CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Leuprolide acetate depot (Lupron Depot-PED) prior authorization — coverage and criteria

Coverage and prior authorization criteria for Lupron Depot-PED (leuprolide acetate depot) for pediatric central precocious puberty and for pubertal suppression related to gender dysphoria in adolescents, including documentation and prescriber requirements.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLeuprolide acetate depot (Lupron Depot-PED) prior authorization — coverage and criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation; initial and continued authorizations may be granted for up to 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period granted for initial and continued therapy

2 indicationscovered uses listed (CPP and gender dysphoria/puberty suppression)

1972-A, 6051-Ainternal document reference numbers

Specialist requiredspecialist involvement required for gender dysphoria prescriptions

Coverage Criteria for Lupron Depot-PED (leuprolide acetate depot)

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.

Initial Therapy — Central Precocious Puberty

Covered when ALL of the following are met

CPP initial criteria: Diagnosis of central precocious puberty confirmed by a pubertal response to a GnRH agonist test or a pubertal level on a third-generation luteinizing hormone (LH) assay.

CPP initial criteria: Assessment of bone age versus chronological age supports the diagnosis of CPP.

Onset age criteria (one required)

Female onset: Member was less than 8 years of age at the onset of secondary sexual characteristics.
Male onset: Member was less than 9 years of age at the onset of secondary sexual characteristics.

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

Authorization up to 12 months

Continuation Therapy — Central Precocious Puberty

Covered when ALL of the following are met

CPP continued therapy: Member is currently receiving the requested medication through a paid pharmacy or medical benefit.

CPP continued therapy: Member is a female less than 12 years of age or a male less than 13 years of age.

CPP continued therapy: Member is not experiencing treatment failure (e.g., clinical pubertal progression, lack of growth deceleration, or continued excessive bone age advancement).

Authorization up to 12 months

Initial Therapy — Gender Dysphoria (pubertal suppression)

Covered when ALL of the following are met

Gender dysphoria initial pubertal suppression: Member has a diagnosis of gender dysphoria.

Gender dysphoria initial pubertal suppression: Member is able to make an informed decision to engage in treatment.

Gender dysphoria initial pubertal suppression: Member has reached Tanner stage 2 of puberty or greater.Tanner stage >= 2

Gender dysphoria initial pubertal suppression: Member's comorbid conditions are reasonably controlled.

Continuation/Reauthorization — Gender Dysphoria (pubertal suppression and gender transition)

Covered when ALL of the following are met

Gender dysphoria continued therapy: Member has a diagnosis of gender dysphoria.

Gender dysphoria continued therapy: Member is able to make an informed decision to engage in treatment.

Pubertal suppression versus transition

Pubertal suppression reauthorization: Member has previously reached Tanner stage 2 of puberty or greater.Tanner stage >= 2 (previous)
Gender transition concomitant therapy:

All indications for leuprolide acetate depot that are not specifically FDA‑approved for pediatric central precocious puberty (CPP) or listed as compendial uses in this policy are considered experimental/investigational and not medically necessary. Requests for these uses will be denied.

Uses of leuprolide acetate depot outside the FDA‑approved indication for CPP are not covered unless they are explicitly listed as compendial uses in this policy. The only compendial use identified here is for gender dysphoria (pubertal suppression in transgender and gender diverse persons); any other off‑label indications not listed are considered not medically necessary.

Drug Coding and Clinical Thresholds

Drug (listed product)NDC | mixed

Lupron Depot-PED

leuprolide acetate depot suspension (brand and generic names and all dosage forms and strengths unless otherwise stated)

Age thresholds for CPP treatment

Onset age — femalesLess than 8 years of age at onset of secondary sexual characteristics

Onset age — malesLess than 9 years of age at onset of secondary sexual characteristics

Continued treatment age limit — femalesLess than 12 years of age for continued therapy

Continued treatment age limit — malesLess than 13 years of age for continued therapy

Tanner stage requirement

Required Tanner stage for initiationTanner stage 2 of puberty or greater required to initiate pubertal suppression

Reauthorization requirementPreviously reached Tanner stage 2 or greater for reauthorization of pubertal suppression

Documentation contextTanner staging requirement applies to adolescents with a diagnosis of gender dysphoria as part of criteria for authorization

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and continuation of therapy. Initial and continued authorizations may be granted for up to 12 months.

Authorization duration: up to 12 months for initial and continued therapy
Prior authorization required before dispensing or administration

Documentation Required

Required Documentation — Gender Dysphoria

For treatment of gender dysphoria, submit documentation that supports the diagnosis and the member's informed decision-making capacity; documentation of Tanner stage (≥ stage 2) for pubertal suppression; evidence that comorbid conditions are reasonably controlled; education provided on contraindications and side effects; and documentation that fertility preservation options were discussed. If medication is for gender transition, include documentation that the member will receive the requested medication concomitantly with gender-affirming hormones. For members <18 years receiving care, the prescriber must be specialized in transgender youth care (e.g., pediatric endocrinologist, family or internal medicine physician, OB-GYN) and have collaborated care with a mental health provider.

Diagnosis of gender dysphoria
Evidence of informed decision-making capacity
Tanner stage documentation (≥ stage 2) for pubertal suppression
Documentation that comorbid conditions are reasonably controlled
Record of education about contraindications and side effects
Documentation that fertility preservation options were discussed prior to therapy
If for gender transition: documentation of concomitant gender-affirming hormone therapy
Prescriber specialty: provider specialized in care of transgender youth or consult with such a provider; collaborative care with a mental health provider for members <18

Step Therapy

No step therapy is specified for these indications in this policy.

There are no step-therapy requirements detailed for central precocious puberty or gender dysphoria in this policy

Definitions

Central precocious puberty (CPP) — definition and confirmation

DefinitionCentral precocious puberty (CPP) is the onset of secondary sexual characteristics before the age thresholds specified in criteria and is an FDA‑approved indication for Lupron Depot‑PED

Confirmation — hormonal testingDiagnosis confirmed by a pubertal response to a GnRH agonist test or a pubertal level on a third‑generation luteinizing hormone (LH) assay

Confirmation — supportive evaluationAssessment of bone age versus chronological age should support the diagnosis

Evaluation for pathologic causesPathologic causes should be assessed when applicable (e.g., imaging for intracranial tumors, genetic testing for familial CPP such as MKRN3 or DLK1 mutations)

Pubertal hormonal suppression (gender dysphoria) — definition and intended use

DefinitionPubertal hormonal suppression is the use of GnRH agonists to suppress puberty in adolescents with a diagnosis of gender dysphoria

Intended use — initiationUsed for pubertal suppression in adolescent members who have reached Tanner stage 2 or greater and can make an informed decision

Intended use — continuation/transitionMay be used during gender transition when given concomitantly with gender‑affirming hormones or continued if member previously reached Tanner stage 2

Associated requirementsRequires education on contraindications/side effects and discussion of fertility preservation options; comorbid conditions should be reasonably controlled

OpenPayer

Leuprolide acetate depot (Lupron Depot-PED) prior authorization — coverage and criteria

Coverage Criteria for Lupron Depot-PED (leuprolide acetate depot)

Drug Coding and Clinical Thresholds

Prior Authorization, Documentation, and Provider Requirements

Background

Definitions