Leuprolide acetate and leuprolide mesylate coverage
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Defines medical necessity and prior authorization criteria for leuprolide acetate (Eligard, Fensolvi, Lupron Depot, Lupron Depot-Ped) and leuprolide mesylate (Camcevi) for Health Net (Medicaid) members.
Added HCPCS codes for Fensolvi and Camcevi; modified commercial approval duration to 6 months or member's renewal date for certain indications.
Added Appendix F listing states with regulations against redirections in cancer and added redirection to Eligard for Lupron Depot prostate cancer requests through the pharmacy benefit.
For uterine fibroids, Lupron Depot must be prescribed concurrently with iron therapy and commercial approval duration revised to 3 months.
Added new 45 mg dosage form for a 6-month Lupron Depot‑Ped dosing regimen.
For gender dysphoria/transition, added requirement for provider attestation of understanding current state regulations and that such care is coverable under those regulations.
Commercial and HIM lines of business were removed from this policy; separate policy will be created.
Coverage Criteria
inv-01: Initial Therapy
Covered when ALL of the following are met for each specific indication
inv-52: Initial Therapy (alternate grouping)
Initial approval requires diagnosis-, prescriber-, age-, prior therapy-, and dosing-related criteria depending on indication.
inv-53: Initial therapy dosing examples
Initial dosing follows product-specific regimens; examples provided below.
inv-54: Initial therapy dosing updates
Initial therapy updates (documented dosing additions and label-aligned changes).
inv-02: Continuation Therapy
Covered when ALL of the following are met for continuation
inv-55: Continuation Therapy — Criteria for continued therapy
Criteria for continued therapy
inv-56: Continuation Therapy — General continuation (re-authorization) criteria requiring current therapy, clinical response, and adherence to dose limits
Continuation (re-authorization) criteria are indication-specific and require current therapy, clinical response, and adherence to dose limits or submission of supporting evidence for higher/off‑label doses.
inv-57: Continuation therapy requirements
Continuation/renewal approvals require evidence of ongoing clinical benefit and adherence to indication‑specific duration limits.
inv-03: Prostate Cancer — Continued Therapy
Continued therapy for Prostate Cancer (must meet ALL of the following)
Prescribed regimen must be FDA‑approved or recommended by NCCN
inv-04: Endometriosis — Continued Therapy
Continued therapy for Endometriosis (must meet ALL of the following)
inv-05: Uterine Fibroids — Re-authorization
Uterine Fibroids — Re-authorization
inv-06: Central Precocious Puberty — Continued Therapy
Central Precocious Puberty (must meet ALL of the following)
Approval duration: 12 months
inv-07: Breast/Ovarian Cancer — Continued Therapy
Breast and Ovarian Cancer (off‑label) continued therapy (must meet ALL of the following)
Approval duration: 12 months
inv-08: Gender Dysphoria — Continued Therapy
Gender Dysphoria / Gender Transition (off‑label) continued therapy
Approval duration: 12 months
inv-09: Salivary Gland Tumors — Continued Therapy
Salivary gland tumors (off‑label) continued therapy
Approval duration: 12 months
inv-10: Other Indications — Process
Other diagnoses/indications handling
inv-11: Indication-specific coverage criteria
Covered when following indication‑specific dosing and duration align with prescribing information and policy requirements.
inv-12: Updated indication-specific coverage nodes
Documented indication- and age-specific coverage updates and requirements
Concurrent iron therapy and duration per FDA label
45 mg per 6 months option added
Appendix F added for states with anti‑redirection regulations
Refer to related no-coverage, non‑formulary, and off‑label use policies when the requested diagnosis, age, dosing regimen, or product is not authorized by this policy. Specifically, follow CP PMN.255 for no‑coverage/formulary exclusions (Medicaid), CP PMN.16 for non‑formulary requests (Medicaid), and CP PMN.53 for off‑label uses (Medicaid).
