CurrentCentenePolicy CP.PHAR.172

Histrelin acetate (Vantas, Supprelin LA) coverage policy

Defines medical necessity criteria, approval durations, and coding implications for histrelin acetate implants (Vantas and Supprelin LA) across Commercial, Medicaid, and HIM medical benefit lines of business, including FDA-approved uses (prostate cancer, central precocious puberty) and specified off-label use for gender dysphoria/gender transition.

Policy Summary

PayerCentene

PolicyHistrelin acetate (Vantas, Supprelin LA) coverage policy

Policy CodePolicy CP.PHAR.172

Change TypeMaterial updates to off-label gender dysphoria criteria and prostate cancer alignment

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.

POLICY UPDATE CHANGES

Added Commercial line of business and off-label use criteria for gender dysphoria or gender transition.

For prostate cancer, added requirement that request is for palliative treatment to align with the FDA-approved indication; corrected units for basal luteinizing hormone level to mIU/mL.

For gender dysphoria and gender transition, added requirement for provider attestation of understanding current State regulations and added Appendix D link and Movement Advancement Project reference.

For gender dysphoria and gender transition, added requirement for HIM that request be for a member in a state other than listed excluded states per Marketplace Integrity and Affordability rule.

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

2FDA-approved indications (Vantas, Supprelin LA)

1Off-label covered indication (gender dysphoria/transition)

50 mgMax implant dose per 12 months

J9225,J9226,J1675Key HCPCS codes referenced

Coverage Summary

Scope: This policy (Reference Number CP.PHAR.172; status: CURRENT) defines medical necessity criteria, approval durations, and coding implications for yearly histrelin acetate implants (Vantas and Supprelin LA) across Commercial, Medicaid, and HIM medical benefit lines of business. Coverage stance: covered with criteria.

Covered FDA-approved indications: Vantas for the palliative treatment of advanced prostate cancer and Supprelin LA for treatment of children with central precocious puberty (CPP).

Specified covered off-label use: gender dysphoria / gender transition is a covered off-label indication when all policy criteria are met, with line-of-business nuances (Commercial, Medicaid, and HIM) including state-specific exclusions and HIM-specific requirements.

Key thresholds & quick facts

Maximum implant dose per 12 months≤ 50 mg (one 50 mg implant per year)

Basal LH threshold> 0.2 - 0.3 mIU/mL (assay-dependent)

Leuprolide‑stimulated LH threshold> 3.3 - 5 IU/L (assay-dependent)

Bone age difference threshold> 1 year (bone age − chronological age)

Implant dosing frequencyOne implant (50 mg) SC per 12 months; Supprelin LA and Vantas both described as 1 implant/12 months

FDA-approved indications count2 (Vantas for palliative advanced prostate cancer; Supprelin LA for central precocious puberty)

Specified off-label covered indication1 (gender dysphoria / gender transition — covered with criteria)

Initial Therapy Criteria

I. Initial Approval Criteria - Prostate Cancer

Covered when ALL of the following are met:

ALL of the following

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

Continuation Therapy Criteria

Diagnoses / Indications Not Authorized

Applicable Codes

HCPCS - Histrelin implants and injectionHCPCSCovered

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

Provider Actions & Prior Authorization

Prior Authorization

Prescriber specialty requirements

Prescriber specialty requirements: Prior authorization requests must be submitted by or in consultation with the specified specialist for the requested indication.

Oncologist or urologist — required for Vantas (prostate cancer).
Pediatric endocrinologist — required for Supprelin LA (central precocious puberty).
Endocrinologist and a provider with certified expertise in transgender care (e.g., WPATH GEI or ITCA certification or affiliation with local transgender health services) — required for gender dysphoria / gender transition requests.

Documentation Required

Support clinical criteria with documentation

Support clinical criteria with documentation: Providers must submit documentary evidence that the member meets all applicable approval criteria.

Clinical Evidence & References

Evidence/references cited in the policy include the Vantas Prescribing Information (FDA label, Feb 2022), the Supprelin LA Prescribing Information (Apr 2022), and the NCCN Prostate Cancer guideline (Version 1.2025).

Numeric/assay thresholds and dosing details

Basal LH (additional detail)> 0.2 - 0.3 mIU/mL; units corrected to mIU/mL per 2Q2024 review

Leuprolide‑stimulated LH (additional detail)> 3.3 - 5 IU/L (assay-dependent as stated in CPP criteria)

Bone age difference (trial/diagnostic threshold)> 1 year (bone age − chronological age) required to confirm CPP

Implant dosing frequency / product dosingSupprelin LA and Vantas: 1 implant (50 mg) subcutaneous providing ~50–65 mcg/day over 12 months; maximum 1 implant per 12 months

Background

Background: Histrelin acetate is a GnRH (gonadotropin-releasing hormone) agonist available as once-yearly subcutaneous implants. Product examples referenced in the policy are Vantas (palliative treatment for advanced prostate cancer) and Supprelin LA (treatment for central precocious puberty).

