CurrentNeighborhood Health Plan of Rhode IslandPolicy nhpriorg

Supprelin LA (histrelin) subcutaneous implant

Policy governing coverage, dosing limits, and medical necessity criteria for Supprelin LA (histrelin) 50 mg subcutaneous implant for Medicaid, Commercial, and MMP members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySupprelin LA (histrelin) subcutaneous implant

Policy CodePolicy nhpriorg

Change TypeNo material changes

Effective Date06/01/2025

Next Review Date

Key ActionObtain prior authorization and submit diagnostic documentation confirming indication and required labs/imaging.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization length

1/12 moquantity limit (50 mg)

J9226HCPCS code for billing

E30.1, E30.8, F64.*example covered diagnosis ICD-10 codes

7covered diagnosis codes listed

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policy rationale references

Medical Necessity and Coverage Criteria

Initial Therapy — Central Precocious Puberty

Covered when ALL of the following are met

Universal Criteria: Patient does not have a hypersensitivity to gonadotropin releasing hormone (GnRH) or GnRH-type medications; MMP members who have previously received this medication within the past 365 days are not subject to these requirements; will not be used in combination with growth hormone.

From Universal Criteria (IV)

CPP-specific Criteria: Patient is between the ages of 2 and less than 13 years; onset of secondary sexual characteristics earlier than age 8 for females and earlier than age 9 for males associated with pituitary gonadotropin activation; diagnosis 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 (SD) beyond chronological age; tumor has been ruled out by appropriate testing (brain imaging to exclude intracranial tumor, pelvic/testicular/adrenal ultrasound to exclude steroid-secreting tumors, and human chorionic gonadotropin levels to exclude hCG-secreting tumors).

From CPP criteria (1-6)

Initial Therapy — Gender Dysphoria / Pubertal Suppression

Covered when ALL of the following are met

Age and pubertal stage: Patient has experienced pubertal development to at least Tanner stage 2 (applies only to patients <18 years of age).

From Gender Dysphoria criteria

Mental health confirmation: Diagnosis of gender dysphoria confirmed by a qualified mental health professional (per policy definition) or by DSM-V criteria; the qualified MHP confirms a long-lasting and intense pattern of gender incongruence/dysphoria, that dysphoria worsened with onset of puberty, coexisting problems that could interfere with treatment have been addressed, patient has sufficient capacity to consent, and informed consent (and parental/guardian involvement when applicable) has been obtained after discussion of effects and potential effects including fertility considerations.

From Gender Dysphoria and DSM-V sections

Specialist confirmation: Pediatric endocrinologist or other clinician experienced in pubertal assessment has confirmed agreement in the indication for treatment and that there are no medical contraindications to treatment.

From Gender Dysphoria criteria

Renewal Criteria

Coverage can be renewed when ALL of the following are met

Continued eligibility: Patient continues to meet the universal criteria and the indication-specific criteria from initial approval (section IV).

From Renewal Criteria

Toxicity assessment: There is absence of unacceptable toxicity (examples include severe implant site reactions, convulsions/seizures, psychiatric events such as marked emotional lability, or signs/symptoms of pseudotumor cerebri/idiopathic intracranial hypertension such as headaches, papilledema, blurred vision, diplopia, eye pain, tinnitus, dizziness, nausea).

From Renewal Criteria examples

Response for CPP: For central precocious puberty (CPP), documented disease response as evidenced by lack of progression or stabilization of secondary sexual characteristics, decreased height velocity, decrease in the ratio of bone age to chronological age (BA:CA), and improvement in predicted final adult height.

From Renewal Criteria CPP section

Coverage aligned to FDA labeling and listed diagnoses

Covered when use aligns with FDA-approved labeling and applicable clinical literature and is for one of the listed diagnoses

Primary coverage criteria

Accepted diagnoses: Diagnosis must be one of the ICD-10 codes listed in Appendix 1 (E30.1, E30.8, F64.0, F64.1, F64.2, F64.8, F64.9).
Appendix 1 Covered Diagnosis Codes

The plan specifies that Supprelin LA must not be used in combination with growth hormone. This restriction is part of the universal eligibility requirements for treatment of central precocious puberty and must be documented with the prior authorization request.

