ModifiedMolina HealthcarePolicy C8757-A

Zoladex (goserelin acetate) Coverage Criteria

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This policy governs Molina Healthcare coverage and prior authorization requirements for Zoladex (goserelin acetate) for prostate cancer, breast cancer, endometriosis, dysfunctional uterine bleeding or uterine leiomyomas, and prevention of chemotherapy-induced premature ovarian insufficiency. It applies to providers requesting coverage for eligible members, subject to the member’s benefit plan and the clinical criteria in this policy.

Policy Summary

PayerMolina Healthcare

PolicyZoladex (goserelin acetate) Coverage Criteria

Policy CodePolicy C8757-A

Change TypeModified

Effective DateAug 30, 2026

Next Review DateJul 1, 2027

Key ActionSubmit complete medical rationale and supporting documentation for the requested indication, including diagnosis, treatment history, and applicable prescriber information.

SourceLink

POLICY UPDATE CHANGES

The policy revision summary identifies updates to required medical information, continuation-of-therapy requirements, and quantity criteria.

The policy revision summary identifies updates to diagnosis requirements, duration of approval, prescriber requirements, FDA-approved uses, and other special considerations.

The policy revision summary identifies updates to continuation-of-therapy and duration-of-therapy requirements.

5Covered indication groups

12 monthsMaximum authorization period for prostate and breast cancer

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ModifiedMolina HealthcarePolicy C8757-A

Zoladex (goserelin acetate) Coverage Criteria

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Sign up for Molina Healthcare Policy C8757-A alerts

Get alerted when Policy C8757-A changes without checking for updates manually.

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Policy Summary

PayerMolina Healthcare

PolicyZoladex (goserelin acetate) Coverage Criteria

Policy CodePolicy C8757-A

Change TypeModified

Effective DateAug 30, 2026

Next Review DateJul 1, 2027

Key ActionSubmit complete medical rationale and supporting documentation for the requested indication, including diagnosis, treatment history, and applicable prescriber information.

SourceLink

POLICY UPDATE CHANGES

The policy revision summary identifies updates to required medical information, continuation-of-therapy requirements, and quantity criteria.

The policy revision summary identifies updates to diagnosis requirements, duration of approval, prescriber requirements, FDA-approved uses, and other special considerations.

The policy revision summary identifies updates to continuation-of-therapy and duration-of-therapy requirements.

5Covered indication groups

12 monthsMaximum authorization period for prostate and breast cancer

6 monthsInitial authorization period for endometriosis and uterine leiomyomas

6 monthsEndometriosis lifetime maximum

18 yearsMinimum age for most indications

3.6 mg or 10.8 mgImplant strengths

Coverage Criteria

Initial therapy — prostate cancer

Covered for prostate cancer when ALL of the following are met.

Required criteria

Diagnosis and clinical appropriateness
- Diagnosis: Documentation of a diagnosis of prostate cancer
- Clinical appropriateness: Documentation that use of a gonadotropin-releasing hormone agonist is recommended for the member’s stage and disease according to updated NCCN guidelines for prostate cancer
Eligard prerequisite
- Trial and failure: Documentation of trial and failure of Eligard (leuprolide acetate)
- Serious side effects: Documentation of serious side effects from Eligard (leuprolide acetate)
- Labeled contraindication: Documentation of a labeled contraindication to Eligard (leuprolide acetate)

Initial therapy — breast cancer

Covered for breast cancer when the diagnosis is documented and ANY one of the following applies.

Breast cancer diagnosis and qualifying circumstance

Diagnosis: Documented diagnosis of breast cancer
Eligible clinical circumstance
- Premenopausal ovarian suppression: Female member who is pre-menopausal at diagnosis and requires ovarian suppression
- Male adjuvant endocrine therapy: Male member requiring adjuvant endocrine therapy

Initial therapy — endometriosis

Covered for endometriosis when ALL of the following are met.

Required criteria

Diagnosis: Documentation of a diagnosis of endometriosis
Failure or contraindication of all required alternatives
- NSAID alternative: Member has tried and failed or has an absolute contraindication to one formulary NSAID, such as ibuprofen or naproxenone formulary NSAID
- Hormonal alternative: Member has tried and failed or has an absolute contraindication to one formulary preferred oral estrogen-progestin contraceptive, medroxyprogesterone, or norethindrone acetateone preferred alternative

Initial therapy — dysfunctional uterine bleeding or uterine leiomyomas

Covered for dysfunctional uterine bleeding or uterine leiomyomas when ALL of the following are met, including ONE treatment-purpose pathway.

