ModifiedCignaPolicy IP0620

Gonadotropin-Releasing Hormone Agonists - Implants for Non-Oncology Indications

Defines medical necessity, dosing, and coverage criteria for histrelin (Supprelin LA) and goserelin (Zoladex) subcutaneous implants when used for non-oncology indications under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyGonadotropin-Releasing Hormone Agonists - Implants for Non-Oncology Indications

Policy CodePolicy IP0620

Change TypeMaterial clinical and coverage updates (criteria removed/added, preferred product rules, dosing additions)

Effective DateJun 1, 2026

Next Review Date

Key ActionObtain prior authorization and ensure specialist prescription/consultation and applicable preferred-product or step-therapy trials are documented when requesting coverage for Supprelin LA or Zoladex.

SourceLink

POLICY UPDATE CHANGES

Removed histrelin acetate medical necessity criteria which defines for use relating to Central Precocious Puberty (onset of secondary sexual characteristics).

Added preferred product requirement criteria for patients with central precocious puberty for employer plans and individual and family plans.

Removed 'Patient is < 2 years of age' from Supprelin LA Central Precocious Puberty Preferred Product Table.

Added dosing guidance for gender‑dysphoric/gender‑incongruent persons and persons undergoing gender reassignment for both Supprelin LA and Zoladex.

Added dosing and supportive evidence for preservation of ovarian function/fertility in patients undergoing chemotherapy and for uterine bleeding/menstrual suppression in patients with hematologic malignancy or prior to bone marrow/stem cell transplantation.

2brand implants covered

1 year

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.

Supprelin LA approval

6 monthsZoladex approval (endometriosis)

J9202,J9226HCPCS codes

2026-06-01Policy effective

Coverage Criteria for GnRH Agonist Implants

Supprelin LA - Central Precocious Puberty (CPP)

Supprelin LA - Central Precocious Puberty (CPP) — Covered when ALL of the following are met:

Patient has a diagnosis of central precocious puberty (onset of secondary sexual characteristics due to activation of the hypothalamic-pituitary-gonadal axis).

Pubertal basal luteinizing hormone (LH) level ≥ 0.2 mIU/mL.

Pubertal LH response to a GnRH agonist stimulation test.

Preferred product criteria is met for the product as listed in the Central Precocious Puberty (CPP) preferred product tables (employer plans: patient has tried ONE of Fensolvi or Triptodur; individual and family plans: patient has tried ONE of Fensolvi or Triptodur).

Dosing/administration: Approve one implant (histrelin acetate 50 mg) inserted subcutaneously in the upper arm once every 12 months.

Supprelin LA - Gender dysphoria

Supprelin LA - Gender dysphoria — Other supported use

Indication: Gender-dysphoric/gender-incongruent persons or persons undergoing gender reassignment (female-to-male or male-to-female).

Prescriber: Prescribed by or in consultation with an endocrinologist or a physician who specializes in treatment of transgender patients.

Approval period and dosing: Approve for 1 year. Dosing: one implant (histrelin acetate 50 mg) inserted subcutaneously in the upper arm once every 12 months.

Zoladex - Non-oncology indications

Zoladex - Non-oncology indications — Covered when ALL of the following are met for each indication

ALL of the following

Abnormal Uterine Bleeding: Zoladex used as an endometrial-thinning agent prior to endometrial ablation.
Prescriber: The medication is prescribed by or in consultation with an obstetrician-gynecologist or a health care practitioner who specializes in the treatment of women's health.
Approval period and dosing: Approve for up to 2 months. Dosing: Zoladex 3.6 mg implant inserted subcutaneously into the anterior abdominal wall once every 28 days.

ALL of the following

Endometriosis: Patient is ≥ 18 years of age.

Covered when applicable policy criteria are met

Covered when applicable policy criteria are met — Considered Medically Necessary when criteria in the applicable policy statements listed above are met

Applicable HCPCS drug supply codes: J9202 (Goserelin acetate implant, per 3.6 mg) and J9226 (Histrelin implant [Supprelin LA], 50 mg).

When the specific indication criteria above are satisfied (including prescriber requirements, age limits, dosing, and prior preferred-product requirements where applicable), coverage is medically necessary per the listed durations and dosing schedules.

Conditions Not Covered: Supprelin LA and Zoladex for any other non-oncology use is considered not medically necessary, including but not limited to Peripheral Precocious Puberty (GnRH-independent precocious puberty) where patients do not respond to GnRH agonist therapy; treatment is directed at removing or blocking production/response to excess sex steroids (e.g., surgical removal of hCG-secreting tumors or glucocorticoids for adrenal steroidogenesis defects).

