Prior authorization validity and renewal periods

Prior authorization is required for Zoladex. Initial authorizations are provided for 12 months (365 days) unless otherwise specified; exceptions include endometriosis (initial PA validity 6 months/180 days) and dysfunctional uterine bleeding (authorization for 2 doses only, given 4 weeks apart). Renewals generally may be provided every 12 months thereafter unless the indication specifies otherwise (endometriosis and dysfunctional uterine bleeding may NOT be renewed; fertility preservation may be renewed every 12 months while chemotherapy continues).

• Initial: 12 months (365 days) standard
• Endometriosis: initial 6 months (180 days); may NOT be renewed
• Dysfunctional uterine bleeding: authorization for 2 doses only (28 days apart); may NOT be renewed
• Fertility preservation while receiving chemotherapy: renewable every 12 months while receiving chemotherapy

Prior authorization consideration for goserelin

Prior authorization should be considered and may be applied for goserelin; the plan's NQTL assessment identified indication and drug cost as factors supporting PA for this drug.

• NQTL checklist: Indication = consider for PA; Cost of drug = consider for PA

Diagnosis code required on authorization

Include an ICD-10 diagnosis code from Appendix 1 with authorization requests to support medical necessity for Zoladex; claims or requests lacking a listed covered diagnosis code risk denial.

• Appendix 1 contains the covered ICD-10 diagnosis codes to support authorization
• Omissions of a covered diagnosis code may lead to non-coverage or denial

Fertility preservation — prior options required

For the fertility-preservation indication, document that the member is premenopausal, receiving cytotoxic chemotherapy with potential to cause ovarian damage, and has failed or is not a candidate for other fertility preservation methods (e.g., cryopreservation).

• Member is premenopausal
• Member is receiving cytotoxic chemotherapy with potential for ovarian toxicity
• Member has failed or is not a candidate for other fertility preservation methods (cryopreservation, etc.)

Step therapy / PA note

No explicit step therapy steps are listed in this excerpt; prior authorization use is based on the plan's NQTL factors (including cost) rather than specified prerequisite drug trials.

• Policy does not specify mandatory prior medication trial steps in the excerpt
• PA consideration is influenced by indication and cost per the NQTL checklist

Indication-specific clinical documentation required

Provide indication-specific clinical documentation with the PA request — examples include hormone receptor status and concurrent endocrine therapy for breast cancer; confirmation of cytotoxic chemotherapy for fertility preservation; androgen-receptor positivity and combination therapy documentation for head and neck salivary gland tumors; ER/PR+ status and suitability for non-surgical management for uterine sarcoma; and mental health assessment/informed consent for gender dysphoria.

• Breast cancer: hormone receptor–positive status and documentation of concurrent endocrine therapy or aromatase inhibitor use (as applicable)
• Fertility preservation: documentation member is receiving cytotoxic chemotherapy
• Head & neck (salivary gland): androgen-receptor positive disease and documentation of combination therapy (abiraterone + prednisone)
• Uterine sarcoma: ER/PR+ disease and rationale for non-surgical management
• Gender dysphoria: qualified MHP confirmation, informed consent, and counseling on fertility effects

Required documentation for PA requests and billing

Document orders with the treated indication and the depot dosing regimen (3.6 mg every 4 weeks OR 10.8 mg every 12 weeks; some indications specify 3.6 mg only). Billing should use HCPCS J9202 (goserelin acetate implant, per 3.6 mg) and the appropriate product NDCs where applicable.

• Order must state indication and dosing schedule (3.6 mg q4 weeks or 10.8 mg q12 weeks; see policy for indications requiring 3.6 mg only or specific sequencing)
• Bill using HCPCS J9202 (1 billable unit = 3.6 mg)
• Use the appropriate NDC: Zoladex 10.8mg 3-Month Implant: 70720-0951-XX; Zoladex 3.6mg Implant: 70720-0950-XX

Medicare coverage and documentation requirements

For Medicare Part B members, follow applicable Medicare guidance (Medicare Benefit Policy Manual and any relevant NCDs, LCDs, or LCAs) and include supporting documentation aligned with the applicable MAC jurisdiction policies.

• Consult NCDs/LCDs/LCAs where applicable and include documentation consistent with those determinations
• Use the CMS Coverage Database to locate applicable MAC/NCD/LCD documents

Unacceptable toxicity may trigger denial of renewal

Renewal or continuation requests may be denied if the member has unacceptable toxicity from the drug; examples include severe QT/QTc prolongation, severe hyperglycemia/diabetes, major cardiovascular events (MI, stroke), hypercalcemia, severe injection-site or vascular injury, tumor flare, severe hypersensitivity or severe cutaneous adverse reactions (SJS/TEN, DRESS, AGEP), new or worsening depression, among others.

• Unacceptable toxicity is a criterion for denial of renewal
• Listed examples include severe QT/QTc prolongation; severe hyperglycemia/diabetes; cardiovascular events (MI, stroke); hypercalcemia; severe injection site/vascular injury; tumor flare; severe hypersensitivity and severe cutaneous adverse reactions (SJS/TEN, DRESS, AGEP); new or worsening depression

PA applied due to indication and cost factors

Prior authorization is applied in part because the plan's NQTL assessment identified indication and cost as reasons to consider PA for this agent; providers should anticipate PA requirements for Zoladex.

• NQTL factors: Indication = consider for PA; Cost = consider for PA

Diagnosis code omission risks denial

Claims or authorization requests that do not include a covered ICD-10 diagnosis code from Appendix 1 are at risk for denial as not medically necessary.

• Appendix 1 lists the ICD-10 codes that support coverage (e.g., N80.* series and related codes)
• Absence of a listed covered diagnosis code may render the claim or PA request not medically necessary

Site-of-care: office (no restrictions specified)

Billing/availability information is provided; no site-of-care restrictions are specified in this excerpt (site listed as office).