CurrentMass General Brigham Health PlanPolicy N/A

Zoladex

Pharmacy-benefit prior authorization policy for Zoladex (goserelin) 3.6 mg and 10.8 mg, covering FDA-approved indications and specified compendial uses with diagnosis-specific authorization criteria, specialty pharmacy requirement, and duration limits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyZoladex

Policy CodePolicy N/A

Change TypeRevised (benefit routing change)

Effective DateJan 1, 2026

Next Review Date

Key ActionSubmit prior authorization through the pharmacy benefit and ensure specialty pharmacy dispensing and documentation of diagnosis-specific criteria to support approval.

SourceLink

POLICY UPDATE CHANGES

Policy updated to indicate that it no longer applies to the medical benefit.

Switched policy classification from SGM to Custom during 12/13/2023 review.

8Covered/compendial indications

1Specialty pharmacy requirement

3Duration categories

Coverage Summary & Scope

This is a pharmacy-benefit prior authorization policy for Zoladex (goserelin) 3.6 mg and 10.8 mg covering FDA-approved indications and specified compendial uses. The policy applies to commercial/exchange plans under the pharmacy benefit and includes a specialty pharmacy dispensing requirement. Zoladex has FDA-approved indications for prostate cancer, endometriosis (3.6 mg strength), endometrial thinning prior to ablation, and advanced breast cancer, and compendial uses include oncology and reproductive indications and gender dysphoria.

Initial Therapy Criteria

General Coverage/Authorization Rules

Authorization may be granted for members new to the plan who are currently receiving treatment with the requested medication, excluding when the product is obtained as samples or via manufacturer's patient assistance programs. OR Authorization may be granted when the following diagnosis-specific criteria are met:

ANY of the following

Existing therapy (new member)
- Member is new to the plan and currently receiving treatment with the requested medication (excluding samples or manufacturer patient assistance programs).
Diagnosis-specific criteria
- Endometriosis: Authorization may be granted for treatment of endometriosis (Zoladex 3.6 mg strength only referenced in FDA-approved indications).
- Endometrial thinning: Endometrial-thinning agent: Authorization may be granted for endometrial thinning prior to endometrial ablation or resection for dysfunctional uterine bleeding.
- Chronic anovulatory uterine bleeding with severe anemia: Authorization may be granted for treatment.
- Gender dysphoria - pubertal suppression
  - Pubertal suppression criteria
    Diagnosis: Member has a diagnosis of gender dysphoria.
    Tanner stage: Member has reached Tanner stage 2 of puberty or greater.
    Comorbid control: Member's comorbid conditions are reasonably controlled.
    Education: Member has been educated on contraindications and side effects to therapy.
    Fertility preservation:
- Gender dysphoria - gender transition
  - Transition criteria
    Diagnosis: Member has a diagnosis of gender dysphoria.
    Concomitant hormones: Member will receive the requested medication concomitantly with gender-affirming hormones.
    Comorbid control: Member's comorbid conditions are reasonably controlled.
    Education: Member has been educated on contraindications and side effects to therapy.
- Preservation of ovarian function: Authorization may be granted when the member is premenopausal and undergoing chemotherapy.
- Acute porphyria prevention: Prevention of recurrent menstrual related attacks in acute porphyria: Authorization may be granted when prescribed by or in consultation with a physician experienced in porphyria management.
- Uterine leiomyomata (fibroids): Authorization may be granted for treatment prior to surgery.
- Oncology NCCN review: Oncology uses (breast cancer, prostate cancer): All oncology criteria will be reviewed against Oncology Medication Review - NCCN guidelines with Category of Evidence and Consensus of 1, 2A, or 2B.

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Continuation / Reauthorization Criteria

Reauthorization / Continuation

All members (including new members) requesting authorization for continuation of therapy for specified indications must meet all initial authorization criteria.

Continuation must meet initial criteria

Endometriosis: reauthorization requires meeting initial criteria.
Endometrial-thinning prior to ablation/resection: reauthorization requires meeting initial criteria.
Preservation of ovarian function: reauthorization requires meeting initial criteria.
Acute porphyria prevention: Prevention of recurrent menstrual related attacks in acute porphyria: reauthorization requires meeting initial criteria.
Uterine leiomyomata (fibroids): reauthorization requires meeting initial criteria.