CurrentmhnPolicy CP.PHAR.175

TRELSTAR (PDF)

Defines medical necessity criteria, prescriber requirements, dosing limits, approved indications (prostate cancer, central precocious puberty) and selected off-label NCCN-supported uses (breast cancer, salivary gland tumors, uterine sarcoma) for Triptorelin pamoate across Commercial, HIM, and Medicaid lines of business, plus continuation criteria and approval durations.

Policy Summary

Payermhn

PolicyTRELSTAR (PDF)

Policy CodePolicy CP.PHAR.175

Change TypeMultiple (added off-label uses; attestation; duration update; unit correction)

Effective DateOct 1, 2016

Next Review Date

Key ActionProvider must submit office chart notes, lab results or other clinical information supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added NCCN compendium supported off-label uses in breast cancer, salivary gland tumors, and uterine sarcoma for Trelstar.

Added requirement for provider attestation of understanding State regulations regarding transgender-related health care and that such care is coverable under State regulations.

Modified Commercial approval duration to 6 months or to member's renewal date, whichever is longer.

Corrected units for basal luteinizing hormone level to mIU/mL.

2FDA-approved indications (Trelstar, Triptodur)

3NCCN-supported off-label uses added

12States excluding gender dysphoria coverage (HIM)

Coverage Summary

Scope: This policy defines medical necessity criteria and coverage parameters for triptorelin pamoate (Trelstar, Triptodur) across Commercial, HIM, and Medicaid lines of business. It covers FDA-approved indications — Trelstar for advanced prostate cancer and Triptodur for pediatric central precocious puberty (CPP) age ≥ 2 — and NCCN compendium–supported off-label uses added for breast cancer, salivary gland tumors, and uterine sarcoma.

Prescriber and specialty requirements, continuation criteria, and approval durations vary by line of business (Commercial: 6 months or to member's renewal date, whichever is longer; HIM/Medicaid: 12 months). Dosing limits are specified: for Trelstar 3.75 mg per 4 weeks; 11.25 mg per 12 weeks; 22.5 mg per 24 weeks; for Triptodur 22.5 mg every 24 weeks.

State-specific exclusions relevant to coverage stance: for HIM gender dysphoria/gender transition coverage is not available for members in the following states — AL, AZ, AR, FL, GA, IN, IA, KS, KY, LA, MS, MO, NE, NH, NC, OH, OK, SC, TN — and provider attestation regarding state regulations is required where applicable.

Initial Therapy Criteria

Initial Approval Criteria

Provider must submit documentation supporting that member has met all approval criteria. Trelstar and Triptodur are medically necessary when the following criteria are met:

Prostate cancer (Trelstar) initial

Core requirements
- Diagnosis of prostate cancer
- Product: Request is for Trelstar
- Prescriber: Prescribed by or in consultation with an oncologist or urologist
- Age ≥ 18 years
- Dose requirement (one of)
  - Within FDA max: Dose does not exceed 3.75 mg per 4 weeks, 11.25 mg per 12 weeks, or 22.5 mg per 24 weeks3.75 mg/4 weeks; 11.25 mg/12 weeks; 22.5 mg/24 weeks

Central Precocious Puberty (Triptodur) initial

Diagnosis of CPP must be confirmed by
- Lab criteria: Elevated basal luteinizing hormone (LH) level > 0.2 - 0.3 mIU/mL and/or elevated leuprolide-stimulated LH level > 3.3 - 5 IU/L (dependent on assay)> 0.2 - 0.3 mIU/mL; > 3.3 - 5 IU/L
- Bone age: Difference between bone age and chronological age > 1 year (bone age - chronological age)> 1 year
- Age at onset of secondary sex characteristics
  - Female onset: Female: < 8 years< 8 years

Breast Cancer (off-label)

Diagnosis of breast cancer
Product: Request is for Trelstar
Prescriber: Prescribed by or in consultation with an oncologist
Disease characteristic: Disease is hormone receptor positive
Dose requirement (one of)
- Within FDA max: Dose does not exceed 3.75 mg per 4 weeks, 11.25 mg per 12 weeks, or 22.5 mg per 24 weeks

Salivary Gland Tumors (off-label)

Diagnosis of salivary gland tumors
Product: Request is for Trelstar
Disease characteristic: Disease is androgen receptor positive and recurrent, unresectable, or metastatic
Prescriber: Prescribed by or in consultation with an oncologist
Dose requirement (one of)
- Within FDA max: Dose does not exceed 3.75 mg per 4 weeks, 11.25 mg per 12 weeks, or 22.5 mg per 24 weeks

