Sacituzumab govitecan-hziy (Trodelvy) — CPB 0971 | AETNA Coverage Update

Aetna modified CPB 0971 for sacituzumab govitecan-hziy (Trodelvy), effective February 25, 2026. Here's what billing teams need to do.

Aetna, a CVS Health company, updated its Trodelvy coverage policy under CPB 0971 on February 25, 2026. The policy governs HCPCS code J9317 (sacituzumab govitecan-hziy, 2.5 mg per unit) across three broad cancer categories: triple-negative breast cancer (TNBC), hormone receptor-positive/HER2-negative breast cancer, and urothelial carcinoma. If your team bills J9317 for any of these indications, this policy sets the prior authorization criteria that determine whether Aetna pays or denies the claim.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna, a CVS Health company
Policy	Sacituzumab govitecan-hziy (Trodelvy) — CPB 0971
Policy Code	CPB 0971
Change Type	Modified
Effective Date	February 25, 2026
Impact Level	High
Specialties Affected	Oncology, Hematology/Oncology, Urology, Infusion Centers
Key Action	Confirm all J9317 precertification requests meet the updated step-therapy and prior-treatment criteria before submitting to Aetna

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Aetna Trodelvy Coverage Criteria and Medical Necessity Requirements 2026

The Aetna Trodelvy coverage policy requires precertification for every claim. Call (866) 752-7021 or fax (888) 267-3277 before administering Trodelvy to any Aetna commercial member. No exceptions. Missing this step guarantees a claim denial.

CPB 0971 covers Trodelvy (J9317) for three cancer types, each with distinct step-therapy requirements. Medical necessity depends on the member clearing every criterion for their specific indication — not just some of them.

Triple-Negative Breast Cancer (TNBC)

Aetna approves Trodelvy for TNBC when the disease is recurrent, unresectable, or metastatic — or when the member had no response to preoperative systemic therapy. The tumor must test negative for all three receptors: HER2, estrogen, and progesterone. Your pathology documentation must confirm all three negative results, not just one or two.

The member also needs at least one prior treatment regimen, with at least one line delivered in the metastatic setting. That's a relatively low bar compared to the HR+/HER2- indication below. Document the prior regimen clearly in the authorization request.

Hormone Receptor-Positive / HER2-Negative Breast Cancer

This indication has the most complex prior authorization requirements in the policy. The disease must be recurrent, unresectable, or metastatic — or the member had no response to preoperative therapy. The member must have received all three of the following before Aetna considers Trodelvy medically necessary:

#	Covered Indication Copy
1	Endocrine therapy — such as anastrozole (billed under S0170), letrozole, or fulvestrant (J9393, J9394, or J9395)
2	A CDK4/6 inhibitor — abemaciclib, palbociclib, or ribociclib (no specific HCPCS codes listed in the policy)
3	At least two lines of chemotherapy, including a taxane (paclitaxel bills as J9267), with at least one line in the metastatic setting

There's a fourth condition that's easy to miss: the member must not be a candidate for fam-trastuzumab deruxtecan-nxki (Enhertu, billed as J9358). Aetna treats Enhertu as the preferred agent first. If your medical team hasn't documented why Enhertu is not appropriate, expect a denial. Get that clinical rationale in writing before you submit the prior auth.

Urothelial Carcinoma (Bladder, Urethra, Upper GU Tract, Prostate UC)

Aetna covers Trodelvy for four urothelial carcinoma sub-types under this coverage policy:

The ICD-10 codes C67.0–C67.9 map to bladder cancer urothelial indications. The codes C68.0–C68.9 apply collectively to urethral, upper GU tract, and urothelial carcinoma of the prostate indications. CPB 0971 does not sub-map specific C68 codes to specific urothelial sub-indications — use the most specific code your documentation supports.

For all urothelial indications, the member must have already received both a platinum-containing chemotherapy and either a PD-1 inhibitor or a PD-L1 inhibitor. That's a firm two-step prior treatment requirement. Gemcitabine (J9184, J9196, J9198, or J9201) in combination with platinum is a common prior regimen you'll see documented here.

Continuation of Therapy

Reauthorization is available when there's no evidence of disease progression or unacceptable toxicity on the current regimen. This is standard maintenance language, but document disease status explicitly at each reauthorization cycle. Vague clinical notes create reimbursement delays.

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Aetna Trodelvy Exclusions and Non-Covered Indications

Aetna's position is direct: all other indications for Trodelvy are experimental, investigational, or unproven. That language covers any use outside the four indication categories above.

Common off-label uses — including lung cancer, cervical cancer, and endometrial cancer — do not meet medical necessity under CPB 0971. If your oncologist is prescribing Trodelvy for an unlisted indication, check whether the member's plan includes a clinical trial benefit or exception process. Outside of those pathways, a denial is the expected outcome.

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Coverage Indications at a Glance

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Aetna Trodelvy Billing Guidelines and Action Items 2026

These are the steps your billing team should take now, given the February 25, 2026 effective date.

Copy Action Items

If you manage a high volume of Trodelvy cases and you're uncertain how the Enhertu non-candidacy requirement or the CDK4/6 step-therapy requirement applies to your patient mix, loop in your compliance officer or billing consultant before the effective date.

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CPT, HCPCS, and ICD-10 Codes for Sacituzumab Govitecan Under CPB 0971

Covered HCPCS Codes (When Selection Criteria Are Met)

Code	Type	Description Copy
J9317	HCPCS	Injection, sacituzumab govitecan-hziy, 2.5 mg

Supporting HCPCS Codes — Prior Therapies and Related Agents

These codes represent therapies required as prior treatment under the HR+/HER2− breast cancer criteria and urothelial carcinoma criteria. They are listed in CPB 0971 as contextually relevant to coverage decisions.

Infusion Administration CPT Codes

CPB 0971 lists all four codes below under the same description: "Chemotherapy administration, intravenous infusion technique." The policy does not assign technique-specific descriptions or usage rules to individual codes. The descriptions below reflect the source policy exactly.

Pathology / Immunohistochemistry CPT Codes

Code	Type	Description Copy
88360	CPT	Morphometric analysis, tumor immunohistochemistry (e.g., HER-2/neu, estrogen receptor/progesterone receptor)
88361	CPT	Morphometric analysis, tumor immunohistochemistry; using computer-assisted technology (note: CPB 0971 lists this code with the abbreviated description "using computer-assisted technology" as a continuation of 88360)

Key ICD-10-CM Diagnosis Codes

Descriptions below reflect the source policy language in CPB 0971 exactly. The policy does not provide anatomical sub-descriptions for individual C67 or C68 codes.

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