CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Leuprolide acetate (injection) — Coverage Criteria

Defines prior authorization, coverage criteria, and continuation rules for leuprolide acetate injections (all brands/generics and strengths) across specified indications for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLeuprolide acetate (injection) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization for leuprolide acetate injections; provide diagnostic documentation for CPP when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration for covered indications

One doseauthorization for use as a stimulation test for CPP

All formsapplies to brand & generic

Coveredcovered when criteria met

Coverage Criteria for Leuprolide Acetate (Injection)

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Initial therapy — Central Precocious Puberty (CPP)

Covered for Central Precocious Puberty (authorization up to 12 months) when ALL of the following are met:

CPP baseline criteria: Diagnosis confirmed by a pubertal response to a GnRH agonist stimulation test OR a pubertal level on a third-generation LH assay; bone age assessment supports the diagnosis of CPP (advanced bone age vs chronological age); age-at-onset criteria met (female onset of secondary sexual characteristics < 8 years OR male onset < 9 years); pathologic causes of CPP have been assessed (for example intracranial imaging and consideration of genetic testing such as MKRN3 or DLK1 mutations).

Authorization of 12 months may be granted when all criteria are satisfied.

Initial therapy — Advancing puberty with growth hormone

Advancing puberty with growth failure (pediatric)

Combination therapy: Authorization of 12 months may be granted when leuprolide acetate is used in combination with growth hormone for a pediatric member with advancing puberty and growth failure.

Initial therapy — ART indications

Assisted reproductive technology (ART)

ART uses: Authorization of 12 months may be granted for inhibition of premature luteinizing hormone (LH) surges in members undergoing ovulation induction/assisted reproductive technology OR for triggering oocyte maturation and ovulation in ART.

Coverage review bypass rules may apply if the requested therapy is part of a procedure already approved under the member's medical benefit.

All indications for leuprolide acetate injections that are not explicitly listed as FDA-approved or compendial uses in this policy are considered experimental/investigational and are not covered. Examples of covered compendial and FDA-listed uses (when criteria are met) include central precocious puberty, use in combination with growth hormone for children with growth failure and advancing puberty, stimulation testing to confirm CPP, prostate cancer, androgen receptor–positive salivary gland tumors, and reproductive medicine uses such as inhibition of premature LH surge and oocyte maturation in ART. Requests for any other diagnoses or treatment intents should be considered not medically necessary and will be subject to denial.

Initial Therapy Authorization Rules

Initial therapy — aggregate initial authorization rules per indication

Initial authorization rules per indication

CPP initial: Diagnosis confirmation via pubertal response to a GnRH agonist stimulation test or pubertal result on a third‑generation LH assay; bone age assessment supportive of CPP; age‑at‑onset criteria met; evaluation for pathologic causes. Authorization up to 12 months may be granted.

Stimulation test: One‑dose authorization may be granted when leuprolide acetate is used solely to confirm the diagnosis of CPP.

Advancing puberty with GH: Authorization up to 12 months may be granted when leuprolide acetate is used in combination with growth hormone for pediatric members with advancing puberty and growth failure.

Prostate cancer: Authorization up to 12 months may be granted for treatment of prostate cancer.

Salivary gland tumors: Authorization up to 12 months may be granted for recurrent, unresectable, or metastatic androgen receptor–positive salivary gland tumors as single‑agent therapy.

ART uses: Authorization up to 12 months may be granted for inhibition of premature LH surges in ovulation induction/ART OR for triggering oocyte maturation and ovulation in ART.

Continuation Therapy and Re-authorization

Continuation therapy criteria

Continuation therapy

CPP continuation: Member is currently receiving the requested medication through pharmacy or medical benefit; member is female < 12 years or male < 13 years; member is not experiencing treatment failure (no clinical pubertal progression, appropriate growth deceleration, and no continued excessive bone age advancement).

Authorization of up to 12 months may be granted.

Prostate cancer continuation: Authorization of 12 months may be granted for continued treatment when the member is experiencing clinical benefit (for example, serum testosterone < 50 ng/dL) and has not experienced unacceptable toxicity.

Salivary gland tumor continuation: Authorization of 12 months may be granted for continued treatment when the member is experiencing clinical benefit and has not experienced unacceptable toxicity.

Continuation therapy (duplicate mapping for continuation section)

Continuation authorization rules

CPP continuation: Current therapy through pharmacy or medical benefit; age limits for continued treatment (female < 12 years, male < 13 years); absence of treatment failure required for continued authorization up to 12 months.

