EmblemHealth LHRH/GnRH Coverage Update

Coverage Criteria for LHRH/GnRH Agonists and Antagonists

Prostate Cancer

Approve for 1 year when ALL of the following are met:

Prostate Cancer approval: Approve Camcevi, Lupron, Zoladex, Firmagon, Trelstar, or Vabrinty for 1 year if ALL of the following are met:1 year

Prescriber: Medication is prescribed by or in consultation with an oncologist or urologist

Disease state: Patient has advanced disease

Abnormal Uterine Bleeding / Pre-ablation

Approve when ALL of the following are met:

AUB prior to ablation: Approve Zoladex 3.6 mg for 2 months when used as an endometrial‑thinning agent prior to endometrial ablation2 months

Prescriber: Medication is prescribed by or in consultation with an obstetrician‑gynecologist or a healthcare practitioner who specializes in women's health

Lupron Depot AUB dosing: Lupron Depot (3.75 mg or 11.25 mg) may be approved for AUB/pre‑ablation per the Lupron-specific criteria (see Lupron Depot dosing and duration limits)see Lupron dosing

See dosing limits for total duration

Breast Cancer

Approve when ALL of the following are met:

Zoladex for breast cancer: Approve Zoladex 3.6 mg for 1 year when used in a premenopausal or perimenopausal woman and prescribed by or in consultation with an oncologist1 year

Lupron Depot for breast cancer: Lupron Depot (3.75 mg or 11.25 mg) may be approved for 1 year when prescribed by or in consultation with an oncologist (see Lupron dosing limits)1 year

Endometriosis

Approve when the listed criteria are met:

Zoladex approval: Approve Zoladex 3.6 mg for 6 months if ALL are met:6 months

Age: Patient is >= 18 years of age>=18 years

Prescriber: Medication is prescribed by or in consultation with an obstetrician‑gynecologist or a women's health specialist

Lupron Depot prior therapy: Approve Lupron Depot (3.75 mg or 11.25 mg) for 1 year if the patient has tried ONE of: a contraceptive (e.g., combination oral contraceptives or a levonorgestrel‑releasing IUD), OR an oral progesterone (e.g., norethindrone), OR a depo‑medroxyprogesterone injection, unless contraindicated

Uterine Leiomyomata

Approve when ALL of the following are met:

Lupron Depot for fibroids: Approve Lupron Depot (3.75 mg or 11.25 mg) for preoperative hematologic improvement of women with anemia caused by uterine leiomyomata when hormonal suppression for 3 months is deemed necessary3 months

Used in combination with iron therapy per product labeling

Central Precocious Puberty

Approve when ALL of the following are met:

CPP: Approve Lupron Depot‑Ped or Triptodur for central precocious puberty for 1 year1 year

Products have pediatric indications; see definitions for prescriber guidance

Salivary Gland Tumors

Approve for 1 year when ALL of the following are met:

Camcevi approval: Approve Camcevi for 1 year if ALL of the following are met:1 year

Metastases: Patient has distant metastases

AR status: Patient has androgen receptor‑positive disease

Prescriber: Medication is prescribed by or in consultation with an oncologist

Lupron alternative:

Gender Dysphoric / Gender-Incongruent Persons

Approve for 1 year when ANY of the following agent-based options is prescribed by or in consultation with an endocrinologist or clinician experienced in transgender care:

Agent options: Approve Lupron Depot, Triptodur, or Trelstar for 1 year when prescribed by or in consultation with an endocrinologist or a physician who specializes in the treatment of transgender patients1 year

Triptodur and Lupron Depot‑Ped are indicated for CPP and may be used off‑label for gender‑dysphoric/gender‑incongruent persons

Oncologic and Fertility Preservation Uses

Approve when ALL of the following are met:

Ovarian cancer: Approve Lupron Depot (various doses) for 1 year when prescribed by or in consultation with an oncologist1 year

Fertility preservation: Approve Lupron Depot (3.75 mg or 11.25 mg) for 1 year if ALL are met: patient is premenopausal; receiving cytotoxic chemotherapy with potential to cause ovarian damage; and medication is prescribed by or in consultation with an oncologist1 year

Menstrual suppression for hematologic malignancy/BMT: Approve Lupron Depot (3.75 mg or 11.25 mg) for 1 year when prescribed by or in consultation with an oncologist1 year

When a member benefits program specifically excludes a service or supply, the terms of that benefits program take precedence even if EmblemHealth’s clinical review finds the service to be medically necessary. Providers must confirm member-specific benefit coverage in addition to meeting the medical necessity criteria in this policy.