Required criteria

Confirmed diagnosis: Uterine leiomyomas confirmed with pelvic imaging
Qualifying symptoms: Member is symptomatic with heavy or prolonged menstrual bleeding, bulk-related symptoms such as pelvic pressure or pain, or reproductive dysfunction such as infertility or obstetric complicationsAt least one qualifying symptom
Treatment purpose
- Preoperative therapy for 3–6 months before surgery because the member has a contraindication to oral iron supplementation and anemia correction is necessary, or volume reduction is necessary before the procedure3–6 months before surgery

Initial therapy — prevention of chemotherapy-induced premature ovarian insufficiency

Covered for prevention of chemotherapy-induced premature ovarian insufficiency when ALL of the following are met.

Required criteria

Post-puberty: Member is post-pubertyPost-puberty
Gonadotoxic treatment: Member is undergoing premenopausal gonadotoxic therapy or gonadotoxic surgeryPremenopausal gonadotoxic therapy or surgery
Cryopreservation status: Prescriber attests that the member is not a candidate for cryopreservation or is not eligible for cryopreservationNot a candidate or not eligible

Continuation therapy — endometriosis and uterine leiomyomas

Continuation therapy is not applicable for endometriosis or dysfunctional uterine bleeding or uterine leiomyomas.

No continuation pathway: Continuation therapy is not applicable for endometriosis or dysfunctional uterine bleeding or uterine leiomyomas

Continuation therapy — all other indications

For all other indications, continuation therapy requires ALL of the following.

Continuation requirements

Tolerability and safety: Prescriber attests to, or clinical reviewer has found, no evidence of intolerable adverse effects or drug toxicity, including tumor flare, hyperglycemia or diabetes, cardiovascular disease such as myocardial infarction, sudden cardiac death, or stroke, QT/QTc prolongation, or convulsionsNo intolerable toxicity
Clinical benefit or ongoing chemotherapy: Documentation of improvement in signs and symptoms and/or stabilization of disease due to therapy, or documentation that the member continues on gonadotoxic chemotherapyImprovement, stabilization, or ongoing gonadotoxic chemotherapy

Age restrictions

Age eligibility depends on the indication.

Age eligibility

Chemotherapy-induced premature ovarian insufficiency: Member must be post-pubertyPost-puberty
All other indications: Member must be 18 years of age or older>=18 years

Continuation therapy is not applicable for endometriosis or for dysfunctional uterine bleeding or uterine leiomyomas.

Hypersensitivity to Zoladex (goserelin acetate) is a contraindication. Pregnancy is also a contraindication unless Zoladex is being used for advanced breast cancer.

All other uses of Zoladex (goserelin acetate) are considered experimental or investigational and follow Molina's Off-Label policy.

Initial Therapy Criteria

Prostate cancer — initial therapy

Initial therapy for prostate cancer requires ALL listed criteria.

Required criteria

Diagnosis and clinical appropriateness
- Diagnosis: Documentation of a diagnosis of prostate cancer
- Clinical appropriateness: Documentation that use of a gonadotropin-releasing hormone agonist is recommended for the member’s stage and disease according to updated NCCN guidelines for prostate cancer
Eligard prerequisite
- Trial and failure:

Continuation Requirements

Continuation requirements — all other indications

For all indications other than endometriosis and dysfunctional uterine bleeding or uterine leiomyomas, continuation therapy requires ALL of the following.

Continuation requirements

Tolerability and safety: Prescriber attests to, or clinical reviewer has found, no evidence of intolerable adverse effects or drug toxicity, including tumor flare, hyperglycemia or diabetes, cardiovascular disease such as myocardial infarction, sudden cardiac death, or stroke, QT/QTc prolongation, or convulsionsNo intolerable toxicity
Clinical benefit or ongoing chemotherapy: Documentation of improvement in signs and symptoms and/or stabilization of disease due to therapy, or documentation that the member continues on gonadotoxic chemotherapyImprovement, stabilization, or ongoing gonadotoxic chemotherapy

Step Therapy Requirements

Step	Indication	Requirement	Required documentation
1	Prostate cancer	Prior use or inability to use Eligard	Trial and failure, serious side effects, or a labeled contraindication to Eligard (leuprolide acetate).

Step	Indication	Requirement	Required documentation
1	Endometriosis	Failure or contraindication to all listed formulary alternatives	Trial and failure or an absolute contraindication to one formulary NSAID (such as ibuprofen or naproxen) and one formulary preferred oral estrogen-progestin contraceptive, medroxyprogesterone, or norethindrone acetate.