Non‑FDA‑approved indications that are not specifically addressed in this policy are excluded from coverage unless the request includes sufficient documentation of efficacy and safety consistent with the applicable off‑label use policy (see CP PMN.53 for Medicaid).
The policy text was updated to remove Lupaneta Pack from the list of covered products because the product is discontinued.
Note: Lupaneta Pack has been removed from this policy’s product list due to discontinuation.
Uses or indications not expressly listed under the Diagnoses/Indications sections and not authorized by the referenced formulary or off‑label policies are not covered. In such cases, refer the request to the applicable no‑coverage, non‑formulary, or off‑label use policy (CP PMN.255, CP PMN.16, CP PMN.53) for determination.
Re‑authorization for uterine fibroids is not permitted under this policy; members must meet the initial approval criteria for any new request.
No explicit “not medically necessary” statements are included in the provided excerpt. Consult the full policy document for complete Non‑Medically‑Necessary (NMN) clauses and conditions.
Per the September SDC updates, Commercial and HIM lines of business have been removed from this policy. Coverage determinations for those lines will be governed by a separate policy.
Coding and Billing
| NDC/CPT/HCPCS not listed in this part | No explicit billing codes are provided in this document segment. |
| J9218 | Leuprolide acetate per mg (used for prostate cancer; central precocious puberty mapping in appendix) |
| J9217 | Lupron Depot/Eligard products (mapped to various month formulations for prostate cancer and salivary gland tumors) |
| J1950 | Leuprolide depot (Lupron Depot 1‑month, pediatric formulations, and breast/ovarian cancer mappings) |
| J1950 | Injection, leuprolide acetate for depot suspension per 3.75 mg |
| J9217 | Leuprolide acetate for depot suspension 7.5 mg |
| J9218 | Leuprolide acetate for depot suspension (designation listed) |
| J9219 | Leuprolide acetate implant 65 mg |
| J1951 | Injection, leuprolide acetate for depot suspension (Fensolvi) 0.25 mg |
| J1954 | Injection, leuprolide acetate for depot suspension (additional code added) |
| J9218 | Mapped for Prostate Cancer and Central Precocious Puberty with billable units and supply day as listed in Appendix D (e.g., Prostate Cancer J9218 billable units 14, supply day 14). |
| J9217 | Mapped for Prostate Cancer and Salivary Gland Tumors with month-formulation billable units and supply day entries in Appendix D (examples: J9217 billable units 3 supply day 84 for 3-month products). |
| J1950 | Mapped for Endometriosis, Uterine Fibroids, CPP pediatric depot formulations, Breast and Ovarian Cancer with billable units and supply day entries in Appendix D. |
| J1954 | HCPCS code added (document notes addition; descriptor listed in coding table: Injection, leuprolide acetate for depot suspension (Cipla) 7.5 mg). |
Provider Actions and Requirements
Prior Authorization Required
Prior authorization is required for requests for leuprolide products. Approval criteria enumerate diagnosis-specific, prescriber, dosing, and prior-failure requirements as applicable. Requests for continued therapy also require prior authorization and must meet the indication-specific continued therapy criteria.
- Prior authorization required for initial and continued therapy.
- Commercial approval durations and certain concurrent therapy requirements updated per most recent reviews (see policy history).
- HCPCS code J1954 added to coding appendix for 4Q 2024 updates.
Lupron Depot step / Redirection Risk for Prostate Cancer
For requests submitted through the pharmacy benefit for Lupron Depot where the indication is prostate cancer, prescribers must document prior failure of Eligard (or provide rationale why Eligard is contraindicated or caused clinically significant adverse effects) before Lupron Depot will be approved, unless the request is for treatment in a state with regulations prohibiting redirection (see Appendix F).
- Lupron Depot pharmacy‑benefit requests for prostate cancer may be redirected to Eligard unless contraindicated or adverse effects documented.
- Appendix F lists states where redirection/step therapy for oncology is prohibited.