For INTEGRITY (Medicare‑Medicaid Plan) members, these clinical coverage criteria apply only in the absence of applicable National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs). When an NCD or LCD applies, that coverage guidance takes precedence over the plan criteria.

Requests that do not demonstrate consistency with FDA‑approved labeling or relevant clinical literature as applied by the plan's coverage criteria may be considered not medically necessary. The plan will give individual consideration based on clinical information submitted by the prescriber.

Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization and dosing limit

Prior authorization is required for Supprelin LA. Coverage will be provided for 12 months and may be renewed. Dosing limit: 1 implant (50 mg) inserted subcutaneously every 12 months (1 billable unit = 50 mg).

Coverage length: 12 months; eligible for renewal.
Quantity limit: 1 implant (50 mg) per 12 months (1 billable unit = 50 mg).

Prior Authorization

Prior authorization required

Prior authorization is required and requests are reviewed against the P&T-adopted clinical coverage criteria to ensure use for a medically accepted indication and to consider cost-effective alternatives.

Step Therapy

Step therapy note — MMP exemption

Billing Codes and Diagnosis Lists

Covered HCPCS CodesHCPCSCovered

J9226

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

NDCNDC

67979-0002-xX

Supprelin LA 50 mg implant 67979-0002-xX

Covered Diagnosis ICD-10 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 identity disorders gender
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 identity disorders gender
F64.9	Gender identity disorder; unspecified

Clinical Background and Indication Summary

Supprelin LA (histrelin) is a gonadotropin‑releasing hormone (GnRH) agonist indicated for treatment of central precocious puberty (CPP) in children. Clinical studies supporting the indication demonstrated suppression of luteinizing hormone and sex steroid levels with clinical stabilization or regression of pubertal signs. The most commonly reported adverse event is implant‑site reaction, and insertion/removal complications have been observed.

Key Terms and Diagnosis Definitions

Central precocious puberty (CPP) — key characteristics

DefinitionCentral precocious puberty (CPP): onset of secondary sexual characteristics due to activation of the hypothalamic–pituitary–gonadal axis prior to age 8 in females and prior to age 9 in males.

Age criteriaPatient age between 2 and less than 13 years at initiation of therapy.

Diagnostic confirmationDiagnosis confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to native GnRH stimulation; bone age advanced >2 standard deviations beyond chronological age.

Tumor exclusionAppropriate imaging and laboratory evaluation required to rule out central nervous system or hCG‑secreting tumors (e.g., brain imaging; pelvic, testicular, or adrenal ultrasound; hCG testing).

Therapeutic noteSupprelin LA (histrelin) suppresses LH and sex steroids and has been shown to stabilize or regress pubertal signs; most common adverse reaction is implant site reaction.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySupprelin LA (histrelin) subcutaneous implant

Policy CodePolicy nhpriorg

Change TypeNo material changes

Effective Date06/01/2025

Next Review Date

Key ActionObtain prior authorization and submit diagnostic documentation confirming indication and required labs/imaging.

SourceLink

On This Page

Response for Gender Dysphoria: For gender dysphoria, demonstrated beneficial response to treatment as evidenced by routine monitoring of clinical pubertal development and applicable laboratory parameters as documented by the treating clinicians.

From Renewal Criteria Gender Dysphoria section

The policy includes Step Therapy language; however, MMP members who have received this medication within the past 365 days are not subject to step therapy requirements.

MMP members previously receiving the medication within 365 days are exempt from step therapy.

Step Therapy

Step therapy considerations

The plan's criteria emphasize using more cost‑effective options when applicable and appropriate, which may imply consideration of step therapy although no specific step sequence is listed.

