CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Leuprolide acetate — coverage and prior authorization criteria

This policy governs coverage and prior authorization requirements for leuprolide acetate injection for FDA‑approved and compendial uses, including central precocious puberty, prostate cancer, certain salivary gland tumors, and reproductive medicine procedures, for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLeuprolide acetate — coverage and prior authorization criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for leuprolide acetate; one dose may be authorized for stimulation testing and up to 12 months for treatment indications when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration for chronic/oncologic and reproductive indications

one doseauthorization allowed for stimulation test to confirm CPP

GnRH stim or 3rd‑gen LHdiagnostic requirement for central precocious puberty

age thresholdsage-based CPP coverage criteria for initiation and continuation

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Covered indications and criteria

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

FDA‑approved indication - prostate cancer: Leuprolide acetate is covered for palliative treatment of advanced prostate cancer when authorization criteria are met.

Central precocious puberty (CPP) - initiation: Authorization of 12 months may be granted when: intracranial tumor has been evaluated by appropriate lab tests and diagnostic imaging (CT, MRI, or ultrasound); the diagnosis of CPP is confirmed by a pubertal response to a GnRH agonist stimulation test or a pubertal level on a third‑generation LH assay; assessment of bone age versus chronological age supports the diagnosis of CPP; and the member was less than 8 years of age at the onset of secondary sexual characteristics.

CPP - stimulation test: Authorization of one dose may be granted for use as a GnRH agonist 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.

Salivary gland tumors: Authorization of 12 months may be granted for treatment of recurrent androgen receptor positive salivary gland tumors as a single agent.

Inhibition of premature LH surge (ART): Authorization of 12 months may be granted for inhibition of premature luteinizing hormone (LH) surge in a member undergoing ovulation induction or assisted reproductive technology.

Oocyte maturation and ovulation trigger (ART): Authorization of 12 months may be granted for triggering oocyte maturation and ovulation in members undergoing ovulation induction or assisted reproductive technology.

Continuation therapy

Continuation of therapy may be authorized when initial criteria were met and the member demonstrates ongoing benefit and absence of treatment‑limiting toxicity

CPP - continuation (female): Authorization up to 12 months may be granted if the member is currently less than 12 years of age and is not experiencing treatment failure such as clinical pubertal progression, lack of growth deceleration, or continued excessive bone age advancement.

CPP - continuation (male): Authorization up to 12 months may be granted if the member is currently less than 13 years of age and is not experiencing treatment failure such as clinical pubertal progression, lack of growth deceleration, or continued excessive bone age advancement.

Prostate cancer and salivary gland tumors - continuation: Authorization of 12 months may be granted for continued treatment when the member is experiencing clinical benefit to therapy and has not experienced unacceptable toxicity.

All other indications not listed as FDA‑approved indications or the compendial uses enumerated in this policy are considered experimental/investigational and not medically necessary.

Requests for use of leuprolide acetate for indications outside the FDA‑approved indications and the compendial uses specified in this policy will be considered not medically necessary.

Drug and Age Coding / Thresholds

Referenced drugmixed

leuprolide acetate injection

Age thresholds for CPP

Onset age threshold (female)Onset of secondary sexual characteristics: member was less than 8 years of age at onset (policy also notes <9 years in alternative wording).

Onset age threshold (male)Policy specifies male criteria for CPP diagnosis but does not list a distinct onset age in the diagnostic section; continuation age for males is specified (see continuation item).

Continuation age threshold (female)Authorization up to 12 months may be granted if the female member is currently less than 12 years of age and not experiencing treatment failure.

Continuation age threshold (male)Authorization up to 12 months may be granted if the male member is currently less than 13 years of age and not experiencing treatment failure.

Treatment-failure criteria affecting continuationTreatment failure includes clinical pubertal progression, lack of growth deceleration, or continued excessive bone age advancement.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for leuprolide requests. Typical authorization durations vary by indication (see items). Providers must submit a medical authorization request when required and confirm any member-specific medical benefit alignment exemptions.

