Last Review Date: 03/05/2024

Date of Origin: 12/01/2022                                      

Dates Reviewed: 12/2022, 03/2023, 03/2024

1. Length of Authorization

Following initial inpatient administration of three doses (step-up dose 1, step-up dose 2, and the first treatment dose), coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

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

• Tecvayli 30 mg/3 mL solution for injection in a single-dose vial: 2 vials every 7 days
• Tecvayli 153 mg/1.7 mL solution for injection in a single-dose vial: 2 vials every 7 days

2. Max Units (per dose and over time) [HCPCS Unit]:
   • 468 billable units (234 mg) every 7 days

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 the step-up dose 1, step-up dose 2, and the first treatment dose; AND
• Patient had an absence of unacceptable toxicity while on inpatient administration; AND

Universal Criteria ¹

• Prescribers are enrolled in and meet the conditions of 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 (e.g., herpes zoster reactivation) according to local guidelines; AND
• Patient immunoglobulin levels will be monitored throughout treatment; AND
• Patient does not have any of the following comorbidities:
  • Stroke
  • Seizure
  • 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 6 months or an autologous stem cell transplant within the previous 12 weeks; AND
• Used as single agent treatment; AND

Multiple Myeloma † ‡ Ф ^1-3

• Patient has relapsed or refractory disease; AND

• Patient has received at least four (4) prior therapies, including a proteasome inhibitor (e.g., bortezomib, carfilzomib, 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 universal and other 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: neurologic toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), severe administration-related/local injection-site reactions, cytokine release syndrome (CRS), hepatotoxicity, neutropenia/febrile neutropenia, severe infections, etc.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J9380 – Injection, teclistamab-cqyv, 0.5 mg; 1 billable unit = 0.5 mg

NDC:

• Tecvayli 30 mg/3 mL solution for injection in a single-dose vial: 57894-0449-xx
• Tecvayli 153 mg/1.7 mL solution for injection in a single-dose vial: 57894-0450-xx

7. References

1. Tecvayli [package insert]. Horsham, PA; Janssen Biotech, Inc.; February 2024. Accessed February 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for teclistamab. 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. Moreau P, Garfall AL, van de Donk NWCJ, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022 Aug 11;387(6):495-505. Doi: 10.1056/NEJMoa2203478. Epub 2022 Jun 5.
6. Usmani SZ, Garfall AL, van de Donk NWCJ, et al. Teclistamab, a B-cell maturation antigen × CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study. Lancet. 2021 Aug 21;398(10301):665-674. Doi: 10.1016/S0140-6736(21)01338-6. Epub 2021 Aug 10. PMID: 34388396.
7. Pillarisetti K, Powers G, Luistro L, et al. Teclistamab is an active T cell-redirecting bispecific antibody against B-cell maturation antigen for multiple myeloma. Blood Adv. 2020 Sep 22;4(18):4538-4549. Doi: 10.1182/bloodadvances.2020002393. PMID: 32956453; PMCID: PMC7509877.

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