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| Goserelin (e.g., Zoladex) | |
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| Description: |
Goserelin is a synthetic gonadotropin-releasing hormone (GnRH) agonist administered as a subcutaneous depot. It is used for the palliative treatment of advanced prostate cancer or breast cancer, for the management of endometriosis, dysfunctional uterine bleeding, and the adjunct medical management of uterine myomas (fibroids). In males, after an initial increase in serum testosterone levels, treatment with goserelin leads to suppression of serum testosterone to castration levels approximately 2 to 4 weeks after initiation of therapy. In females, a similar down-regulation of the pituitary gland leads to decreases in serum estradiol to levels consistent with the postmenopausal state within 3 weeks of the first dose. Transient worsening of tumor symptoms may occur during the first few weeks of treatment, which may include ureteral obstruction and spinal cord compression; monitor patients at risk for complications of tumor flare.
Regulatory Status
Goserelin (e.g., Zoladex) was approved by the U.S. Food and Drug Administration (FDA) in 1989, and currently is approved for the treatment of:
Coding
See CPT/HCPCS Code section below.
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Policy/ Coverage: |
For members of plans that utilize an oncology benefits management program, Prior Approval is required for this service when rendered for oncologic indications and is managed through the oncology benefits management program.
INITIAL AND CONTINUATION APPROVAL will be for duration of the treatment course or 12 months (whichever comes first). Approval timeframes may differ for members/participants of Self-Insured plans.
Effective October 24, 2026
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Goserelin (e.g., Zoladex) meets member benefit certificate
Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes or for members with contracts without Primary Coverage Criteria, is considered
Medically Necessary and is covered when member receives a “recommended” determination from criteria review in InterQual® Goserelin (e.g., Zoladex) based on diagnosis and requested product.
Click the following link to view the specific criteria in InterQual®:
https://prod.ds.interqual.com/service/connect/transparency?tid=27b0a724-ca06-4b22-846b-598b8dae52fc
See Policy #2026011 Chemotherapy and Drug Treatment Regimens for Malignancy for criteria.
Does Not Meet Primary Coverage Criteria Or Is Not Covered For Contracts Without Primary Coverage Criteria
Chemotherapy and Drug Treatment Regimens for Malignancy for indications not listed as labeled or are not consistent with off-label determinations as described above, are considered not
Medically Necessary and are not covered or is investigational. Not Medically Necessary
or Investigational services are Plan exclusions.
Click the following link to view the specific criteria in InterQual® for a specific chemotherapy and drug treatment regimen:
https://prod.ds.interqual.com/service/connect/transparency?tid=27b0a724-ca06-4b22-846b-598b8dae52fc
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Please refer to a separate policy on Maximum Dosage and Frequency (policy #2025031) for pharmacologic/biologic medications.
Effective July 13, 2026 to October 23, 2026
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Goserelin (e.g., Zoladex) meets member benefit certificate
Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes or for members with contracts
without Primary Coverage Criteria, is considered Medically Necessary and is covered, when
ALL the following criteria are met:
FDA Labeled Indications:
The use of this drug is covered if an FDA-approved oncologic indication exists [not listed as an indication below with the member meeting all of the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”).
INITIAL APPROVAL:
AUTHORIZATION RENEWAL:
Off-label Indications:
The use of this drug for off-label indications not listed below is subject to policy 2000030.
INITIAL APPROVAL:
The following indications are covered when the individual meets the related NCCN category 1 or 2A recommendations specific to the indications below (e.g., histology, cancer staging, surgical status, mono- or combination therapy, and previous lines of therapy):
AUTHORIZATION RENEWAL:
Please see the NCCN Drugs and Biologics Compendium for a complete list of NCCN 1 & 2A indications. To view the most recent and complete version of the guideline or Compendium, go online to NCCN.org. Please note, NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Does Not Meet Primary Coverage Criteria Or Is Not Covered For Contracts Without Primary Coverage Criteria
Goserelin (e.g., Zoladex), for any indication or circumstance not described above, does not meet member benefit certificate
Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes and is not covered.
For members with contracts without Primary Coverage Criteria, Goserelin (e.g., Zoladex), for any indication or circumstance not described above, is considered
not Medically Necessary and is not covered or is
investigational. Not Medically Necessary or
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
POLICY GUIDELINES
There should be an absence of unacceptable toxicity from the drug, including severe infusion reactions such as hyperglycemia, cardiovascular disease, etc. (Zoladex, 2025)
DOSAGE AND ADMINISTRATION
For FDA labeled indications, Goserelin (e.g., Zoladex) must be dosed in accordance with the indication specific recommended dose per FDA label unless otherwise specified in the dosage and administration section.
For off-label indications, authorizations will not exceed the maximum FDA labeled dose and frequency across all the FDA labeled indications unless higher dose is allowed for the specific indication in the dosage and administration section.
The recommended dose of Goserelin (e.g., Zoladex) is 3.6 mg per month.
3-month implant is FDA-approved for prostate cancer only.
Goserelin (e.g., Zoladex) is available as an implant of 3.6 mg and implant of 10.8 mg (3-month).
Goserelin (e.g., Zoladex) should be administered as a subcutaneous implant injection by a healthcare professional.
Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Effective May 7, 2025 to July 12, 2026
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Goserelin (e.g., Zoladex) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when
ALL the following criteria are met:
For FDA labeled indications, Goserelin (e.g., Zoladex) must be dosed in accordance with the indication specific recommended dose per FDA label unless otherwise specified in the dosage and administration section.
For off-label indications, authorizations will not exceed the maximum FDA labeled dose and frequency across all the FDA labeled indications unless higher dose is allowed for the specific indication in the dosage and administration section.
