Trelstar (triptorelin pamoate) (Intramuscular) — Prior authorization, dosing, and renewal criteria
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This policy defines prior authorization, dosing limits, initial approval, and renewal criteria for Trelstar (triptorelin pamoate IM) across multiple indications (e.g., prostate cancer, CPP, gender dysphoria, breast cancer, fertility preservation, uterine fibroids, head and neck cancer, uterine sarcoma) for Viva Health members.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
inv-01: Initial Approval - General
Covered when ALL of the following are met:
Applies unless indication-specific age limits exist (e.g., CPP)
inv-02: Initial Approval - Prostate Cancer
Prostate Cancer — Covered when ALL of the following are met:
This is a step requirement before Trelstar
inv-03: Initial Approval - Central Precocious Puberty
Central Precocious Puberty (CPP) — Covered when ALL of the following are met:
Multiple diagnostic tests and tumor exclusion required
inv-04: Initial Approval - Gender Dysphoria
Gender Dysphoria — Covered when ALL of the following are met:
Requires documentation from MHP and, for adolescents, pediatric endocrinologist
inv-05: Initial Approval - Endometriosis
Endometriosis — Covered when ALL of the following are met:
Documentation of workup required
inv-06: Initial Approval - Uterine Leiomyomata
Uterine Leiomyomata (fibroids) — Covered when ALL of the following are met:
Initial approval limited to 6 months and renewals not allowed
inv-07: Initial Approval - Breast Cancer
Breast Cancer — Covered when ALL of the following are met:
Member must be premenopausal if female
inv-08: Initial Approval - Fertility Preservation
Fertility Preservation During Chemotherapy — Covered when ALL of the following are met:
Renewals allowed annually while receiving concomitant chemotherapy
inv-09: Initial Approval - Head and Neck Cancer
Head and Neck Cancer — Covered when ALL of the following are met:
Combination therapy requirement
inv-10: Initial Approval - Uterine Sarcoma
Uterine Neoplasms - Uterine Sarcoma — Covered when ALL of the following are met:
Combination endocrine therapy required
inv-11: Indication-specific medical necessity
Covered when ALL of the following are met for each indication
From policy CPP criteria.
From policy gender dysphoria coverage statement.
From policy fertility preservation statement.
From Dosage/Administration section.
Renewal for uterine leiomyomata (fibroids) is explicitly limited: initial authorization is granted per the initial approval criteria, but renewals are not permitted after the initial approval period. When submitting an initial request, include documentation confirming the diagnosis by workup/evaluation and evidence of concurrent iron therapy, as these elements are required for the initial approval and there is no pathway for extension beyond the initial authorization for this indication.
For central precocious puberty (CPP), the policy requires the member to be younger than 13 years of age. Requests for members who are 13 years or older do not meet the CPP age criterion described in the policy and therefore are not eligible under this CPP-specific coverage pathway.
Medicare rules may supersede this policy for Part B outpatient drugs. Applicable NCDs, LCDs, LCAs, and other CMS/MAC guidance must be followed when submitting claims or requests for Medicare beneficiaries; these determinations can take precedence. The policy also notes that additional indications may be applied at the discretion of the health plan.
Renewal may be denied when the member no longer meets indication‑specific renewal criteria or if there is evidence of unacceptable toxicity from the drug. Examples of unacceptable toxicities listed include hypersensitivity reactions, tumor flare, severe QT/QTc prolongation, metabolic syndrome (e.g., hyperglycemia, diabetes, hyperlipidemia), cardiovascular events (e.g., myocardial infarction, stroke), convulsions, and severe cutaneous adverse reactions (including SJS/TEN, DRESS, and AGEP). Confirm ongoing eligibility at each renewal and document absence of these toxicities and continued meeting of the indication-specific criteria.
