ModifiedPeach State Health PlanPolicy CP.PHAR.172

Histrelin acetate (Vantas, Supprelin LA) coverage

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Defines medical necessity, prior authorization, and coverage criteria for Vantas and Supprelin LA for Peach State Health Plan members across Commercial, Medicaid, and HIM/ICHRA lines of business.

Policy Summary

PayerPeach State Health Plan

PolicyHistrelin acetate (Vantas, Supprelin LA) coverage

Policy CodePolicy CP.PHAR.172

Change TypeMaterial revisions and clarifications

Effective DateOct 1, 2016

Next Review DateN/A

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) and, for gender dysphoria/transition requests, attest understanding of state regulations to support that the member meets approval criteria.

SourceLink

POLICY UPDATE CHANGES

For gender dysphoria and gender transition, added requirement that provider attest understanding of current State regulations regarding transgender-related health care and that such care is coverable under the State regulations.

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

For gender dysphoria continuation requests, added example of positive response: member continues to meet their individual goals of therapy for gender dysphoria.

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ModifiedPeach State Health PlanPolicy CP.PHAR.172

Histrelin acetate (Vantas, Supprelin LA) coverage

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Sign up for Peach State Health Plan Policy CP.PHAR.172 alerts

Get alerted when Policy CP.PHAR.172 changes without checking for updates manually.

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Defines medical necessity, prior authorization, and coverage criteria for Vantas and Supprelin LA for Peach State Health Plan members across Commercial, Medicaid, and HIM/ICHRA lines of business.

Policy Summary

PayerPeach State Health Plan

PolicyHistrelin acetate (Vantas, Supprelin LA) coverage

Policy CodePolicy CP.PHAR.172

Change TypeMaterial revisions and clarifications

Effective DateOct 1, 2016

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

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

For gender dysphoria continuation requests, added example of positive response: member continues to meet their individual goals of therapy for gender dysphoria.

50 mgmax implant dose /12 mo

6 monthsduration (Commercial)

12 monthsduration (Medicaid/HIM)

F 2–11 / M 2–12CPP age limits

J9225,J9226,J1675HCPCS codes

pregnancy/hypersensitivitycontraindication

Coverage Criteria

Initial Therapy - Prostate Cancer

Covered when ALL of the following are met:

Prostate Cancer (Initial): Diagnosis of prostate cancer; request is for Vantas; prescribed by or in consultation with an oncologist or urologist; age ≥ 18 years; request is for palliative treatment; dose does not exceed 50 mg per 12 months (one implant per year) OR dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence); prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Therapy - Central Precocious Puberty

Covered when ALL of the following are met:

Central Precocious Puberty (Initial): Diagnosis of central precocious puberty (CPP) confirmed by all of: (a) elevated basal LH > 0.2–0.3 mIU/mL and/or elevated leuprolide‑stimulated LH > 3.3–5 IU/L (assay dependent); (b) bone age > chronological age by > 1 year; (c) age at onset of secondary sex characteristics: female < 8 years, male < 9 years; request is for Supprelin LA; prescribed by or in consultation with a pediatric endocrinologist; member age within specified ranges (female 2–11 years; male 2–12 years); dose does not exceed 50 mg per 12 months (one implant per year).

Initial Therapy - Gender Dysphoria / Transition (off-label)

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

Gender Dysphoria / Gender Transition (Initial, off-label): For HIM/ICHRA, member must be in a state where gender dysphoria/transition treatment is a covered benefit (not AL, AZ, AR, FL, GA, IN, IA, KS, KY, LA, MS, MO, NE, NH, NC, OH, OK, SC, TN); diagnosis of gender dysphoria or request is for gender transition; prescribed by or in consultation with both an endocrinologist and a provider with expertise in transgender medicine (certified training program or affiliation with local transgender health services); age and pubertal development criteria met: either member < 18 years and has reached or passed through Tanner Stage 2 (approximate age ranges: girls 8–13 years, boys 9–14 years) OR member ≥ 18 years and has failed to achieve physiologic hormone levels with gender‑affirming hormone therapy unless contraindicated; member demonstrates understanding of expected GnRH analogue treatment outcomes and provides consent; psychiatric comorbidity is managed by a mental health provider if present; psychosocial support will be provided during treatment; provider attests understanding of current State regulations regarding transgender‑related health care and that such care is coverable under the State regulations; dose is within FDA maximum for any FDA‑approved indication or is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence if outside FDA limits).

