CurrentCentenePolicy CP.PHAR.172

Histrelin acetate (Vantas, Supprelin LA)

Defines Centene medical necessity criteria for coverage of histrelin acetate implants (Vantas for prostate cancer and Supprelin LA for central precocious puberty), plus off-label coverage criteria for gender dysphoria/gender transition and guidance for other indications; includes dosing limits and approval durations by line of business.

Policy Summary

PayerCentene

PolicyHistrelin acetate (Vantas, Supprelin LA)

Policy CodePolicy CP.PHAR.172

Change TypeAnnual reviews and line-of-business/criteria updates (added ICHRAoff-label/gender dysphoria criteria updated)

Effective Date10.01.16

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added ICHRA line of business.

For gender dysphoria and gender transition, added requirement that HIM requests be for members in states where such care is coverable; listed excluded states.

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

Corrected units for basal luteinizing hormone level to mIU/mL.

Added off-label use criteria for gender dysphoria or gender transition and requirement for provider attestation regarding state regulations.

2FDA‑approved indications covered (Vantas, Supprelin LA)

1Off‑label indication with criteria (gender dysphoria)

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50 mg/12 moMaximum implant dose limit

AL, AZ, AR, FL, GA, IN, IA, KS, KY, LA, MS, MO, NE, NH, NC, OH, OK, SC, TNStates where HIM/ICHRA gender care not covered

Coverage Summary

This policy defines medical necessity criteria for histrelin acetate implants (yearly subcutaneous 50 mg implants). It covers Vantas for the palliative treatment of advanced prostate cancer and Supprelin LA for the treatment of central precocious puberty (CPP), and includes defined off-label coverage criteria for gender dysphoria / gender transition. The policy aligns dosing to one 50 mg implant per 12 months (maximum 50 mg per 12 months) and references applicable regulatory and clinical guidance including the FDA prescribing information, NCCN prostate cancer guidance, and specialty society and practice guidelines for pediatric and transgender care.

Quick facts and thresholds

Maximum implant dose limit50 mg per 12 months (one implant per year)

FDA‑approved indications covered2 (Vantas for palliative advanced prostate cancer; Supprelin LA for central precocious puberty)

Off‑label indication with criteriaGender dysphoria / gender transition — coverage allowed with specified prescriber requirements, patient criteria, state attestation, and dose within FDA limit or supported by guidelines

States excluded for HIM/ICHRAAL, AZ, AR, FL, GA, IN, IA, KS, KY, LA, MS, MO, NE, NH, NC, OH, OK, SC, TN

Product formatYearly subcutaneous implant, 50 mg (approx. 50–65 mcg/day over 12 months)

Initial Therapy Criteria

Initial Approval Criteria

Provider must submit documentation supporting that member has met all approval criteria. Coverage when ALL of the following for each indication are met:

Prostate Cancer (Vantas)

Prostate Cancer (Vantas): Diagnosis of prostate cancer
Request is for Vantas
Prescriber: Prescribed by or in consultation with an oncologist or urologist
Age ≥ 18 years

Continuation Therapy Criteria

Continued Therapy Criteria

Coverage for continuation when ALL of following for each indication are met:

Gender Dysphoria / Gender Transition (off-label) continued

Continuation eligibility: Currently receiving medication via Centene benefit or member has previously met initial approval criteria; OR member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state-specific addendums CC.PHARM.03A and CC.PHARM.03B)
Response: Member is responding positively to therapy (e.g., member continues to meet their individual goals of therapy for gender dysphoria)
HIM/ICHRA state requirement: For HIM/ICHRA, request is for a member in a state other than: AL, AZ, AR, FL, GA, IN, IA, KS, KY, LA, MS, MO, NE, NH, NC, OH, OK, SC, and TN

Diagnoses/Indications Not Authorized

Coverage NOT authorized when:

Non-covered: Non-FDA approved indications not addressed in this policy unless sufficient documentation of efficacy and safety per off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents

Applicable Codes

HCPCS codes (informational)HCPCS

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

Provider Actions & Prior Authorization Requirements

Documentation Required

Provider attestation for gender dysphoria

For gender dysphoria or gender transition requests, the provider must attest they understand current State regulations regarding transgender-related health care and that such care is coverable under those State regulations. This attestation requirement applies to HIM and ICHRA requests and the policy lists excluded states where coverage is not a benefit for HIM/ICHRA.

Attestation of understanding current State regulations and that care is coverable
Applies to HIM/ICHRA requests; excluded states are listed in the policy

Prior Authorization

Prescriber specialty requirements

Prescriptions for each indication must come from or be in consultation with the specialists specified: oncologist or urologist for Vantas (prostate cancer); pediatric endocrinologist for Supprelin LA (CPP); and for gender dysphoria/gender transition, an endocrinologist plus a provider with certified transgender expertise or affiliation with local transgender health services.

