CurrentViva HealthPolicy IC-0151

Zoladex (goserelin acetate) (Subcutaneous)

Clinical coverage and prior authorization rules for goserelin acetate (Zoladex) implants for Viva Health members, including indications, dosing, authorization lengths, renewal rules, and coding.

Policy Summary

PayerViva Health

PolicyZoladex (goserelin acetate) (Subcutaneous)

Policy CodePolicy IC-0151

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrior authorization is required; initial authorization is generally 12 months (6 months for endometriosis; 2 doses only for dysfunctional uterine bleeding).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial PA validity (standard)

6 monthsinitial PA validity (endometriosis)

3.6 / 10.8 mgdose presentations

J9202HCPCS

2NDCs listed

≥100

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Coverage Criteria for Goserelin (Zoladex)

Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Covered when ALL of the following are met:

ALL of the following

Used as a single agent; AND
ANY of the following
- Patient has a diagnosis of Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Mucinous Neoplasms of the Ovary, Clear Cell Carcinoma of the Ovary, Carcinosarcoma (Mixed Malignant Müllerian Tumors), or Grade 1 Endometrioid Carcinoma;
- ALL of the following
  - Patient has a diagnosis of Low-grade Serous Carcinoma; AND
  - Patient has recurrent disease; AND
  - Patient has received prior therapy with an aromatase inhibitor;
- ALL of the following
  - Patient has a diagnosis of stage II-IV granulosa cell tumor; AND
  - Patient has relapsed disease;
Patient has persistent or recurrent disease (excluding immediate treatment of biochemical relapse); OR (see above branches for disease-specific requirements).

Initial Therapy and Dosing Requirements

inv-29: Initial dosing

Dosing and quantity limits for initiation

Standard dosing: Breast cancer and fertility preservation: administer 3.6 mg depot every 4 weeks OR 10.8 mg depot every 12 weeks. Dysfunctional uterine bleeding: 3.6 mg only — administer 3.6 mg for 1 or 2 doses given 28 days apart (surgery timing as specified). Endometriosis: 3.6 mg depot every 28 days for 6 months. Ovarian cancer, salivary gland tumors of the head and neck, and uterine sarcoma: 3.6 mg depot every 4 weeks. Prostate cancer: stage B2–C — administer 3.6 mg depot 8 weeks before radiotherapy followed in 28 days by 10.8 mg depot, or alternatively four 3.6 mg injections every 28 days (two before and two during radiotherapy); palliative advanced prostate cancer — 3.6 mg every 4 weeks OR 10.8 mg every 12 weeks.Max units per dosing period as specified: for prostate, breast, and fertility preservation — up to 3 billable units every 84 days; all other indications — 1 billable unit every 28 days.

Renewal and Continuation Criteria

Renewal — General/Oncology

Covered when ALL of the following are met:

ALL of the following

Patient continues to meet the universal and other indication-specific relevant criteria identified in Section III.
Duration of authorization has not been exceeded (refer to Section I).
Absence of unacceptable toxicity from the drug. Examples include severe QT/QTc interval prolongation; severe hyperglycemia/diabetes; cardiovascular events (myocardial infarction, stroke); hypercalcemia; severe injection site or vascular injury (pain, hematoma, hemorrhage, hemorrhagic shock); tumor flare phenomenon; severe hypersensitivity reactions; new or worsening depression; cervical resistance; or other clinically significant toxicities as determined by the treating clinician.
See renewal denial triggers callout for examples that may prompt denial.

Renewal — Oncology renewal conditions and documentation required

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Obtain prior authorization and note initial validity

Prior authorization is required. Initial authorizations are generally valid for 12 months, except endometriosis (initial validity 6 months) and dysfunctional uterine bleeding (authorization provided for 2 doses only, given 4 weeks apart). Renewals are available every 12 months unless otherwise specified and some indications (endometriosis, dysfunctional uterine bleeding) are not renewable; fertility preservation may be renewed every 12 months while patient is receiving chemotherapy.

Prior Authorization

Include NDC and Appendix 1 diagnosis on PA

When submitting prior authorization requests, identify the Zoladex product by NDC and include a covered diagnosis code from Appendix 1 to support medical necessity.

Zoladex 10.8 mg 3‑Month Implant: NDC 70720-0951-XX
Zoladex 3.6 mg Implant: NDC 70720-0950-XX
Include an ICD-10 code from Appendix 1 to justify the indication

Coding, Units, and Appendix Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J9202

Goserelin acetate implant, per 3.6 mg; 1 billable unit = 3.6 mg

NDCNDC

70720-0951-XX	Zoladex 10.8mg 3-Month Implant: 70720-0951-XX
70720-0950-XX	Zoladex 3.6mg Implant: 70720-0950-XX

NDCsNDC

70720-0951-XX	Zoladex 10.8mg 3-Month Implant: 70720-0951-XX
70720-0950-XX	Zoladex 3.6mg Implant: 70720-0950-XX

