ModifiedHealth NetPolicy CP.PHAR.172

Histrelin Acetate (Vantas, Supprelin LA) Coverage Criteria

Defines medical necessity criteria, authorization and renewal rules for coverage of histrelin acetate implants (Vantas and Supprelin LA) across Centene-affiliated Health Net lines of business including Commercial, Medicaid, and HIM-Medical Benefit/ICHRA.

Policy Summary

PayerHealth Net

PolicyHistrelin Acetate (Vantas, Supprelin LA) Coverage Criteria

Policy CodePolicy CP.PHAR.172

Change TypeMaterial updates to coverage attestation and indication clarifications

Effective DateOct 1, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation (diagnosis, prescriber specialty, dosing, age and lab/clinical confirmation) and provider attestation for gender dysphoria requests when applicable.

SourceLink

POLICY UPDATE CHANGES

For gender dysphoria and gender transition, added requirement that provider attests understanding of current State regulations and that such care is coverable under state regulations, with a reference to the Movement Advancement Project.

For prostate cancer indication, added requirement that request is for palliative treatment to align with FDA-approved indication.

Updated product prescribing information and references (Vantas, Supprelin LA) to 2025 documents.

50 mgimplant dose / year

12 monthsduration per implant

Prostate adultsVantas indication

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.

CPP agesSupprelin LA pediatric

J9225,J9226,J1675HCPCS codes

Excluded liststates excluded

Coverage and Medical Necessity Criteria

Initial Therapy - Prostate Cancer

Covered when ALL of the following are met

Prostate Cancer Initial: 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. Request meets one of the following: a) Dose does not exceed 50 mg per 12 months (one implant per year); or b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.dose <= 50 mg/12 months unless evidence-supported

Approval duration: Medicaid/HIM/ICHRA 12 months; Commercial 6 months or to member's renewal date, whichever is longer.

Initial Therapy - Central Precocious Puberty

Covered when ALL of the following are met

CPP Initial: 1. Diagnosis of central precocious puberty (CPP) confirmed by all of the following: a) Elevated basal luteinizing hormone (LH) > 0.2 - 0.3 mIU/mL and/or elevated leuprolide-stimulated LH > 3.3 - 5 IU/L (assay dependent); b) Bone age exceeds chronological age by > 1 year; c) Age at onset of secondary sex characteristics: female < 8 years, male < 9 years; 2. Request is for Supprelin LA; 3. Prescribed by or in consultation with a pediatric endocrinologist; 4. Member meets one of the following age requirements: female 2-11 years or male 2-12 years; 5. Dose does not exceed 50 mg per 12 months (one implant per year).age and LH thresholds as above

Approval duration: Medicaid/HIM/ICHRA 12 months; Commercial 6 months or to member's renewal date, whichever is longer.

Initial Therapy - Gender Dysphoria / Transition

Covered when ALL of the following are met (off-label)

Gender Dysphoria Initial: 1. For HIM/ICHRA, request is for a member in a state other than the following where gender dysphoria and gender transition treatment is not a covered benefit: AL, AZ, AR, FL, GA, IN, IA, KS, KY, LA, MS, MO, NE, NH, NC, OH, OK, SC, TN; 2. Diagnosis of gender dysphoria or request for gender transition; 3. Prescribed by or in consultation with both: a) an endocrinologist; and b) a provider with expertise in gender dysphoria/transgender medicine (certified training program or affiliation with local transgender health services); 4. Age and pubertal development—either: a) member < 18 years and has reached/passed Tanner Stage 2; or b) member >= 18 years and has failed to achieve physiologic hormone levels with gender-affirming hormonal therapy unless contraindicated; 5. Member demonstrates understanding of expected GnRH analogue treatment outcomes and has given consent; 6. If psychiatric comorbidity present, member is followed by a mental health provider; 7. Psychosocial support will be provided during treatment; 8. Provider attests understanding of current State regulations regarding transgender-related health care and that such care is coverable under the State regulations; 9. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Approval duration: Medicaid/HIM/ICHRA 12 months; Commercial 6 months or to member's renewal date, whichever is longer.