Step Therapy / Redirection for Oncology
Requests for oncology indications may be subject to step therapy or redirection to an alternative product (for example, redirection of Lupron Depot requests to Eligard through the pharmacy benefit) except where prohibited by state regulations listed in Appendix F. Providers should be aware that redirection is distinct from medical necessity review and that exceptions must be documented when applicable.
- Step therapy/redirection may be applied for prostate cancer except in states listed in Appendix F.
- Redirection does not replace medical necessity review; provide clinical justification for exceptions.
Supportive Documentation Required
Providers must submit supporting documentation (office chart notes, lab results, prior medication records, prescribing rationale, and any evidence of contraindication or adverse reaction) demonstrating the member meets all approval criteria. Failure to provide sufficient documentation may result in denial.
- Include documentation showing member is currently receiving the medication (or received it for at least 30 days) and is responding positively when requesting continued therapy.
- If requesting an exception to step therapy (e.g., avoiding redirection to Eligard), include documentation of contraindication or clinically significant adverse effects to the alternative.
Lupron Depot (pharmacy benefit) Prior Failure Requirement
When requesting Lupron Depot through the pharmacy benefit for prostate cancer, the prescriber must attest that Eligard was tried and failed (or provide documentation of contraindication/adverse effects) unless the request originates from a state listed in Appendix F that prohibits redirection. This requirement applies to initial requests submitted via the pharmacy benefit.
- Document prior trial and failure of Eligard or document contraindication/adverse event.
- If the state is listed in Appendix F, note the state and reference the applicable regulation to avoid redirection.
Step Therapy and Therapeutic Alternatives
| Prior step required | Notes |
|---|---|
| Failure of Eligard (prior to approving Lupron Depot via the pharmacy benefit) | Required unless Eligard is contraindicated or clinically significant adverse effects are experienced; applies to Lupron Depot requests through the pharmacy benefit. |
| Therapeutic alternative | Formulary / PA note |
|---|---|
| Preferred alternatives listed in Appendix B (examples include NSAIDs, combined oral contraceptives, progestin-only contraceptives, depot progestin contraceptives) | Alternatives may not be formulary for all lines of business and may require prior authorization per formulary status; see Appendix B for complete list. |
| Redirection / Preferred product | Applicability / exception |
|---|---|
| Requests for Lupron Depot for prostate cancer may be redirected to Eligard (preferred product) when processed through the pharmacy benefit | Redirection may be applied except in states with regulations prohibiting redirection in cancer (see Appendix F); Appendix F lists affected states and scenarios. |
| Limitation | Requirement |
|---|---|
| Commercial approval duration limited to 3 months for uterine fibroids | Lupron Depot must be prescribed concurrently with iron therapy per the FDA indication; treatment per label is limited to three months and commercial approvals reflect this duration. |
Quantity Limits and Formulation Constraints
Site of Care and Administration
Office billing note — use Appendix D HCPCS mappings for billing
HCPCS codes, billable units, and supply‑day mappings in Appendix D are provided to support billing by site of care; providers should use those HCPCS mappings when billing but note the policy does not impose additional site‑of‑care restrictions in this section.
Administration site — SC and IM depot formulations may be given in office or outpatient clinic
Products include both subcutaneous and intramuscular depot formulations (various Lupron Depot, Lupron Depot‑Ped, Camcevi, etc.); site of administration may be office or outpatient clinic as per product labeling and billing guidance.
Mixed benefit redirection risk — pharmacy vs medical routing may change coverage pathway
Prostate cancer requests may be subject to redirection to an alternate product and a different benefit (pharmacy vs medical) depending on routing and state law; providers should verify benefit routing and state redirection rules before submitting PA.
Background
Leuprolide acetate and leuprolide mesylate are gonadotropin‑releasing hormone (GnRH) receptor agonists used to suppress pituitary gonadotropin secretion for hormone‑sensitive conditions. They are indicated across multiple formulations for conditions such as advanced prostate cancer, endometriosis, uterine fibroids, and central precocious puberty; depot and injectable formulations provide dosing intervals ranging from monthly to six months.
Definitions
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