Covered ICD-10 Diagnosis Codes (Appendix 1)ICD-10Covered

C06.9	Malignant neoplasm of mouth, unspecified
C07	Malignant neoplasm of parotid gland
C08.0	Malignant neoplasm of submandibular gland
C08.1	Malignant neoplasm of sublingual gland
C08.9	Malignant neoplasm of major salivary gland, unspecified
C48.1	Malignant neoplasm of specified parts of peritoneum
C48.2	Malignant neoplasm of peritoneum, unspecified
C48.8	Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum
C50.*	Multiple codes for malignant neoplasm of breast (detailed list in chunks 22-25)
C54.*	Multiple codes for malignant neoplasm of uterus (chunks 25-26)

1–10 of 23

1/3

CMS/LCA/LCD referencesmixed

A52453	CMS Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (National Government Services)
A59160	CMS Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (Palmetto GBA)

Maximum units — billing unit rules per indication

Maximum units — prostate/breast/fertility preservation3 billable units every 84 days

Maximum units — all other indications1 billable unit every 28 days

HCPCS unit definitionUnits reported per HCPCS billing unit as specified in policy

Dose presentations — 3.6 mg (monthly) and 10.8 mg (3-month)

Dose presentations available3.6 mg (monthly) implant and 10.8 mg (3‑month) implant

NDC — 10.8 mg 3‑Month Implant

Definitions and Reference Guidance

Depot dosing — 3.6 mg every 4 weeks or 10.8 mg every 12 weeks depending on indication

Depot dosing options3.6 mg depot every 4 weeks OR 10.8 mg depot every 12 weeks depending on indication

Dysfunctional uterine bleeding dosing3.6 mg only — 1 or 2 doses given 28 days apart; surgery timing specified after dosing

Endometriosis dosing3.6 mg depot every 28 days for 6 months (initial authorization 6 months)

NCCN Compendium reference — NCCN Compendium entries referenced for indication guidance

NCCN Compendium referencedNCCN Compendium® entries for goserelin are referenced for indication guidance; access at NCCN.org (Accessed June 2025)

NCCN Guidelines citation

Quantity Limits and Billing Frequency

goserelin acetate (Zoladex) — billing unit limits by indication

Billing unit limits for oncology/fertility indicationsFor prostate cancer, breast cancer, and fertility preservation: 3 billable units every 84 days

Billing unit limits for other indicationsFor all other indications (including most gynecologic and head/neck indications): 1 billable unit every 28 days

Dose-to-unit mapping1 billable unit = one 3.6 mg implant (use 10.8 mg implant billed as 3 units as applicable to period limits)

Step Therapy Requirements

Prior therapy step	Requirement / failure definition
Failure or ineligibility for other fertility preservation methods (e.g., cryopreservation)	Patient has failed or is not a candidate for other fertility preservation methods (examples listed in policy: cryopreservation)
Premenopausal status required	Patient must be premenopausal and receiving cytotoxic chemotherapy with potential to cause ovarian damage

Background on Goserelin (Zoladex)

Goserelin acetate (Zoladex) is a gonadotropin‑releasing hormone (GnRH) agonist supplied as a subcutaneous depot implant. Two depot presentations are used in clinical practice: 3.6 mg administered every 28 days (monthly) and 10.8 mg administered every 12 weeks (3‑month). The depot formulation permits dosing schedules tailored to indication — for example, monthly or 3‑month dosing for breast cancer and fertility preservation, and limited 1–2 dose use of the 3.6 mg depot for dysfunctional uterine bleeding prior to ablation.

Denial Risk

Renewal denial triggers — examples of unacceptable toxicity and other denial conditions

Prior authorization may be denied for continuation when significant or unacceptable toxicity is present, when required documentation or diagnosis coding is missing, or when Medicare coverage criteria are not met.

Prior authorization validity and units: Ensure the PA lists the specific product, quantity/units, and duration requested; authorize only within the documented units and validity period.
Prior authorization: product ID and diagnosis: PA request must include the product NDC/HCPCS or internal product identifier and the primary diagnosis code that supports the indication.
Renewal denial triggers: Examples that may prompt denial include severe QT/QTc prolongation, new or worsening significant cardiovascular events, uncontrolled severe hyperglycemia/diabetes, severe hypersensitivity or anaphylaxis, severe injection site necrosis or vascular injury, tumor flare with clinical deterioration, new or worsening depression with safety concerns, or any toxicity judged by the treating clinician to be unacceptable.
Medicare coverage/denial risk note: For Medicare members, continuation may be denied if the service is not reasonable and necessary under Medicare standards or lacks documentation aligning with Medicare coverage rules.
Required diagnosis coding: Submit applicable ICD-10 diagnosis codes that clearly support the requested indication; undocumented or non‑specific codes may result in denial.
Clinical alignment for step edits: For therapies subject to step edits or prior-line requirements, renewal approval requires documentation that step-therapy criteria continue to be met or that an approved exception rationale is provided.