CurrentmhnPolicy CP.PHAR.172

Histrelin Acetate (Vantas, Supprelin LA)

Defines medical necessity criteria, initial and continued therapy requirements, covered indications (prostate cancer palliative, central precocious puberty, and select off-label gender dysphoria/gender transition), dosing limits (one 50 mg implant per 12 months), provider documentation requirements, approval durations by line of business, and related billing HCPCS/J-codes.

Policy Summary

Payermhn

PolicyHistrelin Acetate (Vantas, Supprelin LA)

Policy CodePolicy CP.PHAR.172

Change TypeMultiple updates (added Commercial LOB, off‑label criteria, state exclusions, provider attestation)

Effective DateOct 1, 2016

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; added off-label use criteria for gender dysphoria or gender transition.

For prostate cancer, added requirement that request is for palliative treatment to align with FDA indication; corrected units for basal LH to mIU/mL.

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

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

For HIM, added state exclusions list where gender dysphoria and gender transition treatment is not covered (Marketplace Integrity and Affordability rule).

3Primary Covered Indications (Prostate cancer, CPP, Gender dysphoria/transition)

50 mg/12 monthsMaximum implant dose per year

Relevant HCPCS J-codes

AL,AZ,AR,FL,GA,IN,IA,KS,KY,LA,MS,MO,NE,NH,NC,OH,OK,SC,TNStates excluding gender transition coverage for HIM

Coverage Summary & Scope

Scope: Defines medical necessity criteria for Vantas and Supprelin LA including initial and continued therapy requirements and covered indications: prostate cancer (palliative), central precocious puberty (CPP), and select off-label gender dysphoria/gender transition. Policy includes provider documentation and specialty requirements, approval durations by line of business, and HCPCS/J-code references.

Coverage stance: covered_with_criteria (coverage with specified clinical criteria and documentation requirements).

Dates: Effective 10.01.16; Last review/last_review date: 05.25. Material changes documented 02.16.23, 01.09.24, 02.12.25, and 02.24.26 with P&T approvals noted in the revision history.

Thresholds / Policy

Policy numberCP.PHAR.172

StatusCURRENT

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

Leuprolide-stimulated LH level> 3.3 - 5 IU/L (dependent on assay)

Bone age difference> 1 year (bone age - chronological age)

Maximum dosing50 mg per 12 months (one implant per year)

Initial Therapy Criteria

Continuation Therapy Criteria

Provider Actions & Prior Authorization Requirements

Documentation Required

Submit supporting documentation

Provider must submit supporting documentation to demonstrate the member meets all approval criteria. Acceptable documentation includes office chart notes, laboratory results, or other clinical information.

Prior Authorization

Prescriber specialty requirements

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

Prostate cancer (Vantas): oncologist or urologist
Central precocious puberty (Supprelin LA): pediatric endocrinologist

Applicable Codes

HCPCS J-codes for histrelinHCPCSCovered

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

Clinical Evidence & Dosing Information

50 mgMax implant dose per 12 months (one implant/year)

Supprelin: 1Supprelin LA dosing: 1 implant (50 mg) SC for 12 months (~65 mcg/day)

Vantas: 1Vantas dosing: 1 implant (50 mg) SC for 12 months (~50 mcg/day)

Clinical/evidence notes: Policy aligns Vantas and Supprelin LA coverage to FDA-approved indications (Vantas for palliative treatment of advanced prostate cancer; Supprelin LA for CPP) and requires that prescribed regimens be FDA‑approved or recommended by NCCN where applicable.

Off-label use: Off-label uses (including gender dysphoria/gender transition) require the prescriber to submit supporting practice guideline or peer-reviewed literature evidence to justify dosing beyond standard limits or non‑FDA uses.

Dosing context: The standard implant dosing is one 50 mg implant per 12 months (annual implant); implant frequency is one implant for 12 months as described in the product dosing information.

Background & Definitions

Background: Histrelin acetate (Vantas and Supprelin LA) is a gonadotropin-releasing hormone (GnRH) agonist available as a yearly 50 mg subcutaneous implant. Vantas is marketed for prostate cancer (palliative) and Supprelin LA for central precocious puberty (CPP).

Policy alignment: Coverage aligns indications with FDA approvals and references NCCN recommendations for prescribing regimens when applicable.

Gender dysphoria note: The policy includes off-label criteria for gender dysphoria/gender transition that require provider attestation of understanding current State regulations; for HIM line of business, state-specific exclusions apply per the listed states and the Movement Advancement Project is referenced for state coverage determinations.

CPP: central precocious puberty — early onset of puberty requiring evaluation and treatment to halt or reverse premature pubertal progression.

GnRH: gonadotropin-releasing hormone — the hypothalamic decapeptide that stimulates pituitary release of gonadotropins.

LH: luteinizing hormone — pituitary hormone measured (basal or stimulated) as part of CPP diagnostic evaluation.

NCCN: National Comprehensive Cancer Network — guideline resource referenced for recommended regimens in FDA‑approved indications (e.g., prostate cancer).

Revision History

02.16.23material_addition

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

05.23P&T_approval

P&T approval for changes added 02.16.23 (Commercial line of business and off‑label gender dysphoria/gender transition criteria).

01.09.24material_revision

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

Appendices & External References

Referenced policies and appendices for criteria cross-reference and coverage determinations:

CP.CPA.190

HIM.PA.33

CP.PMN.255

HIM.PA.103

CP.PMN.16

CP.CPA.09

HIM.PA.154

CP.PMN.53

CC.PHARM.03A

CC.PHARM.03B

Appendix D (transgender care resources) and the Movement Advancement Project for state-level coverage determination reference.

Policy Summary

Payermhn

PolicyHistrelin Acetate (Vantas, Supprelin LA)

Policy CodePolicy CP.PHAR.172

Change TypeMultiple updates (added Commercial LOB, off‑label criteria, state exclusions, provider attestation)

Effective DateOct 1, 2016

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

Gender dysphoria/gender transition: endocrinologist + provider with expertise in transgender medicine

Prior Authorization

Dose supporting evidence for off-label uses

If the dose exceeds the standard 50 mg per 12 months (one implant per year) or the use is an off-label indication supported by literature, the prescriber must submit supporting practice guidelines or peer-reviewed literature to justify the dose or off-label use.

Standard maximum: 50 mg per 12 months (one implant per year)
Prescriber must submit supporting evidence for doses above 50 mg/12 months or for off-label uses

Documentation Required

Provider attestation for gender dysphoria

For gender dysphoria/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. The Movement Advancement Project is referenced as a resource to confirm state-level coverage status.

Documentation Required

Continuity of care

For continued therapy requests, document that the member is currently receiving the medication via the Centene benefit or has previously met initial approval criteria. If continuity-of-care regulations apply, follow the applicable state addendums (CC.PHARM.03A and CC.PHARM.03B).

05.24P&T_approval

P&T approval for 01.09.24 revisions (prostate cancer palliative requirement; basal LH units correction).

02.12.25material_addition

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

05.25P&T_approval

P&T approval recorded for 2Q 2025 annual review (clarification example added for gender dysphoria/gender transition continuation requests).

02.24.26material_additionLatest

For HIM, added state exclusions list 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, and TN) per Marketplace Integrity and Affordability rule.