Currentmedical mutual - ohioPolicy N/A

Lupron Depot (leuprolide) long-acting injectable coverage (Coverage Criteria)

Defines Medical Mutual - Ohio's prior authorization recommendations, covered indications, required prescriber specialties, durations, and conditions not recommended for approval for long-acting injectable leuprolide (Lupron Depot). Affects providers requesting pharmacy benefit coverage for Lupron Depot.

Policy Summary

Payermedical mutual - ohio

PolicyLupron Depot (leuprolide) long-acting injectable coverage (Coverage Criteria)

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateJan 15, 2027

Key ActionObtain prior authorization and document required trials (e.g., Eligard for prostate; contraceptive/progestin/depo or norethindrone for endometriosis) and prescriber specialty when indicated.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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1 yrtypical approval

3 mofibroids duration

response requiredcontinuation rule

25references

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Authorization Criteria for Lupron Depot (leuprolide)

Prostate Cancer (initial)

Prostate Cancer — Approve when ALL criteria are met

Prostate Cancer approval: Prescribed by or in consultation with an oncologist AND patient has tried Eligard.

Approve Lupron Depot 7.5 mg, 22.5 mg, 30 mg, or 45 mg for 1 year.

Endometriosis (initial)

Endometriosis — Approve when ALL criteria are met

Endometriosis approval: Patient has tried ONE of: (A) a contraceptive (e.g., combined oral contraceptives or levonorgestrel IUD), OR (B) an oral progesterone (e.g., norethindrone), OR (C) a depo-medroxyprogesterone injection, unless contraindicated. Exception if patient has previously used a GnRH agonist or antagonist.

Approve Lupron Depot (3.75 mg or 11.25 mg) for 1 year.

Uterine Leiomyomata (fibroids)

Uterine Leiomyomata (fibroids) — Approve when ALL criteria are met

Fibroids approval: Prescribed for uterine leiomyomata (fibroids).duration limited to 3 months

Approve Lupron Depot 3.75 mg or 11.25 mg for up to 3 months; response to therapy is required for continuation.

Other oncology and specialty indications

Other covered indications — Approve when prescribed by or in consultation with specified specialists

Gender dysphoria: Prescribed by or in consultation with an endocrinologist or a clinician who specializes in transgender care.1 year approval

Response to therapy is required for continuation; approve appropriate Lupron Depot formulation for 1 year.

Ovarian/Primary peritoneal/Fallopian tube cancer: Prescribed by or in consultation with an oncologist.1 year approval

Approve Lupron Depot 3.75 mg, 7.5 mg, 11.25 mg, or 22.5 mg for 1 year.

Breast cancer: Prescribed by or in consultation with a hematologist or oncologist.1 year approval

NCCN-guideline supported uses

NCCN-cited indications

NCCN category 1/2A/2B indications: If prescriber provides a specific diagnosis listed in the NCCN guidelines as category 1, 2A, or 2B, approve.

Prescriber must document the specific NCCN-listed diagnosis.

Coverage is not recommended for indications that are not listed in the Recommended Authorization Criteria. Specific conditions identified as not recommended include: menstrual migraine (GnRH analogs eliminate menstrual migraines but their use is limited by significant adverse effects such as vasomotor symptoms, sleep disruption, and marked bone density loss) and polycystic ovarian syndrome (PCOS) (review guidance does not support GnRH agonists as a treatment for PCOS). The policy also notes that this list is not exhaustive and that coverage is not recommended for other circumstances not specified in the criteria until supportive published data are available.

Use of Lupron Depot for menstrual migraine and for polycystic ovarian syndrome (PCOS) is specifically not recommended. For menstrual migraine, although GnRH analogs can eliminate symptoms, their significant adverse effects related to estrogen deficiency (including severe vasomotor symptoms, sleep disruption, and bone loss) limit their appropriateness. For PCOS, evidence reviews and international guidelines do not support GnRH agonists as a treatment modality; GnRH products are only referenced in PCOS guidance in the context of infertility and assisted reproductive techniques. In general, circumstances not listed in the Recommended Authorization Criteria should not be approved.

Initial Therapy: Dosing and Duration Requirements

inv-22: Initial therapy durations and rules

Initial therapy durations and rules

Endometriosis initial: For the first 6 months Lupron Depot may be used as monotherapy or with norethindrone acetate; if retreatment is needed Lupron Depot must be combined with norethindrone acetate for 6 months. Total duration of treatment is limited to 12 months.max 12 months total

Formulations: 3.75 mg monthly or 11.25 mg every 3 months; approve up to 1 year per indication criteria.

Fibroids initial: Recommended duration of treatment for uterine leiomyomata (fibroids) is up to 3 months.3 months

Formulations: 3.75 mg or 11.25 mg; response to therapy required for continuation.

