CurrentViva HealthPolicy IC-0131

Leuprolide (intramuscular, Trelstar) prior authorization and coverage criteria

This policy defines prior authorization length, dosing limits, initial approval and renewal medical necessity criteria for intramuscular leuprolide (Trelstar) across multiple indications for Viva Health members in North Carolina.

Policy Summary

PayerViva Health

PolicyLeuprolide (intramuscular, Trelstar) prior authorization and coverage criteria

Policy CodePolicy IC-0131

Change TypeNo material change

Effective Date

Next Review DateJul 1, 2025

Key ActionObtain prior authorization and support requests with a covered diagnosis code when billing triptorelin (J3315).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial prior auth validity

6 monthsendometriosis/fibroids initial

6max units (prostate)

<13CPP age requirement

3IM dose strengths

>=40

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covered diagnosis codes

Coverage and Medical Necessity Criteria

inv-01: General Initial Requirement

Covered when ALL of the following are met:

General initial requirement: Patient is at least 18 years of age (unless otherwise specified)>=18 yrs unless otherwise specified

applies unless an indication specifies a different age

inv-02: Central Precocious Puberty (CPP)

Covered when ALL of the following are met:

CPP initial criteria: 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 luteinizing hormone (LH) response to stimulation by native gonadotropin-releasing hormone (GnRH); AND bone age advanced greater than 2 standard deviations beyond chronological age; AND tumor has been ruled out by appropriate labs and diagnostic imaging (brain imaging, pelvic/testicular/adrenal ultrasound, hCG as indicated); AND will not be used in combination with growth hormonesee text

Supports use for CPP

inv-03: Gender Dysphoria / Puberty Suppression

Covered when ALL of the following are met:

Gender dysphoria initial criteria: For patients <18 years, patient has experienced pubertal development to at least Tanner stage 2; AND patient has a diagnosis of gender dysphoria confirmed by a qualified mental health professional OR by DSM-5-TR criteria; AND a qualified mental health professional has confirmed: a long-lasting and intense pattern of gender nonconformity or dysphoria, worsening with onset of puberty, that coexisting psychological/medical/social problems have been addressed and the patient has sufficient capacity to give informed consent; AND patient has been informed of treatment effects including potential loss of fertility and options to preserve fertility; AND informed consent has been obtained with parental/guardian consent/support when the adolescent lacks legal consent capacity; AND for adolescents a pediatric endocrinologist or clinician experienced in pubertal assessment has confirmed agreement in the indication for treatment and absence of medical contraindicationssee text

Applies to puberty suppression for gender dysphoria

inv-04: Prostate Cancer

Covered when ALL of the following are met:

Prostate cancer requirement: Patient must have a contraindication, intolerance, or documented failure to Camcevi, Eligard, AND Firmagon prior to consideration of Trelstar (triptorelin)prior failure/intolerance/contraindication to listed agents

Explicit step therapy requirement

inv-05: Endometriosis and Uterine Leiomyomata (fibroids)

Covered when ALL of the following are met:

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

Initial authorization validity 6 months for endometriosis

Uterine leiomyomata (fibroids): Patient's diagnosis has been confirmed by a workup/evaluation (versus presumptive treatment); AND patient is receiving iron therapydiagnostic confirmation and iron therapy

Initial authorization validity 6 months and prior authorization may NOT be renewed for fibroids

inv-06: Breast Cancer

Covered when ANY of the following are met:

Breast cancer premenopausal: Patient is a premenopausal woman with hormone receptor-positive disease used in combination with adjuvant endocrine therapy OR used in combination with endocrine therapy for recurrent unresectable or stage IV (M1) disease; OR patient is male and used in combination with aromatase inhibitor therapyhormone receptor-positive (when applicable)

Also covered for males in combination with aromatase inhibitor therapy

inv-07: Fertility Preservation While Receiving Chemotherapy

Covered when ALL of the following are met:

Fertility preservation during chemotherapy: Patient is premenopausal; AND patient is receiving treatment with 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); AND patient continues to receive cytotoxic chemotherapy for renewal considerationon cytotoxic chemotherapy