Covered Indications

Covered when the request meets the FDA-approved indication or specified off-label criteria and documentation requirements (as described elsewhere in the policy).

Covered indications: Supprelin LA for central precocious puberty; Vantas for palliative therapy of prostate cancer; off-label use for gender dysphoria/gender transition when policy criteria and provider attestation are met and state coverage allows it.

See dosing and product availability for implant strength and duration; providers must submit documentation that approval criteria are met and, for gender dysphoria requests, provider attestation regarding state regulatory coverage as applicable.

Non–FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy for the member's line of business (see CP.CPA.09 for Commercial, HIM.PA.154 for Marketplace/ICHRA, and CP.PMN.53 for Medicaid).

Uses that are non‑FDA approved and are not supported by evidence per the applicable off‑label use policies are considered not authorized and may be denied if submitted for coverage.

Per the Marketplace/ICHRA rule reflected in this policy, gender dysphoria and gender transition treatment is not a covered benefit for members located in the following states: AL, AZ, AR, FL, GA, IN, IA, KS, KY, LA, MS, MO, NE, NH, NC, OH, OK, SC, and TN. For HIM/ICHRA requests, the provider must confirm the member’s state is not on this list before submitting a request.

Coding information in this clinical policy is provided for informational purposes only and does not guarantee coverage. Providers must reference the most current professional coding guidance and payer billing instructions prior to claim submission to ensure correct code selection and reimbursement.

Initial Therapy Requirements and Dosing

Initial Therapy

Initial approval criteria are specified by indication; common elements include prescriber specialty, age limits, diagnostic confirmation where applicable, and dose limits or supporting evidence for higher/off-label dosing.

Initial therapy nodes: Initial approval criteria are specified separately for prostate cancer (Vantas), CPP (Supprelin LA), and gender dysphoria/transition (off-label). Common elements: prescriber specialty requirements, age limits, diagnostic confirmation (e.g., LH thresholds and bone age for CPP), and dose limits (<=50 mg/12 months) or supporting literature for higher/off-label dosing.

See specific criteria in respective indication sections.

Initial Therapy / Dosing

Implant strength, dosing interval, and product-specific release characteristics

Initial dosing: One 50 mg subcutaneous implant (Supprelin LA or Vantas) placed for approximately 12 months of drug release; typical refill interval is one implant per 12 months.50 mg implant, ~12 months

Criteria for Continued Therapy / Renewal

Continuation Therapy

Continuation/renewal requests are covered when ALL of the following are met for the relevant indication

Continuation nodes: See indication-specific continued therapy criteria which require: current receipt of medication via Centene benefit or documentation of prior approval/continuity of care; member is responding positively to therapy; and dose limits are maintained (<=50 mg per 12 months) or higher doses are supported by practice guidelines or peer-reviewed literature with submitted evidence.

Approval duration: Medicaid/HIM/ICHRA 12 months; Commercial 6 months or to member's renewal date, whichever is longer.

Continuation Therapy - Gender Dysphoria

Continuation/renewal for gender dysphoria requests requires documentation of continued benefit and state regulatory attestation where applicable

Continuation for gender dysphoria: 1. Member is currently receiving medication via Centene benefit or previously met initial approval criteria (or continuity of care applies); 2. Member is responding positively to therapy (e.g., continues to meet individual goals of therapy for gender dysphoria); 3. For HIM/ICHRA, member is in a state where such care is covered (not in listed excluded states); 4. 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 (prescriber must submit supporting evidence).

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior Authorization Required — submission of documentation that approval criteria are met (diagnosis, prescriber specialty, dosing, etc.).

Prior authorization required for all indications prior to initiation of therapy.
Submit documentation that member meets the specific indication criteria (e.g., diagnosis, age limits, prescriber specialty, palliative intent for prostate cancer, dosing not to exceed one 50 mg implant per 12 months unless supported by guidelines/literature).
Applicable HCPCS codes: J9225 (Vantas, 50 mg), J9226 (Supprelin LA, 50 mg).

