Pharmacy Prior Authorization Criteria

Zynlonta (loncastuximab tesirine-lpyl)

Indications for Prior Authorization

Zynlonta (loncastuximab tesirine-lpyl)

• For diagnosis of Large B-cell lymphoma
  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).

Criteria

Zynlonta

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• 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. chemotherapy, immunotherapy) [2]

Zynlonta

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-07-31, 2023-07-03, 2022-07-22, 2021-07-07

References

1. Zynlonta Prescribing Information. ADC Therapeutics America. Murray Hill, NJ. October 2022.
2. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: B-Cell Lymphomas. v.2.2024. Available at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed July 23, 2024

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Revision History

• 2024-07-31: 2024 Annual Review. No change to clinical intent. Updated drug example.
• 2023-07-03: Annual review: Removed specialist requirement. Updated references.
• 2022-07-22: Annual review: no criteria changes, updated references.
• 2021-07-07: New program

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