CurrentCareSourcePolicy N/A

Zoladex (goserelin acetate) pharmacy coverage

Defines prior authorization, site of service, quantity limits, and clinical criteria for coverage of Zoladex (goserelin acetate) under the pharmacy benefit for CareSource Arkansas PASSE members.

Policy Summary

PayerCareSource

PolicyZoladex (goserelin acetate) pharmacy coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and submit requests for breast or prostate cancer via the NantHealth/Eviti portal; use a valid NDC for billing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Prior AuthorizationCoverage requirement for non-preferred product

Home/OfficeAllowed site of service

Up to 2Quantity per ablation

6 monthsInitial approval (endometriosis)

Not beyond 6 moReauthorization limit (endometriosis)

Coverage Criteria for Zoladex (goserelin acetate)

inv-01: Dysfunctional Uterine Bleeding - Initial

Covered when ALL of the following are met for dysfunctional uterine bleeding (initial authorization)

Dysfunctional uterine bleeding - initial: Member is premenopausal and >= 18 years old; Medication prescribed by or in consultation with a gynecologist; Member will be undergoing endometrial ablation for dysfunctional uterine bleeding; Member is not pregnant or breastfeeding; Dosage allowed: up to 2 implants (3.6 mg per implant) per ablation procedure; If criteria met, approved for 28 days; Retreatment is not allowed (one-time use).

inv-02: Endometriosis - Initial

Covered when ALL of the following are met for endometriosis (initial authorization)

Endometriosis - initial: Member is premenopausal and >= 18 years old; Medication prescribed by or in consultation with a gynecologist; Member has painful symptoms associated with endometriosis (documentation required); Member has tried and failed 30 days of an NSAID and 3 months of a hormonal contraceptive unless not tolerated or contraindicated; Member is not pregnant or planning to become pregnant while taking medication; Dosage: implant (3.6 mg) subcutaneously every 28 days; If criteria met, approved for 6 months.

Policy Summary

PayerCareSource

PolicyZoladex (goserelin acetate) pharmacy coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and submit requests for breast or prostate cancer via the NantHealth/Eviti portal; use a valid NDC for billing.

SourceLink

On This Page

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inv-03: Cancer

Covered for cancer when authorization pathway requirements are met

Cancer (breast or prostate): Requests for breast cancer or prostate cancer must be submitted through the NantHealth/Eviti portal as stated.

Any cancer requests for breast or prostate cancer require portal submission.

Zoladex (goserelin acetate) is not medically necessary when used to treat diseases or indications that are not specifically listed in this policy document.

Use of Zoladex (goserelin acetate) for any indication not included in this policy is considered not medically necessary and may be denied.

Initial Therapy Rules

inv-14: Initial Therapy

Initial therapy rules per indication

Dysfunctional uterine bleeding initial: See coverage criteria: member is premenopausal and >=18 years old; medication prescribed by or in consultation with a gynecologist; planned endometrial ablation; member not pregnant or breastfeeding; up to 2 implants (3.6 mg each) per ablation; approved for 28 days; one-time use (no retreatment).

Endometriosis initial: See coverage criteria: member is premenopausal and >=18 years old; medication prescribed by or in consultation with a gynecologist; documented painful symptoms of endometriosis required; failed 30 days NSAID and 3 months hormonal contraceptive unless intolerant/contraindicated; member not pregnant or planning pregnancy while on therapy; implant (3.6 mg) every 28 days; if criteria met, approved for 6 months.

Reauthorization / Continuation Criteria

inv-15: Reauthorization

Reauthorization rules

Endometriosis reauthorization: Retreatment will not be authorized beyond 6 months due to lack of clinical data to support use beyond 6 months.

