CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

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

Medical coverage policy for Supprelin LA (histrelin) 50 mg subcutaneous implant governing Medicaid, Commercial, and MMP members; defines indications, authorization limits, dosing, and renewal criteria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

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

Policy CodePolicy N/A

Change TypeNo material change

Effective Date06/01/2025

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation including age, pubertal staging, pubertal gonadal sex steroid levels, GnRH stimulation LH response, bone age assessment, and applicable ICD-10 diagnosis code.

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 billing code

67979-0002-xxNDC

Ages 2 to <13CPP age range

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Coverage Criteria for Supprelin LA (histrelin) 50 mg Implant

Initial Approval — Central Precocious Puberty (CPP)

Covered when ALL of the following Universal and CPP-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; AND Patient does not have a hypersensitivity to gonadotropin releasing hormone (GnRH) or GnRH analog type medications;

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

Initial Approval — Gender Dysphoria

Covered when ALL of the following Universal and Gender Dysphoria-specific criteria are met

Gender Dysphoria-specific: Patient has experienced puberty development to at least Tanner stage 2 (applies only to patients <18 years); AND Patient has a diagnosis of gender dysphoria confirmed by a qualified mental health professional (MHP) or by DSM‑V criteria; AND A qualified MHP has confirmed duration/severity (long‑lasting/intense pattern), that gender dysphoria worsened with onset of puberty, that coexisting issues have been addressed and the adolescent's functioning is stable enough to start treatment, and that the patient has sufficient mental capacity to give informed consent to this reversible treatment; AND Patient has been informed of treatment effects/side effects including potential loss of fertility and options to preserve fertility; AND Informed consent obtained and parents/caregivers involved when applicable; AND A pediatric endocrinologist or clinician experienced in pubertal assessment has confirmed agreement in the indication for treatment and that there are no medical contraindications to treatment.

Supprelin LA coverage application

Coverage criteria established by Neighborhood's P&T Committee and applied to ensure use aligns with FDA labeling and literature.

General application: Requests will be reviewed against plan criteria aligned with FDA labeling and relevant clinical literature; cost‑effective options should be considered first when appropriate; AND For Medicare‑Medicaid Plan (INTEGRITY) members, these coverage criteria apply only in the absence of applicable National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs).

Individual consideration will be given to each request based on information submitted by the prescriber and other plan‑available information.

For Central Precocious Puberty (CPP), Supprelin LA will not be used in combination with growth hormone. This is an explicit exclusion within the CPP-specific approval criteria and must be documented in requests for initial or continued coverage.

Where Medicare applies, National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) take precedence over the policy criteria described here. The policy notes that Medicare Part B covered diagnosis codes are N/A for this appendix, and providers should consult CMS resources for applicable NCDs/LCDs when submitting claims for Medicare beneficiaries.

Continued coverage is contingent on demonstration of disease response. For CPP this includes stabilization or regression of secondary sexual characteristics, a decrease in height velocity, improvement in the bone age to chronological age (BA:CA) ratio, and improved final height prediction. Lack of these objective responses does not support ongoing coverage.

The coverage criteria were adopted to ensure Supprelin LA is used for medically accepted indications consistent with FDA labeling and relevant clinical literature. Requests will be reviewed against these criteria to promote appropriate use and cost-effective care; indications that do not meet the outlined criteria should be considered not medically necessary unless individual consideration supports coverage.

Coding and Diagnosis Appendix

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 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

Covered Diagnosis Codes (Appendix 1)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

Medicare Part B Covered Diagnosis Codes (Appendix note)ICD-10

No codes listed

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Supprelin LA. Requests will be reviewed against clinical criteria adopted by the Neighborhood Health Plan of Rhode Island Pharmacy & Therapeutics (P&T) Committee to ensure use aligns with FDA labeling and relevant clinical literature. Neighborhood will give individual consideration to each request based on information submitted by the prescriber and other plan-available data.

Prior authorization required
Requests reviewed against P&T-established clinical criteria
Individual consideration will be given to each request

Denial Risk

Gender Dysphoria Criteria Not Met

For requests for Supprelin LA to treat gender dysphoria, coverage will be denied when the documented clinical criteria are not met. Common reasons for noncoverage include absence of documented Tanner stage ≥2 for members <18 years old, lack of a diagnosis of gender dysphoria confirmed by a qualified mental health professional (MHP) or by DSM-V criteria, missing documentation that a qualified MHP has confirmed required assessments (duration/intensity of gender dysphoria, worsening with puberty, assessment of coexisting conditions and capacity to consent), missing informed consent (and guardian consent/support when applicable), or absence of confirmation by a pediatric endocrinologist or clinician experienced in pubertal assessment that there are no medical contraindications.

Background and Rationale

Supprelin LA is a gonadotropin‑releasing hormone (GnRH) agonist indicated for children with central precocious puberty (CPP). Clinical studies demonstrate suppression of luteinizing hormone (LH) and sex steroids with resultant stabilization or regression of pubertal signs; implant‑site reactions are among reported adverse events. The plan adopted criteria to align use with FDA labeling and the clinical literature reviewed by the Pharmacy & Therapeutics Committee.

Definitions and Appendix Terms

Central Precocious Puberty (CPP) — Definition and age thresholds

DefinitionEarly activation of the hypothalamic–pituitary–gonadal axis causing onset of secondary sexual characteristics earlier than age 8 in females and 9 in males, confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to GnRH stimulation.

Typical age threshold (female)Onset of secondary sexual characteristics earlier than age 8.

Typical age threshold (male)Onset of secondary sexual characteristics earlier than age 9.

Policy age range for CPP criteriaPatient between ages 2 and less than 13 years for coverage consideration.

DSM‑V Gender Dysphoria — Summary of criteria

Core definition