ZYNLONTA (loncastuximab tesirine-lpyl)

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/m² × (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