CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Leuprolide acetate (coverage and authorization criteria)

Defines covered indications, prior authorization documentation, and authorization durations for leuprolide acetate for Neighborhood Health Plan of Rhode Island members including pediatric CPP, prostate cancer, ART uses, and select compendial uses.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLeuprolide acetate (coverage and authorization criteria)

Policy CodePolicy N/A

Change TypeMinor — no material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; documentation must include CPP diagnostic testing (stimulation test result or third‑generation LH assay) when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical initial/renewal authorization duration for most indications

1 doseauthorization allowed for stimulation test for CPP

20supporting references cited

Coverage and Authorization Criteria

Initial therapy — Central precocious puberty

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CPP initial therapy criteria: Diagnosis confirmed by a pubertal response to a GnRH agonist stimulation test OR a pubertal level on a third‑generation luteinizing hormone (LH) assay

Bone age assessment: Assessment of bone age versus chronological age supports the diagnosis of central precocious puberty

Age at onset of secondary sexual characteristics: Member meets age criteria at onset of secondary sexual characteristics: female < 8 years OR male < 9 years

Pathologic cause assessed: Pathologic cause of CPP has been assessed (e.g., intracranial imaging for tumors, genetic testing for familial CPP such as MKRN3 or DLK1 mutations)

Advancing puberty and growth failure

Authorization of 12 months may be granted for treating advancing puberty and growth failure when ALL are met:

Advancing puberty with growth failure: Leuprolide acetate used in combination with growth hormone in a pediatric member with advancing puberty and growth failure

Authorization duration: 12 months

Prostate cancer

Authorization of 12 months may be granted for prostate cancer when ALL are met:

Prostate cancer initial/continued therapy: Authorization for treatment of prostate cancer; continued therapy requires demonstration of clinical benefit (e.g., serum testosterone < 50 ng/dL) and absence of unacceptable toxicity

Authorization periods: 12 months

Salivary gland tumors

Authorization of 12 months may be granted for salivary gland tumors when ALL are met:

Androgen receptor–positive salivary gland tumors: Recurrent, unresectable, or metastatic salivary gland tumors that are androgen receptor positive; continued therapy requires clinical benefit and absence of unacceptable toxicity

Authorization periods: 12 months

Assisted reproductive technology (ART) uses

Authorization of 12 months may be granted for ART-related uses when ALL are met:

ART-related uses: Use for inhibition of premature luteinizing hormone (LH) surges during ovulation induction/assisted reproductive technology OR for oocyte maturation and ovulation trigger in ART cycles

Specialty Guideline Management coverage review will be bypassed if leuprolide is requested for a procedure already approved under the member's medical benefit; medical authorization number and confirmation of approved procedure(s) required

Continuation therapy — Central precocious puberty

Authorization of up to 12 months may be granted for continued CPP treatment when ALL of the following are met:

CPP continuation: Member is currently receiving the requested medication through a paid pharmacy or medical benefit; member is female < 12 years OR male < 13 years; member is not experiencing treatment failure (e.g., clinical pubertal progression, lack of growth deceleration, continued excessive bone age advancement)

Authorization duration: up to 12 months

Prior Authorization & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required; authorization periods generally 12 months for treatment indications (e.g., CPP initial/renewal, prostate cancer, ART, salivary gland tumors, advancing puberty with growth hormone).

Authorization periods generally 12 months for treatment indications
One-dose authorization may be granted for stimulation test to confirm CPP (diagnostic use)

Note

Medical benefit alignment bypass

If leuprolide is being requested for a procedure already approved under the member's medical benefit plan, Specialty Guideline Management coverage review will be bypassed. A medical authorization number and confirmation of the approved procedure(s) are required. Note: Some plans may opt-out of medical benefit alignment — those members must meet the coverage criteria listed.

Medical authorization number and confirmation of approved procedure(s) required
Some plans may opt-out of medical benefit alignment

Documentation Required

CPP diagnostic documentation

Submission of the following information is necessary to initiate prior authorization review for central precocious puberty (CPP): laboratory report or medical record documenting a pubertal response to a gonadotropin releasing hormone (GnRH) agonist test or a pubertal level on a third‑generation luteinizing hormone (LH) assay.

Laboratory report or medical record documenting pubertal response to a GnRH agonist test
Or a pubertal level on a third‑generation LH assay
For stimulation test use, one dose authorization may be granted to confirm CPP
Continuation requests must show member is currently receiving therapy and meets age/treatment response criteria

Denial Risk

Not covered indications

Requests for indications not listed as FDA‑approved or compendial uses (e.g., uses not in the listed compendial uses) are considered experimental/investigational and not medically necessary.

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

Clinical Background

Leuprolide acetate is a gonadotropin‑releasing hormone (GnRH) agonist. It is FDA‑approved for the palliative treatment of advanced prostate cancer and is also used in multiple compendia‑supported indications including central precocious puberty (CPP), as a stimulation test to confirm CPP, in combination with growth hormone for children with advancing puberty and growth failure, for certain assisted reproductive technology (ART) uses, and for androgen receptor–positive salivary gland tumors.

Key Definitions

Central precocious puberty (CPP) authorization criteria — key elements

Diagnostic confirmationDiagnosis confirmed by pubertal response to a GnRH agonist stimulation test OR a pubertal level on a third‑generation LH assay.

Bone age assessmentBone age versus chronological age assessment supports the diagnosis of CPP.

Age at onset thresholdsFemale onset of secondary sexual characteristics before age 8; male onset before age 9.

Assessment of pathologic causesEvaluation for pathologic causes (e.g., intracranial imaging, genetic testing for familial CPP such as MKRN3 or DLK1 mutations).

Authorization durationAuthorization of 12 months may be granted for treatment when all criteria are met.