Appendix A (NQTL factor table) documents the plan’s assessment of utilization-management factors for triptorelin. It notes that safety/efficacy and potential for misuse/abuse were not prioritized as reasons for prior authorization, while the indication and drug cost were considerations for applying PA. This table does not itself impose non‑medical‑necessity denials but explains the rationale used when designing PA criteria.
Initial Therapy Requirements by Indication
inv-44: Initial Therapy Requirements
Indication-specific initial approval requirements (summarized):
Refer to each indication for required documentation
inv-45: Initial therapy dosing
Initial dosing regimens by indication
From Dosage/Administration.
From Dosage/Administration.
From Dosage/Administration.
From Dosage/Administration.
Renewal and Continuation Therapy
inv-46: Renewal / Continuation Therapy
Renewal criteria by indication
Clinical response documentation required
Objective measures required
Documentation from treating clinicians required
Billing, Codes, and Dosing Units
| HCPCS unit | Described as billable units corresponding to mg strengths (e.g., 1 unit = 3.75 mg; 3 units = 11.25 mg; 6 units = 22.5 mg) |
| J3315 | Injection, triptorelin pamoate, 3.75 mg; 1 billable unit = 3.75 mg |
| 74676-5902-xx | Trelstar 3.75 mg single-dose injection kit:74676-5902-xx |
| 74676-5904-xx | Trelstar 11.25 mg single-dose injection kit: 74676-5904-xx |
| 74676-5906-xx | Trelstar 22.5 mg single-dose injection kit: 74676-5906-xx |
| C06.9 | Malignant neoplasm of mouth, unspecified |
| C07 | Malignant neoplasm of parotid gland |
| C08.0 | Malignant neoplasm of submandibular gland |
| C08.1 | Malignant neoplasm of sublingual gland |
| C08.9 | Malignant neoplasm of major salivary gland, unspecified |
| C50.011 | Malignant neoplasm of nipple and areola, right female breast |
| C50.012 | Malignant neoplasm of nipple and areola, left female breast |
| C50.021 | Malignant neoplasm of nipple and areola, unspecified female breast |
| C50.022 | Malignant neoplasm of nipple and areola, unspecified female breast |
| C50.029 | Malignant neoplasm of nipple and areola, unspecified female breast |
| C50.921 | Malignant neoplasm of axillary tail of left female breast |
| C50.922 | Malignant neoplasm of axillary tail of left female breast |
| C50.929 | Malignant neoplasm of axillary tail of left female breast |
| C50.A0 | Malignant inflammatory neoplasm of unspecified breast |
| C50.A1 | Malignant inflammatory neoplasm of right breast |
| C50.A2 | Malignant inflammatory neoplasm of left breast |
| C54.0 | Malignant neoplasm of isthmus uteri |
| C54.1 | Malignant neoplasm of endometrium |
| C54.2 | Malignant neoplasm of myometrium |
| C54.3 | Malignant neoplasm of fundus uteri |
Quantity and Unit Billing Guidance
Prior Authorization, Documentation, and Denial Risks
Prior authorization required; validity and renewal intervals
Prior authorization is required for Trelstar. Initial approvals are generally issued for 12 months (365 days); for endometriosis or uterine leiomyomata the initial approval period is 6 months (180 days). Renewals are available every 12 months (365 days) unless otherwise specified; note that prior authorization for uterine leiomyomata may NOT be renewed and fertility preservation may be renewed annually while the member remains on cytotoxic chemotherapy.
- Initial PA: 12 months (365 days) standard
- Initial PA: 6 months (180 days) for endometriosis/uterine leiomyomata
- Renewals: every 12 months (365 days) unless otherwise specified
- Uterine leiomyomata: PA may NOT be renewed after initial approval
- Fertility preservation: renewals allowed annually while receiving cytotoxic chemotherapy
PA considered for indication and cost reasons
Prior authorization is applied because authorization depends on the specific clinical indication and the drug cost; these factors are listed as reasons to consider PA in the policy's NQTL assessment.
