CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Leuprolide acetate coverage (coverage criteria and prior authorization)

Coverage criteria and prior authorization requirements for leuprolide acetate (all brands, generics, formulations) for FDA-approved and compendial indications for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLeuprolide acetate coverage (coverage criteria and prior authorization)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with diagnostic documentation for CPP or medical authorization number when medical benefit alignment applies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration for chronic indications (CPP, prostate cancer, ART uses)

one doseauthorization for use as stimulation test for CPP

central precocious pubertyprimary pediatric compendial indication requiring diagnostic confirmation

otherconsidered experimental/investigational and not medically necessary

Coverage Criteria

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inv-01: Initial Therapy — Covered when ALL of the following are met for each indication as specified below

Covered when ALL of the following are met for each indication as specified below

Central Precocious Puberty - Initial (12 months)

Diagnostic confirmation: 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 of bone age versus chronological age supports the diagnosis of CPP.
Age at onset criteria: Either: female with onset of secondary sexual characteristics < 8 years OR male with onset < 9 years.
Pathologic assessment: Pathologic causes of CPP have been assessed as appropriate (e.g., intracranial imaging, genetic testing for familial CPP).

Stimulation Test for CPP: Authorization of one dose may be granted for use as a stimulation test to confirm the diagnosis of CPP.

Advancing Puberty with Growth Failure: Authorization of 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 - Initial: Authorization of 12 months may be granted for palliative treatment of advanced prostate cancer (FDA‑approved indication).

Inhibition of Premature LH Surges (ART): Authorization of 12 months may be granted for inhibition of premature luteinizing hormone (LH) surges in members undergoing ovulation induction or assisted reproductive technology (ART).

Oocyte Maturation and Ovulation Trigger (ART): Authorization of 12 months may be granted for members undergoing ovulation induction or ART. Specialty guideline management review may be bypassed when the request is for a procedure already approved under the member's medical benefit (medical authorization number and confirmation required).

inv-02: Continuation Therapy — Covered for continuation when ALL of the following apply (indication-specific)

Covered for continuation when ALL of the following apply (indication-specific):

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

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

Other Indications - Continuation: All members (including new members) requesting continuation of therapy must meet all requirements in the coverage criteria for the original indication.

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

Use of leuprolide acetate for any indication other than those specifically listed as FDA‑approved or recognized compendial uses is considered not medically necessary.

Coding and Test Thresholds

Covered NDC/DrugNDCCovered

NDC / all strengths/forms

Leuprolide acetate, dosage form = injection solution (all brands and generics as listed)

inv-06: serum testosterone — lab threshold value

Serum testosterone thresholdLess than 50 ng/dL

ContextUsed as an objective marker of clinical benefit for continued treatment of prostate cancer

Authorization implicationAuthorization of 12 months may be granted when serum testosterone is below this threshold

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization durations are specified in the coverage criteria (commonly 12 months). A one-dose authorization may be granted when leuprolide is used solely as a stimulation test to confirm the diagnosis of central precocious puberty (CPP).

Authorization durations commonly 12 months
One-dose authorization allowed for stimulation testing to confirm CPP

Note

Medical Benefit Alignment Bypass

Specialty Guideline Management (SGM) coverage review will be bypassed if the request for leuprolide is for a procedure already approved under the member's medical benefit plan. In such cases, the member is exempt from the listed coverage criteria; a medical authorization number and confirmation of the approved procedure(s) are required. Note that some plans may opt out of medical benefit alignment — those members must meet the standard coverage criteria.

Medical authorization number and confirmation of approved procedure(s) required when bypass applies
Some plans may opt out of medical benefit alignment; those members must meet coverage criteria

Documentation Required

CPP Diagnostic Documentation

For prior authorization requests for central precocious puberty (CPP), submit a laboratory report or medical record documenting a pubertal response to a gonadotropin releasing hormone (GnRH) agonist stimulation test or a pubertal level from a third‑generation luteinizing hormone (LH) assay.