Documentation Required

Required diagnostic documentation

Submit diagnostic documentation confirming the diagnosis: pubertal gonadal sex steroid levels and a pubertal LH response to native GnRH stimulation; bone age advanced >2 standard deviations beyond chronological age; and imaging/labs to rule out tumors (brain imaging, pelvic/testicular/adrenal ultrasound, and hCG).

Pubertal gonadal sex steroid levels and pubertal LH response to native GnRH stimulation.
Bone age >2 SD advanced beyond chronological age.
Tumor exclusion via brain imaging, pelvic/testicular/adrenal ultrasound, and hCG testing.

Documentation Required

Behavioral health and informed consent documentation

For gender dysphoria indications, include documentation from a qualified mental health professional confirming the diagnosis, assessment of capacity for informed consent, that coexisting problems were addressed, and evidence of informed consent (and parental/guardian involvement as applicable); pediatric endocrinologist confirmation of no medical contraindications is also required.

Qualified MHP confirmation of DSM‑V criteria and persistent/intense gender dysphoria.
Assessment of capacity to consent and documentation of informed consent (parents/guardians involved when applicable).
Pediatric endocrinologist or experienced clinician confirms indication and absence of medical contraindications.

Documentation Required

Required clinical justification

The prescriber must submit clinical information demonstrating that the requested use aligns with FDA‑approved labeling or relevant clinical literature; the plan will give individual consideration based on submitted information.

Denial Risk

Denial triggers — hypersensitivity and unmet criteria

Requests may be denied if the patient has a hypersensitivity to GnRH or GnRH‑type medications, or if indication‑specific criteria (such as age limits, diagnostic confirmation, or tumor exclusion) are not met.

Hypersensitivity to GnRH or GnRH‑type medications is a denial trigger.
Failure to meet age, diagnostic confirmation, bone age or tumor‑exclusion criteria may result in denial.

Denial Risk

Denial risk for non‑concordant use

Requests may be denied if they do not demonstrate use consistent with FDA‑approved labeling or relevant clinical literature as applied by the plan's coverage criteria.

Plan will individually review requests and may deny those not aligned with FDA labeling or clinical literature.

Gender Dysphoria (DSM-V) — summary

Core DSM‑V definitionMarked incongruence between one’s experienced/expressed gender and natal gender for at least 6 months, manifested by specified features and associated distress or impairment.

Required symptom clustersAt least two characteristic features (e.g., strong desire to be rid of primary/secondary sex characteristics, strong desire for characteristics of the other gender, strong desire to be treated as the other gender, conviction of having feelings/reactions of the other gender).

Functional impactCondition must be associated with clinically significant distress or impairment in social, occupational, or other important areas of functioning, or exist with a disorder of sex development, or be post‑transition with ongoing/ planned medical treatments.

DocumentationDiagnosis must be confirmed by a qualified mental health professional; informed consent and involvement of parents/guardians when applicable are required for pubertal suppression in minors.

E30.1 — Precocious puberty (ICD-10)

ICD-10 CodeE30.1

DescriptionPrecocious puberty.

Use in policyListed as an accepted diagnosis for coverage (see Appendix 1).

E30.8 — Other disorders of puberty (ICD-10)

ICD-10 CodeE30.8

DescriptionOther disorders of puberty.

Use in policyIncluded among covered diagnoses in Appendix 1 for consideration of therapy.

F64.x — Gender identity / related disorders (ICD-10)

ICD-10 Code RangeF64.x (F64.0, F64.1, F64.2, F64.8, F64.9)

DescriptionsF64.0 Transsexualism; F64.1 Dual role transvestism; F64.2 Gender identity disorder of childhood; F64.8 Other identity disorders gender; F64.9 Gender identity disorder, unspecified.

Policy relevanceThese F64 codes are listed in Appendix 1 as accepted diagnoses for coverage consideration related to gender identity disorders and pubertal suppression.