Health Net histrelin acetate Coverage Update

Coverage Criteria

inv-01: Initial Therapy - Prostate Cancer

Covered when ALL of the following are met

Initial Vantas (Prostate Cancer): 1) Diagnosis of prostate cancer; 2) Request is for Vantas; 3) Prescribed by or in consultation with an oncologist or urologist; 4) Age > 18 years; 5) Request is for palliative treatment; 6) Dose does not exceed 50 mg per 12 months (one implant per year); 7) If for an off-label dosing/indication, dose and use are supported by practice guidelines or peer-reviewed literature and prescriber submits supporting evidence.

Prescribed regimen must be FDA‑approved or recommended by NCCN

inv-02: Initial Therapy - Central Precocious Puberty

Covered when ALL of the following are met

Initial Supprelin LA (CPP): 1) Diagnosis of central precocious puberty (CPP) confirmed by: elevated basal LH (>0.2–0.3 mIU/mL depending on assay) and/or elevated leuprolide-stimulated LH (>3.3–5 IU/L depending on assay); 2) Bone age exceeds chronological age by >1 year; 3) Age at onset of secondary sex characteristics: female <8 years or male <9 years; 4) Request is for Supprelin LA; 5) Prescribed by or in consultation with a pediatric endocrinologist; 6) Member meets age treatment window (female typically 2–11 years; male 2–12 years as written); 7) Dose does not exceed 50 mg per 12 months (one implant per year).

inv-03: Initial Therapy - Gender Dysphoria (Off‑label)

Covered when ALL of the following are met

Initial - Gender Dysphoria: 1) Diagnosis of gender dysphoria or request for gender transition; 2) Prescribed by or in consultation with both an endocrinologist and a provider with expertise in gender dysphoria/transgender medicine; 3) Age and pubertal development meet specified Tanner stage criteria (e.g., <18 years and at/after Tanner Stage 2, or >=18 years with failure to achieve physiologic hormone levels unless contraindicated); 4) Member demonstrates understanding of expected GnRH analogue outcomes and provides consent; 5) If psychiatric comorbidity is present, member is followed by a mental health provider; 6) Provider attests understanding of current State regulations regarding transgender-related health care and that such care is coverable under state regulations; 7) Psychosocial support will be provided during treatment; 8) Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature with prescriber submission of supporting evidence.

Off‑label use requires supporting evidence

inv-04: Continuation Therapy - Prostate Cancer

Covered when ALL of the following are met for continuation

Continued Vantas (Prostate Cancer): 1) Currently receiving medication via Centene benefit or documentation supports member has received Vantas for at least 30 days; 2) Request is for Vantas; 3) Member is responding positively to therapy; 4) If request is for a dose increase, new dose does not exceed 50 mg per 12 months (one implant per year) or is supported by practice guidelines/peer-reviewed literature with prescriber submission of supporting evidence.

Prescribed regimen must be FDA‑approved or recommended by NCCN

inv-05: Continuation Therapy - Central Precocious Puberty

Covered when ALL of the following are met for continuation

Continued Supprelin LA (CPP): 1) Currently receiving medication via Centene benefit or previously met initial approval criteria; 2) Request is for Supprelin LA; 3) Member is responding positively to therapy as evidenced by decreased growth velocity, cessation of menses, softening of breast tissue or testes, or arrested pubertal progression; 4) Member meets age requirements for continued therapy (female <11 years; male <12 years); 5) If request is for a dose increase, new dose does not exceed 50 mg per 12 months (one implant per year).

Continuity of care provisions apply when enrolled in applicable states/products

inv-06: Continuation Therapy - Gender Dysphoria (Off‑label)

Covered when ALL of the following are met for continuation

Continued - Gender Dysphoria: 1) Currently receiving medication via Centene benefit or previously met initial approval criteria; 2) Member is responding positively to therapy (for example, member continues to meet their individualized goals of therapy); 3) If request is for a dose increase, new dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature with prescriber submission of supporting evidence.

Continuity of care provisions may apply

inv-07: Covered and conditional indications

Coverage stance by indication and special authorization requirements:

Covered Indications: Includes central precocious puberty (Supprelin LA) and palliative therapy for prostate cancer (Vantas) when aligned with FDA-approved palliative intent; gender dysphoria/gender transition is off-label and may be considered only when all off-label criteria, supporting evidence, and applicable state regulatory attestation are met.

See prior authorization module for attestation requirements and off-label policy references.

Requests for histrelin acetate for non–FDA‑approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with applicable off‑label use policies (for example, CP CPA.09 for Commercial or CP PMN.53 for Medicaid) or other evidence of coverage documents.

Non‑FDA approved indications are not authorized under this policy unless supported by adequate clinical documentation per the referenced off‑label use policies (CP CPA.09 for Commercial, CP PMN.53 for Medicaid) or other applicable evidence of coverage guidance.