Renewal contingent on continued chemotherapy; prior authorization renewals permitted every 12 months while receiving concomitant cytotoxic chemotherapy

inv-08: Head and Neck Cancer (salivary gland)

Covered when ALL of the following are met:

Head and neck cancer: Patient has salivary gland tumors; AND therapy is used 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 RTandrogen-receptor positive recurrent disease

Indication-specific combination therapy required

inv-09: Uterine Neoplasms - Uterine Sarcoma

Covered when ALL of the following are met:

Uterine sarcoma: Patient has a diagnosis of low-grade endometrial stromal sarcoma (ESS) or adenosarcoma without sarcomatous overgrowth; AND patient is premenopausal and not suitable for surgery (e.g., bilateral salpingo-oophorectomy); AND used for patients with small tumor volume or indolent growth and in combination with anastrozole, letrozole, or exemestanespecific histology and surgical unsuitability

Compendia-recommended indication

inv-10: Coverage criteria and dosing requirements

Covered when ALL of the following are met for specific indications as referenced in the policy:

General monitoring/response requirement: Patient has shown a beneficial response to treatment as evidenced by routine monitoring of clinical pubertal development (if applicable) and applicable laboratory parameters.

supports continuation or assessment of benefit

Fertility preservation concurrent chemotherapy: Patient is still receiving treatment with cytotoxic chemotherapy.

required to qualify for fertility preservation while receiving chemotherapy

Dosing by indication: Dosing varies by indication: prostate cancer — 3.75 mg IM every 4 weeks or 11.25 mg IM every 12 weeks or 22.5 mg IM every 24 weeks; head and neck cancer — 3.75 mg IM every 4 weeks or 11.25 mg IM every 12 weeks; gender dysphoria — 3.75 mg IM at weeks 0, 2, 4 and every 4 weeks thereafter; all other indications — 3.75 mg IM every 4 weeks.

Use the appropriate dosing schedule per indication and supporting documentation

Prior authorization for intramuscular leuprolide used to treat endometriosis or uterine leiomyomata (fibroids) is granted initially for 6 months. Per policy, prior authorization for uterine leiomyomata (fibroids) may NOT be renewed; clinicians should plan treatment and documentation accordingly when requesting coverage for these indications.

Use of intramuscular leuprolide may be considered not medically necessary when the patient has demonstrated unacceptable toxicityhypersensitivity reactions, tumor flare, severe QT/QTc interval prolongation, metabolic syndrome (e.g., hyperglycemia, diabetes, hyperlipidemia), and cardiovascular disease (e.g., myocardial infarction, stroke). Requests may also be denied if the duration of authorization has been exceeded.

Codes, Dosing Strengths, and Diagnosis Lists

Covered HCPCS CodesHCPCSCovered

J3315

Injection, triptorelin pamoate, 3.75 mg; 1 billable unit = 3.75 mg

Covered NDCsNDC

74676-5902-xx	Trelstar 3.75 mg single-dose injection kit
74676-5904-xx	Trelstar 11.25 mg single-dose injection kit
74676-5906-xx	Trelstar 22.5 mg single-dose injection kit

Covered HCPCS dosing limitsHCPCSCovered

J3315

Max units vary by indication: Prostate Cancer: 6 units every 168 days; Gender Dysphoria: 1 unit at weeks 0,2,4 then every 28 days; Head and Neck Cancer: 3 units every 84 days; All Other Indications: 1 unit every 28 days

Covered ICD-10 Diagnosis Codes (selected excerpts)ICD-10Covered

C06.9	Malignant neoplasm of mouth, unspecified
C07	Malignant neoplasm of parotid gland
C08.0	Malignant neoplasm of submandibular gland
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
C61	Malignant neoplasm of prostate
D25.0	Submucous leiomyoma of uterus
E30.1	Precocious puberty
F64.0	Transsexualism

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CMS guidance and MAC jurisdictionsmixed

CMS_REF	Medicare Part B coverage and NCD/LCD/LCA references - see Medicare Coverage Database (https://www.cms.gov/medicare-coverage-database/search.aspx)
MAC_JURISDICTIONS	List of MAC contractors and jurisdictions (Noridian, NGS, Palmetto GBA, Novitas, WPS, First Coast, CGS)