Initial Therapy Authorization Rules

Initial therapy

Initial authorization rules vary by indication; approvals are granted when the indication-specific criteria below are met.

Prostate cancer initial: Prescriber specialty and advanced disease required; approval typically for 1 year; covered agents include Camcevi, Lupron, Zoladex, Firmagon, Trelstar, Vabrinty1 year

See Prostate Cancer criteria

Endometriosis initial: Zoladex approval requires age >=18 and appropriate prescriber; Lupron Depot requires prior trial of alternative therapies unless contraindicated; durations specified per agent6-12 months depending on agent

See Endometriosis criteria and Lupron dosing limits

Continuation and Renewal Criteria

Continuation therapy durations

Continuation/renewal approvals follow the same indication-specific criteria; duration limits are applied per indication below.

Typical renewal: Many indications are approved for a fixed duration (commonly 1 year or specified months); continuation beyond initial approval requires meeting the same criteria as initial authorization and appropriate prescriber involvementsee indication-specific durations

Durations specified per criteria (e.g., 1 year for prostate cancer; 6 months for certain Zoladex uses; 3 months for fibroids; Lupron Depot total duration limits apply)

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required and Approval Durations

Prior authorization is required for medications and indications described in this policy. Approval durations are indication-specific (for example: Lupron Depot for endometriosis — 1 year; Zoladex for abnormal uterine bleeding — 2 months; Lupron Depot for uterine leiomyomata — 3 months; many cancer indications — typically 1 year).

Example approval durations: Lupron Depot (endometriosis) — 1 year; Zoladex (abnormal uterine bleeding) — 2 months; Lupron Depot (uterine leiomyomata) — 3 months; various oncology indications — 1 year.

Step Therapy

Endometriosis Step Therapy Requirement for Lupron Depot

For endometriosis, approval of Lupron Depot (3.75 mg or 11.25 mg) for up to 1 year requires that the patient has tried ONE of the following unless contraindicated: a contraceptive (e.g., combination oral contraceptives or a levonorgestrel-releasing intrauterine system such as Mirena or Liletta), an oral progesterone (e.g., norethindrone), or a depo‑medroxyprogesterone injection.

Lupron Depot (3.75 mg or 11.25 mg) — trial of contraceptive OR oral progesterone OR depo‑medroxyprogesterone required prior to approval (unless contraindicated).

Procedure, Drug and Diagnosis Codes

Applicable Procedure CodesHCPCS

J9217	Leuprolide acetate (for depot suspension), 7.5 mg, 22.5mg, 30mg, 45mg.
J1950	Injection, leuprolide acetate (for depot suspension) (Lupron Depot-Ped), 3.75 mg, 7.5mg, 11.25, 15mg, 30mg.
J9155	Injection, degarelix, 1 mg, Firmagon.
J1952	Leuprolide injectable, Camcevi.
J9202	Goserelin acetate implant, Zoladex.
J3315	Injection, triptorelin pamoate, 3.75 mg, Trelstar.
J3316	Injection, triptorelin, extended-release, 3.75 mg.

Applicable NDCsNDC

00074-3641-xx	Lupron Depot 1-Month 3.75 mg.
00074-3642-xx	Lupron Depot 1-Month 7.5 mg.
00074-3663-xx	Lupron Depot 3-Month 11.25 mg.
00074-3346-xx	Lupron Depot 3-Month 22.5 mg.
00074-3683-xx	Lupron Depot 4-Month 30 mg.
00074-3473-xx	Lupron Depot 6-Month 45 mg.
00074-2282-xx	Lupron Depot-Ped 7.5 mg / 11.25 mg.
00074-3779-xx	Lupron Depot-Ped 3-Month 11.25 mg.
00074-2440-xx	Lupron Depot-Ped 15 mg.
00074-9694-xx	Lupron Depot-Ped 3-Month 30 mg.