CPP (central precocious puberty): authorization may be granted for up to 12 months.
Stimulation test to confirm CPP diagnosis: authorization of one dose may be granted.
Prostate cancer: authorization may be granted for up to 12 months.
Recurrent androgen receptor–positive salivary gland tumors: authorization may be granted for up to 12 months as single-agent therapy.
Inhibition of premature LH surge for ovulation induction/ART: authorization may be granted for up to 12 months.
Oocyte maturation and ovulation trigger for ovulation induction/ART: authorization may be granted for up to 12 months.

Note

Medical Benefit Alignment Exemption

Specialty Guideline Management (SGM) coverage review will be bypassed when leuprolide is requested for a procedure already approved and covered under the member's medical benefit plan. In these cases the provider must supply the medical authorization number and confirmation of the approved procedure. Note that some plans may opt out of medical benefit alignment; for members on those plans the standard SGM requirements apply.

Provide medical authorization number and confirmation of approved procedure(s) when claiming medical benefit alignment exemption.
If the member's plan has opted out of medical benefit alignment, submit standard Section III documentation for SGM review.

Documentation Required

Required Clinical Documentation

Submit clinical documentation to support the requested use. For central precocious puberty (CPP) include objective diagnostic evidence and relevant imaging/laboratory results.

For CPP: pubertal response to a GnRH agonist stimulation test OR a pubertal level on a third-generation luteinizing hormone (LH) assay.
Assessment of bone age vs chronological age supporting CPP diagnosis.
Documentation that intracranial tumor has been evaluated (CT, MRI, or ultrasound) when indicated.
For stimulation test indication: documentation supporting the need for one diagnostic dose.
For ART/ovulation induction and oncology indications: relevant fertility or oncology workup and prior imaging/lab results as applicable.

Denial Risk

Experimental/Investigational Exclusion

Requests for indications that are not FDA‑approved or supported by recognized compendia are considered experimental or investigational and will be denied as not medically necessary. Providers should ensure the indication and supporting evidence fall within FDA‑approved or compendial uses before submission.

Indications limited to those listed as FDA‑approved or compendial uses in the policy are covered.
Off‑label uses without compelling peer‑reviewed compendia support are considered experimental/investigational and are not covered.

Background

Leuprolide acetate is a gonadotropin‑releasing hormone (GnRH) agonist used to suppress the hypothalamic‑pituitary‑gonadal axis for a range of clinical purposes. Compendial uses included in this policy comprise: stimulation testing to confirm central precocious puberty (CPP); treatment of CPP; use in combination with growth hormone for children with growth failure and advancing puberty; inhibition of premature luteinizing hormone (LH) surge during ovulation induction or assisted reproductive technology; palliative treatment of prostate cancer; treatment of androgen receptor–positive salivary gland tumors; and triggering oocyte maturation and ovulation in assisted reproductive technology cycles.

Definitions

Definition of Central Precocious Puberty (CPP)

Core diagnostic definitionCentral precocious puberty (CPP) is defined by premature onset of secondary sexual characteristics with supporting diagnostic evidence required for authorization.

GnRH stimulation testDiagnosis of CPP must be confirmed by a pubertal response to a gonadotropin releasing hormone (GnRH) agonist stimulation test; authorization of one dose may be granted to perform this stimulation test.

Third‑generation LH assayAlternatively, a pubertal level on a third‑generation luteinizing hormone (LH) assay can confirm the diagnosis of CPP.

Bone age assessmentAssessment of bone age versus chronological age must support the diagnosis of CPP and is required as part of diagnostic evaluation.

Evaluation for intracranial pathologyAppropriate laboratory tests and diagnostic imaging (CT, MRI, or ultrasound) must be performed to evaluate for intracranial tumor as part of the CPP workup.

OpenPayer

Leuprolide acetate — coverage and prior authorization criteria

Coverage Criteria for Leuprolide Acetate

Drug and Age Coding / Thresholds

Provider Actions and Authorization Requirements

Background

Definitions