Viva Health leuprolide depot Prior Auth & Coverage

Coverage Criteria and Indications

Central Precocious Puberty (CPP)

Initial approval provided when ALL of the following are met for Central Precocious Puberty (CPP):

CPP criteria: Patient must have a contraindication, intolerance, or failure to Leupron Depot-Ped, Supprelin LA, AND Triptodur prior to consideration of Fensolvi; AND patient is less than 13 years of age; AND onset of secondary sexual characteristics earlier than age 8 for females and 9 for males associated with pubertal pituitary gonadotropin activation; AND diagnosis is confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to stimulation by native GnRH; AND bone age advanced greater than 2 standard deviations beyond chronological age; AND tumor has been ruled out by appropriate imaging/labs (brain imaging, pelvic/testicular/adrenal ultrasound, and hCG levels); AND will not be used in combination with growth hormoneage<13; bone age >2 SD

Prior authorization initial validity generally 12 months unless otherwise specified; see Section I for indication-specific durations

Endometriosis

Initial approval provided when ALL of the following are met for Endometriosis:

Endometriosis criteria: Patient's diagnosis has been confirmed by a workup/evaluation (versus presumptive treatment).diagnosis confirmed

Initial PA validity for endometriosis is provided for 6 months per Section I

Uterine Leiomyomata (fibroids)

Initial approval provided when ALL of the following are met for Uterine Leiomyomata (fibroids):

Fibroids criteria: Patient's diagnosis has been confirmed by a workup/evaluation; AND patient is receiving iron therapy.receiving iron therapy

Initial PA validity for uterine fibroids is provided for 3 months per Section I

Breast Cancer

Initial approval provided when ALL of the following are met for Breast Cancer:

Breast cancer criteria: Either: (1) Patient is a premenopausal woman with hormone receptor-positive disease AND used in combination with adjuvant endocrine therapy OR used in combination with endocrine therapy for recurrent unresectable or stage IV disease; OR (2) Patient is a male AND used in combination with aromatase inhibitor therapy.premenopausal OR male

Applicable HCPCS include J9217 and J1950 as noted in document

Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Initial approval provided when ALL of the following are met for Ovarian/Fallopian Tube/Primary Peritoneal Cancer:

Ovarian cancer criteria: Used as a single agent AND either: patient has stage II–IV granulosa cell tumor with relapsed disease; OR patient has specified epithelial/mucinous/clear cell/carcinosarcoma/grade 1 endometrioid histology with persistent or recurrent disease (excluding immediate biochemical relapse); OR patient has low-grade serous carcinoma with disease recurrence after prior aromatase inhibitor therapy.prior aromatase inhibitor for low-grade serous carcinoma

HCPCS referenced: J9217 and J1950

Prostate Cancer

Initial approval provided when ALL of the following are met for Prostate Cancer:

Prostate cancer criteria: Patient must have a contraindication, intolerance, or failure to Camcevi, Eligard, AND Firmagon prior to consideration of Lupron.trial/failure of listed agents

See dosing section for product-specific regimens and HCPCS (J9217, J1952, J1954)

Uterine Neoplasms - Uterine Sarcoma

Initial approval provided when ALL of the following are met for Uterine Sarcoma:

Uterine sarcoma criteria: Diagnosis of low-grade endometrial stromal sarcoma (ESS) or adenosarcoma without sarcomatous overgrowth; AND patient is premenopausal and not suitable for surgery; AND used for small tumor volume or indolent growth; AND used in combination with anastrozole, letrozole, or exemestane.premenopausal; combination endocrine therapy

HCPCS referenced: J9217 and J1950

Head and Neck Cancer

Initial approval provided when ALL of the following are met for Head and Neck Cancer (salivary gland tumors):

Head and neck cancer criteria: Patient has salivary gland tumors; AND used as a single agent OR in combination with abiraterone and prednisone; AND patient has androgen-receptor positive recurrent disease with distant metastases OR unresectable locoregional recurrence with prior radiation therapy OR unresectable second primary with prior radiation therapy.androgen-receptor positive recurrent disease

HCPCS referenced: J9217, J1952, J1954

Prevention/Management of Menstrual Bleeding Associated with HCT

Initial approval provided when ALL of the following are met for Prevention/Management of Menstrual Bleeding Associated with HCT:

HCT bleeding management criteria: Patient is premenopausal; AND patient will receive myeloablative conditioning with cytotoxic chemotherapy OR patient has menorrhagia due to thrombocytopenia related to delayed platelet engraftment.premenopausal; conditioning chemo OR thrombocytopenia-related menorrhagia

Initial PA validity for HCT indication is 6 months per Section I

Fertility Preservation While Receiving Chemotherapy

Initial approval provided when ALL of the following are met for Fertility Preservation During Chemotherapy:

Fertility preservation criteria: Patient is premenopausal; AND receiving cytotoxic chemotherapy with potential to cause ovarian damage/toxicity; AND patient has failed or is not a candidate for other fertility preservation methods (e.g., cryopreservation).receiving gonadotoxic chemo; failed/unsuitable for other preservation

Prior authorization for fertility preservation may be renewed every 12 months while patient remains on cytotoxic chemotherapy (see Section I)

Gender Dysphoria

Initial approval provided when ALL of the following are met for Gender Dysphoria:

Gender dysphoria criteria: Patient has experienced puberty development to at least Tanner stage 2 (applies to patients <18 years); AND diagnosis of gender dysphoria confirmed by a qualified mental health professional OR meets DSM-5-TR criteria; AND a qualified mental health professional has confirmed long-lasting/intense gender nonconformity, worsening with puberty, coexisting problems addressed, and patient's capacity to consent; AND patient has been informed of effects and side effects including potential loss of fertility and options to preserve fertility; AND informed consent obtained with parental/guardian involvement when required; AND for adolescents, a pediatric endocrinologist or clinician experienced in pubertal assessment has confirmed indication and absence of medical contraindications.Tanner stage >=2 for <18; MHP confirmation; informed consent

HCPCS referenced include J1950 and J1951; dosing and administration guidance in dosing section

Gender dysphoria — initial and continuation

Covered when ALL of the following are met:

Gender dysphoria criteria: Patient has a diagnosis of gender dysphoria confirmed by a qualified mental health professional OR meets DSM-5-TR criteria.

See DSM-5-TR criteria and qualified MHP definition in the document

Adolescent pubertal status: For patients <18 years, patient has experienced puberty development to at least Tanner stage 2.Tanner stage >=2

MHP confirmation: Qualified MHP confirms long-lasting/intense pattern of gender nonconformity, worsening with puberty, addressed coexisting problems, and sufficient capacity to consent.

Qualified MHP definition in document

Informed consent and parental involvement:

Central precocious puberty (CPP)

Covered when ALL of the following are met:

Age: Patient is less than 13 years of age.<13 years

Disease response monitoring: Evidence of disease response including lack of progression or stabilization of secondary sexual characteristics, decreased height velocity, decreased BA:CA ratio, and improved final height prediction.

Safety: Absence of unacceptable toxicity from the drug (examples provided such as convulsions, worsening psychiatric symptoms, pseudotumor cerebri).

No GH combination: Will not be used in combination with growth hormone.

Endometriosis — retreatment and continuation

Covered when ALL of the following are met:

Prior duration: Patient has not received a total of 12 months of therapy with a GnRH-agonist (e.g., leuprolide acetate).<12 months total prior therapy

Per Section I, initial and renewal durations for endometriosis are limited (initial 6 months; may be renewed once for 6 months)

Symptom persistence: Patient continues to have symptoms of endometriosis or symptoms recur after the initial 6-month course of therapy.

Bone density assessment: Patient will have bone density assessment prior to retreatment.

Add-back therapy: Extended GnRH-agonist retreatment will be used in combination with norethindrone add-back therapy.

Oncology and fertility preservation indications — continuation

Covered when ALL of the following are met:

Disease response with treatment as defined by stabilization of disease or decrease in tumor size or spread (for cancer indications).

Ongoing chemotherapy for fertility preservation: Patient is still receiving cytotoxic chemotherapy (for fertility preservation indication).

Fertility preservation PAs may be renewed every 12 months while patient remains on chemotherapy per Section I

Safety: Absence of unacceptable toxicity from the drug (examples provided).

ICD-10-linked coverage

Coverage and prior authorization for J1950 are tied to specified ICD-10 diagnoses and utilization management decisions

ICD-10 mapping: J1950 billed with one of the enumerated ICD-10 diagnosis codes (see ICD-10 codes list) for indications such as malignant neoplasms, leiomyoma, endometriosis, precocious puberty, gender dysphoria, fertility preservation, or complications of bone marrow transplant.

