CurrentEmblemHealthPolicy N/A

Luteinizing Hormone Releasing Hormone (LHRH) Agonists or Antagonists

Defines accepted indications, contraindications, exclusions, and coding for LHRH agonists and antagonists (e.g., leuprolide, goserelin, triptorelin, degarelix, relugolix) for cancer treatment and fertility preservation; applies to medication requests processed by Evolent on behalf of the payer and affects ordering providers and members.

Policy Summary

PayerEmblemHealth

PolicyLuteinizing Hormone Releasing Hormone (LHRH) Agonists or Antagonists

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization required for listed LHRH agents; requests must cite FDA labeling or authoritative compendia/guidelines.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3primary indication groups

13listed HCPCS/J-codes

30Orgovyx monthly limit

Commercial, Medicaidlines of business

Coverage Criteria for LHRH (GnRH) Agonists and Antagonists

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Breast cancer

Covered when meeting indication-specific guidance:

Breast cancer indication: Luteinizing Hormone Releasing Hormone (LHRH) Agonists (leuprolide acetate, goserelin, or triptorelin) may be used in combination with endocrine therapy (e.g., tamoxifen, aromatase inhibitors) for ovarian suppression in premenopausal women and in men with ER/PR-positive breast cancer as adjuvant therapy or for recurrent/metastatic disease.

Fertility preservation in women undergoing cytotoxic chemotherapy

Fertility preservation indication: For women undergoing cytotoxic chemotherapy, Luteinizing Hormone Releasing Hormone (LHRH) Agonists (leuprolide acetate, goserelin, or triptorelin) may be used in conjunction with fertility preservation methods.

Supported by ASCO guidance and cited literature.

Prostate cancer

Prostate cancer indication: Luteinizing Hormone Releasing Hormone (LHRH) Agonists and Antagonists (leuprolide acetate/mesylate, goserelin, triptorelin, degarelix, or relugolix) may be used as a single agent or in combination with an antiandrogen with or without chemotherapy for the treatment of castrate-sensitive or castrate-resistant M0 or M1 prostate cancer.

Exclusions apply when requested dosing exceeds the policy’s specified single-dose or continuation-dose limits for listed products. Examples include but are not limited to Lupron/Eligard (leuprolide acetate) 45 mg every 6 months, Lutrate Depot (leuprolide acetate) 22.5 mg every 3 months, Camcevi SC Depot (leuprolide mesylate) 42 mg every 6 months, Zoladex (goserelin) 10.8 mg every 3 months, Trelstar (triptorelin) 22.5 mg every 6 months, Firmagon (degarelix) 240 mg loading or 80 mg monthly continuation, and Orgovyx (relugolix) 360 mg loading or 120 mg monthly continuation. Requests that would exceed the Orgovyx limit of 30 (120 mg) tablets per month are specifically excluded.

Use is considered not medically necessary for investigational or off‑label indications that lack sufficient supporting evidence as defined by the policy. Determinations of insufficient evidence include inadequate representation of the relevant patient and cancer characteristics in published studies, lack of representation of the concomitant oncologic regimen, outcomes that do not meet predefined thresholds for clinical meaningfulness (for example ASCO‑recommended effect sizes), or weak experimental design. Single‑case reports, uncontrolled anecdotal reports, and abstracts without a full peer‑reviewed publication generally do not provide adequate evidence to support coverage.

Coding and Quantity Limits

Listed HCPCS/J-codesHCPCS

J1950	Injection, leuprolide acetate (for depot suspension), per 3.75 mg
J1952	Leuprolide injectable, camcevi, 1 mg
J1954	Injection, leuprolide acetate for depot suspension (lutrate depot), 7.5 mg
J9217	Leuprolide acetate (for depot suspension), 7.5 mg
J9218	Leuprolide acetate, per 1 mg
J9219	Leuprolide acetate implant, 65 mg
J3315	Injection, triptorelin pamoate, 3.75 mg
J3316	Injection, triptorelin, extended-release, 3.75 mg
J9202	Goserelin acetate implant, per 3.6 mg
J9155	Injection, degarelix, 1 mg