Note: The explicit age exclusion previously listed in the Supprelin LA preferred product table (e.g., 'Patient is < 2 years of age') has been removed per revision history. See Revision Details for history of changes.

Previous histrelin acetate criteria specific to central precocious puberty were removed (see Revision Details / Revision History).

Billing and Code References

Considered Medically Necessary CodesHCPCSCovered

J9202	Goserelin acetate implant, per 3.6 mg.
J9226	Histrelin implant (Supprelin LA), 50 mg

Covered HCPCS CodesHCPCSCovered

J9202	Goserelin acetate implant, per 3.6 mg.
J9226	Histrelin implant (Supprelin LA), 50 mg

Basal LH threshold for Central Precocious Puberty (CPP)

Basal LH threshold for CPP>= 0.2 mIU/ml

Requirement linked to approvalPubertal basal LH >= 0.2 mIU/ml is one of the criteria required for 1-year approval for Central Precocious Puberty

Associated testingA pubertal LH response to a GnRH agonist stimulation test is also required in addition to the basal LH threshold

Provider Actions, Prior Authorization, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for histrelin (Supprelin LA) and goserelin (Zoladex) implants. Coverage is contingent on meeting the medical necessity criteria in this policy; approvals are time-limited per indication (for example, Supprelin LA for central precocious puberty is approved for 1 year).

Prior authorization required for J9226 (Histrelin implant, Supprelin LA) and J9202 (Goserelin acetate implant, per 3.6 mg).
Approval durations vary by indication (e.g., Supprelin LA for CPP: 1 year; Zoladex approvals: 28 days, 3 months, or 1 year depending on indication).
Providers must document that all applicable clinical criteria in the policy are met at time of request.

Denial Risk

Claims May Be Subject to Coverage Determination

Claims submitted without an approved prior authorization or without supported covered diagnosis/procedure codes may be denied or subject to a coverage determination review. When J9202 or J9226 is billed, the claim may be reviewed to confirm the medical necessity criteria were met.

Key Definitions

Central precocious puberty (CPP) — definition and policy context

DefinitionCentral precocious puberty (CPP) is gonadotropin-dependent precocious puberty caused by early maturation of the hypothalamic-pituitary-gonadal axis

Standard of careGnRH agonists (including histrelin implants) are the standard of care for CPP

Policy applicationSupprelin LA (histrelin implant) is approved for CPP when criteria including basal LH and stimulation test response are met; dosing: one 50 mg implant every 12 months

Pubertal suppression (gender-dysphoria) — definition and usage notes

DefinitionPubertal suppression (gender-dysphoria) refers to use of GnRH agonists to suppress physical changes of puberty in gender-dysphoric/gender-incongruent persons; typically initiated after Tanner stage G2/B2 and reversible upon discontinuation

Clinical guidance

Initial Therapy — Authorization and Dosing

Continuation / Renewal Criteria

Step Therapy and Preferred Product Requirements

Step	Required prior trial(s)	Plan scope / notes
1	Patient has tried ONE of Fensolvi or Triptodur	Applies to Employer and Individual/Family plans for Supprelin LA (Central Precocious Puberty)

Coverage label	Preferred product requirement (summary)	Plan(s) effective date / notes
Preferred product requirement added	Preferred product requirement criteria were added for patients with central precocious puberty (Supprelin LA) — implies step/preferred product rules apply; prior trial of listed alternatives (e.g., Fensolvi or Triptodur) required per plan-specific tables	Listed as added in revision history; effective dates noted in revision details (additions for employer and individual/family plans).

Site of Care and Procedure Notes

Note

Document implant insertion site (upper arm for Supprelin LA; anterior abdominal wall for Zoladex)

Implants are inserted subcutaneously per the dosing statements: Supprelin LA is inserted in the upper arm; Zoladex is inserted into the anterior abdominal wall. Document the insertion site and site‑of‑care in the record and on claim forms as applicable.

Supprelin LA insertion site: upper arm (subcutaneous).
Zoladex insertion site: anterior abdominal wall (subcutaneous).

Background and Clinical Context

Central precocious puberty (CPP) results from early activation of the hypothalamic‑pituitary‑gonadal axis and is managed by suppressing gonadotropin release. Gonadotropin‑releasing hormone (GnRH) agonist implants such as Supprelin LA (histrelin implant) and Zoladex (goserelin implant) are standard therapy for CPP; for CPP the policy requires biochemical evidence (for example, a pubertal basal LH of >= 0.2 mIU/mL and appropriate stimulated LH response) and specialist involvement, with typical dosing of one 50 mg histrelin implant every 12 months (Supprelin LA) or goserelin 3.6 mg every 28 days (Zoladex) depending on indication.

