Aetna Commercial Clinical Policy

Aetna Teclistamab-cqyv (Tecvayli) Form

Effective Date

01/10/2023

Last Reviewed

10/12/2023

Original Document

  Reference



Background for this Policy

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).

Per the prescribing information, teclistamab-cqyv (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, teclistamab-cqyv (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).

    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 (commercial), or fax (888) 267-3277. For Statement of Medical Necessity (SMN) precertification forms, see Specialty Pharmacy Precertification . For Medicare Part B plans, call (866) 503-0857, or fax (844) 268-7263.

    Criteria for Initial Approval

    Multiple Myeloma

    Aetna considers teclistamab-cqyv (Tecvayli) medically necessary for treatment of relapsed, refractory or progressive multiple myeloma in members who have received at least 4 prior therapies, including at least

    one

    drug from each of the following categories:

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

    • Aetna considers all other indications as experimental and investigational.

    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, 2022