Dosage and Quantity Limits

Zoladex quantity limits

IndicationProstate cancer

Implant strength3.6 mg or 10.8 mg

Dosing intervalOne 3.6 mg implant per 4 weeks or one 10.8 mg implant per 12 weeks

Zoladex quantity limits

IndicationBreast cancer

Implant strength3.6 mg or 10.8 mg

Dosing interval3.6 mg every 28 days or one 10.8 mg implant per 12 weeks

Site of Care Guidance

Denial Risk

Provider Action: Site of Care and Coverage Requirements

Before administration, the provider must complete benefit and medical necessity review and confirm that the applicable coverage, clinical, documentation, prescribing, and billing requirements are satisfied. Injectable implant medications covered under this policy may be administered under the pharmacy or medical benefit only in a non-hospital, facility-based place of service.

Benefit and medical necessity review: Confirm the applicable benefit and establish medical necessity before treatment.
Qualified prescriber required: Treatment must be prescribed and managed by a qualified prescriber.
Prostate cancer criteria not met: Do not administer or bill when the applicable prostate cancer coverage criteria are not met.
Indication-specific criteria not met: Do not administer or bill when the criteria for the requested indication are not satisfied.
Administrative and dosing requirements not met: Confirm that all authorization, administration, frequency, and dosing requirements are met before treatment.
Contraindications: Review for contraindications and do not administer when a contraindication is present.
Improper billing or noncovered benefit: Do not submit claims for improper billing, an ineligible place of service, or a noncovered benefit.

Coding Information

HCPCS CodeHCPCS

J9202

Goserelin acetate implant, per 3.6mg

Provider Requirements and Denial Risks

Prior Authorization

Complete the benefit and medical necessity review

Coverage is subject to the member’s benefit eligibility and this guideline. Submit complete medical rationale for any exception; if the drug received an updated FDA label within the prior 180 days, medical necessity may be reviewed case by case using the updated label information.

Prior Authorization

Use a qualified prescriber

Ensure the prescriber meets the indication-specific specialty requirement or provides the required consultation.

Prostate or breast cancer: oncologist or urologist.
Endometriosis or dysfunctional uterine bleeding or uterine leiomyomas: gynecologist or women’s health specialist.
Prevention of chemotherapy-induced premature ovarian insufficiency: gynecologist or oncologist.

Policy Background

Zoladex (goserelin acetate) is covered for specified hormone-sensitive oncology and gynecologic uses, including androgen or ovarian suppression for prostate or breast cancer, treatment of endometriosis and symptomatic uterine leiomyomas, and prevention of chemotherapy-induced premature ovarian insufficiency.

Indication Definitions

Qualifying symptomatic uterine leiomyomas

ConfirmationUterine leiomyomas must be confirmed with pelvic imaging

Bleeding symptomsHeavy or prolonged menstrual bleeding

Bulk-related symptomsPelvic pressure or pain

Reproductive dysfunctionInfertility or obstetric complications

Chemotherapy-induced premature ovarian insufficiency prevention

Puberty statusMember must be post-puberty

Treatment statusUndergoing premenopausal gonadotoxic therapy or gonadotoxic surgery

Policy Summary

PayerMolina Healthcare

PolicyZoladex (goserelin acetate) Coverage Criteria

Policy CodePolicy C8757-A

Change TypeModified

Effective DateAug 30, 2026

Next Review DateJul 1, 2027

Key ActionSubmit complete medical rationale and supporting documentation for the requested indication, including diagnosis, treatment history, and applicable prescriber information.

SourceLink

On This Page

Either stated preoperative rationale may qualify

Transitional therapy for a member in late perimenopause as the member moves to menopause

See the policy’s reference to ASCO recommendations

Documentation of trial and failure of Eligard (leuprolide acetate)

Serious side effects: Documentation of serious side effects from Eligard (leuprolide acetate)

Labeled contraindication: Documentation of a labeled contraindication to Eligard (leuprolide acetate)

Breast cancer — initial therapy

Initial therapy for breast cancer requires a documented diagnosis plus ANY one qualifying circumstance.

Breast cancer diagnosis and qualifying circumstance

Diagnosis: Documented diagnosis of breast cancer
Eligible clinical circumstance
- Premenopausal ovarian suppression: Female member who is pre-menopausal at diagnosis and requires ovarian suppression
- Male adjuvant endocrine therapy: Male member requiring adjuvant endocrine therapy

Endometriosis — initial therapy

Initial therapy for endometriosis requires ALL listed criteria.