FDA Labeled Indications:
The use of this drug is covered if an FDA-approved oncologic indication exists [not listed as an indication below with the member meeting all of the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”)].
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUED APPROVAL for up to 12 months:
Off-label Indications:
The use of this drug for off-label indications not listed below is subject to policy 2000030.
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
The following indications are covered when the individual meets the related NCCN category 1 or 2A recommendations specific to the indications below (e.g., histology, cancer staging, surgical status, mono- or combination therapy, and previous lines of therapy):
CONTINUED APPROVAL for up to 12 months:
Please see the NCCN Drugs and Biologics Compendium for a complete list of NCCN 1 & 2A indications. To view the most recent and complete version of the guideline or Compendium, go online to NCCN.org. Please note, NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Dosage and Administration
Dosing per FDA Guidelines unless otherwise specified below.
The recommended dose of Goserelin (e.g., Zoladex) is 3.6 mg per month.
3-month implant is FDA-approved for prostate cancer only.
Goserelin (e.g., Zoladex) is available as an implant of 3.6 mg and implant of 10.8 mg (3-month).
Goserelin (e.g., Zoladex) should be administered as a subcutaneous implant injection by a healthcare professional.
Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Goserelin (e.g., Zoladex), for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, Goserelin (e.g., Zoladex), for any indication or circumstance not described above, is considered
investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective December 11, 2024 to May 6, 2025
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Goserelin (e.g., Zoladex) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when
ALL the following criteria are met:
FDA Labeled Indications:
For FDA labeled indications, all products must be dosed in accordance with the FDA label unless otherwise specified.
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUED APPROVAL for up to 12 months:
Off-label Indications:
For off-label indications, authorizations will not exceed
10.8 mg every 12 weeks OR maximum recommended doses as outlined in dosage and administration section unless medical literature supports a higher dose.
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
The following indications are covered when the individual meets the related NCCN category 1 or 2A recommendations specific to the indications below (e.g., histology, cancer staging, surgical status, mono- or combination therapy, and previous lines of therapy):
CONTINUED APPROVAL for up to 12 months:
Off-label
The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).
Dosage and Administration
Dosing per FDA Guidelines where applicable. For off-label indications, authorizations will not exceed
10.8 mg every 12 weeks or
maximum recommended doses as outlined below unless medical literature supports a higher dose.
The recommended dose of Goserelin (e.g., Zoladex) is 3.6 mg per month.
3-month implant is FDA-approved for prostate cancer only.
Goserelin (e.g., Zoladex) is available as an implant of 3.6 mg and implant of 10.8 mg (3-month).
Goserelin (e.g., Zoladex) should be administered as a subcutaneous implant injection by a healthcare professional.
Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Goserelin (e.g., Zoladex), for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, Goserelin (e.g., Zoladex), for any indication or circumstance not described above, is considered
investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
Goserelin, a synthetic decapeptide analog of gonadotropin-releasing hormone (GnRH), is a GnRH agonist. It inhibits pituitary gonadotropin secretion when administered in the biodegradable formulation. In animal and in vitro studies, administration of goserelin resulted in the regression or inhibition of growth of the hormonally sensitive dimethylbenzanthracene (DMBA)-induced rat mammary tumor and Dunning R3327 prostate tumor (Zoladex, 2023).
In males, goserelin causes an initial increase in serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels, with subsequent increases in serum levels of testosterone. Over time, chronic administration of goserelin leads to sustained suppression of pituitary gonadotropins causing serum testosterone levels to fall to castration levels approximately 2 to 4 weeks after initiation of therapy; this leads to accessory sex organ regression. In clinical trials with follow-up of more than 2 years, suppression of serum testosterone to castrate levels has been maintained for the duration of therapy (Zoladex, 2023).
In females, a similar down-regulation of the pituitary gland occurs with chronic exposure to goserelin leading to suppression of gonadotropin secretion, a decrease in serum estradiol to levels consistent with the postmenopausal state, and would be expected to lead to a reduction of ovarian size and function, reduction in the size of the uterus and mammary gland, as well as a regression of sex hormone-responsive tumors, if present. Serum estradiol is suppressed to levels similar to those observed in postmenopausal women within 3 weeks after the initial dose; however, after suppression was attained, isolated elevations of estradiol were seen in 10% of patients. Serum LH and FSH are suppressed to follicular phase levels within 4 weeks after the first dose of goserelin and typically remain at that range with continued treatment. Serum LH and FSH levels are not suppressed to follicular phase levels on day 28 after a single 3.6 mg depot injection in 5% of women or less. Estradiol, LH, and FSH levels return to pretreatment values within 12 weeks after the last implant is placed (Zoladex, 2023).
2025 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2025. NCCN 1 and 2A guidelines update.
2026 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2026. NCCN guidelines updated.
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| CPT/HCPCS: | |
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| References: |
NCCN(2024) Drugs & Biologics Compendium for goserelin (Zoladex). Accessed November 20, 2024. online to NCCN.org.
NCCN(2026) Drugs & Biologics Compendium for goserelin (Zoladex). © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed [April 17, 2026]. To view the most recent and complete version of the Compendium, go online to NCCN.org. Zoladex 10.8mg implant(2020) Prescribing information Lake Forest, IL: TerSera Therapeutics; December 2020. Zoladex 10.8mg implant(2025) prescribing information Lake Forest, IL: TerSera Therapeutics; 2025. Zoladex 3.6mg implant(2023) Prescribing information Lake Forest, IL: TerSera Therapeutics; March 2023. Zoladex 3.6mg implant(2025) prescribing information Lake Forest, IL: TerSera Therapeutics; 2025. |
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| Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants. | |
| CPT Codes Copyright © 2026 American Medical Association. | |