Teclistamab-cqyv (Tecvayli)

Number: 1018

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses teclistamab-cqyv (Tecvayli) for commercial medical plans. For Medicare criteria, see Medicare Part B Criteria.

Note: Requires Precertification:

Precertification of teclistamab-cqyv (Tecvayli) is required of all Aetna participating providers and members in applicable plan designs. For precertification of teclistamab-cqyv (Tecvayli), call (866) 752-7021 or fax (888) 267-3277. For Statement of Medical Necessity (SMN) precertification forms, see Specialty Pharmacy Precertification. 

1. Criteria for Initial Approval

   Multiple Myeloma

   Aetna considers teclistamab-cqyv (Tecvayli) medically necessary for treatment of relapsed or refractory multiple myeloma in members who have received at least 4 prior therapies, including at least one drug from each of the following categories:

   1. Anti-CD38 monoclonal antibody (e.g., daratumumab); and
   2. Proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib); and
   3. Immunomodulatory agent (e.g., lenalidomide, pomalidomide)

   Aetna considers all other indications as experimental, investigational, or unproven.

2. Continuation of Therapy

   Aetna considers continuation of teclistamab-cqyv (Tecvayli) therapy medically necessary in members requesting reauthorization for an indication listed in Section I when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Dosage and Administration

Teclistamab-cqyv is supplied as Tecvayli 30 mg/3 mL (10 mg/mL) and 153 mg/1.7 mL (90 mg/mL) in a single-dose vial injection for subcutaneous use.

Multiple Myeloma

The recommended dosage of Tecvayli is step-up doses of 0.06 mg/kg and 0.3 mg/kg followed by 1.5 mg/kg once weekly until disease progression or unacceptable toxicity. See full prescribing information for preparation and administration instructions and dosage modifications for adverse reactions.

Source: Janssen Biotech, 2023

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Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Other CPT codes related to the CPB:
96365 - 96368	Intravenous infusion
96413 - 96417	Chemotherapy administration
HCPCS codes covered if selection criteria are met:
J9380	Injection, teclistamab-cqyv, 0.5 mg
Other HCPCS codes related to the CPB:
Ixazomib, Lenalidomide, Pomalidomide -no specific code
J9041	Injection, bortezomib, 0.1 mg
J9044	Injection, bortezomib, not otherwise specified, 0.1 mg
J9047	Injection, carfilzomib, 1 mg
J9145	Injection, daratumumab, 10 mg
ICD-10 codes covered if selection criteria are met:
C90.00 - C90.02	Multiple myeloma

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Background

U.S. Food and Drug Administration (FDA)-Approved Indications 

• Tecvayli is 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.

Teclistamab-cqyv is available as Tecvayli (Janssen Biotech, Inc.) and is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. Teclistamab-cqyv binds to the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. Teclistamab-cqyv initiated T-cells, in vitro, caused the release of various proinflammatory cytokines with resultant lysis of multiple myeloma cells (Janssen Biotech, 2022).

According to the prescribing information, Tecvayli carries the following black box warnings:

• Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving Tecvayli. Initiated treatment with Tecvayli step-up dosing schedule to reduce risk of CRS. Withhold Tecvayli until CRS resolves or permanently discontinue based on severity.
• Neurologic toxicity, including immune effector cell-associated neurotoxcity syndrome (ICANS) and serious life-threatening reactions, can occur in patients receiving Tecvayli. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment. Withhold Tecvayli until neurologic toxicity resolves or permanently discontinue based on severity.

Per the prescribing information, Tecvayli carries the following warnings and precautions:

• Hepatotoxicity: Including fatalities. Monitor liver enzymes and bilirubin at baseline during treatment as clinically indicated.
• Infections: Can cause severe, life-threatening, or fatal infections. Monitor for signs and symptoms of infection and treat appropriately. Withhold with active infection during the step-up dosing schedule.
• Neutropenia: Monitor complete blood cell counts at baseline and periodically during treatment.
• Hypersensitivity and other administration reactions: Systemic administration-related reactions and local injection site reactions can occur. Withhold or consider permanent discontinuation based on severity.
• Embryo-fetal toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.

Per the prescribing information, Tecvayli carries the following adverse reactions: 

• Most common adverse reactions (≥20%): pyrexia, cytokine release syndrome, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea
• Most common grade 3 to 4 laboratory abnormalities (≥20%): decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.

On October 25, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to teclistamab-cqyv (Tecvayli) for 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 anti-CD38 monoclonal antibody. The FDA approval was based on an evaluation of Tecvayli efficacy in the MajesTEC-1 study, a single-arm, open-label, multi-center, phase 1-2 trial (FDA, 2022; Janssen Biotech, 2022).

The MajesTEC-1 study consisted of patients with relapsed or refractory multiple myeloma who had previously received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Patients received step-up doses of 0.06 mg/kg and 0.3 mg/kg of Tecvayli followed by Tecvayli 1.5 mg/kg subcutaneously once weekly thereafter until disease progression or unacceptable toxicity. Efficacy was evaluated in 110 patients with the main efficacy outcome measure as overall response rate (ORR). The results noted an ORR of 61.8% (95% Confidence Interval [CI]: 52.1, 70.9) with a median follow-up of 7.4 months among responders, the estimated duration of response (DOR) rate was 90.6% (95% CI: 80.3%, 95.7%) at 6 months and 66.5% (95% CI: 38.8%, 83.9%) at 9 months (FDA, 2022; Janssen Biotech, 2022).

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References