Uterine Sarcoma (off-label)

Diagnosis of uterine sarcoma
Product: Request is for Trelstar
Prescriber: Prescribed by or in consultation with an oncologist
Histology: Member has endometrial stromal sarcoma or adenosarcoma without sarcomatous overgrowth
Menopausal status: Member is premenopausal

Other diagnoses/indications

Fallback actions: If drug underwent label change within last 6 months not reflected in policy, follow specified formulary/non-formulary policies (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16); If requested use is not specifically listed under Diagnoses/Indications not authorized, refer to off-label use policy for relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Continuation Therapy Criteria

Continued Therapy

Members currently receiving therapy must meet the following continuation criteria by indication:

Prostate Cancer continued therapy

Continuity: Currently receiving medication via Centene benefit, or documentation supports current receipt of Trelstar for prostate cancer and member has received medication for at least 30 days
Product: Request is for Trelstar
Response: Member is responding positively to therapy
Dose increase (one of)

Diagnoses / Indications Not Authorized

Diagnoses/Indications Not Authorized

Coverage not authorized for non-FDA approved indications not addressed in this policy unless sufficient documentation per off-label use policies is provided.

Diagnoses/Indications Not Authorized: Non-FDA approved indications which are not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety according to off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents.

Provider Actions

Documentation Required

Submit supporting documentation

Submit office chart notes, laboratory results, or other clinical information that documents the member meets all approval criteria (diagnosis, prescriber specialty/consultation, age, relevant laboratory or imaging thresholds, dosing limits, treatment response, and any additional condition-specific requirements).

Prior Authorization

Prescriber specialty requirements

Prescriptions must be written by or in consultation with the specialists required for the indication: oncologist or urologist for prostate cancer; pediatric endocrinologist for central precocious puberty (CPP); and both an endocrinologist and a provider with expertise in transgender medicine (e.g., provider with certified training or affiliation with local transgender health services) for gender dysphoria/gender transition.

Applicable Codes

HCPCS codes (informational)HCPCS

J3315	Injection, triptorelin pamoate, 3.75 mg
J3316	Injection, triptorelin, extended-release, 3.75 mg

Clinical Evidence & References

Evidence and references include the Trelstar Prescribing Information (Verity Pharmaceuticals, March 2025) and the Triptodur Prescribing Information (Arbor Pharmaceuticals, December 2022) as primary product references.

Key clinical literature cited: Klein K et al., Triptorelin efficacy and safety of the 6‑month formulation in patients with central precocious puberty, J Pediatr Endocrinol Metab. November 2016 (study of 6-month formulation).

Product availability and dosing details are referenced in the dosing/administration and product availability sections of the policy (maximum dose limits and single‑dose vial formulations).

Note: NCCN compendium–supported off‑label uses for Trelstar in breast cancer, salivary gland tumors, and uterine sarcoma were added to the policy in the 4Q 2025 annual review per the changes log.

Background

Background: Triptorelin pamoate is a GnRH receptor agonist. Brand indications: Trelstar — advanced prostate cancer; Triptodur — pediatric CPP for patients aged ≥ 2 years.

Available formulations: single‑dose vials for reconstitution — 3.75 mg, 11.25 mg, and 22.5 mg (Trelstar kits include Mixject; Triptodur available as 22.5 mg kit).

Revision History

11.25 (P&T Approval Date), 4Q 2025 (Date = 07.10.25)material_addition - off-label uses (NCCN)Latest

Added NCCN compendium supported off-label uses for Trelstar in breast cancer, salivary gland tumors, and uterine sarcoma (4Q 2025 annual review; P&T Approval Date 11.25). Reference list and related criteria updated.

02.12.25material_addition - gender dysphoria criteria

Added requirement for provider attestation of understanding current State regulations regarding transgender-related health care and that such care is coverable under State regulations; added to gender dysphoria and gender transition criteria and Appendix D (dated 02.12.25).

4Q 2021 (Date = 07.14.21; P&T Approval Date = 11.21)

Policy Summary

Payermhn

PolicyTRELSTAR (PDF)

Policy CodePolicy CP.PHAR.175

Change TypeMultiple (added off-label uses; attestation; duration update; unit correction)

Effective DateOct 1, 2016

Next Review Date

Key ActionProvider must submit office chart notes, lab results or other clinical information supporting that member meets all approval criteria.