Requirements for Continued Authorization

inv-23: Continuation therapy requirements

Continuation requirements

Continuation for fibroids: Response to therapy is required for continuation of treatment beyond the initial approved duration for uterine leiomyomata.

Initial duration limited to 3 months.

Continuation for gender dysphoria: Response to therapy is required for continuation of treatment for gender dysphoria/gender-affirming care.

Initial approval duration is 1 year.

Required Trials of Alternative Therapies

Indication	Required prior trial(s) before approval	Notes / Approval duration
Prostate cancer	Trial of Eligard documented	Prescribed by or in consultation with an oncologist; approve Lupron Depot 7.5 mg, 22.5 mg, 30 mg, or 45 mg for 1 year
Endometriosis	Trial of ONE of: (A) a contraceptive (e.g., combination oral contraceptive or levonorgestrel IUD), OR (B) an oral progesterone (e.g., norethindrone), OR (C) depo‑medroxyprogesterone injection, unless contraindicated	Approve Lupron Depot (3.75 mg or 11.25 mg) for 1 year; exception if prior GnRH agonist/antagonist has been used

Prescriber, Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for pharmacy benefit coverage of Lupron‑Depot. Approvals are provided when the conditions in the policy criteria for the specific diagnosis are met. No specific automated prior authorization program is described in these reference chunks (Automation: None).

Prior authorization recommended for pharmacy benefit coverage of Lupron‑Depot.
Automation: None — no automated prior auth program specified in these chunks.

Note

Prescriber Specialty / Consultation Requirements

Certain indications require that Lupron‑Depot be prescribed by or in consultation with a specialist. Examples from the policy include oncologists for prostate, ovarian, uterine, head and neck, and other cancers; hematologist/oncologist for breast cancer and certain hematologic indications; endocrinologists for gender‑affirming care; and physicians who specialize in transgender care for transgender patients.

Prescriber specialty or consultation required as specified per indication (oncologist, hematologist/oncologist, endocrinologist, or clinician specializing in transgender care).

Drug and Guideline Definitions

inv-19: Lupron Depot — GnRH agonist (leuprolide) long-acting injectable

Drug classGonadotropin-Releasing Hormone (GnRH) agonist — leuprolide long‑acting injectable (Lupron Depot).

Common formulations (selected)3.75 mg monthly; 11.25 mg every 3 months; 7.5 mg monthly; 22.5 mg every 3 months; 30 mg every 4 months; 45 mg every 6 months.

Typical indications (examples)Palliative treatment of advanced prostate cancer; endometriosis (monotherapy or with norethindrone acetate); preoperative hematologic improvement for uterine leiomyomata (fibroids).

Typical initial treatment durationsEndometriosis: up to 6 months (total retreatment limited to 12 months when combined with norethindrone acetate); Fibroids: recommended up to 3 months; prostate formulations: labeling does not specify duration.

Alternative uses / guideline‑discussed contextsUsed in other contexts per practice guidelines (e.g., NCCN) such as menstrual suppression in oncology, gender‑affirming care, and preservation of ovarian function during chemotherapy.

Clinical Background and Drug Overview

Lupron Depot (leuprolide acetate) is a long-acting gonadotropin-releasing hormone (GnRH) agonist available as monthly and multi-month depot injections. It is used for a range of conditions including endometriosis, preoperative reduction of fibroid-associated uterine volume and anemia, and palliative treatment of advanced prostate cancer. Treatment formulations and durations vary by indication; for example, endometriosis regimens may use 3.75 mg monthly or 11.25 mg every 3 months with total therapy limited to 12 months in typical treatment algorithms, while use for fibroids is often limited to 3 months when used as a preoperative or temporizing measure.

Policy Revision History

2026-01-15policy reviewedLatest

Policy last reviewed; clinical content and references validated as of this review date.

2021-01-15references updated/accessed

Multiple guideline and reference sources (NCCN, ACOG, Endocrine Society, WPATH, RCOG, manufacturer prescribing information) were accessed and cited on January 15, 2021.

2019-03manufacturer prescribing information

AbbVie Lupron Depot prescribing information (most recent manufacturer PI cited) dated March 2019 was added to references.

Policy Summary

Payermedical mutual - ohio

PolicyLupron Depot (leuprolide) long-acting injectable coverage (Coverage Criteria)

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateJan 15, 2027

SourceLink

On This Page

Approve Lupron Depot 3.75 mg, 7.5 mg, 11.25 mg, or 22.5 mg for 1 year.

Preservation of ovarian function: Prescribed by or in consultation with an oncologist for patients undergoing chemotherapy.1 year approval

Approve Lupron Depot 3.75 mg or 11.25 mg for 1 year.

