CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1041

Luteinizing Hormone Releasing Hormone (LHRH) Agonists and Antagonists

Clinical coverage and utilization management criteria for LHRH agonists and antagonists (examples: leuprolide, goserelin, triptorelin, degarelix, relugolix) for cancer treatment and related indications; applies to medication requests processed by Evolent/UM for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLuteinizing Hormone Releasing Hormone (LHRH) Agonists and Antagonists

Policy CodePolicy UM ONC_1041

Change TypeNo material changes

Effective DateJuly 26, 2024

Next Review Date

Key ActionObtain prior authorization through Evolent Utilization Management for medication requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Jul 26, 2024Effective date

Jul 10, 2024Approval date

Multiple agentsDrug names covered

1 yrContinuation exemption

Coverage Criteria for LHRH Agonists and Antagonists

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Continuation Therapy (exemption)

Continuation requests are exempt from this policy when ALL of the following are met:

Continuation exemption criteria: The requested medication was used within the last year

policy II.A.1

Continuation exemption criteria: The member has not experienced disease progression and/or no intolerance to the requested medication

policy II.A.2

Continuation exemption criteria: Additional medication(s) are not being added to the continuation request

policy II.A.3

Breast Cancer Indication

Covered when ALL of the following are met:

Breast cancer ovarian suppression: LHRH agonists (leuprolide acetate, goserelin, or triptorelin) 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.

policy II.B

Fertility Preservation Indication

Covered when ALL of the following are met:

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

policy II.C

Prostate Cancer Indication

Covered when ALL of the following are met:

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

policy II.D

Coverage is excluded for requests where dosing exceeds the specified single-dose limits for the listed products. Per the policy, the single-dose limits are: Lupron Depot/Eligard (leuprolide acetate) IM Depot — 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 dose or 80 mg every month continuation dose; and Orgovyx (relugolix) — 360 mg loading dose or 120 mg continuation dose.

Coverage is excluded when treatment with Orgovyx (relugolix) exceeds the stated monthly tablet limit. The policy specifies a maximum of 30 tablets (120 mg) per month; requests exceeding this quantity are excluded.

Investigational use or off-label indications are excluded when the available evidence is insufficient or not generally accepted by the medical community. The policy requires that supporting evidence be adequate in multiple dimensions, including that the patient and cancer characteristics and the relevant oncologic therapy regimens are represented in the published evidence, that reported outcomes are clinically meaningful, and that study design and quality (for example randomized trials versus non-randomized trials, case reports, or abstracts) provide an appropriate basis for accepted use. Case reports and abstracts without full peer‑reviewed articles generally lack adequate supportive evidence.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required — Medication requests are processed by Evolent Utilization Management (UM). Final approval is granted by the UM Committee. Providers must obtain prior authorization for LHRH agonists/antagonists before administration to ensure coverage and reimbursement.

Evolent UM processes all medication requests
Final approval by Utilization Management Committee

Prior Authorization

Continuation Exemption

Continuation exemption — Previously used medication within the last year may be exempt from new prior authorization if the member has not experienced disease progression or intolerance and no additional medications are being added to the regimen.

Requested medication used within the last 12 months
No disease progression and no intolerance to the requested medication
No additional medications added to the continuation request

Documentation Required

Supportive Evidence Required

Supportive evidence required — Use must be supported by FDA labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS standards. Off-label requests must include sufficient evidence demonstrating that the patient and treatment regimen are represented in the published evidence and that outcomes are clinically meaningful.

Acceptable sources: FDA product labeling, CMS compendia, NCCN, ASCO, or peer-reviewed literature
Off-label use requires evidence that: patient/cancer characteristics and therapy regimen are represented; study outcomes are clinically meaningful (e.g., ASCO benchmarks such as HR < 0.80 or ≥3 months OS/PFS benefit when applicable); study design is appropriate; non-randomized trials with substantial subjects may be acceptable; case reports and abstracts without full peer-reviewed articles are generally insufficient

Denial Risk

Dose and Quantity Exceed Limits

Dose and quantity exceed limits — Requests that exceed single-dose or monthly quantity limits may be denied. Specific limits include product-specific single-dose maximums and the Orgovyx (relugolix) 30-tablet (120 mg) per month maximum.

Single-dose limits by product (examples): Lupron Depot/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
Monthly quantity limit: Orgovyx (relugolix) 30 tablets (120 mg) per month

Dose and Quantity Limits by Product

inv-16: Lupron Depot/Eligard (leuprolide acetate) — product dosing and frequency limits

ProductLupron Depot/Eligard (leuprolide acetate)

Allowed single-dose / frequency45 mg every 6 months; 22.5 mg every 3 months (Lutrate 22.5 mg q3mo)

Policy referenceExclusion criterion: dosing exceeds single dose limits

inv-17: Camcevi (leuprolide mesylate) — product dosing and frequency limits

ProductCamcevi (leuprolide mesylate)

Allowed single-dose / frequency42 mg every 6 months

Policy referenceExclusion criterion: dosing exceeds single dose limits

inv-18: Zoladex (goserelin) — product dosing and frequency limits

ProductZoladex (goserelin)

Allowed single-dose / frequency10.8 mg every 3 months

Policy referenceExclusion criterion: dosing exceeds single dose limits

inv-19: Trelstar (triptorelin) — product dosing and frequency limits

ProductTrelstar (triptorelin)

Allowed single-dose / frequency22.5 mg every 6 months

Policy referenceExclusion criterion: dosing exceeds single dose limits

inv-20: Firmagon (degarelix) — loading and monthly continuation doses

ProductFirmagon (degarelix)

Loading dose240 mg

Monthly continuation dose80 mg every month

inv-21: Orgovyx (relugolix) — loading dose, continuation dose, and maximum tablets per month

ProductOrgovyx (relugolix)

Loading dose360 mg

Continuation dose120 mg per month (oral)

Maximum tablets per month30 tablets (120 mg) per month

Background

Luteinizing Hormone Releasing Hormone (LHRH) agonists and antagonists are pharmacologic agents that suppress gonadal hormone production and are used in hormone‑sensitive conditions. Examples covered by this policy include leuprolide acetate (Lupron/Eligard/Lutrate), leuprolide mesylate (Camcevi), triptorelin (Trelstar), goserelin (Zoladex), degarelix (Firmagon), and relugolix (Orgovyx). These agents are used for ovarian suppression in premenopausal patients with ER/PR‑positive breast cancer, for fertility preservation in women undergoing cytotoxic chemotherapy (used in conjunction with fertility preservation methods), and for androgen deprivation in castrate‑sensitive or castrate‑resistant prostate cancer, either alone or with antiandrogen therapy and/or chemotherapy.

OpenPayer

Luteinizing Hormone Releasing Hormone (LHRH) Agonists and Antagonists

Coverage Criteria for LHRH Agonists and Antagonists

Provider Requirements and Prior Authorization

Criteria for Continuation Therapy Exemption

Dose and Quantity Limits by Product

Background

Definitions