Provider Requirements, Prior Authorization, and Denial Risks

Prior Authorization

Prior authorization validity and dosing limits

Prior authorization validity will be provided initially for 12 months (unless otherwise specified). For endometriosis and uterine leiomyomata (fibroids) initial prior authorization validity is 6 months. Renewals may be granted every 12 months thereafter unless otherwise specified. Note: Endometriosis/uterine leiomyomata authorizations may NOT be renewed; fertility preservation authorizations may be renewed every 12 months only while the patient is receiving concomitant cytotoxic chemotherapy.

Initial authorization: 12 months (6 months for endometriosis/uterine fibroids).
Renewal: every 12 months unless otherwise specified.
Endometriosis/uterine fibroids: not renewable (initial 6 months only).
Fertility preservation: renewable every 12 months only while on cytotoxic chemotherapy.

Prior Authorization

Prior authorization for J3315 and covered diagnoses

HCPCS J3315 (triptorelin pamoate, 3.75 mg; 1 billable unit = 3.75 mg) requires prior authorization and must be supported by a covered diagnosis appropriate to the requested indication.

Clinical Background and Drug Overview

Leuprolide administered intramuscularly is a gonadotropin-releasing hormone (GnRH) agonist used for medical castration and suppression of sex-hormone production across a range of hormone-sensitive conditions. Indications addressed in this policy include prostate cancer, central precocious puberty, gender dysphoria (puberty suppression), breast cancer, fertility preservation during cytotoxic chemotherapy, selected head and neck salivary gland tumors, uterine sarcoma, endometriosis, and uterine leiomyomata. Use must follow indication-specific diagnostic confirmation, dosing schedules, and monitoring requirements as specified in the policy.

Trelstar (triptorelin pamoate) — product and formulation

Generic / brandTriptorelin pamoate (Trelstar) — intramuscular GnRH agonist

FormulationsSingle-dose IM injection kits in 3.75 mg, 11.25 mg, and 22.5 mg strengths

Indications (summary)Used for medical castration/suppression of puberty and other labeled indications per product labeling and compendia

Reference (product labeling)Trelstar package insert (Verity Pharmaceuticals), cited in policy references

Definitions and Diagnostic Criteria

Qualified mental health professional — definition

Minimum qualificationsLicensed by statutory body with at least a master's degree or equivalent in a relevant clinical field

Clinical competenciesAble to identify and distinguish co-existing mental health or psychosocial concerns from gender dysphoria

Diagnostic competenceCompetent using ICD (where required) or equivalent taxonomy for diagnosis

Additional skillsAble to assess capacity to consent and experienced/qualified to evaluate gender dysphoria; maintains continuing education

DSM-5-TR Gender Dysphoria criteria (adolescents & adults)

Duration criterionMarked incongruence for at least 6 months

Policy Revision History

2011-11-28policy_origin

Policy originated (Date of Origin).

2011-12dates_reviewed

Policy reviewed (12/2011).

2012-03dates_reviewed

Policy reviewed (03/2012).

Policy Summary

PayerViva Health

PolicyLeuprolide (intramuscular, Trelstar) prior authorization and coverage criteria

Policy CodePolicy IC-0131

Change TypeNo material change

Effective Date

Next Review DateJul 1, 2025

Key ActionObtain prior authorization and support requests with a covered diagnosis code when billing triptorelin (J3315).

SourceLink

On This Page

HCPCS: J3315 - Injection, triptorelin pamoate, 3.75 mg.
Prior authorization required and request must include a covered diagnosis code from the policy's Appendix 1.

Billing Rule

Covered diagnosis codes (ICD-10)

Use the policy-listed ICD-10 diagnosis codes when requesting services or drugs for endometriosis-related care, uterine leiomyomata, precocious puberty, gender dysphoria, malignancies, fertility preservation, and other covered indications. Include the specific ICD-10 code in the authorization request.

