CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

LHRH Agonists and Antagonists for Oncology Indications (Coverage Criteria)

Clinical guideline governing use and prior authorization expectations for luteinizing hormone releasing hormone (LHRH) agonists and antagonists (e.g., leuprolide, goserelin, triptorelin, degarelix, relugolix) for oncology indications including breast cancer, fertility preservation with cytotoxic chemotherapy, and prostate cancer; applies to Neighborhood Health Plan of Rhode Island lines of business processed by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLHRH Agonists and Antagonists for Oncology Indications (Coverage Criteria)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent with supporting FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3primary clinical indications

≥12named drugs/products

~14J-/HCPCS codes listed

Commercial/Exchange/MedicaidApplicable LOBs

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Breast Cancer

Covered when ALL of the following are met for breast cancer:

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

Supported by chunk 3

Fertility Preservation during Cytotoxic Chemotherapy

Covered when ALL of the following are met for fertility preservation:

Fertility preservation indication: LHRH agonists (leuprolide acetate, goserelin, or triptorelin) used in conjunction with fertility preservation methods for women undergoing cytotoxic chemotherapy.

Supported by chunk 4

Prostate Cancer

Covered when ALL of the following are met for prostate cancer:

Prostate cancer indication: LHRH agonists and antagonists (leuprolide acetate/mesylate, goserelin, triptorelin, degarelix, or relugolix) used as a single agent or in combination with an antiandrogen, with or without chemotherapy, for treatment of castrate‑sensitive or castrate‑resistant M0 or M1 prostate cancer.

Supported by chunk 5

Coverage will be denied when dosing exceeds established single-dose limits for listed agents. Specified single-dose limits include: Lupron IM/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, and Firmagon (degarelix) 240 mg (loading) or 80 mg every month (continuation). For Orgovyx (relugolix) the policy specifies a maximum of 360 mg for a loading dose and 120 mg for a continuation dose, and treatment that would exceed a monthly supply of 30 tablets of the 120 mg strength is not approvable.

The policy does not consider uncontrolled anecdotal evidence adequate to support coverage. Specifically, case reports are characterized as uncontrolled and anecdotal and generally insufficient, and meeting abstracts without a corresponding full peer‑reviewed article lack adequate supporting evidence to establish an accepted use for a drug.

Coverage decisions require evidence that meets recognized standards. Uses considered investigational or off‑label will not be approved unless supported by CMS‑recognized compendia or acceptable peer‑reviewed literature. The policy lists specific evidentiary considerations: whether the patient and cancer characteristics are represented in published studies; whether the concurrent oncologic regimen is represented; whether the reported outcomes are clinically meaningful (for example ASCO‑recommended benchmarks such as a Hazard Ratio < 0.80 or at least a 3‑month OS/PFS benefit); and whether the study design is appropriate for the question. The policy further states that non‑randomized trials with a substantial number of subjects may provide supportive evidence, whereas case reports and meeting abstracts without full articles are not adequate.

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 (relugolix) monthly tablet limit

Monthly tablet maximum (Orgovyx, relugolix 120 mg)≤ 30 tablets per month (120 mg strength)

Orgovyx dosing — continuation dose120 mg daily (continuation dose); 360 mg for loading dose noted in exclusions

Exclusion for excess treatmentTreatment exceeding the Orgovyx maximum limit of 30 (120 mg) tablets per month is excluded

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization for LHRH agonists/antagonists is required and is processed by Evolent on behalf of Neighborhood Health Plan of Rhode Island. Requests must be supported by FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature that meets CMS standards.

Evolent processes all medication requests from network ordering providers.
Supporting evidence: FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

Prior Authorization

Continuation Exemption

Continuation (renewal) requests may be exempt from new prior authorization requirements when continuity and non-progression 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 medication(s) are being added to the continuation request.

Documentation Required

Evidence Documentation Required

Documentation must demonstrate that the requested use is supported by one of the accepted sources of evidence.

Acceptable support: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Denial Risk

Triggers for Denial

Denial may be triggered when dosing, quantity limits, or unsupported investigational/off-label uses are identified.

Dosing that exceeds single-dose limits (e.g., Lupron IM/Eligard 45 mg every 6 months; Lutrate Depot 22.5 mg every 3 months; Camcevi 42 mg every 6 months; Zoladex 10.8 mg every 3 months; Trelstar 22.5 mg every 6 months; Firmagon 240 mg loading or 80 mg monthly continuation; Orgovyx 360 mg loading or 120 mg continuation).
Exceeding the Orgovyx (relugolix) maximum of 30 tablets (120 mg) per month.
Investigational use or off-label indications lacking sufficient evidence or not generally accepted by the medical community (insufficient representation of patient/cancer characteristics in evidence; oncologic regimen not represented; outcomes not clinically meaningful per ASCO benchmarks such as HR < 0.80 or survival benefit thresholds; or inappropriate experimental design).

Covered Regimens and Combinations

Regimen	Indication	Coverage
LHRH agonists/antagonists alone	Ovarian suppression in premenopausal women when used with endocrine therapy (e.g., tamoxifen, aromatase inhibitors); adjuvant or for recurrent/metastatic ER/PR-positive breast cancer in men	Covered when used as indicated in combination with endocrine therapy for breast cancer
LHRH agonists/antagonists combined with antiandrogens	Androgen-deprivation therapy for castrate sensitive or castrate resistant M0 or M1 prostate cancer	Covered when used as single agent or in combination with an antiandrogen, with or without chemotherapy, for prostate cancer
LHRH agonists/antagonists combined with chemotherapy	Ovarian suppression in premenopausal breast cancer when clinically indicated; adjunctive therapy in prostate cancer regimens when clinically indicated	Covered when clinically indicated as part of combination regimens

Definitions

LHRH agonists/antagonists — drugs and brief definition

DefinitionLHRH agonists/antagonists are drugs that suppress gonadal hormone production used in oncology (examples below).

Agonists — leuprolide formulationsLeuprolide acetate/mesylate products (Eligard/Lupron IM/Lutrate Depot, Camcevi SC Depot) listed as LHRH agonists

Agonists — goserelin and triptorelinGoserelin (Zoladex) and triptorelin (Trelstar) listed as LHRH agonists

Antagonists — degarelix and relugolixDegarelix (Firmagon) and relugolix (Orgovyx) listed as LHRH antagonists

Clinical uses (brief)Used for ovarian suppression in premenopausal breast cancer, fertility preservation during cytotoxic chemotherapy, and androgen-deprivation therapy in castrate sensitive or resistant prostate cancer

OpenPayer

LHRH Agonists and Antagonists for Oncology Indications (Coverage Criteria)

Coverage Criteria

Coding and Quantity Limits

Provider Actions and Documentation Requirements

Covered Regimens and Combinations

First-line and Continuation Therapy

Definitions

Background