Prostate cancer continuation: Clinical benefit (e.g., serum testosterone < 50 ng/dL) and absence of unacceptable toxicity required for 12‑month continuation.

Salivary gland tumor continuation: Clinical benefit and absence of unacceptable toxicity required for 12‑month continuation.

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization required for leuprolide when used for central precocious puberty (CPP), advancing puberty with growth failure, prostate cancer, androgen receptor–positive salivary gland tumors, inhibition of premature LH surges for ART/ovulation induction, and oocyte maturation/ovulation triggering for ART when billed under the pharmacy benefit. Authorization durations are generally 12 months for ongoing indications; a single dose authorization may be granted when used as a stimulation test to confirm CPP.

Authorization durations: typically 12 months (CPP, advancing puberty with growth hormone, prostate cancer, salivary gland tumors, ART indications).
Stimulation test for CPP: authorization of one dose may be granted.

Note

Medical benefit alignment exemption

If the requested leuprolide is for a procedure already approved under the member's medical benefit, Specialty Guideline Management (SGM) coverage review will be bypassed. Members with a medical authorization number and confirmation of the approved procedure(s) are exempt from the SGM requirements. Note: some plans may opt out of medical benefit alignment; for those members, the standard coverage criteria still apply.

Medical authorization number and confirmation of approved procedure(s) required to bypass SGM.
Plans that opt out of medical benefit alignment are not exempt and must meet coverage criteria.

Documentation Required

CPP Diagnostic Documentation

For requests for treatment of central precocious puberty (CPP), submit documentation of diagnosis: a laboratory report or medical record showing a pubertal response to a gonadotropin releasing hormone (GnRH) agonist stimulation test OR a pubertal-level result from a third-generation luteinizing hormone (LH) assay. Also include assessment of bone age versus chronological age and any relevant evaluations for pathologic causes (for example, imaging for intracranial lesions or genetic testing when indicated).

Required: laboratory report or medical record documenting pubertal response to GnRH agonist test OR pubertal-level third-generation LH assay.
Include bone age vs chronological age assessment.
Include evaluation for pathologic causes (e.g., imaging, genetic testing) when applicable.

Denial Risk

Non-covered Indications

Requests for indications not listed under covered or compendial uses (including uses outside central precocious puberty, combination therapy with growth hormone when indicated, stimulation testing for CPP, prostate cancer, androgen receptor–positive salivary gland tumors, and ART-related uses) are considered experimental/investigational and therefore not medically necessary.

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

Site of Care / Benefit Alignment

Billing Rule

Infusion‑center requests bypass SGM if procedure approved under medical benefit

When leuprolide is being requested for administration in an infusion center as part of a procedure already approved under the member’s medical benefit, Specialty Guideline Management review will be bypassed; the provider must provide the medical authorization number and confirmation of the approved procedure(s).

If the member’s plan has opted out of medical benefit alignment, the bypass does not apply and the request must meet the coverage criteria.
This site‑of‑care rule aligns infusion center requests with the member’s medical benefit status.

Key Definitions

Central precocious puberty (CPP) definition and diagnostic criteria

DefinitionOnset of secondary sexual characteristics at an unusually early age; diagnosis supported by a pubertal response to a GnRH agonist stimulation test or a pubertal level on a third‑generation LH assay and bone age assessment.

Age criteria for onsetFemale: onset of secondary sexual characteristics before 8 years; Male: onset before 9 years.

Diagnostic confirmationPubertal response to a GnRH agonist stimulation test OR pubertal level on a third‑generation LH assay (stimulation testing may be authorized as a one‑dose use to confirm diagnosis).

Supporting assessmentBone age assessment consistent with advancing skeletal maturation to support CPP diagnosis.

Evaluation for pathologic causesAssessment for pathologic etiologies (for example, intracranial imaging or genetic testing for familial CPP) should be performed as clinically indicated.

Background and Drug Information

Leuprolide acetate is a gonadotropin-releasing hormone (GnRH) agonist that suppresses gonadotropin secretion. The policy recognizes its FDA-approved palliative indication for advanced prostate cancer and multiple compendial uses, including treatment of central precocious puberty (CPP), use with growth hormone for children with advancing puberty and growth failure, use as a stimulation test to confirm CPP, management of androgen receptor–positive salivary gland tumors, and roles in assisted reproductive technology such as inhibition of premature LH surge and triggering oocyte maturation.