Required criteria

Diagnosis: Documentation of a diagnosis of endometriosis
Failure or contraindication of all required alternatives
- NSAID alternative: Member has tried and failed or has an absolute contraindication to one formulary NSAID, such as ibuprofen or naproxenOne formulary NSAID
- Hormonal alternative: Member has tried and failed or has an absolute contraindication to one formulary preferred oral estrogen-progestin contraceptive, medroxyprogesterone, or norethindrone acetateOne preferred alternative

Dysfunctional uterine bleeding or uterine leiomyomas — initial therapy

Initial therapy for dysfunctional uterine bleeding or uterine leiomyomas requires ALL listed criteria and ONE treatment-purpose pathway.

Required criteria

Confirmed diagnosis: Uterine leiomyomas confirmed with pelvic imaging
Qualifying symptoms: Member is symptomatic with heavy or prolonged menstrual bleeding, bulk-related symptoms such as pelvic pressure or pain, or reproductive dysfunction such as infertility or obstetric complicationsAt least one qualifying symptom
Treatment purpose
- Preoperative therapy for 3–6 months before surgery because the member has a contraindication to oral iron supplementation and anemia correction is necessary, or volume reduction is necessary before the procedure3–6 months before surgery
- Transitional therapy for a member in late perimenopause as the member moves to menopause

Prevention of chemotherapy-induced premature ovarian insufficiency — initial therapy

Initial therapy for prevention of chemotherapy-induced premature ovarian insufficiency requires ALL listed criteria.

Required criteria

Post-puberty: Member is post-pubertyPost-puberty
Gonadotoxic treatment: Member is undergoing premenopausal gonadotoxic therapy or gonadotoxic surgeryPremenopausal gonadotoxic therapy or surgery
Cryopreservation status: Prescriber attests that the member is not a candidate for cryopreservation or is not eligible for cryopreservationNot a candidate or not eligible

Zoladex quantity limits

IndicationEndometriosis

Implant strength3.6 mg

Schedule and limitEvery 28 days for up to 6 months

Zoladex quantity limits

IndicationDysfunctional uterine bleeding or uterine leiomyomas

Implant strength3.6 mg

Schedule and limitEvery 28 days for up to 2 doses

Zoladex quantity limits

IndicationPrevention of chemotherapy-induced premature ovarian insufficiency

Implant strength3.6 mg

Dosing intervalEvery 28 days

Zoladex quantity limits

IndicationProstate cancer

Implant strength3.6 mg or 10.8 mg

Dosing intervalOne 3.6 mg implant every 4 weeks or one 10.8 mg implant every 12 weeks

Zoladex quantity limits

IndicationBreast cancer

Implant strength3.6 mg or 10.8 mg

Dosing intervalOne 3.6 mg implant every 28 days or one 10.8 mg implant every 12 weeks

Zoladex quantity limits

IndicationEndometriosis

Implant strength3.6 mg

Schedule and limitEvery 28 days for up to 6 months

Zoladex quantity limits

IndicationDysfunctional uterine bleeding or uterine leiomyomas

Implant strength3.6 mg

Schedule and limitEvery 28 days for up to 2 doses

Zoladex quantity limits

IndicationPrevention of chemotherapy-induced premature ovarian insufficiency

Implant strength3.6 mg

Dosing intervalEvery 28 days

Breast cancer documentation: Maintain documentation supporting the breast cancer indication and medical necessity, when applicable.

Endometriosis documentation: Maintain documentation supporting the endometriosis diagnosis, indication, and medical necessity, when applicable.

Consultation notes: Include relevant specialist consultation notes in the clinical record when required to support treatment.

Formulary alternatives for endometriosis: Document consideration, trial, failure, intolerance, or inappropriateness of applicable formulary alternatives when required for endometriosis treatment.

Provider action: Verify all applicable policy requirements, document the review, and use the appropriate covered benefit and site of care before administration.

Step Therapy

Meet the Eligard prerequisite

For prostate cancer, document that the member has tried and failed Eligard (leuprolide acetate), experienced serious side effects, or has a labeled contraindication to Eligard.

Step Therapy

Document formulary alternatives for endometriosis

For endometriosis, document trial and failure or an absolute contraindication to all required formulary alternatives.

One formulary NSAID, such as ibuprofen or naproxen.
One formulary preferred oral estrogen-progestin contraceptive, medroxyprogesterone, or norethindrone acetate.

