CurrentHealth NetPolicy CP PHAR.171

Goserelin Acetate (Zoladex)

Clinical policy defining medical necessity criteria, initial and continuation approval requirements, approved indications, dosing limits, approval durations, exclusions, and coding guidance for goserelin acetate (Zoladex) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyGoserelin Acetate (Zoladex)

Policy CodePolicy CP PHAR.171

Change TypeAnnual review; criteria additions/clarifications

Effective Date10.01.16

Next Review Date

Key ActionProvider must submit office chart notes, lab results, or other clinical information supporting that member meets all approval criteria.

POLICY UPDATE CHANGES

4Q 2024 annual review: added Commercial line of business; references reviewed and updated.

Added criteria set for off-label use in gender dysphoria/gender transition (added in 4Q 2021 previously).

4Q 2021 annual review: clarified endometriosis total duration should not exceed 6 months and added dysfunctional uterine bleeding approval durations.

5Covered Indications (listed)

6 monthsMax duration for endometriosis

3.6/10.8 mgAvailable implant strengths

Coverage Summary

Coverage stance: covered_with_criteria for the listed indications: prostate cancer, breast cancer (palliative, pre-/perimenopausal), endometriosis, dysfunctional uterine bleeding (as an endometrial‑thinning agent prior to ablation), and selected off‑label use for gender dysphoria / gender transition. Scope summary: clinical policy defining medical necessity criteria, initial and continuation approval requirements, approved indications, dosing limits, approval durations, exclusions, and coding guidance for goserelin acetate (Zoladex) across Commercial, HIM, and Medicaid lines of business. Approved implant strengths: 3.6 mg and 10.8 mg.

Key Thresholds

Age for adult indications≥ 18 years

Endometriosis total duration≤ 6 months total goserelin therapy

Dysfunctional uterine bleeding implants≤ 2 implants per ablation procedure; approval duration 4–8 weeks

Maximum dosing — 3.6 mg formulation3.6 mg per 28 days (monthly)

Maximum dosing — 10.8 mg formulation10.8 mg per 3 months (alternative dosing)

Initial Therapy Criteria

Initial Approval Criteria

Zoladex is medically necessary when the following criteria are met:

Provider must submit documentation (e.g., office chart notes, lab results or other clinical information) supporting that member has met all approval criteria

Approval duration: 12 months for prostate and breast cancer; 6 months for endometriosis; 8 weeks (2 implants) for dysfunctional uterine bleeding initial approval; 12 months for gender dysphoria/gender transition