Prophylaxis/treatment of uterine bleeding in cancer/BMT: Prescribed by or in consultation with a hematologist or oncologist.1 year approval

Approve Lupron Depot 3.75 mg or 11.25 mg for 1 year.

Abnormal uterine bleeding: Prescribed for abnormal uterine bleeding.up to 3 months

Approve Lupron Depot 3.75 mg or 11.25 mg for up to 3 months.

Premenstrual disorders: Patient is ≥ 18 years of age AND has severe, refractory premenstrual symptoms per prescriber AND has tried one of: (i) an SSRI OR (ii) a combined oral contraceptive.1 year approval

Approve Lupron Depot 3.75 mg or 11.25 mg for 1 year.

Uterine cancer: Prescribed by or in consultation with an oncologist.1 year approval

Approve Lupron Depot 7.5 mg, 22.5 mg, 30 mg, or 45 mg for 1 year.

Head and neck (salivary gland) tumors: Patient has recurrent, unresectable, or metastatic disease AND androgen receptor (AR)-positive disease AND the medication is prescribed by or in consultation with an oncologist.1 year approval

Approve Lupron Depot 3.75 mg, 7.5 mg, 11.25 mg, or 22.5 mg for 1 year.

Initial approval requires prescription by or consultation with an appropriate specialist for many indications.

Step Therapy

Step Therapy Requirements

Step‑therapy requirements are specified for select indications: for prostate cancer, a trial of Eligard is required prior to approval; for endometriosis, approval requires trial of one of the listed alternatives (combined contraceptive, oral progesterone, or depot‑medroxyprogesterone) unless contraindicated, with a possible exception if the patient has previously used a GnRH agonist/antagonist.

Prostate cancer: trial of Eligard required prior to approval.
Endometriosis: trial of ONE of the following unless contraindicated — combined contraceptive, oral progesterone (e.g., norethindrone), or depo‑medroxyprogesterone. Exception if prior use of a GnRH agonist/antagonist.

Documentation Required

Documentation May Be Requested

The Company may request additional documentation to support medical necessity. Documentation that may be requested includes patient medical records, test results, and provider credentials. Providers should make available any requested documentation as part of the coverage determination process.

The Company reserves the right to request patient records, test results, and/or credentials of the provider ordering or performing the service.
Additional documentation supporting medical necessity must be provided upon request.

Note

Reference Citations and Guidelines

The policy text and appended reference lists provide supporting citations and guideline sources that inform the coverage rationale. These references do not by themselves prescribe provider actions but are available for clinical context and evidence support.

Policy includes prescribing information and guideline citations (e.g., AbbVie Lupron Depot prescribing information; ACOG, NCCN, Endocrine Society, WPATH, and other society guidelines).
References support rationale for specialty requirements, indications, and duration criteria.

Denial Risk

Denial Risk / Conditions That May Lead to Denial

Denial criteria are not listed as separate detailed criteria in these reference chunks; however, the Company may deny reimbursement when the drug or services are determined not medically necessary, investigational/experimental, not within the member's benefits, or when inappropriate/excessive billing patterns are identified.

No separate denial criteria section included in these chunks.
Company may deny reimbursement for lack of medical necessity, investigational/experimental use, services outside benefit scope, or inappropriate/excessive billing.

inv-20: Lupron Depot prescribing information — formulations and prescribing information cited (1-,3-,4-,6-month formulations)

Manufacturer prescribing information (cited)Lupron Depot prescribing information — AbbVie Inc.; March 2019 (lists 1‑, 3‑, 4‑, and 6‑month formulations and dosing).

Available dosing schedulesMonthly (3.75 mg, 7.5 mg), every 3 months (11.25 mg, 22.5 mg), every 4 months (30 mg), every 6 months (45 mg).

Label‑specified duration notes3.75 mg and 11.25 mg: specific duration guidance for endometriosis and fibroids (see label); 7.5/22.5/30/45 mg: labeling does not specify treatment duration for prostate cancer formulations.

inv-21: Clinical guideline sources — Professional society guidelines and oncology practice guideline sources cited (ACOG, WPATH, Endocrine Society, NCCN, RCOG)

ACOG (American College of Obstetricians and Gynecologists)Multiple ACOG references cited including Practice Bulletins on endometriosis and abnormal uterine bleeding and patient FAQs (see refs 4,5,10).

Endocrine SocietyEndocrine Society clinical practice guidelines cited for transgender care and evaluation/treatment of hirsutism (ref 11; also ref 19).

NCCN and WPATHNCCN oncology guideline versions cited (Breast, Head & Neck, Ovarian, AYA) and WPATH Standards of Care (ref 12) are referenced as supporting guideline sources for specialty/oncology uses.