Documentation Required

Required Documentation

Providers must submit clinical documentation to support that the member meets all approval criteria. Examples include office chart notes, relevant laboratory results (e.g., basal and/or stimulated LH levels, bone age assessments), consultation notes, and any supporting literature for off‑label dosing.

Billing and Coding References

HCPCS Codes referencedHCPCS

J9225	Histrelin implant (Vantas), 50 mg
J9226	Histrelin implant (Supprelin LA), 50 mg
J1675	Injection, histrelin acetate, 10 micrograms

Basal and stimulated LH thresholds for CPP diagnosis

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

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

Diagnostic requirement summaryCPP diagnosis requires elevated basal and/or stimulated LH plus bone age > chronological age by >1 year and age at onset of secondary sex characteristics (female <8, male <9)

Implant dosing interval

Recommended intervalOne implant per 12 months (approximately 12 months of drug release)

Implant strength associated with interval50 mg implant (Supprelin LA or Vantas) typically placed for the 12-month interval

Dose and Quantity Limits

histrelin acetate (implant) — maximum dose

Maximum implant dose50 mg per 12 months

Formulations referencedHistrelin acetate implant (Supprelin LA, Vantas) — 50 mg strength

Replacement intervalOne implant per year (dose described as per 12 months)

histrelin acetate implant (Supprelin LA, Vantas) — quantity limit

Quantity limit1 implant per 12 months

Implant strength50 mg (Supprelin LA, Vantas)

Billing implication

Administration and Site of Care

Step Therapy

Office placement — subcutaneous implant

Place subcutaneous histrelin acetate implants (office setting allowed); document site of care and procedure details in the medical record and PA submission.

Document implant placement site and date in the office note
Include procedure details when submitting supporting documentation

Key Definitions and Abbreviations

Central precocious puberty (CPP) — definition

Definition (abbreviation)CPP = central precocious puberty

Clinical meaningOnset of secondary sex characteristics earlier than typical (female <8 years; male <9 years)

Diagnostic componentsDiagnosis requires hormonal confirmation (LH thresholds), advanced bone age (>1 year above chronological age), and appropriate age of onset

GnRH — definition

TermGnRH = gonadotropin-releasing hormone

RoleHypothalamic hormone that stimulates pituitary release of LH and FSH

Class context

Background and Drug Information

Histrelin acetate is a gonadotropin‑releasing hormone (GnRH) agonist available as subcutaneous implants marketed as Vantas and Supprelin LA. Vantas (50 mg implant) is indicated for palliative treatment of advanced prostate cancer in adults; Supprelin LA (50 mg implant) is indicated for treatment of central precocious puberty in pediatric patients. Each 50 mg implant is designed to deliver medication over approximately 12 months, with typical dosing described as one implant per 12 months.

Pathway for Other or Off-Label Indications

Other/Off-label Indications Pathway

If the requested indication is not specifically listed in this policy, follow the pathway below

Other Indications: 1. If this drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, refer to the appropriate no coverage or non-formulary policy for the relevant line of business; OR 2. If the requested use (diagnosis, age, dosing regimen) is not listed under authorized indications and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53 as appropriate).

References: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53 as appropriate.

Step Therapy

Step	Requirement / Description
No explicit step therapy sequence specified in this document.	This policy does not require prior failure of or stepwise trials of alternative therapies before approval; prior authorization is required and coverage is based on meeting the specific indication-based criteria (see Initial and Continued Therapy sections).

Policy Summary

PayerHealth Net

PolicyHistrelin Acetate (Vantas, Supprelin LA) Coverage Criteria

Policy CodePolicy CP.PHAR.172

Change TypeMaterial updates to coverage attestation and indication clarifications

Effective DateOct 1, 2016

Next Review Date

SourceLink

On This Page

Supprelin LA: implant 50 mg (~65 mcg/day over 12 months). Vantas: implant 50 mg (~50 mcg/day over 12 months).

Provider must attest understanding of state regulations as required for initial requests.

Continued Therapy - Prostate Cancer

Continuation covered when ALL of the following are met

Prostate Cancer Continued: 1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Vantas for prostate cancer and has received this medication 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 or is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).