Mechanism overview: as a GnRH agonist, histrelin acetate produces suppression of gonadotropin secretion when administered continuously, consistent with the class designation in the policy.

Policy alignment and off-label use: the policy aligns coverage to FDA-approved indications and explicitly specifies conditions and documentation required for the covered off-label use of gender dysphoria/gender transition, including required prescriber specialties (e.g., oncologist/urologist for Vantas; pediatric endocrinologist for Supprelin LA; endocrinologist and provider with transgender-care expertise for gender dysphoria) and state-specific HIM requirements (provider attestation that care is coverable in the member's state and exclusion of listed states).

Dosage note: implant dosing is specified as one 50 mg implant per 12 months for both Vantas and Supprelin LA.

Glossary: CPP = central precocious puberty; GnRH = gonadotropin-releasing hormone; NCCN = National Comprehensive Cancer Network; HIM = Health Insurance Marketplace / HIM-Medical Benefit line of business.

Revision History

02.16.23added

Added Commercial line of business and off-label use criteria for gender dysphoria or gender transition. P&T approval date 05.23.

01.09.24revised

2Q 2024 annual review: For prostate cancer, added requirement that request is for palliative treatment to align with the FDA-approved indication; corrected units for basal luteinizing hormone level to mIU/mL. P&T approval date 05.24.

02.12.25added

For gender dysphoria and gender transition, added requirement for provider attestation of understanding current State regulations and added Appendix D link and Movement Advancement Project reference.

Policy Summary

PayerCentene

PolicyHistrelin acetate (Vantas, Supprelin LA) coverage policy

Policy CodePolicy CP.PHAR.172

Change TypeMaterial updates to off-label gender dysphoria criteria and prostate cancer alignment

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.

On This Page

Dose does not exceed 50 mg per 12 months (one implant per year)
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

Office chart notes documenting diagnosis, clinical history, and treatment plan.
Relevant laboratory results (e.g., basal or leuprolide-stimulated LH for CPP) and imaging or bone age assessments where applicable.
Records of prior therapies, consultations, and any multidisciplinary evaluations (e.g., mental health or transgender care team notes).
Other clinical information as needed to demonstrate the member meets the specific criteria for the requested indication.

Documentation Required

Evidence required for off-label dosing

Evidence required for off-label dosing: When requested dosing exceeds the standard implant limit or is otherwise off-label, prescribers must provide supporting evidence.

If dose exceeds 50 mg per 12 months (one implant per year) or is outside FDA-approved limits, submit a relevant practice guideline or peer-reviewed literature supporting the dosing regimen.
Clearly state the clinical rationale and reference(s) that justify the higher or off-label dose for the member's condition.
Failure to provide supportive guideline or literature may result in denial or delay of prior authorization.

Documentation Required

Document clinical response for continuation

Document clinical response for continuation: For continuation requests, provide objective evidence the member is responding to therapy.

For CPP: evidence such as decreased growth velocity, arrested pubertal progression, softening of breast tissue or testes, or normalization of LH/hormone measures.
For prostate cancer: documentation of palliative benefit per treating oncologist/urologist, clinical notes supporting symptom control or other markers of response.
For gender dysphoria/gender transition: documentation that member is meeting individual treatment goals and responding to therapy (e.g., achievement of target physiologic hormone levels when applicable, stabilization toward gender-affirming goals).
When psychiatric comorbidity exists, documentation of ongoing follow-up with mental health provider and provision of psychosocial support.
If request is for dose increase, include evidence supporting need and any supporting literature if dose exceeds standard limits.

Prior Authorization

State coverage attestation & provider attestation for HIM gender dysphoria requests

State coverage attestation & provider attestation for HIM gender dysphoria requests: Additional attestations are required for HIM line-of-business requests for gender dysphoria / gender transition.

Provider must attest the member is located in a state where gender dysphoria and gender transition treatment is a covered benefit. Requests for HIM must NOT be for members in the following excluded states: AL, AZ, AR, FL, GA, IN, IA, KS, KY, LA, MS, MO, NE, NH, NC, OH, OK, SC, and TN.
Provider must attest they understand current state regulations regarding transgender-related health care and that the requested care is coverable under those state regulations (see Appendix D and Movement Advancement Project/state references).
For HIM requests, include the required specialist attestations (endocrinologist and certified transgender-care provider) and any supporting documentation demonstrating provider qualifications (e.g., certification or affiliation).
Failure to provide the state coverage attestation or provider attestation of state regulations may result in denial for HIM members.

02.12.25clarified

2Q 2025 annual review: For gender dysphoria continuation requests, added example of positive response: member continues to meet their individual goals of therapy for gender dysphoria. (Non-material change.)

02.24.26addedLatest

For gender dysphoria and gender transition, as a result of the Marketplace Integrity and Affordability rule, added requirement for HIM that request is for a member in a state other than the listed excluded states where such treatment is not a covered benefit.