(Subcutaneous)

Last Review Date: 03/05/2024

Date of Origin: 09/05/2023                                      

Dates Reviewed: 09/2023, 03/2024

1. Length of Authorization

Following initial inpatient administration of all step-up doses, coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Talvey 3 mg/1.5 mL solution for injection in a single-dose vial: 3 vials per week
• Talvey 40 mg/mL solution for injection in a single-dose vial: 3 vials per week

2. Max Units (per dose and over time) [HCPCS Unit]:
   • Step-up doses: 12 billable units (3 mg) on day one, 36 billable units (9 mg) on day four, and 160 billable units (40 mg) on day seven
   • Maintenance: 160 billable units (40 mg) weekly thereafter

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND
• Used as continuation therapy following inpatient administration of all step-up doses; AND
• Patient had an absence of unacceptable toxicity while on inpatient administration of step-up doses; AND

Universal Criteria ¹

• Prescribers are enrolled in the TECVAYLI and TALVEY REMS program; AND
• Patient does not have an active infection, including clinically important localized infections; AND
• Patient will be administered prophylaxis for infection according to local guidelines; AND

• Patient does not have active CNS involvement or clinical signs of meningeal involvement of multiple myeloma; AND

• Patient has not had an allogenic stem cell transplant within the previous six (6) months or an autologous stem cell transplant within the previous twelve (12) weeks; AND
• Patient weight and signs of oral and skin toxicity will be monitored at baseline and periodically during therapy; AND

Multiple Myeloma † ‡ Ф ^1-5

• Used as a single agent; AND
• Patient has relapsed or refractory disease; AND

• Patient has received at least four (4) prior therapies, including a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib, etc.), an immunomodulatory agent (e.g., lenalidomide, thalidomide, pomalidomide, etc.), and an anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab, etc.)

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: cytokine release syndrome (CRS), neurologic toxicity (e.g., Immune Effector Cell-Associated Neurotoxicity Syndrome [ICANS]), severe oral toxicity and weight loss, severe infections, severe cytopenias (e.g., neutropenia, thrombocytopenia, etc.), severe skin toxicity, hepatotoxicity, etc.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code(s):

• J3055 – Injection, talquetamab-tgvs, 0.25 mg; 1 billable unit = 0.25 mg (Effective 04/01/2024)
• J9999 – Not otherwise classified, antineoplastic drugs (Discontinue use on 04/01/2024)
• C9163 – Injection, talquetamab-tgvs, 0.25 mg; 1 billable unit = 0.25mg (Discontinue use on 04/01/2024)

NDC(s):

• Talvey 3 mg/1.5 mL solution for injection in a single-dose vial: 57894-0469-xx
• Talvey 40 mg/mL solution for injection in a single-dose vial: 57894-0470-xx

7. References

1. Talvey [package insert]. Horsham, PA; Janssen Biotech, Inc.; August 2023. Accessed January 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for talquetamab. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed January 2024.
3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma, Version 2.2024. National Comprehensive Cancer Network, 2024. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed January 2024.
4. BGM Durie, J-L Harousseau, J S Miguel, et al on behalf of the International Myeloma Working Group. International uniform response criteria for multiple myeloma. Leukemia.  Sep; 20(9):1467-73.
5. Schinke CD, Touzeau C, Minnema MC, et al. Pivotal phase 2 MonumenTAL-1 results of talquetamab (tal), a GPRC5DxCD3 bispecific antibody (BsAb), for relapsed/refractory multiple myeloma (RRMM). Journal of Clinical Oncology 2023 41:16_suppl, 8036-8036.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A