Policy Summary

PayerCigna

PolicyGonadotropin-Releasing Hormone Agonists - Implants for Non-Oncology Indications

Policy CodePolicy IP0620

Change TypeMaterial clinical and coverage updates (criteria removed/added, preferred product rules, dosing additions)

Effective DateJun 1, 2026

Next Review Date

SourceLink

On This Page

Prescriber: The medication is prescribed by or in consultation with an obstetrician-gynecologist or a health care practitioner who specializes in the treatment of women's health.

Approval period and dosing: Approve for up to 6 months. Dosing: Zoladex 3.6 mg implant inserted subcutaneously into the anterior abdominal wall once every 28 days.

ALL of the following

Gender-dysphoric/gender-incongruent persons; persons undergoing gender reassignment (female-to-male or male-to-female).
Prescriber: Prescribed by or in consultation with an endocrinologist or a physician who specializes in treatment of transgender patients.
Approval period and dosing: Approve for up to 1 year. Dosing options (inserted subcutaneously into the anterior abdominal wall): Zoladex 3.6 mg every 28 days OR Zoladex 10.8 mg every 12 weeks.

ALL of the following

Preservation of ovarian function/fertility in patients undergoing chemotherapy.
Prescriber: Prescribed by or in consultation with an obstetrician-gynecologist or an oncologist.
Approval period and dosing: Approve for up to 1 year. Dosing options (inserted subcutaneously into the anterior abdominal wall): Zoladex 3.6 mg every 28 days OR Zoladex 10.8 mg every 12 weeks.

ALL of the following

Prophylaxis or treatment of uterine bleeding or menstrual suppression in patients with hematologic malignancy, or undergoing cancer treatment, or prior to bone marrow/stem cell transplantation.
Prescriber: The medication is prescribed by or in consultation with an oncologist.
Approval period and dosing: Approve for up to 1 year. Dosing options (inserted subcutaneously into the anterior abdominal wall): Zoladex 3.6 mg every 28 days OR Zoladex 10.8 mg every 12 weeks.

Claims billed with J9202 or J9226 may be subject to coverage determination if medical necessity criteria are not documented.
Claims lacking covered diagnosis or procedure codes consistent with this policy may be denied as not covered.

Documentation Required

Specialist Prescribing / Consultation Required

Prescriptions and prior authorization requests must be written by, or in consultation with, an appropriate specialist for the indication (for example, pediatric endocrinologist for central precocious puberty; obstetrician-gynecologist or women's health specialist for gynecologic indications; oncologist for fertility preservation or oncology-related indications; endocrinologist or transgender care specialist for gender‑dysphoria treatment).

Supprelin LA (CPP) requests should be from or in consultation with a pediatric endocrinologist or clinician experienced in pediatric puberty disorders.
Zoladex for uterine/gynecologic indications must be prescribed by or in consultation with an obstetrician-gynecologist or women's health specialist.
Oncology or fertility preservation uses should be prescribed by or in consultation with an oncologist or obstetrician-gynecologist as specified.

Billing Rule

Billing Guidance — HCPCS Codes

Use the HCPCS codes below when billing for covered implants; coverage requires meeting the medical necessity criteria in this policy.

J9202 — Goserelin acetate implant, per 3.6 mg (bill when medically necessary criteria for Zoladex are met).
J9226 — Histrelin implant (Supprelin LA), 50 mg (bill when medically necessary criteria for Supprelin LA are met).
Claims with these codes will be reviewed against the policy criteria and prior authorization status.

Endocrine Society and WPATH support off-label use of GnRH agonists for pubertal suppression with specialist oversight

Policy noteSupprelin LA and Zoladex may be approved for pubertal suppression (gender-dysphoria) for 1 year when prescribed by or in consultation with an appropriate specialist

Central Precocious Puberty — alternate references

Alternate definition sourceSupprelin LA prescribing information and guideline references include CPP as gonadotropin-dependent precocious puberty due to early HPG axis maturation

Supporting referencesPrescribing information for Supprelin LA and Zoladex (Sept 2025) and pediatric endocrine consensus statements provide clinical support for CPP management

Evidence contextInternational consortium updates and pediatric endocrine society consensus documents reiterate GnRH agonists as effective treatments for CPP