Off-label — prescriber must submit supporting evidence for regimens outside FDA limits.

Continuation Therapy - Prostate Cancer

Continued therapy covered when ALL of the following are met:

Prostate Cancer (Continued): Member is currently receiving Vantas via Centene benefit or documentation supports current receipt for at least 30 days; request is for Vantas; member is responding positively to therapy; 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.

Continuation Therapy - Central Precocious Puberty

Continued therapy covered when ALL of the following are met:

Central Precocious Puberty (Continued): Member currently receiving medication via Centene benefit or member previously met initial approval criteria (or continuity of care applies); request is for Supprelin LA; member is responding positively to therapy as evidenced by improvement in parameters such as decreased growth velocity, cessation of menses, softening of breast tissue or testes, or arrested pubertal progression; member age at or below thresholds (female ≤ 11 years; male ≤ 12 years); if request is for a dose increase, new dose does not exceed 50 mg per 12 months (one implant per year).

Continuation Therapy - Gender Dysphoria / Transition

Continued therapy covered when ALL of the following are met:

Gender Dysphoria / Gender Transition (Continued): Member currently receiving medication via Centene benefit or previously met initial criteria (or continuity of care applies); member is responding positively to therapy (e.g., continues to meet individual goals of therapy for gender dysphoria); for HIM/ICHRA, member must be in a state where gender dysphoria/transition treatment is a covered benefit (not AL, AZ, AR, FL, GA, IN, IA, KS, KY, LA, MS, MO, NE, NH, NC, OH, OK, SC, TN); if request is for a dose increase, new dose is within FDA maximum for any FDA‑approved indication OR is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).

Off‑label — supporting evidence required for regimens outside FDA maximums.

Other Indications

Other uses (not specifically listed):

Other diagnoses/indications: If the drug has undergone a recent label change (within the last 6 months) not yet reflected in this policy, refer to formulary/no‑coverage or non‑formulary policies as applicable; if the requested use (diagnosis, age, dosing regimen) is not specifically listed under section III and criterion 1 above 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 applicable).

See referenced policies for pathway.

Indication-specific coverage

Covered when ALL of the following are met for the indicated condition

Central precocious puberty (Supprelin LA): Request is for Supprelin LA implant for treatment of central precocious puberty; dosing is 1 × 50 mg subcutaneous implant for 12 months; maximum 1 implant per 12 months.

References: prescribing information and pediatric endocrine guidelines.

Prostate cancer (Vantas): Request is for Vantas implant for prostate cancer and is specifically for palliative treatment to align with the FDA‑approved indication; dosing is 1 × 50 mg subcutaneous implant for 12 months.

Added requirement in 2Q 2024 review.

Gender dysphoria / gender transition (off‑label): Request is for use in gender dysphoria/gender transition consistent with off‑label criteria; provider must attest understanding of State regulations and that care is coverable in the member's state; continuation may be supported by documentation that the member meets individual goals of therapy.

Commercial line of business and state coverage restrictions noted in revisions.

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 policies: CP.CPA.09 (Commercial), HIM.PA.154 (Marketplace/ICHRA), or CP.PMN.53 (Medicaid). Supporting documentation should include pertinent clinical notes, laboratory results, imaging, guideline or peer‑reviewed literature that justify the requested off‑label use.

For requests related to gender dysphoria or gender transition, treatment may be not a covered benefit in certain states. Providers must ensure the member’s state allows coverage for transgender‑related health care; for HIM/ICHRA requests the member must be in a state other than the following list where such 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. The policy also requires the provider to attest that they understand current State regulations and that the requested care is coverable under those regulations. See Appendix D for the Movement Advancement Project link to confirm state‑level coverage status.

Off‑label use of histrelin acetate (for indications outside the FDA‑approved labeling) may be considered when the prescriber submits sufficient supporting evidence. Review follows the referenced off‑label use policies for the member’s line of business; providers should include clinical rationale, relevant literature or guidelines, and supporting documentation when requesting prior authorization for off‑label indications.

