ZYNLONTA (loncastuximab tesirine-lpyl) 

Office Administration – IV

Indications for Prior Authorization:
  • Indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.

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).

Coverage Criteria:

For diagnosis of large B-cell lymphoma:

  • Dose does not exceed 0.15 mg/kg every 3 weeks for the first 2 cycles and 0.075 mg/kg every 3 weeks for subsequent cycles, AND
  • Patient is 18 years of age or older, AND
  • Prescribed by or in consultation with a hematologist/oncologist, AND
  • One of the following diagnoses:
    • Diffuse large B-cell lymphoma (DLBCL)
    • DLBCL arising from low-grade lymphoma
    • High-grade B-cell lymphoma, AND
  • Disease is one of the following:
    • Relapsed
    • Refractory, AND
  • Patient has received at least two prior systemic therapies (e.g., rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, dexamethasone, cisplatin, cytarabine)
Reauthorization Criteria:

For diagnosis of large B-cell lymphoma:

  • Dose does not exceed 0.075 mg/kg every 3 weeks, AND
  • Patient is 18 years of age or older, AND
  • Prescribed by or in consultation with a hematologist/oncologist, AND
  • Patient does not show evidence of progressive disease while on therapy
Coverage Duration:
  • Initial: 1 year
  • 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:
  • For patients with a body mass index (BMI) ≥ 35 kg/m2, calculate the dose based on an adjusted body weight (ABW) as follows:
    • ABW in kg = 35 kg/m× (height in meters)2
  • The concentration of Zynlonta™ after reconstitution is 5 mg/mL
  • Zynlonta™ dosage is delayed or modified for neutropenia, thrombocytopenia, edema or effusion and other adverse reactions. 
  • Refer to package insert for complete information regarding administration instructions, and dosage delays/modifications.
  • Zynlonta™ is a hazardous drug. Follow applicable special handling and disposal procedures.
Policy Updates:
  • 10/19/2021 – New policy approved by P&T.
References:
  • Zynlonta Prescribing Information. ADC Therapeutics America. Murray Hill, NJ. April 2021.
  • National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: B-Cell Lymphomas. v.4.2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed May 14, 2021

 

 

 

Last review date: October 19, 2021

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