDA-approved ART-related indications; other uses are considered experimental/investigational and not medically necessary.