This section does not include explicit standalone statements labeling specific uses as “not medically necessary.” Instead, non‑FDA indications lacking sufficient supporting evidence are handled per the off‑label use and no‑coverage policies referenced elsewhere in the document.

Coding

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)

Assay dependency noteThreshold ranges depend on the type of assay used; document lab method and results with prior authorization submission.

Implant dosing interval

Standard intervalOne implant per 12 months (one 50 mg implant provides ~12 months of therapy)

Implant duration noteEach 50 mg subcutaneous implant is intended to provide approximately 12 months of drug exposure per product labeling.

Provider Actions and Documentation

Prior Authorization

Prior authorization required — submit clinical documentation

Prior authorization is required. Provider must submit clinical documentation demonstrating the diagnosis and that all approval criteria are met (for example: for Vantas — prostate cancer diagnosis, oncologist/urologist involvement, age ≥18 years, request for palliative treatment, dose ≤50 mg per 12 months or regimen supported by guidelines/literature; for Supprelin LA — CPP diagnostic confirmation, pediatric endocrinologist involvement, age within specified ranges, dose ≤50 mg per 12 months).

Documentation must show the specific indication requested (Vantas or Supprelin LA) and meet the indication-specific criteria listed in the policy.
If the requested dose is outside the 50 mg per 12 months limit, prescriber must submit supporting practice guideline or peer‑reviewed literature evidence.

Billing Rule

Background

Histrelin acetate is a gonadotropin‑releasing hormone (GnRH) agonist marketed as Vantas and Supprelin LA. Vantas is FDA‑approved for the palliative treatment of advanced prostate cancer, and Supprelin LA is FDA‑approved for the treatment of central precocious puberty (CPP) in children. The products are administered as a subcutaneous implant delivering a 50 mg dose designed to provide approximately one year of therapy per implant; dosing, indication specifics, and contraindications (for example, pregnancy is a contraindication for Supprelin LA and hypersensitivity to GnRH agonists) are detailed in the prescribing information and appendices of this policy.

Definitions

Gonadotropin‑releasing hormone (GnRH) agonist

DefinitionGonadotropin‑releasing hormone (GnRH) agonist: a drug that acts on the pituitary to stimulate and then downregulate gonadotropin release; histrelin acetate is a GnRH agonist.

Class examplesIncludes histrelin acetate formulations (Vantas, Supprelin LA), which are GnRH agonists used in prostate cancer and central precocious puberty respectively.

Clinical roleUsed to suppress gonadotropin secretion for indications such as central precocious puberty and palliative treatment of advanced prostate cancer.

CPP (abbreviation)

AbbreviationCPP = central precocious puberty

ContextUsed throughout the policy to denote the pediatric diagnosis for which Supprelin LA is indicated.

Initial Therapy Criteria

Initial therapy nodes

Initial therapy requests must meet the following top-level conditions:

Diagnosis confirmation: Documentation must confirm the diagnosis specific to the requested indication (prostate cancer, CPP, or gender dysphoria/transition) per the criteria in the indication‑specific sections.

Provider must submit supporting clinical documentation such as office notes and relevant laboratory or imaging results.

Specialist involvement: Prescription must be by or in consultation with the specialist appropriate to the indication: oncologist or urologist for prostate cancer; pediatric endocrinologist for CPP; endocrinologist and a provider with expertise in transgender medicine for gender dysphoria/transition.

Provider attestation of expertise or consultation documentation may be required.

Age and development criteria: Member must meet the age and pubertal development requirements specific to the indication: prostate cancer age ≥ 18; CPP age ranges female 2–11, male 2–12 with diagnostic thresholds as specified; gender dysphoria criteria per Tanner stage or adult treatment failure as detailed in the off‑label criteria.

Continuation Therapy Criteria

Continuation therapy nodes

Criteria for continued therapy differ by indication and require evidence of positive response and adherence to dose limits or guideline‑supported dosing:

Prostate Cancer continuation nodes: Member is currently receiving Vantas via benefit or has documentation of at least 30 days of therapy; member is responding positively to therapy; dose increases must not exceed 50 mg per 12 months unless supported by guidelines or literature (prescriber must submit evidence).

Prescribed regimen must be FDA‑approved or recommended by NCCN.