- PA considered based on indication
- PA considered because of drug cost
Verify Medicare (Part B) coverage rules and NCD/LCD guidance
For Medicare Part B members, outpatient drug coverage may be governed by CMS National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and MAC guidance; verify and comply with any applicable NCDs/LCDs/LCAs when submitting requests for Part B beneficiaries.
- Medicare Part B coverage rules (NCD/LCD/LCA) take precedence where applicable
- Use the CMS coverage database to identify applicable determinations
Document prior failure/intolerance to Camcevi, Eligard, and Firmagon for prostate cancer
For prostate cancer, prior authorization consideration for Trelstar requires documentation that the patient has a contraindication, intolerance, or documented failure to Camcevi, Eligard, AND Firmagon before Trelstar will be considered.
- Document contraindication, intolerance, or treatment failure to Camcevi, Eligard, and Firmagon
No explicit step therapy sequence provided
The policy does not specify an explicit step therapy sequence for Trelstar in the provided document portion.
- No formal step therapy sequence is listed in this policy excerpt
CPP: required diagnostic confirmation and tumor exclusion
For central precocious puberty (CPP), documentation must include confirmation by pubertal gonadal sex steroid levels and a pubertal LH response to GnRH stimulation, bone age advanced >2 SD, and appropriate imaging/labs to exclude tumors.
- Pubertal gonadal sex steroid levels confirming activation
- Pubertal LH response to native GnRH stimulation
- Bone age advanced >2 standard deviations
- Imaging and labs to rule out intracranial or steroid‑secreting tumors (e.g., brain imaging, pelvic/testicular/adrenal ultrasound, hCG levels)
Required clinical documentation showing age and disease response or ongoing treatment
Clinical documentation submitted for PA or renewal must demonstrate relevant patient age (when applicable), evidence of disease response or ongoing treatment (e.g., CPP: stabilization/lack of progression of secondary sexual characteristics, decreased height velocity and BA:CA ratio, improved final height prediction), and indication‑specific evidence of benefit or continued need.
- Document member age where relevant (e.g., CPP <13 years)
- For CPP: show lack of progression/stabilization of secondary sexual characteristics, decreased height velocity, decreased BA:CA ratio, and improved final height prediction
- For gender dysphoria: routine monitoring showing beneficial pubertal suppression response and applicable lab parameters
- For fertility preservation: documentation that member remains on cytotoxic chemotherapy
Document and bill with covered ICD‑10 diagnosis codes from Appendix 1
When submitting claims or PA requests, include an appropriate covered ICD‑10 diagnosis code from Appendix 1 that corresponds to the treated condition (Appendix 1 lists malignant neoplasms, endometriosis, precocious puberty, fertility preservation Z‑codes, and related history codes).
- Use Appendix 1 ICD‑10 codes relevant to the indication (e.g., C61 for prostate cancer, N80.x for endometriosis, CPP codes listed)
- Z31.84 for fertility preservation encounters and listed personal history Z85 codes where applicable
Denial risk if unacceptable toxicity is present at renewal
Renewal may be denied if there is unacceptable toxicity from the drug; listed examples include hypersensitivity reactions, tumor flare, severe QT/QTc prolongation, metabolic syndrome (hyperglycemia/diabetes/hyperlipidemia), cardiovascular events (e.g., myocardial infarction, stroke), convulsions, and severe cutaneous adverse reactions (SJS/TEN, DRESS, AGEP).
- Document absence of unacceptable toxicity at renewal
- Be aware that listed toxicities are grounds for denial of renewal
Age‑based denial risk for CPP: member must be <13 years
Requests for CPP for members age 13 years or older do not meet the policy's CPP age criterion and therefore present a denial risk; CPP coverage requires the member to be less than 13 years of age.
- CPP eligibility: member must be <13 years
- Requests for CPP in members ≥13 years may be denied
Ensure compliance with applicable Medicare NCDs/LCDs for Part B claims
For Medicare members, coverage determinations must follow applicable NCDs and LCDs; failure to follow Medicare coverage policies and contractor guidance may result in coverage denial for Part B outpatient drugs.
