Datroway (datopotamab deruxtecan-dlnk) — Medical Drug Clinical Criteria
Clinical criteria governing prior authorization and medical necessity determinations for Datroway for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer and for certain EGFR‑mutated NSCLC patients; affects providers seeking coverage under Anthem medical benefit plans.
Added FDA indication for use in EGFR-mutated NSCLC in locally advanced or metastatic disease in those with prior EGFR and platinum based chemotherapy.
Wording and formatting criteria changes during annual review.
Coding update replacing prior HCPCS/NOC codes and consolidating to J9011 as the HCPCS code for Datroway.
Coverage Criteria
Approval criteria (Initial therapy and indications)
Requests for Datroway may be approved when ALL of the following grouped criteria are met (logical structure preserved):
Allows approval for patients under 19.
Based on Label and NCCN 2A.
Based on Label and NCCN 2A.
Requests for Datroway will not be approved when the individual has clinically active brain metastases. Active brain metastases are an explicit exclusion to coverage and represent a denial risk for prior authorization requests.
Requests that do not meet the specified clinical criteria for the listed indications are not approved (not medically necessary). If the documented condition, biomarker status, prior therapies, or other required criteria are not satisfied as outlined in the policy, coverage should be denied.
Covered Regimens (per label)
| Regimen | Indication | Coverage |
|---|---|---|
| Datroway (datopotamab deruxtecan-dlnk) | ||
| Unresectable or metastatic, hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease | ||
| Covered with criteria |
| Regimen | Indication | Coverage |
|---|---|---|
| Datroway (datopotamab deruxtecan-dlnk) | ||
| Locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-mutated disease in individuals who have received prior EGFR-directed therapy and platinum-based chemotherapy | ||
| Covered with criteria |
Coding
| J9011 | Injection, datopotamab deruxtecan-dlnk, 1 mg [Datroway] |
| C33 | Malignant neoplasm of trachea |
| C34.00-C34.92 | Malignant neoplasm of bronchus and lung |
| C50.011-C50.A2 | Malignant neoplasm of breast |
| Z17.411 | Hormone receptor positive with human epidermal growth factor receptor 2 negative status [HR+ with HER2-] |
| Z92.21 | Personal history of antineoplastic chemotherapy |
Provider Actions & Requirements
Prior Authorization Required
Prior authorization is required. Approval is granted only when the clinical criteria for the specified indication are met (breast cancer or EGFR‑mutated NSCLC).
- Prior authorization required for Datroway (datopotamab deruxtecan‑dlnk).
- Approval granted only when ALL applicable clinical criteria for the requested indication are satisfied.
Required Clinical Documentation
Document the diagnosis and supporting clinical information demonstrating the requested indication and prior treatments.
- For unresectable or metastatic HER2‑negative breast cancer: submit pathology/HER2 testing results showing IHC 0, IHC 1+, or IHC 2+ with negative ISH as appropriate.
- Include documentation that disease is HR+ (hormone receptor positive).
- Provide detailed prior treatment history confirming prior endocrine‑based therapy and prior chemotherapy for unresectable or metastatic disease (agents, dates, responses).
NSCLC Documentation
For NSCLC requests, provide documentation of disease extent and molecular testing and prior systemic therapy.
- Confirm locally advanced or metastatic NSCLC and presence of an EGFR mutation (test report).
- Document prior EGFR‑directed therapy (agent and dates) and prior platinum‑based chemotherapy (agent and dates).
Prior Therapy Requirements
Approval for the breast cancer and NSCLC indications requires prior therapies as a condition of coverage.
- Breast cancer: patient must have received prior endocrine‑based therapy AND prior chemotherapy for unresectable or metastatic HR+ HER2‑negative disease.
- NSCLC: patient must have received prior EGFR‑directed therapy AND prior platinum‑based chemotherapy for locally advanced or metastatic EGFR‑mutated disease.
Line of Therapy Requirements
after prior endocrine-based therapy and chemotherapy
Covered when the following prior therapy requirement is satisfied:
Required prior lines before Datroway use.
after prior EGFR-directed therapy and platinum chemotherapy
Covered when the following prior therapy requirement is satisfied:
Required prior lines before Datroway use.
Biomarker & Testing Requirements
Definitions
Background
Datroway (datopotamab deruxtecan-dlnk) is a Trop-2-directed antibody-drug conjugate with a topoisomerase inhibitor payload. It is indicated for adults with unresectable or metastatic disease per the product labeling, including use for specified breast cancer and certain EGFR-mutated non–small cell lung cancer indications.
Revision History
Wording and formatting criteria changes; ICD-10-CM range for C50 updated to include C50.A0–C50.A2 (added to existing range C50.011–C50.929).
Removed HCPCS C9174 and J9999 effective 2025-09-30 and added J9011 effective 2025-10-01 as the HCPCS code for Datroway.
Added FDA indication for EGFR-mutated locally advanced or metastatic NSCLC for individuals with prior EGFR-directed and platinum-based chemotherapy; coding reviewed and ICD-10-CM codes C33 and C34.00–C34.92 added.
Removed HCPCS NOC C9399 effective 2025-06-30 and added C9174 effective 2025-07-01; ICD-10-CM codes C50.011–C50.929, Z17.411, and Z92.21 were added.
New clinical criteria document for Datroway added; HCPCS NOC C9399, J9999, and diagnosis pend codes were added during coding review.
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