Loncastuximab Tesirine-lpyl (Zynlonta) — CPB 0994 | AETNA Coverage Update

TL;DR: Aetna, a CVS Health company, modified CPB 0994 for loncastuximab tesirine-lpyl (Zynlonta), effective December 10, 2025. Here's what billing teams need to do.

This update to the Aetna Zynlonta coverage policy expands the medically necessary indications beyond the FDA-approved label for relapsed/refractory large B-cell lymphoma. The revised CPB 0994 Aetna policy now explicitly covers four distinct indication categories, each with specific eligibility gates. The primary billing code is HCPCS J9359 (loncastuximab tesirine-lpyl, 0.075 mg), administered via CPT 96413–96417 for intravenous infusion. If your oncology or hematology practice bills Zynlonta to Aetna commercial plans, this is the policy governing your claims.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna, a CVS Health company
Policy	Loncastuximab Tesirine-lpyl (Zynlonta) — CPB 0994
Policy Code	CPB 0994
Change Type	Modified
Effective Date	December 10, 2025
Impact Level	High
Specialties Affected	Hematology/Oncology, Infusion Centers, Hospital Outpatient
Key Action	Verify all four indication pathways and confirm prior authorization before billing J9359

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Aetna Zynlonta Coverage Criteria and Medical Necessity Requirements 2025

Aetna requires precertification for every Zynlonta claim under commercial plans. Before your team submits a single unit of J9359, precertification must be in place. Call (866) 752-7021 or fax (888) 267-3277 to initiate. Statement of Medical Necessity forms are available through Aetna's Specialty Pharmacy Precertification portal.

This is not a light prior authorization requirement. Aetna will deny claims without it. Build this into your intake workflow before the drug is ordered, not after.

Indication 1: Large B-cell Lymphoma

Aetna considers Zynlonta medically necessary for large B-cell lymphoma — including DLBCL NOS, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma — when the member has partial response, no response, relapsed, progressive, or refractory disease.

Both criteria below must be met:

#	Covered Indication Copy
1	The member has received two or more prior lines of systemic therapy
2	Zynlonta is used as a single agent (no combination regimens)

The two-prior-lines floor is firm. One prior line of therapy doesn't qualify. Document the treatment history clearly in the authorization request — prior line count is the first thing a reviewer will check.

The single-agent requirement is equally firm. If a physician wants to combine Zynlonta with another agent for large B-cell lymphoma under this indication, Aetna will not cover it under this coverage policy. That's not ambiguous; it's written in black and white.

Indication 2: Histologic Transformation of Indolent Lymphomas to DLBCL

This indication covers patients whose indolent lymphoma has transformed to diffuse large B-cell lymphoma. The member must have partial response, no response, progressive, or relapsed disease.

Both criteria must be met:

#	Covered Indication Copy
1	The member has received an anthracycline-based regimen (e.g., doxorubicin — billed as J9000)
2	The member is not a candidate for transplant

Notice what's different here: no two-prior-lines requirement. Anthracycline exposure plus transplant ineligibility is the gate. This is the one indication where a patient with fewer prior lines could still qualify — as long as the clinical picture fits.

Transplant candidacy documentation will matter here. Make sure your physician notes explicitly address why the patient is not a transplant candidate. Vague documentation leads to claim denial.

Indication 3: HIV-Related B-cell Lymphomas

Aetna covers Zynlonta for HIV-related diffuse large B-cell lymphoma, primary effusion lymphoma, and HHV8-positive DLBCL when the member has partial response, relapsed, progressive, or refractory disease.

Both criteria must be met:

#	Covered Indication Copy
1	Two or more prior lines of systemic therapy
2	Zynlonta used as a single agent

This mirrors the large B-cell lymphoma criteria almost exactly. The same documentation standards apply. Confirm HIV status and prior line count are explicitly supported in the clinical record before submitting the prior authorization.

Indication 4: Post-Transplant Lymphoproliferative Disorders (PTLD)

Aetna covers Zynlonta for monomorphic PTLD of B-cell type when the member has partial response, relapsed, progressive, or refractory disease.

Both criteria must be met:

#	Covered Indication Copy
1	Two or more prior lines of systemic therapy
2	Zynlonta used as a single agent

The ICD-10 code for this indication is D47.Z1 (post-transplant lymphoproliferative disorder, monomorphic B-cell type). Morphic subtype matters here — polymorphic PTLD is not covered under this policy. The histopathology report should be in the file.

Continuation of Therapy

Reauthorization is straightforward when documented correctly. Aetna considers continued Zynlonta therapy medically necessary when there is no evidence of unacceptable toxicity and no disease progression on the current regimen.

Your reauthorization request needs to address both of those points directly. A gap in toxicity documentation or an ambiguous treatment response note creates unnecessary friction. Be explicit.

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Aetna Zynlonta Exclusions and Non-Covered Indications

Aetna considers all indications not listed in the four categories above to be experimental, investigational, or unproven. That's a broad exclusion.

If a provider wants to use Zynlonta for a B-cell malignancy that doesn't fit one of the four covered categories — or for any T-cell or other lymphoma subtype — Aetna will not cover it under this coverage policy. There is no appeals pathway for investigational use under commercial plans unless the member's plan has a specific exception benefit.

The histologic transformation indication has one notable constraint: the patient must have received an anthracycline-based regimen. Zynlonta for transformed DLBCL in a patient who never received doxorubicin or an equivalent will be denied.

Also watch the single-agent rule for large B-cell lymphoma, HIV-related lymphomas, and PTLD. Combination use under any of those three indications falls outside this policy. If you see an order for Zynlonta plus another agent for one of those indications, resolve it before you bill — not after you get the denial.

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Coverage Indications at a Glance

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Aetna Zynlonta Billing Guidelines and Action Items 2025

The effective date for this modified policy is December 10, 2025. If you bill Zynlonta to Aetna commercial plans, these are the steps to take now.

Copy Action Items

If your practice sees a high volume of Zynlonta patients across multiple indication types, or if you're not sure how this policy applies to your specific patient mix, talk to your compliance officer before December 10, 2025.

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CPT, HCPCS, and ICD-10 Codes for Loncastuximab Tesirine-lpyl Under CPB 0994

Covered HCPCS Code (When Selection Criteria Are Met)

Code	Type	Description Copy
J9359	HCPCS	Injection, loncastuximab tesirine-lpyl, 0.075 mg

Key ICD-10-CM Diagnosis Codes

Code	Description Copy
C83.30–C83.3A	Diffuse large B-cell lymphoma (relapsed or refractory)
D47.Z1	Post-transplant lymphoproliferative disorder (PTLD), monomorphic (B-cell type)

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