State and School Employees' Health Insurance Plan - Zoladex (goserelin)

POLICY NUMBER

S.5.01.432

Zoladex (goserelin)

Please perform a search of the State Health Plan Medical Drug Formulary for drugs administered and billed through the medical setting.

DESCRIPTION

Zoladex (goserelin) is a synthetic decapeptide analog of gonadotropin-releasing hormone (GnRH). It acts as an inhibitor of pituitary gonadotropin secretion. In males, Zoladex (goserelin) causes an initial increase in serum luteinizing hormone (LH) and follicle stimulating hormone (FSH) values with subsequent increases in serum levels of testosterone. Chronic administration leads to sustained suppression of pituitary gonadotropins, and testosterone serum levels consequently fall into the range normally seen in surgically castrated men. This leads to accessory sex organ regression. In females, a similar down-regulation of the pituitary gland by chronic exposure to Zoladex (goserelin) leads 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 and a regression of sex hormone-responsive tumors, if present.

Zoladex (goserelin) is indicated for management of locally confined stage B2-C prostate cancer (in combination with flutamide), palliative treatment in advanced prostate cancer, endometriosis, endometrial thinning prior to endometrial ablation, and palliative treatment of breast cancer in pre- and perimenopausal women.

POLICY

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

Initial Criteria

Zoladex (goserelin) may be considered medically necessary when ALL of the following criteria are met:

1. The individual is 18 years of age or older;

2. ONE of the following:

   1. The individual has a diagnosis of advanced breast cancer and BOTH of the following:

      1. The individual is pre- or perimenopausal; AND

      2. The individual has hormone-receptor positive breast cancer;

   2. The individual has a diagnosis of prostate cancer and the requested agent ONE of the following:

      1. The individual has T2b-T4 (stage B2-C) prostate cancer and Zoladex (goserelin) will be used in combination with flutamide;

      2. The individual has advanced prostate cancer;

   3. The individual has a diagnosis of endometriosis and BOTH of the following:

      1. The individual is not pregnant and will use effective nonhormonal contraception during therapy and for 12 weeks following discontinuation of therapy; AND

      2. Treatment will be limited to 6 months; OR

   4. The individual has dysfunctional uterine bleed and BOTH of the following:

      1. The requested agent will be used for endometrial thinning prior to endometrial ablation; AND

      2. The request is for one or two depots (with each depot given four weeks apart) and ONE of the following:

         1. Surgery will be performed at four weeks when one depot is administered; OR

         2. Surgery will be performed within two to four weeks following administration of the second depot;

3. The individual does not have any contraindication(s) to therapy with the requested agent; AND

4. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval:

• Breast cancer: 12 months

• Prostate cancer: 12 months

• Endometriosis: 6 months

• Endometrial thinning: 2 months 

Renewal Criteria

Zoladex (goserelin) may be approved for RENEWAL when ALL of the following criteria are met:

1. The individual has been previously approved for therapy through BCBSMS review process;

2. ONE of the following:

   1. The individual has a diagnosis of advanced breast cancer;

   2. The individual has a diagnosis of advanced prostate cancer;

3. The individual does not have any contraindication(s) to therapy with the requested agent; AND

4. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage. 

Length of Approval:

• Breast Cancer: 12 months

• Prostate Cancer: 12 months 

Zoladex (goserelin) for endometriosis beyond 6 months is considered investigational and will not be approved.

Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

Medical Policy Manual coverage guidelines should not be used in lieu of the Participant's specific benefit plan language outlined in the Mississippi's State and School Employees’ Life and Health Insurance Plan.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Participant’s illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Participant’s condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Participant, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to the Participant. When applied to the care of an Inpatient, it further means that services for the Participant’s medical symptoms or conditions require that the services cannot be safely provided to the Participant as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

07/01/2023: New policy added.

10/01/2024: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated. Initial length of approval for breast cancer changed from "Up to 5 years" to "12 months." Renewal length of approval for breast cancer changed from "Up to 5 years OR length of tamoxifen/aromatase inhibitor therapy" to "12 months." Sources updated.

09/09/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description and policy section revised with minor changes for clarity purposes; intent unchanged. Sources updated.

10/01/2025: Code Reference section updated to add new ICD-10 diagnosis codes C50.A0, C50.A1, and C50.A2.

SOURCE(S)

Zoladex prescribing information. TerSera Therapeutics LLC. March 2023. Last accessed July 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.