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ICD-10 Diagnoses (selected examples)ICD-10

C61	Malignant neoplasm of prostate.
D25.0	Submucous leiomyoma of uterus.
E30.1	Precocious puberty.
N80.0	Endometriosis of uterus.
Z85.3	Personal history of malignant neoplasm of breast.

Lupron Depot — Endometriosis duration

Total duration limitLupron Depot total duration of treatment for endometriosis is limited to 12 months.

Retreatment requirementIf retreatment is needed, Lupron Depot must be used in combination with norethindrone acetate for 6 months (per dosing limits).

Initial therapy optionsFor the first 6 months, Lupron Depot may be used as monotherapy or in combination with norethindrone acetate.

Step Therapy Requirements

Step	Required prior therapy (must try ONE unless contraindicated)	Notes
1	A contraceptive (e.g., combination oral contraceptives or levonorgestrel-releasing intrauterine system such as Mirena or Liletta)	Lupron Depot (3.75 mg or 11.25 mg) approval for endometriosis requires trial of ONE of the listed options unless contraindicated; approval duration = 1 year.
2	An oral progesterone (e.g., norethindrone tablets)	If a trial of an oral progesterone has been undertaken and documented, Lupron Depot may be approved per criteria.
3	A depo‑medroxyprogesterone injection	Trial of depo‑medroxyprogesterone is acceptable unless contraindicated; any one of the three alternatives satisfies the step requirement.

Quantity Limits and Dosing

Camcevi — Quantity / dosing

Dose strengthCamcevi 42 mg (subcutaneous), administered as 42 mg every 6 months.

RouteSubcutaneous injection.

NDC exampleCamcevi NDC listed: 72851-0042-xx.

Zoladex — Quantity / dosing

Dose strengthZoladex 3.6 mg (subcutaneous implant) typically 3.6 mg every 28 days; 10.8 mg formulation is indicated for prostate cancer only.

RouteSubcutaneous implant.

NDC exampleZoladex NDC listed: 70720-0950-36 (3.6 mg).

Administration Site and Route

Note

Follow product-specific route and administer in office/appropriate setting

Routes of administration and site of care must follow the product labeling: some products are subcutaneous (e.g., Camcevi, Zoladex, Firmagon) and others intramuscular (e.g., Lupron Depot, Trelstar, Triptodur); these agents are administered in the office or other appropriate clinical setting per labeling.

Camcevi — subcutaneous administration (42 mg every 6 months).
Lupron Depot — intramuscular administration with indication-specific dosing schedules.
Administer in office or an appropriate setting consistent with the product's route and labeling.

Product Definitions and Formulations

Background and Clinical Context

Luteinizing hormone–releasing hormone (LHRH)/gonadotropin‑releasing hormone (GnRH) agonists (for example, leuprolide and triptorelin products) and GnRH antagonists are used to suppress gonadal hormone production for a range of hormone‑dependent conditions, including advanced prostate cancer, certain breast cancers, endometriosis, uterine fibroids, central precocious puberty, and for fertility preservation or menstrual suppression during cytotoxic therapy. Use of these agents requires submission of clinical evidence that the member meets the policy criteria for review; without that documentation EmblemHealth cannot properly evaluate preauthorization or post‑payment requests.

Revision History

2025-10-06additionLatest

Added Vabrinty to the policy as an authorized agent for prostate cancer use.

2025-02-04addition

Added gender-dysphoric criteria specifying Triptodur and Trelstar (and noting Triptodur off-label use) for suppression of puberty in gender-dysphoric/gender-incongruent persons.

2024-11-25addition

OpenPayer

LHRH Agonists/Antagonists (Camcevi, Firmagon, Lupron Depot, Lupron Depot-Ped, Trelstar, Triptodur, Zoladex)

Coverage Criteria for LHRH/GnRH Agonists and Antagonists

Initial Therapy Authorization Rules

Continuation and Renewal Criteria

Provider Actions and Documentation Requirements

Procedure, Drug and Diagnosis Codes

Step Therapy Requirements

Quantity Limits and Dosing

Administration Site and Route

Product Definitions and Formulations

Background and Clinical Context

Revision History