- Verify applicable NCDs/LCDs/LCAs and MAC contractor guidance before submitting for Medicare Part B beneficiaries
- Noncompliance with Medicare coverage determinations may trigger denial
Step Therapy / Prior Treatments
| Required prior agents | Notes |
|---|---|
| Camcevi (relugolix) | |
| Eligard (leuprolide) | |
| Firmagon (degarelix) |
| Step therapy requirement | Policy note |
|---|---|
| No explicit step therapy sequence provided in this document portion | |
| Prior authorization is considered due to indication and drug cost per the NQTL factor checklist |
Administration Setting and Billing Guidance
Administer intramuscularly per dosing schedule; no site‑of‑care restriction specified here
Administer intramuscularly per the dosing schedule for the selected indication; this portion of the policy does not specify additional site‑of‑care restrictions.
- Give IM injection at the selected interval (per dosing regimens in Dosage/Administration)
- No specific office vs. facility site‑of‑care restriction provided in this section
Follow CMS/MAC Part B guidance for hospital outpatient billing
For Medicare Part B outpatient billing, follow CMS/MAC policies and applicable Part B guidance when the drug is billed to Medicare; verify contractor‑specific requirements for site‑of‑care billing and claims payment.
- Use CMS Medicare Benefit Policy Manual and MAC guidance for Part B billing
- Check jurisdiction/MAC contractor guidance listed in Appendix 2 as needed
Appendices: Codes and Diagnosis Lists
| See Appendix 1 | Comprehensive list of covered ICD-10 diagnosis codes for oncology, endometriosis, precocious puberty, fertility preservation, leiomyomata, and related histories as listed in Appendix 1 (see policy Appendix 1 pages). |
| (comprehensive list) | Full ICD-10 lists in Appendix 1 covering malignant neoplasms, endometriosis, precocious puberty, leiomyomata, and related codes (see Appendix 1). |
| Z31.84 | Encounter for fertility preservation procedure |
| Z85.3 | Personal history of malignant neoplasm of breast |
| Z85.42 | Personal history of malignant neoplasm of other parts of uterus |
| Z85.46 | Personal history of malignant neoplasm of prostate |
| J3315 | HCPCS J3315 maps to injection, triptorelin pamoate, 3.75 mg (1 billable unit = 3.75 mg); bill units to match 11.25 mg (3 units) and 22.5 mg (6 units) strengths |
| 74676-5902-xx | Trelstar 3.75 mg single-dose injection kit NDC |
| 74676-5904-xx | Trelstar 11.25 mg single-dose injection kit NDC |
| 74676-5906-xx | Trelstar 22.5 mg single-dose injection kit NDC |
Definitions and Clinical Terms
Clinical Background
Triptorelin is a gonadotropin‑releasing hormone (GnRH) agonist indicated across multiple hormone‑responsive conditions. The policy enumerates its use for oncology and benign gynecologic indications as well as pediatric and gender‑related indications, including prostate cancer, central precocious puberty (CPP), gender dysphoria (pubertal suppression), hormone receptor–positive breast cancer in premenopausal women, fertility preservation during cytotoxic chemotherapy, endometriosis, uterine leiomyomata (fibroids), head and neck salivary gland tumors, and certain uterine sarcomas. Coverage requires meeting the indication‑specific diagnostic, prior‑therapy, and monitoring criteria described in the policy.
Policy Revision History
Policy IC-0131 last reviewed and effective date recorded; renewal and authorization intervals specified (initial PA generally 12 months; endometriosis/uterine leiomyomata initial 6 months; renewals every 12 months unless specified otherwise).
Appendix 2 added/updated clarifying that Medicare Part B coverage (NCDs/LCDs/LCAs) may apply and take precedence and providing CMS coverage search link and jurisdiction listings for contractor MACs.
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