Lurbinectedin (Zepzelca) — CPB 0978 | AETNA Coverage Update

Aetna modified CPB 0978 for lurbinectedin (Zepzelca), effective December 10, 2025. Here's what billing teams need to know before submitting claims under this updated coverage policy.

Aetna, a CVS Health company, updated Clinical Policy Bulletin 0978 to define medical necessity criteria for lurbinectedin (Zepzelca) — a chemotherapy agent used in small cell lung cancer (SCLC) treatment. The primary HCPCS code for billing is J9223 (injection, lurbinectedin, 0.1 mg), and the policy also touches chemotherapy administration codes 96413 and 96415, plus central venous access codes 36555 through 36571. If your practice treats SCLC patients with Aetna commercial coverage, this policy governs every prior authorization request and reimbursement claim you submit for this drug in 2025 and 2026.

---

Quick-Reference Table

Field	Detail Copy
Payer	Aetna, a CVS Health company
Policy	Lurbinectedin (Zepzelca) — CPB 0978
Policy Code	CPB 0978
Change Type	Modified
Effective Date	December 10, 2025
Impact Level	High
Specialties Affected	Medical oncology, hematology/oncology, infusion centers, hospital outpatient
Key Action	Verify prior authorization using the updated CPB 0978 criteria before billing J9223 for any lurbinectedin claim

---

Aetna Lurbinectedin Coverage Criteria and Medical Necessity Requirements 2025

CPB 0978 Aetna's coverage policy draws a tight circle around small cell lung cancer. That's the only indication where Aetna considers lurbinectedin medically necessary. Full stop.

Precertification is required for all Aetna participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277 to initiate prior authorization. For Statement of Medical Necessity forms, use the Specialty Pharmacy Precertification portal on Aetna's provider site.

Single-Agent Use

Aetna covers lurbinectedin as a single agent for subsequent treatment of SCLC in three scenarios.

First, relapse following complete or partial response, or stable disease, with initial treatment. Second, primary progressive disease. Third, metastatic disease following progression on or after platinum-based chemotherapy.

The third criterion is the one most oncology billing teams will see most often. Patients who progressed through carboplatin (J9045) or cisplatin (J9060) qualify — as long as the clinical documentation makes that prior treatment and subsequent progression clear.

Combination Maintenance Therapy

The second covered regimen is more specific and was likely the focus of this policy modification. Aetna now covers lurbinectedin in combination with atezolizumab (J9022) or atezolizumab and hyaluronidase-tqjs (J9024) as maintenance treatment for extensive-stage SCLC.

Two conditions must both be met. The patient must have received first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide (J9181 or J8560). And the patient must show no disease progression after that induction therapy.

This is a narrow path. Your clinical documentation needs to show the exact induction regimen and confirm no progression before maintenance begins. If the documentation gaps exist, the claim will deny.

Continuation of Therapy

Aetna considers continuation of lurbinectedin medically necessary at reauthorization when two conditions hold. The member must be seeking reauthorization for an indication already listed in the initial approval criteria. And there must be no evidence of unacceptable toxicity or disease progression on the current regimen.

This means your reauthorization submissions need current clinical notes showing treatment tolerance and disease status — not just a renewal request. Missing either piece is a fast track to a claim denial.

---

Aetna Lurbinectedin Exclusions and Non-Covered Indications

Aetna's position here is blunt. All indications outside of SCLC are experimental, investigational, or unproven.

That language matters for billing. If a physician wants to use Zepzelca for any indication outside of SCLC — any off-label use — Aetna will not cover it under this policy. The ICD-10 codes in CPB 0978 explicitly call out that C34.x codes are covered for SCLC only, and are not covered for non-small cell lung cancer.

Do not bill J9223 with a non-SCLC diagnosis code expecting coverage. The denial will come back, and an appeal won't change Aetna's published policy position.

---

Coverage Indications at a Glance

---

Aetna Lurbinectedin Billing Guidelines and Action Items 2025

Copy Action Items

---

CPT, HCPCS, and ICD-10 Codes for Lurbinectedin Under CPB 0978

Primary HCPCS Code — Covered When Selection Criteria Are Met

Code	Type	Description Copy
J9223	HCPCS	Injection, lurbinectedin, 0.1 mg

CPT Codes — Chemotherapy Administration and Vascular Access

Supporting HCPCS Codes — Combination Regimen and Supportive Care

Antiemetic and Corticosteroid Supportive Care HCPCS Codes

G-CSF and Biosimilar Supportive Care HCPCS Codes

Key ICD-10-CM Diagnosis Codes — SCLC Only

All C34.x codes listed in CPB 0978 apply exclusively to small cell lung cancer. The policy explicitly excludes non-small cell lung cancer under the same code range.

The full ICD-10-CM list in CPB 0978 includes 115 codes across the C34.x range. All are restricted to SCLC diagnoses. Use the complete code set as listed in the full policy bulletin at Aetna CPB 0978.

---