CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Leuprolide acetate injection coverage and prior authorization criteria

Defines medical-benefit coverage, authorization criteria, continuation criteria and required documentation for leuprolide acetate injection for FDA-approved indications and selected compendial uses (e.g., central precocious puberty, prostate cancer, use with growth hormone, ART indications, androgen receptor positive salivary gland tumors). All other indications are investigational/not covered.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLeuprolide acetate injection coverage and prior authorization criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization request with required documentation (e.g., lab report showing pubertal response to a GnRH agonist test or a third-generation LH assay and bone age assessment).

POLICY UPDATE CHANGES

No material clinical or coverage changes were made in this update.

7Listed covered indications (FDA + compendial)

1Single-dose authorization for CPP stimulation test

12Typical authorization duration (months)

Coverage Summary

Defines medical-benefit coverage, authorization criteria, continuation criteria and required documentation for leuprolide acetate injection for FDA-approved indications and selected compendial uses including central precocious puberty (CPP), palliative treatment of advanced prostate cancer, use in combination with growth hormone for advancing puberty and growth failure, assisted reproductive technology (ART) indications (inhibition of premature LH surges and triggering oocyte maturation), and treatment of androgen receptor positive salivary gland tumors. All other indications are considered investigational/not covered.

Provider Documentation Requirements

Documentation Requirements for CPP prior authorization

Submission of the following information is necessary to initiate prior authorization review for central precocious puberty.

CPP documentation requirement: Laboratory report or medical record of a pubertal response to a GnRH agonist test OR a pubertal level of a third-generation LH assay

Documentation Required

Documentation required for CPP diagnosis

Provide a laboratory report or medical record demonstrating either 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 a bone age assessment (comparison of bone age to chronological age) that supports the diagnosis of central precocious puberty (CPP).

Prior Authorization

Prior authorization required for leuprolide acetate (medical benefit) except when procedure already approved under medical benefit

Submit a prior authorization request for leuprolide acetate (medical benefit) with the required supporting documentation (see CPP documentation requirements). Specialty Guideline Management coverage review will be bypassed when the drug is being requested for a procedure that has already been approved under the member's medical benefit plan. In that case, provide the medical authorization number and confirmation of the approved procedure(s).

Prior Authorization

Authorization durations

Initial and continuation authorizations for the listed indications are generally granted for up to 12 months. Authorization of one dose may be granted for use as a stimulation test to confirm the diagnosis of CPP.

Denial Risk

Requests for non-listed indications

Requests for indications not listed among the FDA‑approved or compendial uses are considered investigational and are denied as not medically necessary.

Clinical Evidence & References

Evidence cited includes the Leuprolide acetate injection package insert (Vgyaan Pharmaceuticals LLC.; September 2023) and multiple clinical guidance sources and compendia such as the NCCN Drugs & Biologics Compendium (2024), pediatric endocrine consensus statements and reviews, and American Society for Reproductive Medicine guidance. The policy aligns coverage to FDA-approved uses and selected compendial/guideline-recommended indications.

Background

Leuprolide acetate is a gonadotropin-releasing hormone (GnRH) agonist used for the palliative treatment of advanced prostate cancer and for multiple pediatric and reproductive indications, including central precocious puberty (CPP), use with growth hormone for advancing puberty and growth failure, and assisted reproductive technology (ART) applications. The policy aligns coverage to FDA-approved uses and selected compendial recommendations and requires diagnostic confirmation for CPP prior to authorization.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLeuprolide acetate injection coverage and prior authorization criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization request with required documentation (e.g., lab report showing pubertal response to a GnRH agonist test or a third-generation LH assay and bone age assessment).

On This Page

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OpenPayer

Leuprolide acetate injection coverage and prior authorization criteria

Coverage Summary

Continuation Therapy Criteria

Not Covered / Investigational

Provider Documentation Requirements

Applicable Codes

Key Clinical Thresholds

Clinical Evidence & References

Background

Definitions

Revision History