Prior authorization required; validity and renewal durations

Prior authorization is required for Trelstar. Initial authorizations are generally valid for 12 months (365 days); for endometriosis and uterine leiomyomata (fibroids) initial prior authorization is valid for 6 months (180 days). Renewals are generally every 12 months thereafter unless otherwise specified; endometriosis/fibroids may not be renewed, while fertility preservation may be renewed annually while the member continues cytotoxic chemotherapy.

• Initial: 12 months (365 days) by default.
• Endometriosis/fibroids: initial validity 6 months (180 days); may NOT be renewed.
• Fertility preservation: may be renewed every 12 months while member is receiving cytotoxic chemotherapy.
• Renewals follow criteria in Section III and IV.

PA considered based on indication and cost (NQTL)

Prior authorization was applied as a utilization management tool after consideration of clinical indications and cost factors per the NQTL checklist; cost was identified as a factor to consider for PA.

• NQTL assessment lists 'Indication' = consider for PA and 'Cost of drug' = consider for PA.

Supply covered diagnosis codes from Appendix 1 for coverage support

Appendix 1 lists the ICD-10 diagnosis codes that support coverage determinations for Trelstar; these codes should be supplied with claims/PA requests to demonstrate a covered diagnosis.

• Appendix 1 enumerates covered ICD-10 codes (N80.* and related codes) to support coverage determinations.

Fertility preservation: trial or contraindication to other methods required

For the fertility preservation indication during cytotoxic chemotherapy, the member must have failed or be not a candidate for other fertility preservation methods (for example, cryopreservation) before Trelstar is covered.

• Member must be premenopausal and receiving cytotoxic chemotherapy with potential for ovarian damage, and have failed or be unsuitable for other fertility preservation methods.

Utilization management applied; no specific step therapy mandates

Utilization management (including prior authorization) was considered for this drug class due to cost; no additional mandatory step therapy sequences are specified in the policy.

• Policy notes UM/NQTL considerations; no explicit step therapy steps mandated beyond the fertility preservation requirement.

Required diagnostic and indication-specific documentation

Provide documentation confirming diagnosis-specific workup or evaluation (not presumptive treatment) appropriate to the indication—e.g., diagnostic confirmation for endometriosis, confirmation of fibroids and iron therapy, hormone receptor status and use with endocrine therapy for breast cancer, or confirmation of cytotoxic chemotherapy for fertility preservation.

• Endometriosis: documentation of diagnostic workup/evaluation (not presumptive).
• Fibroids: diagnostic confirmation and evidence the member is receiving iron therapy.
• Breast cancer: premenopausal status, hormone receptor positivity, and plan for endocrine therapy.
• Fertility preservation: evidence of active cytotoxic chemotherapy and prior failure/unsuitability of other preservation methods.

Document routine monitoring and response for continuation

For continuation/renewal, document routine monitoring that demonstrates a beneficial clinical response where applicable—examples include monitoring of clinical pubertal development and relevant laboratory parameters for gender dysphoria/puberty suppression and CPP.

• Routine monitoring of pubertal development and applicable labs to show benefit is required for continuation in relevant indications.

Ensure Medicare Part B documentation and NCD/LCD/LCA compliance

Medicare Part B claims must comply with the Medicare Benefit Policy Manual and any applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs); local contractor requirements listed in Appendix 2 apply where relevant.

• Check NCD/LCD/LCA guidance for Part B drugs and local contractor policies prior to Medicare billing.

Renewal may be denied for unacceptable toxicity

Renewal may be denied if the member has unacceptable toxicity from the drug; examples of unacceptable toxicity include hypersensitivity reactions, tumor flare, severe QT/QTc prolongation, metabolic syndrome (hyperglycemia, diabetes mellitus, hyperlipidemia), cardiovascular events, convulsions, and severe cutaneous adverse reactions (e.g., SJS/TEN, DRESS, AGEP).

• Absence of unacceptable toxicity is required for renewal; listed examples may trigger denial of continued coverage.

Coverage contingent on continued treatment context (e.g., active chemotherapy)

Coverage for certain indications (for example, fertility preservation) requires evidence the member remains in the treatment context—e.g., the member must still be receiving cytotoxic chemotherapy for fertility preservation coverage to continue.

• For fertility preservation, renewal is contingent on ongoing receipt of cytotoxic chemotherapy.

Include Appendix 1 diagnosis code on claim or PA to avoid denial

Claims submitted for Trelstar that do not include one of the covered diagnosis codes listed in Appendix 1 may be denied for lack of a covered diagnosis; include an appropriate Appendix 1 ICD-10 code on claims and PA requests.

• Appendix 1 lists explicit ICD-10 codes (including multiple N80.* endometriosis codes and related Z85/Z31.84 codes) that must appear on claims to support coverage.

Bill using HCPCS J3315 and document administration site

Bill Trelstar using HCPCS code J3315 (Injection, triptorelin pamoate, 3.75 mg; 1 billable unit = 3.75 mg). The product is supplied as single-dose injection kits and is administered intramuscularly in the office, infusion center, or hospital outpatient setting per dosing.

Adhere to Medicare Part B coverage and local contractor guidance

For Medicare Part B coverage and site-of-care administration, follow applicable CMS NCDs/LCDs/LCAs and local contractor policies as listed in Appendix 2; these may govern coverage and claims payment for outpatient Part B drugs.

NQTL checklist documents UM considerations

The NQTL checklist is included in Appendix A and documents that indication and drug cost were factors considered when designing the utilization management approach.