Clinical Evidence & References

Key references include the Vantas and Supprelin LA Prescribing Information (September 2025), NCCN Prostate Cancer Version 5.2026, and key pediatric and transgender care literature and trials (for example, the phase 3 multicenter trial reported in J Clin Endocrinol Metab 2015 on once-yearly histrelin implants). Relevant society guidelines for transgender and pediatric endocrine care are also referenced.

Background

Histrelin acetate is a gonadotropin-releasing hormone (GnRH) agonist available as a yearly subcutaneous implant formulation (one 50 mg implant providing continuous release over 12 months). Both Vantas and Supprelin LA are supplied as a single 50 mg implant intended for approximately 12 months of therapy. 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. The policy dosing schedule—one 50 mg implant per 12 months—and labeled uses align with the FDA prescribing information and are applied consistent with NCCN and specialty society guidance referenced in the policy.

Definitions

CPPCentral precocious puberty

LHLuteinizing hormone

NCCNNational Comprehensive Cancer Network

Revision History

02.16.23added

Added Commercial line of business and off-label use criteria for gender dysphoria/gender transition; provider attestation requirement for state regulations included.

01.09.24material_revised

2Q 2024 annual review: For prostate cancer, added requirement that requests be for palliative treatment to align with the FDA-approved indication.

02.12.25added

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

Policy Summary

PayerCentene

PolicyHistrelin acetate (Vantas, Supprelin LA)

Policy CodePolicy CP.PHAR.172

Change TypeAnnual reviews and line-of-business/criteria updates (added ICHRAoff-label/gender dysphoria criteria updated)

Effective Date10.01.16

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

SourceLink

On This Page

Intent: Request is for palliative treatment

Dose requirement

Dose does not exceed limit: Dose does not exceed 50 mg per 12 months (one implant per year)50 mg per 12 months
Off-label dose support: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Regimen requirement: Prescribed regimen must be FDA-approved or recommended by NCCN

Prior Authorization

Prescriber specialty requirements

Prescriptions must come from the specialists listed for each indication: Vantas (prostate cancer) must be prescribed by or in consultation with an oncologist or urologist; Supprelin LA (central precocious puberty) must be prescribed by or in consultation with a pediatric endocrinologist; requests for gender dysphoria/gender transition must be prescribed by or in consultation with an endocrinologist and a provider with expertise in gender dysphoria/transgender medicine.

Documentation Required

Submit supporting documentation

Include clinical documentation with the prior authorization request to show criteria are met. Acceptable supporting documentation includes office chart notes, lab results (e.g., basal LH, leuprolide-stimulated LH, bone age), and other clinical information demonstrating diagnosis, age/pubertal status, treatment intent, and response.

Office chart notes
Laboratory results (basal LH, stimulated LH)
Bone age assessment
Other clinical information demonstrating diagnosis/response

Dose increase requirement (gender dysphoria): 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)Maximum dose per 12 months: 50 mg per 12 months (one implant per year)

Billing Rule

Dose limit per year

Dose is limited to one 50 mg implant per 12 months (50 mg/12 months). Requests exceeding this must be supported by practice guidelines or peer‑reviewed literature and the prescriber must submit supporting evidence.

J9225
J9226

Denial Risk

State Medicaid precedence

For Medicaid members, state Medicaid coverage provisions override this clinical policy. If state provisions conflict with the policy, the state rules may result in noncoverage of a request.

See state-specific continuity of care addendums CC.PHARM.03A and CC.PHARM.03B

Providers must submit supporting documentation such as office chart notes, laboratory results, or other clinical information to demonstrate that the member meets all approval criteria. Requests for off-label indications or for doses beyond the standard 50 mg per 12 months limit require the prescriber to submit supporting peer-reviewed literature or practice guideline evidence. Refer to the off-label and continuity policies as applicable: CP.CPA.09, HIM.PA.154, and state-specific continuity addendums (CC.PHARM.03A and CC.PHARM.03B) where noted.

02.24.26material_added

As a result of the Marketplace/ICHRA Integrity and Affordability rule, added requirement that HIM/ICHRA requests for gender dysphoria/gender transition be for members in states where such care is coverable and listed excluded states (AL, AZ, AR, FL, GA, IN, IA, KS, KY, LA, MS, MO, NE, NH, NC, OH, OK, SC, TN).

03.26.26addedLatest

2Q 2026 annual review: references reviewed and updated; added ICHRA line of business.

clarified

Corrected units for basal luteinizing hormone (LH) level to mIU/mL.