Endometriosis codes: N80.00, N80.391–N80.D9, N80.40–N80.569, N80.6, N80.9, N80.A0–N80.A69, N80.B1–N80.B6, N80.C0–N80.C19, N80.D0–N80.D9.
Uterine leiomyomata: D25.0–D25.9.
Precocious puberty and related: E30.1, E30.8.
Gender identity disorders: F64.0–F64.9.
Other relevant history and encounters: Z31.84 (fertility preservation), Z85.x history of malignancy as listed in Appendix 1.

Denial Risk

Denial triggers

Requests may be denied for failure to meet age requirements, indication‑specific criteria, prior‑authorization duration limits, lack of required step‑therapy, missing or inadequate documentation of response, or unacceptable toxicity.

Age requirement not met (e.g., CPP criteria require age <13 for initiation and specific puberty onset ages).
Indication‑specific criteria from Section III not met.
Authorization duration exceeded (see Length of Authorization).
Required step therapy or prior agent trial not documented (e.g., prostate cancer requirements).
Unacceptable toxicity documented (hypersensitivity, severe QT/QTc prolongation, metabolic or cardiovascular events).
HCPCS/drug billed without matching covered diagnosis or prior authorization.

Documentation Required

Insufficient treatment response documentation

Lack of documentation showing beneficial treatment response or lacking routine monitoring when required may result in denial of renewal or continuation requests.

For Gender Dysphoria: documentation of beneficial response based on clinical pubertal development and labs.
For other indications: evidence of symptomatic or objective improvement as specified by the indication's renewal criteria.

Documentation Required

Fertility preservation concurrent treatment requirement

Fertility preservation prior authorization is valid only while the patient is receiving concomitant cytotoxic chemotherapy; the request and renewal must document ongoing cytotoxic chemotherapy treatment.

Fertility preservation coverage requires the patient to be currently receiving cytotoxic chemotherapy.
Include documentation of chemotherapy regimen and treatment dates with the authorization request.

Note

NCD/LCD compliance

Claims and prior authorization decisions must comply with applicable Medicare NCDs, LCDs, and LCAs for Medicare Part B drugs where relevant; failure to comply may result in denial for Medicare members.

Search applicable NCD/LCD/LCA documents using the CMS Medicare Coverage Database.
Be aware of contractor‑specific documents (examples cited: A52453, A59160) and contractors named in policy appendices.

Documentation Required

Required diagnostic confirmation

Diagnosis confirmation is required by appropriate workup/evaluation (not presumptive treatment) for endometriosis, uterine leiomyomata, and central precocious puberty; tumor causes must be ruled out where specified.

Endometriosis: documented diagnostic workup confirming diagnosis (not presumptive).
Uterine leiomyomata: documented diagnostic workup and evidence of iron therapy.
CPP: confirmation by pubertal sex steroid levels, LH stimulation testing, advanced bone age, and imaging/lab tests to exclude tumors.

Documentation Required

Required clinical documentation

Include required clinical documentation with authorization requests: indication‑specific diagnostic workups, prior treatment trials or contraindications, evidence of beneficial response for renewals, routine monitoring data, and documentation of absence of unacceptable toxicity.

Initial requests: diagnostic confirmation, prior therapy trials or documented contraindications/intolerance (e.g., prostate cancer step therapy), current medications, and relevant labs/imaging.
Renewal requests: documentation that patient continues to meet criteria, evidence of benefit, duration not exceeded, and absence of unacceptable toxicity.
For J3315 billing: include HCPCS code, dosage/units requested, and matching ICD‑10 covered diagnosis code.

Step Therapy

Prostate cancer step therapy

For prostate cancer indication, evidence of trial of—or documented contraindication/intolerance/failure to—Camcevi, Eligard, and Firmagon is required prior to consideration of alternative agents.

Document trial dates and clinical response or documented reasons for intolerance/contraindication for Camcevi®, Eligard®, and Firmagon®.
If trials are not feasible, provide clear medical rationale.

Note

Medicare policy references

Medicare Part B outpatient drug coverage follows CMS Medicare Benefit Policy Manual Chapter 15 §50 and any applicable NCDs/LCDs/LCAs. Use the CMS Coverage Database to locate contractor‑specific guidance; additional plan discretion may apply for non‑Medicare members.