Documentation Required

Provide complete medical records

Submit medical records, test results, and the credentials of the provider ordering or performing the drug or service when requested. Molina may require additional documentation for coverage determination, quality improvement, and fraud, waste, and abuse prevention.

Documentation Required

Support dosing and exceptions

Provide member-specific dosing information when the requested product is dosed by weight, body surface area, or another member-specific measurement, and provide complete medical rationale for guideline exceptions.

Documentation Required

Document prostate cancer requirements

For prostate cancer, document the diagnosis, that a gonadotropin-releasing hormone agonist is recommended for the member’s stage and disease under updated NCCN guidelines, and the applicable Eligard pathway.

Trial and failure, serious side effects, or labeled contraindication to Eligard (leuprolide acetate).

Documentation Required

Document breast cancer requirements

For breast cancer, document the diagnosis and the applicable clinical circumstance.

Female member who was pre-menopausal at diagnosis and requires ovarian suppression.
Male member requiring adjuvant endocrine therapy.

Documentation Required

Document endometriosis requirements

For endometriosis, document the diagnosis and trial and failure or an absolute contraindication to each required formulary alternative.

One formulary NSAID, such as ibuprofen or naproxen.
One formulary preferred oral estrogen-progestin contraceptive, medroxyprogesterone, or norethindrone acetate.

Documentation Required

Document uterine leiomyoma requirements

For dysfunctional uterine bleeding or uterine leiomyomas, document pelvic-imaging confirmation, qualifying symptoms, and the treatment purpose.

Qualifying symptoms include heavy or prolonged menstrual bleeding, pelvic pressure or pain, infertility, or obstetric complications.
Treatment must be preoperative therapy for 3–6 months or transitional therapy for a member in late perimenopause moving to menopause.

Documentation Required

Document ovarian insufficiency prevention requirements

For prevention of chemotherapy-induced premature ovarian insufficiency, document that the member is post-puberty, is undergoing premenopausal gonadotoxic therapy or gonadotoxic surgery, and is not a candidate for or eligible for cryopreservation as attested by the prescriber.

Documentation Required

Submit consultation notes

When treatment is prescribed in consultation, submit the consultation notes with both the initial request and reauthorization requests.

Denial Risk

Avoid insufficient supporting documentation

Coverage may be denied when submitted documentation does not support medical necessity, non-investigational or non-experimental use, benefit eligibility, or appropriate billing and utilization.

Denial Risk

Prostate cancer criteria must be met

A prostate cancer request may be denied without a documented diagnosis, a recommendation for a gonadotropin-releasing hormone agonist appropriate to the member’s stage and disease, or an applicable Eligard pathway.

The Eligard pathway must show trial and failure, serious side effects, or a labeled contraindication.

Denial Risk

Meet indication-specific criteria

Requests may be denied when required indication-specific documentation is missing or incomplete for endometriosis, uterine leiomyomas, or prevention of chemotherapy-induced premature ovarian insufficiency.

Endometriosis: diagnosis and required formulary-alternative trial and failure or absolute contraindications.
Uterine leiomyomas: imaging confirmation, qualifying symptoms, and an eligible treatment purpose.
Ovarian insufficiency prevention: post-puberty status, gonadotoxic therapy or surgery, and cryopreservation status.

Denial Risk

Satisfy administrative and dosing requirements

Requests may be denied when prescriber specialty, age or post-puberty requirements, consultation documentation, or indication-specific dose and duration limits are not satisfied.

Members must be 18 years of age or older for indications other than prevention of chemotherapy-induced premature ovarian insufficiency.
Dose and duration limits vary by indication.

Denial Risk

Use only specified covered indications

Coverage may be denied when Zoladex is requested for uses other than the specified covered indications because those uses are considered experimental or investigational and follow Molina’s Off-Label policy.

Denial Risk

Screen for contraindications

Do not request Zoladex for a patient with hypersensitivity to goserelin acetate or for a patient who is pregnant, except when Zoladex is being used for advanced breast cancer.

Billing Rule

Bill appropriately and verify coverage

Use appropriate, industry-standard coding and confirm that the service is a covered benefit before submitting the claim. Molina may reject or deny an improperly billed or noncovered claim and recover claim payments; listing a code does not guarantee coverage.

HCPCS code J9202 describes goserelin acetate implant, per 3.6 mg.
Deleted or ineffective codes may not be eligible for reimbursement.

CryopreservationPrescriber must attest that the member is not a candidate for or is not eligible for cryopreservation