Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Zynlonta (loncastuximab) requires prior authorization.

2)    Zynlonta is used to treat a type of lymphoma.

3)    Zynlonta is a specialty medication covered under the medical benefit.

Zynlonta (loncastuximab tesirine-lpyl) is considered medically necessary for members meeting the following criteria:

Large B-Cell Lymphoma

1)    Diagnosis of large B-cell lymphoma (including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma, high-grade B-cell lymphoma, AIDS-related DLBCL, primary effusion lymphoma, HHV8-positive DLBCL not oetherwise specified); AND

2)    Prescribed by or in consultation with an oncologist or hematologist; AND

3)    Age > 18 years; AND

4)    Request meets one of the following (a or b)

a) Disease is refractory or member has relapsed after > 2 lines of systemic therapy;

b) Member is not a candidate for transplant and request is for second-line therapy for partial response, no response, or progressive disease following chemoimmunotherapy in patients with histologic transformation to DLBCL (off-label)

5)    Request meets one of the following (a or b)*:

a.    Dose does not exceed 0.15mg/kg IV every 3 weeks for 2 cycles, then 0.075mg/kg every 3 weeks for subsequent cycles;

b.    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

*Prescribed regiment must be FDA-approved or recomended by NCCN.

Initial Approval Duration: 6 months

Reauthorization (12 months)

1)    Currently receiving medication via QualChoice benefit, or documentation supports that member is currently receiving Zynlonta for a covered indication and has received this medication for at least 30 days;

2)    Member is responding positively to therapy;

3)    If request is for dose increase, request meets one of the following (a or b)*:

a.    New dose does not exceed 0.075mg/kg every 3 weeks;

b.    New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

*Prescribed regimen must be FDA-approved or recommended by NCCN.

Codes Used In This BI:

J9359       Injection, loncastuximab tesirine-lypl, 0.075mg

1. Zynlonta Prescribing Information. Murray Hill, NJ: ADC Therapeutics America; September 2021. Available at: www.zynlonta.com. Accessed May 3, 2022.

2. National Comprehensive Cancer Network. B-Cell Lymphomas Version 3.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed May 3, 2022.

Addendum:

Effective 01-01-2022: New Policy

Effective 10/01/2023: Updated types of large B-cell lymphoma in criteria for which drug can be approved and added approval language if member not a transplant candidate and used as second line therapy.