Claim/PA must include an appropriate diagnosis code from the listed ICD-10 codes in the document

HCPCS and ICD-10 mapping / Medicare references

Mapping of HCPCS to covered ICD-10 diagnosis codes and Medicare coverage references

HCPCS-to-ICD-10 mapping: Various ICD-10 diagnosis codes are listed as covered/associated diagnoses for the HCPCS codes J1950, J9217, J1951, J1952, and J1954; Medicare NCD/LCD/LCA documents are referenced for coverage specifics.

Follow applicable Medicare NCD/LCD/LCA documents where relevant; see Appendix 2 for Medicare guidance

Prior authorization is required for leuprolide depot products. Initial authorizations are typically valid for 12 months unless an indication-specific shorter duration is specified. Per the policy: endometriosis and HCT bleeding prevention/management authorizations are initially valid for 6 months, and uterine leiomyomata (fibroids) authorizations are initially valid for 3 months. Renewal is generally available every 12 months thereafter unless an indication-specific rule applies.

The policy specifies several combination and retreatment constraints. For Central Precocious Puberty, therapy will not be used in combination with growth hormone. For endometriosis, extended GnRH‑agonist retreatment requires documentation that the patient has not received a total of 12 months of prior GnRH‑agonist therapy, that symptoms persist or recur after an initial 6‑month course, and that retreatment will be combined with norethindrone add‑back therapy and preceded by a bone density assessment. Providers should follow the listed dosing/admin routes for products that must be administered by a healthcare professional.

Within the sections reviewed there are no discrete, additional exclusion statements beyond the indication‑specific renewal and safety constraints; utilization management is implemented via prior authorization and the NQTL checklist rather than a separate exclusion list.

The document is intended for non‑Medicare coverage determinations. Medicare Part B coverage may differ and is governed by the Medicare Benefit Policy Manual and applicable NCDs/LCDs/LCAs; the policy directs providers to follow those Medicare documents where applicable.

Use is not supported when treatment goals or monitoring criteria are unmet. Specifically, continuation or retreatment is contingent on evidence of disease response or stabilization (e.g., tumor size decrease/stabilization for oncology, lack of progression and improvements in growth metrics for CPP), and coverage may be denied when there is disease progression or unacceptable toxicity (examples include convulsions, psychiatric worsening, pseudotumor cerebri, significant bone mineral density loss, or other serious adverse events).

The reviewed sections do not include an explicit standalone statement phrased as ‘not medically necessary.’ Instead, medical necessity determinations are implemented through the specified indication‑based criteria, safety/response requirements, and prior authorization processes described in the policy and the NQTL factor checklist.

Initial Therapy Coverage Rules

Initial therapy criteria — indication-specific diagnostic confirmation and prior therapy trials

Initial therapy coverage criteria are indication-specific and require diagnostic confirmation and/or prior therapy trials as listed.

Initial per indication: See individual coverage criteria nodes for each indication (e.g., CPP, endometriosis, fibroids, cancer, gender dysphoria). Diagnostic confirmation or documented contraindication/intolerance/failure to specified alternatives is required where listed.see indication-specific nodes

Prior authorization required; initial validity typically 12 months unless otherwise specified in Section I

Initial dosing / administration per indication

Dosing regimens and administration per indication:

Endometriosis dosing: Administer 3.75 mg intramuscularly monthly or 11.25 mg intramuscularly every 3 months.

Renewal and Continuation Rules

Renewal/Continuation Therapy — renewal rules vary by indication

Renewal rules vary by indication:

Renewal general: Renewal prior authorization may be granted when the patient continues to meet indication-specific criteria and the authorization duration has not been exceeded; renewal intervals and limits vary by indication (see Section I and renewal-specific criteria in Section IV).duration not exceeded; indication-specific requirements met

Endometriosis: may be renewed once for 6 months; HCT and fibroids: not renewable; fertility preservation: may be renewed every 12 months while on chemotherapy

Continuation / Renewal — renewal permitted when criteria met

Renewal of prior authorization is permitted when continuation criteria are met:

Meet indication criteria: Patient continues to meet the indication-specific criteria identified in Section III (e.g., disease response for oncology, stabilization for CPP, ongoing chemotherapy for fertility preservation).

