CurrentCareSourcePolicy N/A

Gonadotropin-Releasing Hormone Agonist Implants (Supprelin LA, Zoladex) — Utilization Management

Defines prior authorization, coverage criteria, dosing, and prescriber requirements for Supprelin LA (histrelin implant) and Zoladex (goserelin implant) for medical-benefit indications under CareSource.

Policy Summary

PayerCareSource

PolicyGonadotropin-Releasing Hormone Agonist Implants (Supprelin LA, Zoladex) — Utilization Management

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateFeb 12, 2025

Key ActionObtain prior authorization and ensure prescriptions are by or in consultation with an appropriate specialist for the listed indications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2products covered (Supprelin LA, Zoladex)

Central precocious pubertyFDA-approved indication for Supprelin LA

Prior authauthorization requirement

Some oncologyeviCore-managed items

Coverage Criteria

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inv-01: Supprelin LA — Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Supprelin LA - Central Precocious Puberty: Patient has central precocious puberty AND treatment is prescribed by or in consultation with an appropriate specialist; approve one 50 mg implant every 12 months (inserted subcutaneously in the upper arm)one implant per 12 months

Approve for 1 year

inv-02: Zoladex — Indication-based Criteria — Covered when criteria for the specific indication are met

Covered when criteria for the specific indication are met

Abnormal uterine bleeding - endometrial thinning prior to ablation: Zoladex is used as an endometrial-thinning agent to facilitate endometrial ablation AND medication is prescribed by or in consultation with an obstetrician-gynecologist or women's health specialistApprove Zoladex 3.6 mg implant once every 28 days

Approve for 2 months

Breast cancer (palliative or ovarian suppression): Medication prescribed by or in consultation with an oncologistApprove Zoladex 3.6 mg every 28 days OR Zoladex 10.8 mg every 12 weeks

Approve for 1 year; some breast indications managed by eviCore

Endometriosis: Patient is >= 18 years of age AND medication is prescribed by or in consultation with an obstetrician-gynecologist or women's health specialistApprove Zoladex 3.6 mg every 28 days

Approve for 6 months

Head and neck salivary gland tumors: Patient has recurrent, unresectable, or metastatic disease AND androgen receptor-positive tumor AND medication is prescribed by or in consultation with an oncologistApprove Zoladex 3.6 mg every 28 days

Approve for 1 year; eviCore-managed

Ovarian, fallopian tube, primary peritoneal cancers: Medication prescribed by or in consultation with an oncologistApprove Zoladex 3.6 mg every 28 days

Approve for 1 year; eviCore-managed

Prostate cancer: Patient with prostate cancer AND medication is prescribed by or in consultation with an oncologistApprove ONE of: Zoladex 3.6 mg every 28 days OR Zoladex 10.8 mg every 12 weeks

Approve for 1 year; eviCore-managed

Uterine cancer: Medication prescribed by or in consultation with an oncologistApprove Zoladex 3.6 mg every 28 days

Approve for 1 year; eviCore-managed

Peripheral (GnRH-independent) precocious puberty is not a covered indication for Supprelin LA or Zoladex. Children with peripheral precocious puberty do not respond to GnRH agonist therapy, and treatment for these patients is directed at removing or blocking the source of excess sex steroids (for example, surgical removal of hCG‑secreting tumors or medical management such as glucocorticoids for adrenal steroidogenesis defects).

Products, Strengths, and Dosing

Covered products and strengthsmixedCovered

Supprelin LA 50 mg implant	histrelin acetate subcutaneous implant (documented product)
Zoladex 3.6 mg implant	goserelin acetate subcutaneous implant (3.6 mg)
Zoladex 10.8 mg implant	goserelin acetate subcutaneous implant (10.8 mg)

Dosing interval thresholds

Supprelin LA (50 mg)One implant every 12 months (approve one 50 mg implant once every 12 months)

Zoladex 3.6 mgOne implant every 28 days (approve Zoladex 3.6 mg implant once every 28 days)

Zoladex 10.8 mgOne implant every 12 weeks (approve Zoladex 10.8 mg implant once every 12 weeks)

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended for medical benefit coverage of Supprelin LA and Zoladex. Approval is recommended only for requests that meet the policy's Recommended Authorization Criteria and dosing. Approvals are provided for the duration specified in the criteria; when duration is given in months, 1 month = 30 days. Requests for doses outside the dosing regimens documented in this policy will be reviewed on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist). Because of the specialized skills required for evaluation, diagnosis, monitoring of adverse events, and long-term efficacy, these agents must be prescribed by or in consultation with a physician who specializes in the condition being treated (for example, pediatric endocrinologist for central precocious puberty; oncologist for cancer indications; obstetrician-gynecologist or women's health specialist for gynecologic indications).

Prior authorization recommended for Supprelin LA and Zoladex
Approvals only when Recommended Authorization Criteria and dosing are met
Duration of approval as specified; 1 month = 30 days
Dose exceptions reviewed case-by-case by clinician (Medical Director or Pharmacist)
Prescriber requirement: prescribed by or in consultation with appropriate specialist (e.g., pediatric endocrinologist, oncologist, obstetrician-gynecologist)

Documentation Required

Prescriber and Referral Documentation

Prescriptions must be written by or in documented consultation with a specialist appropriate to the indication. Examples: pediatric endocrinologist for central precocious puberty; oncologist for prostate, breast, ovarian, uterine, head and neck, or other cancer indications; obstetrician-gynecologist or women's health specialist for abnormal uterine bleeding, endometriosis, or use as an endometrial-thinning agent. Ensure documentation of the specialist's involvement is included in the submission.

