CurrentAetnaPolicy N/A

Zynlonta (loncastuximab tesirine-lpyl) Medication Precertification Request / Coverage Criteria

Precertification request form and requirements for coverage consideration of Zynlonta (loncastuximab tesirine-lpyl) for Aetna members; applies to providers requesting initiation or continuation of therapy.

Policy Summary

PayerAetna

PolicyZynlonta (loncastuximab tesirine-lpyl) precertification request

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and submit the Aetna precertification form (phone or fax) with required clinical information for initiation or continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 pageform length

Requiredclinical info

1-866-752-7021precert phone

1-888-267-3277precert fax

Coverage Criteria for Zynlonta (loncastuximab tesirine-lpyl)

Initiation Requests (HIV-related B-cell lymphoma)

Coverage consideration requires completion of clinical fields relevant to the indication and treatment history.

Initiation Requests - HIV-related B-cell lymphoma: For HIV-related B-cell lymphoma, request must indicate clinical setting (select relapsed, refractory, progressive, or other), whether the patient has received two or more prior lines of systemic therapy (Yes or No), and whether the requested drug will be used as a single agent (Yes or No).

From initiation section

Initiation Requests (Histologic transformation)

Initiation Requests - Histologic transformation: For histologic transformation of indolent lymphomas to diffuse large B-cell lymphoma, requester must indicate place in therapy (first-line or subsequent) and whether the patient is a candidate for transplant (Yes or No).

From initiation section

Policy Summary

PayerAetna

PolicyZynlonta (loncastuximab tesirine-lpyl) precertification request

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and submit the Aetna precertification form (phone or fax) with required clinical information for initiation or continuation requests.

SourceLink

On This Page

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Initiation Requests (Large B-cell lymphoma)

Initiation Requests - Large B-cell lymphoma: For large B-cell lymphoma (e.g., DLBCL NOS, DLBCL arising from low grade lymphoma, high-grade B-cell lymphoma), request must indicate clinical setting (select relapsed, refractory, progressive, or other), whether the patient has received two or more prior lines of systemic therapy (Yes or No), and whether the requested drug will be used as a single agent (Yes or No).

From initiation section

Continuation Therapy

Continuation Requests

Continuation: For continuation, indicate whether the patient has experienced disease progression or an unacceptable toxicity while on the current regimen (Yes or No).

From continuation section

The precertification form does not list any explicit, standalone clinical exclusions. Instead, clinical contraindications or reasons to deny coverage are evaluated during review based on the information provided in the required clinical fields. Reviewers will assess submitted details such as clinical setting (e.g., relapsed, refractory, progressive), prior lines of systemic therapy, single‑agent use, transplant candidacy, and documented progression or unacceptable toxicity on current therapy to determine medical necessity.

Initial Therapy Documentation Requirements

Initiation documentation

Initiation requests require specified clinical setting and prior therapy history.

Initiation documentation: Indicate clinical setting (relapsed, refractory, progressive, or other), document prior lines of systemic therapy (specifically whether two or more), state if the drug will be used as a single agent, and where applicable indicate transplant candidacy for histologic transformation cases.

From initiation section

Continuation Therapy Documentation

Continuation documentation

Continuation requests must document response and toxicity status.

Continuation documentation: Document whether disease progression or an unacceptable toxicity has occurred while on the current regimen (select Yes or No).

From continuation section

Billing and Diagnosis Codes

Administration codesCPT

Administration code(s) (CPT)

Administration CPT codes to be provided by requester as applicable

Diagnosis codesICD-10

Primary ICD Code	Requester-provided primary ICD-10 diagnosis code
Secondary ICD Code	Requester-provided secondary ICD-10 diagnosis code
Other ICD Code	Requester-provided additional ICD-10 diagnosis code

What Providers Must Do

Prior Authorization

Precertification Required

Precertification is required for initiation or continuation of Zynlonta. Complete and legible precertification form must be submitted to Aetna prior to starting therapy or to continue treatment.

Use Aetna precertification form shown; all fields must be completed and legible
For initiation indicate Start of treatment and date; for continuation indicate Date of last treatment

Prior Authorization

Prior-line Therapy Information

The precertification form asks whether the patient has received two or more prior lines of systemic therapy. Answering this question is required for initiation requests and may affect coverage determination.

Check Yes or No as applicable on the form

Documentation Required

Required Clinical & Administrative Documentation

Submit complete clinical and administrative documentation with the precertification request. Incomplete or illegible forms may delay review or result in denial.

Completed and legible precertification form including sections G and H
Appropriate ICD-10 diagnosis codes and treatment dates
Documentation of prior therapies (number and dates) and clinical setting (relapsed/refractory/progressive)
For continuation requests, documentation whether disease progression or unacceptable toxicity occurred while on current regimen
Requester name, phone, fax, and signature with date

Denial Risk

Risk of Fraudulent Information

Knowingly providing materially false or misleading information on the precertification request is a fraudulent insurance act and may result in criminal and civil penalties.

Requester must sign and date the form acknowledging the fraud warning
False statements or concealment of material information may lead to denial and legal penalties

Background

This form supports precertification requests for Zynlonta in B‑cell lymphoma indications. It is intended for use in HIV‑related B‑cell lymphoma (specified on the form as HIV‑related diffuse large B‑cell lymphoma, primary effusion lymphoma, and HHV8‑positive DLBCL), histologic transformation of indolent lymphomas to diffuse large B‑cell lymphoma, and large B‑cell lymphoma (including DLBCL NOS, DLBCL arising from low‑grade lymphoma, and high‑grade B‑cell lymphoma). For initiation requests the form requires the clinical setting, prior lines of systemic therapy (including whether the patient has received two or more prior lines), whether the drug will be used as a single agent, and transplant candidacy or place in therapy where applicable. For continuation requests the form requires documentation of whether the patient has experienced disease progression or unacceptable toxicity on the current regimen.

Key Definitions

HIV-related B-cell lymphoma — included diagnoses

HIV-related diffuse large B-cell lymphomaIncluded diagnosis listed on the form

Primary effusion lymphomaIncluded diagnosis listed on the form

HHV8-positive diffuse large B-cell lymphomaIncluded diagnosis listed on the form

Step Therapy / Prior Treatment History

Prior-line therapy question	Required response options
Has the patient received two or more prior lines of systemic therapy? (HIV-related B-cell lymphoma initiation)	Yes \| No
Has the patient received two or more prior lines of systemic therapy? (Large B-cell lymphoma initiation)	Yes \| No
For continuation requests: Has the patient experienced disease progression or an unacceptable toxicity while on the current regimen?	Yes \| No

Place of Administration

Note

Select place of administration

Indicate the place of administration on the form by selecting the appropriate option (self‑administered, physician’s office, outpatient infusion center, or home infusion center).

Self-administered
Physician's Office
Outpatient Infusion Center
Home Infusion Center