CPP continuation nodes: Member is currently receiving Supprelin LA via benefit or previously met initial criteria; member is responding positively to therapy as shown by decreased growth velocity, cessation of menses, softening of breast tissue or testes, or arrested pubertal progression; age limits continue to apply; dose increases must not exceed 50 mg per 12 months.

Gender dysphoria continuation nodes: Member is currently receiving therapy via benefit or previously met initial criteria (or continuity of care applies); member is responding positively to therapy; for HIM/ICHRA, member must be in a state where such care is covered; dose increases must be within FDA maximums or supported by guidelines/literature (prescriber must submit supporting evidence).

Step Therapy

Step therapy instruction
If the requested use is not listed in this policy because of a recent label change (within the last 6 months) or the use is not specified under section III, refer to the applicable formulary/no-coverage or non‑formulary policies for the relevant line of business before approval (see policy CP.CPA.190, HIM.PA.33, CP.PMN.255 for formulary/no-coverage and CP.CPA.190, HIM.PA.103, CP.PMN.16 for non‑formulary pathways).

Step therapy instruction

If the requested use is not listed in this policy because of a recent label change (within the last 6 months) or the use is not specified under section III, refer to the applicable formulary/no-coverage or non‑formulary policies for the relevant line of business before approval (see policy CP.CPA.190, HIM.PA.33, CP.PMN.255 for formulary/no-coverage and CP.CPA.190, HIM.PA.103, CP.PMN.16 for non‑formulary pathways).

Step therapy summary
No step therapy sequence is specified in this policy; instead prior authorization and indication-specific requirements (including documentation of diagnosis, specialist involvement, age and dosing limits) apply as the approval pathway.

Quantity Limits

Histrelin acetate (implant) — implant strength

Maximum implant strength50 mg per implant (maximum standard strength for histrelin acetate implant)

Duration per implantEach 50 mg implant is intended to provide therapy for approximately 12 months per product labeling.

Products50 mg implant strength applies to both Supprelin LA and Vantas formulations as represented in the dosing table.

Histrelin acetate implant — quantity limit

Quantity limitLimit of 1 implant per 12 months (one 50 mg implant per year)

Billing/coding implicationAuthorizations and claims should reflect one 50 mg implant every 12 months unless prescriber provides guideline‑supported evidence for alternate dosing.

Site of Care

Note

Office placement of subcutaneous implant (site of care)

Subcutaneous implant placement is described; the policy specifies placement of one 50 mg SC implant per 12 months and notes the setting as office for implant placement.

Implant: 1 x 50 mg subcutaneous implant for 12 months
Site/setting noted as: office

Revision History

2026-03-26annual_reviewLatest

2Q 2026 annual review: no significant changes; references reviewed and updated; added HIM requirement noting states where gender dysphoria/transition treatment is not a covered benefit per Marketplace/ICHRA rule.

2025-02-12policy_change

Added requirement that provider attest understanding of current State regulations regarding transgender-related health care and that such care is coverable under State regulations; added Movement Advancement Project link notation in Appendix D.

2025-05-25

Policy Summary

PayerPeach State Health Plan

PolicyHistrelin acetate (Vantas, Supprelin LA) coverage

Policy CodePolicy CP.PHAR.172

Change TypeMaterial revisions and clarifications

Effective DateOct 1, 2016

Next Review DateN/A

SourceLink

On This Page

Quantity implicationAuthorization and billing should reflect a single implant per 12‑month period unless guideline-supported evidence for alternate dosing is provided.

Prior authorization linked to HCPCS coding for histrelin implants

Prior authorization is required for histrelin acetate implants and providers should bill using the referenced HCPCS codes; documentation must support the indicated product and dosing (one 50 mg implant per 12 months).

J9225 — Histrelin implant (Vantas), 50 mg
J9226 — Histrelin implant (Supprelin LA), 50 mg
J1675 — Injection, histrelin acetate, 10 micrograms (listed in coding table)

Note

Refer to formulary / non‑coverage policies for new indications

If a requested use is not specified in this policy and the drug had a recent label change, providers must check formulary/no‑coverage or non‑formulary policies for the relevant line of business before seeking approval.

Follow the no coverage criteria or non‑formulary policy referenced in the policy (e.g., CP.CPA.190, HIM.PA.33, CP.PMN.255) as applicable.

