CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Leuprolide acetate (coverage criteria)

Defines prior authorization, coverage indications, and continuation criteria for leuprolide acetate, including pediatric central precocious puberty, prostate cancer, assisted reproductive technology, salivary gland tumors, and use with growth hormone.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLeuprolide acetate (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with diagnostic documentation for CPP or evidence of clinical benefit for continuation; one-dose authorization may be granted for stimulation testing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

1 dosestimulation test authorization

CPP, prostate cancer, ART, salivary tumors, GH combocovered indications

All other indicationsnot medically necessary

Coverage criteria and medical necessity

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

All indications for leuprolide acetate that are not listed among the FDA-approved or compendial uses in this policy are classified as experimental/investigational and not medically necessary. This includes any use outside the compendial list such as central precocious puberty, stimulation testing for CPP, combination use with growth hormone for growth failure, prostate cancer, ART-related indications, and androgen receptor–positive salivary gland tumors. Requests for continuation of therapy for any other indication will not meet coverage criteria and may be denied.

Requests to use leuprolide acetate for indications that are not listed in the FDA-approved or compendial sections of this policy are considered not medically necessary. Providers seeking authorization for indications outside those specifically enumerated should anticipate denial unless the indication is subsequently added to the policy’s covered list.

Covered drugs, codes, and clinical thresholds

Covered drugNDC|mixedCovered

leuprolide acetate

Dosage Form = injection solution

Age thresholds for central precocious puberty (CPP)

Initiation age — femalesOnset of secondary sexual characteristics before 8 years of age (female) for initiation of CPP treatment.

Initiation age — malesOnset of secondary sexual characteristics before 9 years of age (male) for initiation of CPP treatment.

Continuation age — femalesMember must be female and less than 12 years of age for continued treatment authorization (up to 12 months).

Continuation age — malesMember must be male and less than 13 years of age for continued treatment authorization (up to 12 months).

Prostate cancer response marker

Clinical response markerSerum testosterone < 50 ng/dL cited as an example of clinical benefit for continued prostate cancer treatment.

Use contextApplied when assessing continued benefit for members on leuprolide for prostate cancer; authorization of 12 months may be granted if clinical benefit and no unacceptable toxicity are present.

Toxicity considerationContinued treatment requires absence of unacceptable toxicity in addition to clinical benefit (e.g., testosterone suppression).

Prior authorization, documentation, and billing guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required and may be granted for specified indications (see criteria). Typical authorization periods are up to 12 months.

Documentation Required

Continuation / Renewal Requirements

Continuation/renewal requests require evidence of clinical benefit and absence of treatment failure. For continuation of therapy for central precocious puberty (CPP), the member must be currently receiving the requested medication through a paid pharmacy or medical benefit and must meet age thresholds (female <12 years; male <13 years).

Billing Rule

Medical Benefit Alignment

If leuprolide is being requested for a procedure already approved under the member's medical benefit plan, Specialty Guideline Management review will be bypassed. Provide the medical authorization number and confirmation of the approved procedure(s). Note: some plans may opt out of medical benefit alignment; members under such plans must meet the coverage criteria.

Clinical definitions and terms

Central precocious puberty (CPP) — definition and diagnostic criteria

DefinitionOnset of secondary sexual characteristics before age 8 years in females or before age 9 years in males, consistent with central precocious puberty (CPP).

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

Supporting evaluationAssessment of bone age versus chronological age should support the diagnosis; evaluate for pathologic causes (e.g., intracranial imaging, genetic testing).

Background and drug information

Leuprolide acetate is a gonadotropin-releasing hormone (GnRH) agonist used to suppress the hypothalamic–pituitary–gonadal axis. The FDA-approved indication included in this policy is palliative treatment of advanced prostate cancer; additional compendial uses referenced here include central precocious puberty (CPP), use as a stimulation test to confirm CPP, combination therapy with growth hormone for children with growth failure and advancing puberty, inhibition of premature luteinizing hormone (LH) surges for assisted reproductive technology, triggering oocyte maturation/ovulation in ART cycles, and treatment of androgen receptor–positive salivary gland tumors.