TECVAVLI (teclistamab-cqyv)

TECVAVLI (teclistamab-cqyv)

Office-Administration – intended for subcutaneous injection by a healthcare provider only.

Diagnosis considered for coverage:

Multiple Myeloma: Indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

Coverage Criteria:

For diagnosis of relapsed or refractory multiple myeloma (MM):

• Documented diagnosis of MM; AND
• Disease is one of the following:
  • Relapsed
  • Refractory; AND
• Prescribed by or in consultation with an oncologist or hematologist; AND
• Patient has received at least four (4) prior lines of therapy which include all of the following:
  • An immunomodulatory agent (e.g., Revlimid [lenalidomide], Thalomid [thalidomide])
  • A proteasome inhibitor (e.g., Velcade [bortezomib], Kyprolis [carfilzomib])
  • A CD38-directed monoclonal antibody (e.g. Darzalex [daratumumab])

Reauthorization Criteria:

For diagnosis of MM:

• Patient does not show evidence of progressive disease while on therapy.

Dosing:

• Follow the manufacture’s labeling (package insert) to determine the total dose, injection volume, and number of vials required based on patient’s actual body weight.

Coverage Duration:

• Initial and Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• On October 25, 2022, the Food and Drug Administration (FDA) granted accelerated approval to teclistamab-cqyv for its indication based on response rate. Continued approval for the indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
• Tecvayli is intended for subcutaneous use by a healthcare provider only.
• Tecvayli is available only through a restricted program called the Tecvayli Risk Evaluation and Mitigation Strategy (REMS).
• Tecvayli contains black box warnings for signs or symptoms of Cytokine Release Syndrome (CRS) and Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).

Policy Review History:

• 06/01/2023 – New criteria for utilization management program approved by WHA P&T (05/16/2023).

References:

1. Tecvayli Prescribing Information. Janssen Biotech, Inc. Horsham, PA. October 2022.
2. Food and Drug Administration. Centers for drug evaluation and research: Multi-discipline review for Tecvayli. Application Number: 761291Orig1s000. October 24, 2022. [Internet] FDA.gov. Accessed March 28, 2023.
3. Food and Drug Administration. FDA News Release: FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma. October 25, 2022. [Internet] FDA.gov. Accessed March 28, 2023.
4. Moreau P, Garfall AL, van de Donk NWCJ, et al. Teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2022;387(6):495-505.
5. National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology: Multiple myeloma. Version 3.2023 – December 8, 2022. NCCN Web site. https://www.nccn.org/. Accessed March 28, 2023.
6. Rajkumar SV and Kumar S. Multiple myeloma: Diagnosis and treatment. Mayo Clin Proc. 2016;91(1):101-119.