Use of histrelin acetate for non‑FDA indications without the required off‑label documentation or evidence of coverage is considered not authorized and such requests may be denied if supporting information is not provided.

Coding and Clinical Thresholds

HCPCS Codes referencedHCPCS

J9225	Histrelin implant_ Vantas
J9226	Histrelin implant (Supprelin LA) 50 mg
J1675

Basal and stimulated LH thresholds for CPP

Basal LH thresholdBasal luteinizing hormone (LH) > 0.2–0.3 mIU/mL (assay-dependent)

Leuprolide-stimulated LH thresholdLeuprolide-stimulated LH > 3.3–5 IU/L (assay-dependent)

Assay dependenceThresholds vary by type of assay used; interpret in laboratory context

Maximum implant dose

Maximum annual doseDoes not exceed 50 mg per 12 months (one implant per year)

Product examplesApplies to Supprelin LA and Vantas (each implant = 50 mg)

Dose context

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit a prior authorization request and meet the policy's diagnosis‑specific criteria for the requested indication (e.g., prostate cancer, central precocious puberty, gender dysphoria/gender transition).

Prior authorization required per policy criteria for histrelin acetate implants (Vantas, Supprelin LA).

Documentation Required

Required Clinical Documentation

Provider must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, relevant laboratory results (e.g., basal or leuprolide‑stimulated LH for CPP), bone age assessment, documentation of Tanner stage where applicable, consultation notes from specialist(s), and any evidence cited for off‑label use.

Office chart notes and specialty consult documentation (oncologist, urologist, pediatric endocrinologist, endocrinologist or provider with expertise in transgender care as applicable).

Initial Therapy

inv-28: Initial Therapy — Initial authorization criteria by indication

Initial authorization criteria by indication

Initial therapy: See indication-specific initial criteria for prostate cancer (Vantas), central precocious puberty (Supprelin LA), and specified off-label uses (gender dysphoria) requiring specialty prescribers, diagnostic thresholds, age limits, and dose limits.

Prescriber must submit supporting evidence for off-label uses

inv-29: Initial therapy dosing — Dosing and administration

Dosing and administration

Standard dosing: 1 implant (50 mg) subcutaneously for 12 months; repeat no more frequently than once per 12 months.Does not exceed 50 mg per 12 months; 1 implant per 12 months

Product-specific dosing listed for Supprelin LA (CPP) and Vantas (prostate cancer).

Continuation Therapy

inv-30: Continuation Therapy — Continuation therapy requirements per indication

Continuation therapy requirements per indication

Continuation general: Member must be currently receiving medication via Centene benefit or have previously met initial approval criteria; member must be responding positively to therapy; dose limitations apply as specified per indication.

See indication‑specific nodes

inv-31: Continuation therapy — gender dysphoria — Continuation of therapy notes for gender dysphoria/transition

Continuation of therapy notes for gender dysphoria/transition

Continuation example: Example of positive response: member continues to meet their individualized goals of therapy for gender dysphoria.

Added as illustrative guidance; continuation still requires documentation of ongoing benefit.

Step Therapy

Step	Description
1	No specific step therapy algorithm documented in this section; coverage is determined by indication-specific prior authorization criteria (see COVERAGE CRITERIA) and prior authorization requirements.
2	When formulary or off‑label routing applies, follow referenced formulary/non‑formulary and off‑label use policies prior to approval of treatment (see Provider Actions / Prior Authorization).

Quantity Limits

Histrelin acetate implant — strength

Product strength50 mg

FormulationSubcutaneous implant intended to provide histrelin delivery over ~12 months

Products referencedSupprelin LA and Vantas implants are each available as 50 mg implants

Histrelin acetate implant (Supprelin LA, Vantas) — units

Number of implants per treatment1

Associated productsApplies to Supprelin LA (CPP) and Vantas (prostate cancer)

Typical duration per implant

Background

Histrelin acetate is a gonadotropin‑releasing hormone (GnRH) agonist available as Vantas and Supprelin LA. Vantas is indicated for palliative treatment of advanced prostate cancer, and Supprelin LA is indicated for the treatment of central precocious puberty (CPP). The product is supplied as a 50 mg subcutaneous implant designed to provide approximately 12 months of therapy, and dosing is limited to one implant per 12 months (50 mg/12 months) unless otherwise supported by practice guidelines or peer‑reviewed literature.

Definitions

Definition — central precocious puberty

Termcentral precocious puberty

AbbreviationCPP

ContextUsed in policy criteria for pediatric indication (Supprelin LA)

Definition — gonadotropin-releasing hormone

Termgonadotropin-releasing hormone

AbbreviationGnRH

ContextClass of drug: GnRH agonist (histrelin acetate) referenced in policy

OpenPayer

Clinical Policy: Histrelin Acetate (Vantas, Supprelin LA)

Coverage Criteria

Coding and Clinical Thresholds

Provider Actions and Requirements

Initial Therapy

Continuation Therapy

Step Therapy

Quantity Limits

Background

Definitions