Primary navigation

    Monjuvi®

    Drug - Monjuvi® (tafasitamab-cxix injection) [MorphoSys US Inc.]

    March 2021

    Therapeutic area - Oncology

    Initial approval criteria

    • Patient is ≥ 18 years AND
    • Patient has diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma (excluding primary refractory AND “double or triple hit” disease) AND
    • Patient has ≥ 1 measurable lesion AND
    • Patient’s disease is relapsed or refractory AND
    • Patient does NOT have central nervous system (CNS) lymphoma involvement AND
    • Patient has NOT received an allogeneic or autologous stem cell transplant within the prior 3 months AND
    • Patient is NOT a candidate for autologous stem cell transplant AND
    • Patient has NOT received prior therapy with an immunomodulatory agent (e.g., lenalidomide) AND
    • Tafasitamab-cxix (Monjuvi) will be used in combination with lenalidomide for a maximum of 12 cycles of concomitant therapy (maintenance therapy as monotherapy tafasitamab-cxix may be continued until disease progression or unacceptable toxicity) AND
    • Patient has NOT received prior therapy with CD19-directed therapy (e.g., axicabtagene, tisagenlecleucel) OR
    • Patient previously received anti-CD19 therapy and re-biopsy indicated CD-19 positive disease
    • Initial approval is for 6 months

    Renewal criteria

    • Patient must continue to meet the above criteria AND
    • Disease response with treatment as defined by stabilization of or improvement in disease AND
    • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include serious infections, severe thrombocytopenia, severe neutropenia, or severe infusion-related reactions
    • Renewal approval is for 6 months

    Quantity limits

    • 12mg/kg according to the following dosing schedule:
      • o Cycle 1: Days 1, 4, 8, 15 and 22 of the 28-day cycle
      • o Cycles 2 and 3: Days 1, 8, 15 and 22 of each 28-day cycle
      • o Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle
    • Patient’s weight (in kg) must be provided at time of request

    Billing for Monjuvi

    Monjuvi must be billed as a medical claim.

    Background

    Monjuvi is FDA-approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

    back to top