HCPCS, ICD-10, and NDC Mapping

HCPCS / Billing codes referencedHCPCS

J1950	Leuprolide acetate for depot suspension (various strengths)
J1951	Injection, leuprolide acetate for depot suspension (fensolvi), 0.25 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

NDC Codes referenced (examples)NDC

00074-3641-xx	Lupron Depot 1-Month, 3.75 mg
00074-3642-xx	Lupron Depot 1-Month, 7.5 mg
00074-3663-xx	Lupron Depot (various presentations)
00074-3346-xx	Lupron Depot 3-Month mapping example
00074-3683-xx	Lupron Depot 4-Month mapping example
00074-3473-xx	Lupron Depot 6-Month mapping example
00074-2108-xx	Lupron Depot-Ped 1-Month example
00074-2282-xx	Lupron Depot-Ped 1-Month example
00074-3779-xx	Lupron Depot-Ped 3-Month example
00074-2440-xx	Lupron Depot-Ped 1-Month example

1–10 of 30

1/3

ICD-10 Codes mapped to J1950 (malignant neoplasms and related)ICD-10

C48.1	Malignant neoplasm of specified parts of peritoneum
C48.2	Malignant neoplasm of peritoneum, unspecified
C48.8	Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum
C50.011	Malignant neoplasm of nipple and areola, right female breast
C50.012	Malignant neoplasm of nipple and areola, left female breast
C50.019	Malignant neoplasm of nipple and areola, unspecified female breast
C50.021	Malignant neoplasm of nipple and areola, right female breast (alternate)
C50.022	Malignant neoplasm of nipple and areola, left female breast (alternate)
C50.029	Malignant neoplasm of nipple and areola, unspecified female breast (alternate)

ICD-10 Codes - Endometriosis and related conditions (mapped to J1950)ICD-10Covered

N80.00	Endometriosis of the uterus, unspecified
N80.01	Superficial endometriosis of the uterus
N80.02	Deep endometriosis of the uterus
N80.03	Adenomyosis of the uterus
N80.101	Endometriosis of right ovary, unspecified depth
N80.102	Endometriosis of left ovary, unspecified depth
N80.103	Endometriosis of bilateral ovaries, unspecified depth
N80.109	Endometriosis of ovary, unspecified side, unspecified depth
N80.111	Superficial endometriosis of right ovary
N80.112	Superficial endometriosis of left ovary

1–10 of 143

1/15

Provider Requirements, Documentation & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for J1950 (and related HCPCS in this drug group). Initial authorizations are typically valid for 12 months unless a shorter duration is specified by indication (e.g., endometriosis 6 months, uterine leiomyomata 3 months). Renewals are allowed when renewal criteria are met and duration limits have not been exceeded; some indications (e.g., endometriosis) have limited renewal allowance and others (e.g., HCT-related bleeding, fibroids) may not be renewable. See Section I for indication-specific length of authorization.

Prior authorization required for J1950 and related HCPCS (see policy code groups)
Initial PA validity generally 12 months; Endometriosis 6 months; Fibroids 3 months
Renewals permitted per renewal criteria in Section IV; endometriosis limited to one 6-month renewal; certain indications are non-renewable

Note

NQTL Informs Use of Prior Authorization

When utilization management methods such as prior authorization are applied, they are governed by the plan's NQTL analysis to ensure equivalent application across Medical Benefit drugs for MH/SUD and M/S conditions. Providers should expect PA criteria to reflect evidence, safety, and cost considerations identified in the NQTL checklist.

Step Therapy and Prior Trials

Requirement	Details
Prior trial/failure or contraindication	Patient must have a contraindication, intolerance, or failure to Leupron Depot-Ped, Supprelin LA, AND Triptodur prior to consideration of Fensolvi (or alternative specified products).
Indication-specific application	Requirement applies for Central Precocious Puberty (CPP) prior to coverage of specified leuprolide products; similar prior trial/failure to Camcevi, Eligard, AND Firmagon is required prior to consideration of Lupron for prostate cancer.

Requirement	Details
Retreatment add‑back therapy required	Extended GnRH‑agonist treatment for endometriosis will be used in combination with norethindrone add‑back therapy prior to retreatment.
Additional retreatment prerequisites	Patient must not have received a total of 12 months of prior GnRH‑agonist therapy; patient continues to have recurrent or persistent symptoms; and bone density assessment will be performed prior to retreatment.
Safety requirement	Absence of unacceptable toxicity from the drug (examples include significant loss of bone mineral density, hypersensitivity reactions, convulsions, new or worsening clinical depression).