SourceLink

On This Page

Supported by evidence: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Regimen: Prescribed regimen must be FDA-approved or recommended by NCCN

Male onset: Male: < 9 years< 9 years

Product & prescriber: Request is for Triptodur; Prescribed by or in consultation with a pediatric endocrinologist

Member age requirement (one of)

Female age: Female: 2 - 11 years2 - 11 years
Male age: Male: 2 - 12 years2 - 12 years

Dose limit: Dose does not exceed 22.5 mg per 24 weeks22.5 mg/24 weeks

3.75 mg/4 weeks; 11.25 mg/12 weeks; 22.5 mg/24 weeks

Supported by evidence: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Regimen: Prescribed regimen must be FDA-approved or recommended by NCCN

3.75 mg/4 weeks; 11.25 mg/12 weeks; 22.5 mg/24 weeks

Supported by evidence: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Regimen: Prescribed regimen must be FDA-approved or recommended by NCCN

Combination therapy:

Prescribed in combination with anastrozole, letrozole or exemestane

Dose requirement (one of)

Within FDA max: Dose does not exceed 3.75 mg per 4 weeks, 11.25 mg per 12 weeks, or 22.5 mg per 24 weeks3.75 mg/4 weeks; 11.25 mg/12 weeks; 22.5 mg/24 weeks
Supported by evidence: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Regimen: Prescribed regimen must be FDA-approved or recommended by NCCN

Within FDA max: New dose does not exceed 3.75 mg per 4 weeks, 11.25 mg per 12 weeks, or 22.5 mg per 24 weeks3.75 mg/4 weeks; 11.25 mg/12 weeks; 22.5 mg/24 weeks

Supported by evidence: New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Regimen: Prescribed regimen must be FDA-approved or recommended by NCCN

Central Precocious Puberty continued therapy

Membership status (one of)
- Currently receiving or met initial: Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Continuity of care regs: Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state-specific addendums CC.PHARM.03A and CC.PHARM.03B)
Product: Request is for Triptodur
Response: Member is responding positively to therapy as evidenced by decreased growth velocity, cessation of menses, softening of breast tissue or testes, arrested pubertal progression
Age requirement (one of)
- Female age: Female: ≤ 11 years≤ 11 years
- Male age: Male: ≤ 12 years≤ 12 years
Dose increase limit: If dose increase requested, new dose does not exceed 22.5 mg per 24 weeks22.5 mg/24 weeks

Breast Cancer, Salivary Gland Tumors, Uterine Sarcoma continued therapy

Continuity: Currently receiving medication via Centene benefit, or documentation supports current receipt of Trelstar for the indication and member has received medication for at least 30 days
Product: Request is for Trelstar
Response: Member is responding positively to therapy
Dose increase (one of)
- Within FDA max: New dose does not exceed 3.75 mg per 4 weeks, 11.25 mg per 12 weeks, or 22.5 mg per 24 weeks3.75 mg/4 weeks; 11.25 mg/12 weeks; 22.5 mg/24 weeks
- Supported by evidence: New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
Regimen: Prescribed regimen must be FDA-approved or recommended by NCCN

Other diagnoses/indications continued therapy

Fallback actions: If drug underwent label change within last 6 months not reflected in policy, follow specified formulary/non-formulary policies (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16); If requested use is not specifically listed under Diagnoses/Indications for which coverage is NOT authorized, refer to the off-label use policy for relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Documentation Required

Provider attestation for gender transition

For gender dysphoria/gender transition requests, the provider must attest they understand current State regulations regarding transgender-related health care and that such care is coverable under the State regulations. Refer to the policy Appendix and the listed excluded states for HIM where treatment is not a covered benefit.

Denial Risk

Dose limit denials

Requests that exceed the stated maximum doses (3.75 mg per 4 weeks; 11.25 mg per 12 weeks; 22.5 mg per 24 weeks for Trelstar; 22.5 mg per 24 weeks for Triptodur) may be denied unless the prescriber submits supporting evidence demonstrating the higher dose is justified by practice guidelines or peer-reviewed literature. Submit the supporting literature or guideline citations with the request.

Billing Rule

Follow formulary/non-formulary and off-label policies when applicable

If the requested use or a recent label change is not reflected in this policy, follow the appropriate formulary/non-formulary or off-label use policies listed for the relevant line of business. Providers should reference the specific policy codes noted in the clinical policy when submitting requests or appeals.

CP.CPA.190
HIM.PA.33
CP.PMN.255
HIM.PA.103
CP.PMN.16
CP.CPA.09
HIM.PA.154
CP.PMN.53

revised - approval duration (prior commercial duration change)

Modified Commercial approval duration to 6 months or to member's renewal date, whichever is longer (recorded in 4Q 2021 annual review).

02.08.24correction - units

Corrected units for basal luteinizing hormone (LH) level to mIU/mL (correction recorded 02.08.24).