Document specialist prescriber or documented consultation in the request
Specialist examples: pediatric endocrinologist, oncologist, obstetrician-gynecologist, women's health specialist

Denial Risk

Denial Triggers

Requests that do not meet the policy's Recommended Authorization Criteria or are for conditions listed as not recommended (for example, peripheral precocious puberty or indications not listed in the Recommended Authorization Criteria) are subject to denial. Provide complete documentation to support medical necessity and adherence to dosing regimens to reduce denial risk.

Denial triggers include: peripheral (GnRH-independent) precocious puberty, indications not listed in Recommended Authorization Criteria, insufficient specialist documentation, dosing outside documented regimens without clinical justification

Note

Provider Action Callout

Provider action: Ensure the prior authorization request includes (1) indication matching the Recommended Authorization Criteria, (2) chosen dosing regimen consistent with policy dosing (e.g., Supprelin LA 50 mg implant once every 12 months for central precocious puberty; Zoladex dosing per indication — 3.6 mg every 28 days or 10.8 mg every 12 weeks where applicable), (3) duration requested matching policy-approved durations, and (4) documentation of specialist prescriber or documented consultation. Requests for off-label or non-standard dosing should include clinical rationale and will be reviewed by a clinician.

Include indication and match to Recommended Authorization Criteria
Include dosing regimen per policy (implant strength and interval) and duration
Include specialist prescriber or documented consultation note
Provide clinical rationale for off-label or non-standard dosing

Background

Gonadotropin‑releasing hormone (GnRH) agonist implants are effective for central (gonadotropin‑dependent) precocious puberty but are not effective in peripheral (GnRH‑independent) forms. For peripheral precocious puberty, treatment is aimed at removing or blocking the excess sex steroid source—examples include surgical resection of hCG‑secreting tumors or medical therapy such as glucocorticoids for adrenal steroidogenesis defects—rather than GnRH agonist therapy.

Definitions

Central precocious puberty — definition

DefinitionCentral precocious puberty is gonadotropin-dependent early activation of the hypothalamic-pituitary-gonadal axis

Standard treatmentGonadotropin-releasing hormone (GnRH) agonists are the standard of care for central precocious puberty

Clinical guidanceInternational and pediatric endocrine society guidance supports use of GnRH agonists (e.g., histrelin implants) despite different routes and dosing

Peripheral precocious puberty — definition

DefinitionPeripheral (GnRH-independent) precocious puberty is caused by excess sex steroids from non-central sources

Response to GnRH agonistsPatients with peripheral precocious puberty do not respond to GnRH agonist therapy

Treatment approachManagement is directed at removing or blocking production/response to excess sex steroids (eg, surgery for hCG-secreting tumors or glucocorticoids for adrenal steroidogenesis defects)

Initial Therapy Criteria

inv-15: Initial Therapy Rules — Initial authorization rules per product and indication

Initial authorization rules per product and indication

Supprelin LA initial: One 50 mg implant subcutaneously every 12 months for central precocious puberty; prescriber is or in consultation with an appropriate specialist

Zoladex initial - uterine bleeding: Zoladex 3.6 mg implant once every 28 days for endometrial thinning prior to ablation; prescriber must be an OB-GYN or women's health specialist

Zoladex initial - breast cancer: Approve either Zoladex 3.6 mg every 28 days or Zoladex 10.8 mg every 12 weeks; prescriber is or in consultation with an oncologist

Zoladex initial - endometriosis: Patient >= 18 years AND prescriber is an OB-GYN or women's health specialist; Zoladex 3.6 mg every 28 days

Continuation Therapy

inv-16: Continuation Therapy — Continuation/extended approvals allowed if patient continues to meet criteria and dosing

Continuation/extended approvals allowed if patient continues to meet criteria and dosing

Supprelin LA continuation: Approve renewals for continued suppression when ongoing criteria are met; one implant every 12 months

Zoladex continuation: Approve extensions for duration noted per indication when continuing to meet criteria and dosing intervals (per-indication durations as listed)

Step	Requirement	Notes
1	No explicit step-therapy requirement or mandatory prior use of other GnRH agonists is stated in this policy	Clinical guideline context references alternative GnRH agents (e.g., leuprolide, triptorelin, goserelin) as acceptable options but does not impose prior-agent failure as a coverage condition

Quantity Limits and Dispensing

Supprelin LA (50 mg) — quantity limit

Quantity limit1 implant per year

ProductSupprelin LA (50 mg histrelin acetate subcutaneous implant)

Approval noteApprove one 50 mg implant once every 12 months (inserted subcutaneously in the upper arm)

Zoladex 3.6 mg — quantity limit

Quantity limit1 implant per month

ProductZoladex 3.6 mg (goserelin acetate subcutaneous implant)

Typical dosingApprove Zoladex 3.6 mg implant once every 28 days (inserted subcutaneously into the anterior abdominal wall)

Zoladex 10.8 mg — quantity limit

Quantity limit1 implant per 3 months

ProductZoladex 10.8 mg (goserelin acetate subcutaneous implant)

Indication note10.8 mg formulation is indicated for prostate cancer; dosing approved once every 12 weeks

Site of Care

Step Therapy

Office insertion site and setting

Implants are intended to be inserted subcutaneously in the office setting: Supprelin LA in the upper arm and Zoladex in the anterior abdominal wall as documented in the dosing instructions.

Supprelin LA: one 50 mg implant inserted subcutaneously in the upper arm (approve one implant every 12 months).
Zoladex: implants are inserted subcutaneously into the anterior abdominal wall (3.6 mg every 28 days or 10.8 mg every 12 weeks as appropriate).

Policy Summary

PayerCareSource

PolicyGonadotropin-Releasing Hormone Agonist Implants (Supprelin LA, Zoladex) — Utilization Management

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateFeb 12, 2025

Key ActionObtain prior authorization and ensure prescriptions are by or in consultation with an appropriate specialist for the listed indications.

SourceLink

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