NQTL Consideration	Summary
NQTL factors considered	Non‑quantitative treatment limitations (NQTLs) were assessed; factors include indication, safety/efficacy, potential for misuse/abuse, and cost. Cost of drug was identified as a reason to consider prior authorization.
Operational effect	Utilization management methods such as prior authorization may be applied based on the NQTL assessment; no specific step therapy algorithms or step sequences are detailed in the NQTL checklist.

Quantity Limits by HCPCS Code

J1950 per-indication unit limits

J1950 — Endometriosis / Fibroids / Gender dysphoria3 units every 84 days

J1950 — Certain cancers (breast/ovarian/uterine sarcoma)6 units every 84 days

J1950 — CPP24 units every 168 days

J1951 unit limits

J1951 — CPP and Gender Dysphoria180 billable units every 168 days

Associated HCPCS mappingJ1951 appears in gender dysphoria and CPP sections as alternate HCPCS to represent specific formulations

Claim linkage

Administration Setting

Note

Recognize available IM and SQ depot formulations (no site‑of‑care restriction listed)

Formulations include both intramuscular (IM) and subcutaneous (SQ) depot products; the policy does not impose a site‑of‑care restriction for administration.

IM products: Lupron Depot, Lupron Depot‑Ped, Lutrate Depot, Leuprolide Acetate Depot.
SQ products: Eligard, Vabrinty, Fensolvi, Camcevi.

Note

Administer provider‑only formulations in an appropriate clinical setting

Some specific formulations must be administered by a healthcare provider (examples: Camcevi, Eligard, Vabrinty, Fensolvi, and Lupron Depot‑Ped); ensure administration occurs in an appropriate setting (office, infusion center, or hospital outpatient) as required by the product labeling.

Verify product‑specific administration requirements and document site of administration when required.
Administer provider‑only products in a healthcare setting as specified.

Key Definitions

Qualified mental health professional definition

Minimum qualificationLicensed by statutory body and hold at minimum a master's degree or equivalent in a relevant clinical field

Clinical competenciesAble to identify coexisting mental health or psychosocial concerns and distinguish them from gender dysphoria

Assessment skillsAble to assess capacity to consent and experienced in clinical aspects of gender dysphoria

Qualified mental health professional — alternate wording

Licensed clinician requirementQualified mental health professional must be licensed and hold at least a master's degree (or equivalent) in a relevant clinical field

Ongoing educationShould undergo continuing education related to gender dysphoria, incongruence, and diversity

Clinical Background

Background: Leuprolide is a gonadotropin‑releasing hormone (GnRH) agonist used across multiple indications including central precocious puberty, endometriosis, uterine fibroids, hormone‑sensitive cancers, fertility preservation during cytotoxic chemotherapy, management of menstrual bleeding around hematopoietic stem cell transplant (HCT), and gender dysphoria. Clinical eligibility in this policy requires indication‑specific diagnostic confirmation, age or pubertal stage thresholds where applicable, and documentation of prior therapy trials or contraindications to alternative agents.

Medicare & Reference Documents

Document references — NCD/LCA/LCD identifiers cited

Document identifiers citedExample Medicare documents cited include A52453 and A59160

Contractor mappingCited documents indicate applicable Medicare contractors (e.g., National Government Services, Palmetto GBA)

Scope noteAppendix notes that preceding info is intended for non‑Medicare determinations but references CMS manuals and NCD/LCD/LCA where applicable

Policy Revision History

Medicare guidance referenced

Policy references Medicare Part B coverage rules and specific NCD/LCA/LCD documents applicable to HCPCS codes J1950, J9217, J1952, and J1954 (e.g., A52453, A59160) and instructs providers to follow Medicare coverage determinations where applicable.

Medicare coverage note addedLatest

Appendix clarifies that the document is intended for non‑Medicare coverage determinations and directs users to the CMS Medicare Coverage Database for NCDs/LCDs/LCAs governing Part B drug coverage.

OpenPayer

Leuprolide suspension (selected depot formulations) — prior authorization and coverage criteria

Coverage Criteria and Indications

Initial Therapy Coverage Rules

Renewal and Continuation Rules

HCPCS, ICD-10, and NDC Mapping

Provider Requirements, Documentation & Authorization

Step Therapy and Prior Trials

Quantity Limits by HCPCS Code

Administration Setting

Key Definitions

Clinical Background

Medicare & Reference Documents

Policy Revision History