Lab report or medical record documenting pubertal response to GnRH stimulation test
Or third‑generation LH assay showing pubertal LH level

Denial Risk

Non‑Covered Indications

Requests for indications not listed among FDA‑approved indications or recognized compendial uses (including uses outside central precocious puberty, stimulation testing, advancing puberty with growth hormone, prostate cancer, inhibition of premature LH surges for ART, and oocyte maturation/ovulation trigger in ART) are considered experimental/investigational and are not medically necessary.

Compendial/covered uses include: CPP, stimulation testing for CPP, advancing puberty with growth hormone, prostate cancer, inhibition of premature LH surges in ART, oocyte maturation/ovulation trigger in ART
All other indications are experimental/investigational and not medically necessary

Background

Leuprolide acetate is a gonadotropin‑releasing hormone (GnRH) agonist used across several endocrine and reproductive indications. Common clinical uses include treatment of central precocious puberty (CPP), use as a stimulation test to confirm CPP, combined use with growth hormone for children with advancing puberty and growth failure, palliative treatment of advanced prostate cancer, and suppression of premature luteinizing hormone (LH) surges or triggering oocyte maturation during assisted reproductive technology (ART) procedures.

Definitions

inv-12: Central precocious puberty (CPP) — definition and diagnostic confirmation requirement

DefinitionOnset of secondary sexual characteristics before age 8 in females or before age 9 in males

Diagnostic confirmation requiredDiagnosis must be confirmed by a pubertal response to a GnRH agonist stimulation test OR a pubertal-level result on a third-generation LH assay

Additional evaluationAssessment of bone age versus chronological age must support the diagnosis

Pathologic assessmentPathologic causes should be assessed (e.g., intracranial imaging, genetic testing such as MKRN3 or DLK1 mutations)

Initial Therapy Criteria by Indication

inv-13: Initial therapy — Initial authorization rules by indication

Initial authorization rules by indication

CPP initial: Authorization of 12 months may be granted if diagnostic confirmation is present (pubertal response to GnRH stimulation OR pubertal level on a third‑generation LH assay), bone age assessment supports CPP, age at onset criteria are met (female <8 years; male <9 years), and pathologic causes have been assessed.

Stimulation test: Authorization of one dose may be granted to perform a GnRH agonist stimulation test to confirm the diagnosis of CPP.

Advancing puberty with GH: Authorization of 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 initial: Authorization of 12 months may be granted for treatment of prostate cancer.

ART indications: Authorization of 12 months may be granted for inhibition of premature LH surges and for oocyte maturation/ovulation trigger in members undergoing ovulation induction or assisted reproductive technology; medical benefit alignment exception may apply.

Continuation Therapy Criteria by Indication

inv-14: Continuation therapy — Continuation coverage rules by indication

Continuation coverage rules by indication

CPP continuation: Member is currently receiving the requested medication through a paid benefit; female <12 years or male <13 years; and no treatment failure observed (no clinical pubertal progression, adequate growth deceleration, and no continued excessive bone age advancement).

Prostate cancer continuation: Member demonstrates clinical benefit (e.g., serum testosterone < 50 ng/dL) and has not experienced unacceptable toxicity; authorization of 12 months may be granted.

Other indications continuation: All members requesting continuation (including new members) must meet all requirements in the coverage criteria for the original indication.

Step Therapy / Medical Benefit Alignment

Policy Point	Details
Medical benefit alignment exemption
Specialty Guideline Management coverage review will be bypassed for leuprolide if it is being requested for a procedure that has been approved under a member's medical benefit plan. A medical authorization number and confirmation of the approved procedure(s) are required. Note that some plans may opt out of medical benefit alignment; members on those plans must meet the coverage criteria.

Site of Care Considerations

Step Therapy

Infusion/Procedure medical‑benefit alignment bypass

If the leuprolide request is for a procedure that has been approved under the member's medical benefit (e.g., an ART procedure), Specialty Guideline Management review will be bypassed and the member is exempt from the coverage criteria requirements once a medical authorization number and confirmation of the approved procedure(s) are provided.

Some plans may opt out of medical benefit alignment; members under those plans must meet the coverage criteria despite a medical authorization.