Prescribed regimen must be FDA-approved or recommended by NCCN. Approval duration: Medicaid/HIM/ICHRA 12 months; Commercial 6 months or to member's renewal date, whichever is longer.

Continued Therapy - Central Precocious Puberty

Continuation covered when ALL of the following are met

CPP Continued: 1. Member meets one of the following: a) currently receiving medication via Centene benefit or previously met initial approval criteria; or b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 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 age: 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).

Approval duration: Medicaid/HIM/ICHRA 12 months; Commercial 6 months or to member's renewal date, whichever is longer.

Continued Therapy - Gender Dysphoria / Transition

Continuation covered when ALL of the following are met

Gender Dysphoria Continued: 1. Currently receiving medication via Centene benefit or previously met initial approval criteria or continuity of care applies; 2. Member is responding positively to therapy (continues to meet individual goals); 3. For HIM/ICHRA, member is in a state where such care is covered (not in listed excluded states); 4. 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 (prescriber must submit supporting evidence).

Approval duration: Medicaid/HIM/ICHRA 12 months; Commercial 6 months or to member's renewal date, whichever is longer.

Lack of adequate documentation may result in denial of the request.
For off‑label indications, include supporting peer‑reviewed literature or applicable off‑label use policy references (CP.CPA.09, HIM.PA.154, CP.PMN.53) as applicable.

Denial Risk

Documentation Insufficiency / Non‑covered Indication

Documentation insufficiency or requests for non‑covered indications may be denied. If the clinical information submitted does not demonstrate that the member meets ALL policy criteria, the request may be pended for additional information or denied.

Denial risk applies to non‑FDA indications not addressed by this policy unless sufficient evidence is provided per off‑label use policies.
Operational note: providers should include clear rationale and supporting data for any off‑label use to avoid delays or denials.

Documentation Required

Provider Attestation for Gender Dysphoria / Transition Requests

For requests related to gender dysphoria or gender transition, the prescribing provider must attest they understand current State regulations regarding transgender‑related health care and confirm that the requested care is a covered benefit under the member's State plan.

Provider attestation must be included with the prior authorization submission for gender dysphoria/gender transition requests.
For HIM/Marketplace/ICHRA lines of business, requests for members residing in states where gender dysphoria/transition treatment is excluded (AL, AZ, AR, FL, GA, IN, IA, KS, KY, LA, MS, MO, NE, NH, NC, OH, OK, SC, TN) may be non‑covered — provider must verify member's state coverage.
Providers may reference the Movement Advancement Project to confirm whether transgender‑related health care is coverable under the member's State regulations.

Billing Rule

Prior Authorization and Coding

Prior authorization submission must include applicable coding information and clinical justification to support medical necessity.

Include HCPCS codes J9225 or J9226 on the PA request as applicable.
Providers should reference up‑to‑date coding guidance; inclusion of a code in this policy does not guarantee coverage.

Note

Provider Operational Responsibilities

Provider action: verify member benefits and state applicability prior to submission to reduce risk of non‑coverage. If the member's state plan excludes transgender‑related services, do not submit PA as a covered benefit without confirmation.

For HIM/Marketplace/ICHRA, confirm member is not in an excluded state before submitting gender dysphoria/gender transition requests.
If unsure, contact the payer's provider services for benefit verification.

Documentation noteRequests must comply with product-specific dosing and coverage criteria (e.g., age, indication) when submitting for authorization

Prior authorization required for implant placement and coding per policy

Histrelin acetate is a GnRH agonist used to suppress puberty or sex-hormone driven processes

LH — definition

TermLH = luteinizing hormone

Diagnostic useMeasured as basal LH or after leuprolide stimulation to confirm central activation of puberty

Thresholds referencedBasal LH > 0.2-0.3 mIU/mL or stimulated LH > 3.3-5 IU/L (assay dependent)

Central precocious puberty — shorthand/term mapping

Shorthand mappingCPP = central precocious puberty

Alternate termsCentral precocious puberty may be abbreviated as CPP in this policy and appendices

Context of useUsed throughout coverage criteria to denote the pediatric indication for Supprelin LA