Required Medication Trials / Step Therapy

Step	Required trial	Duration / details	Coverage status
1	Nonsteroidal anti-inflammatory drug (NSAID)	30 days	Member must have tried and failed unless not tolerated or contraindicated
2	Hormonal contraceptive	3 months	Member must have tried and failed unless not tolerated or contraindicated

Quantity Limits and Dosing

inv-17: Zoladex (goserelin acetate) — Up to 2 implants (3.6 mg per implant) per ablation procedure

Quantity limitUp to 2 implants (3.6 mg per implant) per endometrial ablation procedure

Per authorizationOne-time use prior to endometrial ablation (retreatment not allowed)

Approval durationApproved for 28 days when criteria met

inv-18: Zoladex (goserelin acetate) — Implant (3.6 mg) every 28 days

Dosage intervalImplant (3.6 mg) subcutaneously every 28 days

Indication contextUsed for endometriosis when initial authorization criteria are met (documentation of painful symptoms required)

Approval durationIf criteria met, approved for 6 months

Billing and Coding

Billing/NDC requirementNDC

NDC	Must use a valid NDC code

inv-07: Age — >= 18 years

Minimum age>= 18 years

PopulationPremenopausal members for gynecologic indications

ApplicabilityRequired for initial authorization across dysfunctional uterine bleeding and endometriosis

Provider Actions, Documentation & Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for Zoladex (goserelin acetate) as a non-preferred product under the pharmacy benefit. Requests for breast cancer or prostate cancer must be submitted through the NantHealth/Eviti portal.

Must use a valid NDC code on claims.
Benefit type: Pharmacy; Site of service allowed: Home/Office.
Coverage requirement: Prior Authorization Required (Non-Preferred Product).

Documentation Required

Clinical Documentation Required

For endometriosis, dysfunctional uterine bleeding, and cancer indications, document the clinical diagnosis and supporting clinical information. For endometriosis include documentation of painful symptoms (e.g., pelvic pain, dysmenorrhea). For breast or prostate cancer, submit the request through the NantHealth/Eviti portal.

Endometriosis: documentation of symptoms and prior medication trials required.
Dysfunctional uterine bleeding: documentation of planned endometrial ablation and gynecologist involvement.
Cancer: submit via NantHealth/Eviti for breast or prostate cancer requests.

Step Therapy

Required Prior Medication Trials & Clinical Criteria

Prior medication trials required for endometriosis: member must have tried and failed both of the following unless not tolerated or contraindicated — 30 days of an NSAID and 3 months of a hormonal contraceptive. For dysfunctional uterine bleeding, medication must be prescribed by or in consultation with a gynecologist and member must be premenopausal (≥18 years) and not pregnant or breastfeeding.

Endometriosis initial authorization: premenopausal and ≥18 years, painful symptoms documented, prescribed by/with gynecologist, not pregnant or planning pregnancy, dosage: 3.6 mg implant every 28 days, approval up to 6 months.
Dysfunctional uterine bleeding initial authorization: premenopausal and ≥18 years, prescribed by/with gynecologist, undergoing endometrial ablation, not pregnant or breastfeeding, dosage: up to 2 implants (3.6 mg per implant) per ablation procedure, approved for 28 days, retreatment not allowed.

Denial Risk

Not Medically Necessary / Denial Risk

Use of Zoladex for indications not listed in this policy is considered not medically necessary and may be denied. Retreatment beyond the stated durations is not authorized due to lack of supporting clinical data (e.g., endometriosis beyond 6 months, dysfunctional uterine bleeding retreatment not allowed).

Not medically necessary: any disease states not listed in this document.
Reauthorization: retreatment beyond approved durations (endometriosis >6 months) will not be authorized.

Allowed Site of Care

Note

Site of care: home allowed

Zoladex may be administered at the member's home.

Note

Site of care: office allowed

Zoladex may be administered in an office setting.

Definitions

inv-13: Non-preferred product — Non-preferred product: Zoladex is classified as non-preferred under the pharmacy benefit and requires prior authorization for coverage.

Coverage classificationNon-preferred product under the pharmacy benefit

Prior authorizationPrior authorization required for coverage

Billing requirementMust use a valid NDC code for billing

Site of serviceAllowed at home or office

Background

Goserelin acetate (Zoladex) is a gonadotropin-releasing hormone (GnRH) agonist used for hormone-responsive conditions such as certain cancers, endometriosis, and as an adjunct prior to endometrial ablation in dysfunctional uterine bleeding. The policy specifies indication-specific eligibility, duration limits, and required prescriber specialty or consultation for gynecologic indications; notably, retreatment and reauthorization beyond 6 months is not authorized due to lack of clinical data to support use beyond that duration.