BlueCross BlueShield of Tennessee Medical Policy Manual
Goserelin Acetate (Zoladex®)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indications
Prostate cancer
Endometriosis
For the management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy. Experience with Zoladex for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months (Zoladex 3.6 mg strength only)
Endometrial thinning
For use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding (Zoladex 3.6 mg strength only)
Advanced breast cancer
For use in the palliative treatment of advanced breast cancer in pre-and perimenopausal women (Zoladex 3.6 mg strength only)
Compendial Uses
All other indications are considered experimental/investigational and not medically necessary.
EXCLUSIONS
Coverage will not be provided for members with any of the following exclusions: Use of the 10.8 mg strength for diagnoses other than prostate cancer, breast cancer, and gender dysphoria.
DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review: Hormone receptor status testing results (where applicable).
PRESCRIBER SPECIALTIES
Gender Dysphoria
The medication must be prescribed by or in consultation with a provider specialized in the care of transgender youth (e.g., pediatric endocrinologist, family or internal medicine physician, obstetrician-gynecologist) that has collaborated care with a mental health provider for members less than 18 years of age.
Prevention of recurrent menstrual related attacks in acute porphyria
The medication must be prescribed by or in consultation with a provider experienced in the management of porphyrias.
COVERAGE CRITERIA
Breast Cancer
Authorization of 12 months may be granted for the treatment of hormone receptor-positive breast cancer.
Prostate Cancer
Authorization of 12 months may be granted for treatment of prostate cancer.
Epithelial Ovarian, Fallopian Tube, Primary Peritoneal Cancer or Malignant Sex Cord-Stromal Tumor
Authorization of 12 months may be granted for treatment of persistent or recurrent epithelial ovarian, fallopian tube, primary peritoneal cancer or malignant sex cord-stromal tumor when used as a single agent.
Endometriosis
Authorization of a total of 6 months may be granted to members for treatment of endometriosis.
Endometrial-Thinning Agent
Authorization of 2 doses may be granted for endometrial thinning prior to endometrial ablation or resection for dysfunctional uterine bleeding.
Authorization of a total of 6 months may be granted for treatment of chronic anovulatory uterine bleeding with severe anemia.
Gender Dysphoria
*Individual is age 18 or older or the individual is less than age 18 as permissive under applicable law.
Authorization of 12 months may be granted for pubertal hormonal suppression in an adolescent member when all of the following criteria are met:
Authorization of 12 months may be granted for gender transition when all of the following criteria are met:
Preservation of Ovarian Function
Authorization of 3 months may be granted for preservation of ovarian function when the member is premenopausal and undergoing chemotherapy.
Prevention of Recurrent Menstrual Related Attacks in Acute Porphyria
Authorization of 12 months may be granted for prevention of recurrent menstrual related attacks in members with acute porphyria.
CONTINUATION OF THERAPY
Breast Cancer and Ovarian Cancer
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization who are experiencing clinical benefit to therapy and who have not experienced an unacceptable toxicity.
Prostate Cancer
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization who are experiencing clinical benefit to therapy (e.g., serum testosterone less than 50 ng/dL) and who have not experienced an unacceptable toxicity.
Gender Dysphoria
*Individual is age 18 or older or the individual is less than age 18 as permissive under applicable law.
Authorization of 12 months may be granted for continued treatment for pubertal hormonal suppression in adolescent members requesting reauthorization when all of the following criteria are met:
Authorization of 12 months may be granted for continued treatment for gender transition in members requesting reauthorization when all of the following criteria are met:
All other indications
All members (including new members) requesting authorization for continuation of therapy must meet all requirements in the coverage criteria section.
OTHER
Per state regulatory guidelines around gender dysphoria, age restrictions may apply.
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 8/12/2025
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.