1–10 of 11

1/2

Orgovyx monthly tablet limit

Monthly tablet limitOrgovyx (relugolix) — 30 tablets (120 mg) per month

Continuation dose capOrgovyx continuation dose limit described as 120 mg (continuation) corresponding to the 30-tablet monthly supply

Treatment exceeding limitTreatment requests that exceed the Orgovyx maximum limit (30 tablets per month) may be excluded

Orgovyx (relugolix) — quantity limit summary

Quantity limit (summary)Orgovyx (relugolix) quantity limit = 30 tablets per month (120 mg total)

Loading vs continuation dosingPolicy identifies Orgovyx loading dose 360 mg and continuation dose 120 mg as dosing thresholds (loading/continuation may trigger exclusion if exceeded)

Exclusion for excess supplyRequests exceeding the 30-tablet per month Orgovyx supply may be excluded from coverage

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for listed LHRH agents processed by Evolent; requests must cite supporting labeling or authoritative sources.

Applies to: Lupron IM/Eligard (leuprolide acetate), Lutrate Depot (leuprolide acetate), Camcevi SC Depot (leuprolide mesylate), Trelstar (triptorelin), Zoladex (goserelin), Firmagon (degarelix), Orgovyx (relugolix).
Requests must reference FDA product labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.

Note

Continuation Exemption Conditions

Continuation requests may be exempt from Evolent prior authorization when all conditions are met.

Member has not experienced disease progression on the requested medication.
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
No additional medications are being added to the continuation request.

Documentation Required

Supporting Evidence Required

Use must be supported by one of the following sources; provide documentation with the request.

FDA approved product labeling.
CMS-recognized compendia.
NCCN or ASCO clinical practice guidelines.
Peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Billing Rule

Dose and Quantity Limits

Dose and quantity limits are enforced; requests exceeding these limits will be denied or require clinical review.

Single-dose limits: Lupron IM/Eligard 45 mg every 6 months; Lutrate Depot 22.5 mg every 3 months; Camcevi SC Depot 42 mg every 6 months; Zoladex 10.8 mg every 3 months; Trelstar 22.5 mg every 6 months; Firmagon 240 mg loading dose or 80 mg monthly continuation; Orgovyx 360 mg loading dose or 120 mg monthly continuation.
Quantity limit: Orgovyx (relugolix) maximum 30 tablets (120 mg) per month.

Denial Risk

Insufficient Evidence for Off-Label Use

Off-label or investigational uses lacking sufficient evidence as defined below are not covered.

Insufficient evidence if not supported by CMS-recognized compendia, NCCN/ASCO guidance, FDA labeling, or acceptable peer-reviewed literature meeting CMS standards.
Evidence gaps may include: inadequate patient or cancer representation in published studies; oncologic regimen in studies not representative of the requested concomitant therapies; reported outcomes not clinically meaningful (ASCO benchmarks such as HR <0.80 or ≥3 months OS/PFS benefit commonly considered); or inappropriate experimental design for the question being addressed.
Requests for off-label indications must include literature demonstrating adequate representation and clinically meaningful benefit; otherwise the request will be denied as investigational.

Background

Luteinizing Hormone Releasing Hormone (LHRH/GnRH) agonists and antagonists act by suppressing pituitary luteinizing hormone release and downstream gonadal steroid production, producing ovarian suppression in women and androgen deprivation in men. These agents — including depot injectables, implants, and the oral antagonist relugolix — are used in oncology for hormone‑sensitive breast and prostate cancers and as an adjunct for ovarian suppression during cytotoxic chemotherapy for fertility preservation. Clinical use and agent selection should align with FDA labeling and authoritative guidance such as NCCN or ASCO.

OpenPayer

Luteinizing Hormone Releasing Hormone (LHRH) Agonists or Antagonists

Coverage Criteria for LHRH (GnRH) Agonists and Antagonists

Coding and Quantity Limits

Provider Actions and Documentation Requirements

Initial Therapy Requirements

Continuation Therapy and Exemptions

Definitions

Background