Documentation Required

Required documentation to accompany prior authorization

Submit supporting clinical documentation with the prior authorization request. Examples include office chart notes, laboratory results, and other clinical information that demonstrate the member meets all approval criteria.

For CPP: basal LH and/or stimulated LH results, bone age reports, documentation of age at onset of secondary sex characteristics.
For prostate cancer: oncology/urology consult notes indicating palliative intent.
For off‑label uses: supporting literature or guideline citations when dosing/regimen is outside FDA limits.

Documentation Required

Provider attestation required for gender dysphoria / transition requests

For requests for gender dysphoria or gender transition treatment, the provider must attest they understand current State regulations regarding transgender‑related health care and that such care is coverable under those State regulations.

The policy adds a required provider attestation and references tools (e.g., Movement Advancement Project) to confirm state coverage status.

Denial Risk

Denial risk: insufficient documentation or unsupported off‑label use

Requests lacking supporting documentation or seeking non‑FDA (off‑label) uses without sufficient evidence may be denied.

Insufficient office notes, labs, or other clinical information to show approval criteria are met is grounds for denial.
Non‑FDA indications not supported per off‑label use policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53) may be denied.

Denial Risk

Denial risk: state coverage restriction for gender dysphoria/transition

Requests for gender dysphoria or gender transition treatment may be denied if the provider does not attest the member is in a state where such treatment is a covered benefit; the policy lists specific states where it is not covered.

States listed as not covered include: AL, AZ, AR, FL, GA, IN, IA, KS, KY, LA, MS, MO, NE, NH, NC, OH, OK, SC, and TN.
For HIM/ICHRA, requests must be for members in states other than these listed non‑coverage states.

Appendix referenceListed in Appendix A: Abbreviation/Acronym Key.

Central precocious puberty (synonym)

Synonymcentral precocious puberty (CPP)

Diagnostic criteria linkCPP diagnosis in this policy is confirmed by basal and/or leuprolide‑stimulated LH thresholds, advanced bone age, and age of secondary sex characteristic onset.

Typical age criteriaPolicy references female onset <8 years and male onset <9 years as part of CPP diagnostic criteria.

Gonadotropin‑releasing hormone (GnRH)

Short definitionGonadotropin‑releasing hormone (GnRH): the hypothalamic peptide that stimulates pituitary LH and FSH release; 'GnRH' is used as the abbreviation in this policy.

Usage in policy'GnRH' appears in appendices and definitions to describe the drug class (GnRH agonist) and related terminology.

RelevanceGnRH and GnRH agonists are central to the mechanism of action for histrelin acetate products described in this policy.

See indication sections for assay‑dependent LH thresholds and Tanner stage approximations.

Dosing limits: Initial dosing must align with product labeling: typically 1 × 50 mg subcutaneous implant per 12 months; requests exceeding 50 mg/12 months require guideline or literature support (prescriber to submit evidence).

See Appendix D dosing table and coding for implant strength and interval.

Initial therapy dosing

Initial dosing regimen per product labeling:

Supprelin LA initial dosing: One 50 mg subcutaneous implant, effective for approximately 12 months (≈65 mcg/day over 12 months).1 implant per 12 months

For CPP treatment; see prescribing information.

Vantas initial dosing: One 50 mg subcutaneous implant, effective for approximately 12 months (≈50 mcg/day over 12 months).1 implant per 12 months

For palliative treatment of advanced prostate cancer; see prescribing information.

Continuation: gender dysphoria/transition

Continuation requests for gender dysphoria and gender transition:

Examples of positive response: Member continues to meet their individual goals of therapy for gender dysphoria.

Added as an example of acceptable documentation for continuation.

Applies toThis quantity limit applies to histrelin acetate implants (Supprelin LA and Vantas) per policy dosing and quantity limits.

2Q 2025 annual review: no significant changes; added example for gender dysphoria continuation that member continues to meet individual goals of therapy; references reviewed and updated.

2016-10-01effective_date

Policy effective date recorded as 2016-10-01.

2026-02-24policy_change

As a result of the Marketplace/ICHRA Integrity and Affordability rule, added HIM requirement that requests for gender dysphoria/gender transition be for members in states where such treatment is a covered benefit and listed states where it is not covered.