CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Supprelin LA (histrelin) (Subcutaneous Implant) — Coverage Criteria

Defines coverage, dosing limits, clinical indications, and authorization/renewal criteria for Supprelin LA (histrelin) implant for Neighborhood Health Plan of Rhode Island members (Medicaid, Commercial, MMP).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySupprelin LA (histrelin) (Subcutaneous Implant) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date06/01/2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation that the patient meets universal and indication-specific criteria, including diagnostic testing and specialist confirmation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period per approval

1 / 12 moquantity limit (50 mg implant)

J9226HCPCS code

67979-0002-xxNDC

7Covered ICD-10 diagnosis count

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Coverage Criteria for Supprelin LA (histrelin) Implant

Initial Therapy — Covered when ALL of the following Universal Criteria AND indication-specific criteria are met

Covered when ALL of the following Universal Criteria AND indication-specific criteria are met

Universal Criteria: MMP members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements; Patient does not have a hypersensitivity to gonadotropin releasing hormone (GnRH) or GnRH analog type medications

From Universal Criteria

Central Precocious Puberty (CPP): Patient is between the ages of 2 and less than 13 years; Will not be used in combination with growth hormone; Onset of secondary sexual characteristics earlier than age 8 for females and 9 for males associated with pubertal pituitary gonadotropin activation; Diagnosis is confirmed by pubertal gonadal sex steroid levels and a pubertal luteinizing hormone (LH) response to stimulation by native GnRH; Bone age advanced greater than 2 standard deviations beyond chronological age; Tumor has been ruled out by appropriate imaging/labs (brain imaging, pelvic/testicular/adrenal ultrasound, and hCG as indicated); Patient has experienced inadequate response, intolerance, or is contraindicated to treatment with Lupron Depot-Ped (leuprolide)

CPP-specific requirements

Gender Dysphoria: (If applicable) Patient meets clinician assessment for gender dysphoria per the plan's requirements and has documentation from qualified mental health and pediatric endocrinology specialists as appropriate (see documentation requirements)

Gender dysphoria criteria referenced in policy definitions and documentation guidance

Renewal Therapy — Renewal covered when ALL of the following are met

Renewal covered when ALL of the following are met

Universal Renewal: Patient continues to meet the universal and indication-specific criteria from initial approval; Absence of unacceptable toxicity to the drug (examples include severe implant site reactions, convulsions/seizures, psychiatric events, signs/symptoms of pseudotumor cerebri/idiopathic intracranial hypertension)

See policy for examples of unacceptable toxicity

CPP Renewal: Patient is less than 13 years of age; Disease response demonstrated by stabilization or lack of progression of secondary sexual characteristics, decreased height velocity, decreased ratio of bone age to chronological age (BA:CA), and improved final height prediction

CPP-specific renewal criteria

Gender Dysphoria Renewal: Patient has shown a beneficial response to treatment as evidenced by routine monitoring of clinical pubertal development and applicable laboratory parameters

Gender dysphoria renewal criteria

Clinical coverage criteria — Covered when criteria from the Neighborhood P&T Committee are met and diagnosis aligns with Appendix 1

Covered when criteria from the Neighborhood P&T Committee are met and diagnosis aligns with Appendix 1

Primary coverage requirements: Use must align with FDA-approved labeling and/or relevant clinical literature; diagnosis must be one of the covered ICD-10 codes listed in Appendix 1; prescriber must submit supporting information for individual consideration

Neighborhood P&T Committee criteria and Appendix 1 diagnoses govern coverage; NCD/LCD applicable for Medicare members

Use of Supprelin LA in combination with growth hormone is explicitly excluded. Requests indicating concurrent administration with growth hormone will not meet the coverage criteria and should be denied unless documentation demonstrates adherence to a different covered indication or special circumstances approved by the plan.

Medicare National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) take precedence where applicable. Providers should consult CMS coverage guidance when submitting requests for Medicare members. This document does not list any Medicare Part B covered diagnosis codes (listed as N/A).

Use that does not conform to FDA-approved labeling, relevant clinical literature, or the plan's clinical criteria may be considered not medically necessary. Neighborhood will review prescriber-submitted information and other available plan data to determine whether individual requests meet these standards and may deny coverage if the submitted information does not demonstrate alignment with accepted indications or supporting evidence.

Coding and Diagnosis

Covered HCPCS CodesHCPCSCovered

J9226

Histrelin implant (Supprelin LA), 50 mg; 1 billable unit = 50 mg

NDCNDCCovered

67979-0002-xx

Supprelin LA 50 mg implant NDC

Covered Diagnosis Codes (ICD-10)ICD-10Covered

E30.1	Precocious puberty
E30.8	Other disorders of puberty
F64.0	Transsexualism
F64.1	Dual role transvestism
F64.2	Gender identity disorder of childhood
F64.8	Other gender identity disorders
F64.9	Gender identity disorder, unspecified

Covered ICD-10 Diagnosis CodesICD-10Covered

E30.1	Precocious puberty
E30.8	Other disorders of puberty
F64.0	Transsexualism
F64.1	Dual role transvestism
F64.2	Gender identity disorder of childhood
F64.8	Other gender identity disorders
F64.9	Gender identity disorder, unspecified

Medicare Part B Covered Diagnosis CodesICD-10

No codes listed

Age limits

Initial approval age rangePatient is between the ages of 2 and less than 13 years

Renewal age requirementPatient must be less than 13 years for renewal approvals

Combination therapy restrictionWill not be used in combination with growth hormone

Bone age advancement

Bone age advancement threshold> 2 standard deviations (SD) beyond chronological age

Documentation requirement

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests will be evaluated against Neighborhood's clinical coverage criteria to confirm the request aligns with FDA-approved labeling and relevant clinical literature. For INTEGRITY (MMP) members, these criteria apply only in the absence of applicable NCD or LCD; individual consideration will be given based on prescriber-submitted documentation and other available plan information.

Prior authorization required for Supprelin LA and other GnRH analogs when used for covered indications
Requests reviewed for consistency with FDA labeling, clinical literature, and plan criteria
INTEGRITY (MMP) members: national/local coverage determinations supersede plan criteria when applicable

Step Therapy

Step Therapy Exemption for MMP Members

MMP members who have received the medication within the past 365 days are exempt from Step Therapy requirements. Prescribers should document prior use to support an exemption request.

Background and Clinical Context

Supprelin LA (histrelin) is a gonadotropin-releasing hormone (GnRH) agonist indicated for treatment of central precocious puberty (CPP) in children. Evidence supporting its use includes single-arm open-label studies demonstrating suppression of luteinizing hormone and sex steroids with clinical stabilization of pubertal progression; the most commonly reported adverse events are implant site reactions. Coverage decisions and criteria for Supprelin LA were reviewed and adopted by Neighborhood's Pharmacy & Therapeutics Committee to ensure use consistent with FDA labeling and relevant clinical literature.

Definitions

Central Precocious Puberty (CPP)

Definition (CPP)Onset of secondary sexual characteristics earlier than age 8 for females and 9 for males associated with pubertal pituitary gonadotropin activation

Diagnostic confirmationRequires pubertal gonadal sex steroid levels and a pubertal LH response to native GnRH stimulation

Tumor exclusionTumor must be ruled out by brain imaging, pelvic/testicular/adrenal ultrasound, and hCG levels

Disease response for renewalStabilization of secondary sexual characteristics, decreased height velocity, decreased BA:CA ratio, and improved final height prediction

Qualified Mental Health Professional (for gender dysphoria)

Minimum qualifications