Reference: Medicare Benefit Policy Manual (Pub. 100‑02), Chapter 15, §50 Drugs and Biologicals.
Search for NCD/LCD/LCA documents at https://www.cms.gov/medicare-coverage-database/search.aspx.

Manifestations (need ≥2)Examples include incongruence with primary/secondary sex characteristics, strong desire to be rid of these characteristics, strong desire for characteristics of other gender, desire to be treated as other gender, conviction of typical feelings/reactions of other gender

Associated impactCondition associated with clinically significant distress or impairment in social, occupational, or other important areas of functioning

Endometriosis — ICD-10 N80.x series

Code familyICD-10 N80.x series — Endometriosis codes

ScopeDescribes endometriosis by site and depth (superficial, deep, unspecified) across multiple anatomical locations

ExamplesIncludes codes such as N80.391 (superficial pelvic peritoneum), N80.511 (superficial rectum), N80.A1 (superficial bladder), and many others enumerated in Appendix 1

NCD / LCD / LCA — CMS coverage instruments

DefinitionsNCD = National Coverage Determination; LCD = Local Coverage Determination; LCA = Local Coverage Article

PurposeCMS-issued coverage instruments that may govern Medicare Part B drug coverage and claims payment

AccessSearchable via the CMS Medicare Coverage Database (https://www.cms.gov/medicare-coverage-database/search.aspx); compliance required where applicable

Policy reviewed (06/19/2012).

2012-09dates_reviewed

Policy reviewed (09/2012).

2012-12dates_reviewed

Policy reviewed (12/2012).

2013-03dates_reviewed

Policy reviewed (03/2013).

2013-06dates_reviewed

Policy reviewed (06/2013).

2013-09dates_reviewed

Policy reviewed (09/2013).

2013-12dates_reviewed

Policy reviewed (12/2013).

2014-03dates_reviewed

Policy reviewed (03/2014).

2014-06dates_reviewed

Policy reviewed (06/2014).

2014-09dates_reviewed

Policy reviewed (09/2014).

2014-12dates_reviewed

Policy reviewed (12/2014).

2015-03dates_reviewed

Policy reviewed (03/2015).

2015-05dates_reviewed

Policy reviewed (05/2015).

2015-08dates_reviewed

Policy reviewed (08/2015).

2015-11dates_reviewed

Policy reviewed (11/2015).

2016-02dates_reviewed

Policy reviewed (02/2016).

2016-05dates_reviewed

Policy reviewed (05/2016).

2016-08dates_reviewed

Policy reviewed (08/2016).

2016-11dates_reviewed

Policy reviewed (11/2016).

2017-02dates_reviewed

Policy reviewed (02/2017).

2017-05dates_reviewed

Policy reviewed (05/2017).

2017-08dates_reviewed

Policy reviewed (08/2017).

2017-11dates_reviewed

Policy reviewed (11/2017).

2018-02dates_reviewed

Policy reviewed (02/2018).

2018-05dates_reviewed

Policy reviewed (05/2018).

2019-04dates_reviewed

Policy reviewed (04/2019).

2020-04dates_reviewed

Policy reviewed (04/2020).

2021-04dates_reviewed

Policy reviewed (04/2021).

2022-03dates_reviewed

Policy reviewed (03/2022).

2022-10dates_reviewed

Policy reviewed (10/2022).

2023-01-01reference_update

CMS Local Coverage Article A52453 updated effective 2023-01-01 (referenced in policy appendices).

2023-04dates_reviewed

Policy reviewed (04/2023).

2024-02-07reference_update

Palmetto GBA Local Coverage Article A59160 updated on 2024-02-07 with effective date 2024-03-15 (referenced in policy appendices).

2024-04dates_reviewed

Policy reviewed (04/2024).

2025-04dates_reviewed

Policy reviewed (04/2025).

2025-06references_updated

Package insert and guideline references accessed/updated (March 2025 package insert; NCCN and other references accessed June 2025).

2025-07-01last_review_dateLatest

Last review date recorded (07/01/2025).