ModifiedAnthemPolicy CC-0279

Datroway (datopotamab deruxtecan-dlnk) coverage

Clinical criteria governing prior authorization and medical necessity determinations for Datroway for unresectable/metastatic HER2-negative HR+ breast cancer and for EGFR-mutated locally advanced/metastatic NSCLC, affecting Anthem members/providers.

Policy Summary

PayerAnthem

PolicyDatroway (datopotamab deruxtecan-dlnk) coverage

Policy CodePolicy CC-0279

Change TypeMaterial revision — added NSCLC indicationcoding and clinical criteria updates

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, biomarker results (HER2 IHC/ISH or EGFR mutation), required prior therapies, and absence of clinically active brain metastases.

SourceLink

POLICY UPDATE CHANGES

Added FDA indication for use in EGFR-mutated NSCLC in locally advanced or metastatic disease for patients with prior EGFR-directed therapy and platinum-based chemotherapy.

Coding update: removed prior miscellaneous HCPCS codes and consolidated to J9011 (datopotamab deruxtecan-dlnk, 1 mg).

New clinical criteria added specifying covered HER2-negative breast cancer populations by IHC/ISH status and prior therapies required.

2distinct FDA label tumor types

1current HCPCS billing code

3HER2 IHC categories accepted

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Coverage Criteria

Initial therapy - HR+, HER2-negative breast cancer

Covered when ALL of the following are met for breast cancer:

Breast cancer coverage requirements: Member has unresectable or metastatic HER2-negative (HER2-) breast cancer AND hormone-receptor positive (HR+) disease AND has received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

HER2-negative is defined as IHC 0, IHC 1+, or IHC 2+ with ISH negative per ASCO/CAP testing criteria referenced in definitions.

HER2 test acceptable results: IHC 0 OR IHC 1+ OR IHC 2+ with ISH negative

Per IHC/ISH categories defining HER2-negative status.

Initial therapy - EGFR-mutated locally advanced/metastatic NSCLC

Covered when ALL of the following are met for NSCLC:

NSCLC coverage requirements: Member has a diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-mutated disease AND has received prior EGFR-directed therapy AND prior platinum-based chemotherapy.

Per labeled indication for EGFR-mutated locally advanced or metastatic NSCLC.

Individuals with clinically active brain metastases are not eligible for approval of Datroway (datopotamab deruxtecan-dlnk).

Use of Datroway for indications not meeting the specified coverage criteria is considered not approved / not medically necessary. Requests that do not satisfy the listed diagnosis, biomarker, prior therapy, and exclusion requirements should be denied.

Coding

HCPCSHCPCSCovered

J9011

Injection, datopotamab deruxtecan-dlnk, 1 mg [Datroway]

ICD-10 DiagnosisICD-10

C33	Malignant neoplasm of trachea
C34.00-C34.92	Malignant neoplasm of bronchus and lung
C50.011-C50.929	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

HER2 IHC/ISH categories

HER2 IHC 0IHC 0 is accepted as HER2-negative for eligibility

HER2 IHC 1+IHC 1+ is accepted as HER2-negative for eligibility

HER2 IHC 2+ with ISH negativeIHC 2+ combined with ISH-negative (ISH-) is accepted as HER2-negative for eligibility

Provider Actions

Prior Authorization

Prior authorization required per clinical criteria

Prior authorization is required. Approvals are granted only when the member meets the documented diagnosis, biomarker, prior therapy, and exclusion criteria in the policy (e.g., unresectable or metastatic HER2‑negative HR+ breast cancer meeting IHC/ISH definitions, or EGFR‑mutated locally advanced/metastatic NSCLC with required prior therapies).

Policy requires matching clinical diagnosis, biomarker results, prior therapy history, and absence of exclusions before approval

Step Therapy

Prior therapy prerequisites (not step therapy)

This is not a step‑therapy program, but prior therapies are required before approval: for breast cancer, prior endocrine‑based therapy and prior chemotherapy for unresectable/metastatic disease; for NSCLC, prior EGFR‑directed therapy and prior platinum‑based chemotherapy.

Breast cancer: prior endocrine-based therapy AND prior chemotherapy for unresectable or metastatic disease
NSCLC: prior EGFR-directed therapy AND prior platinum-based chemotherapy

Definitions

HER2 testing (IHC/ISH) — ASCO/CAP definitions

ASCO/CAP - Positive HER2 (IHC)IHC 3+: circumferential membrane staining that is complete, intense and observed in >10% of invasive tumor cells

ASCO/CAP - Positive HER2 (ISH)ISH positive if single‑probe average HER2 copy number ≥6.0 signals/cell OR dual‑probe HER2/CEP17 ratio ≥2.0 with average HER2 copy number ≥4.0 signals/cell (among other ISH positive definitions)

ASCO/CAP - Equivocal HER2IHC 2+ (incomplete and/or weak/moderate or intense within ≤10% of cells) OR ISH results with single‑probe average HER2 copy number ≥4.0 and <6.0 signals/cell or dual‑probe ratio <2.0 with average HER2 copy number ≥4.0 signals/cell

ASCO/CAP - Negative HER2IHC 0 or IHC 1+ as defined (IHC 0: no staining or faint/incomplete ≤10% of cells; IHC 1+: faint/incomplete >10% of cells) OR ISH negative (single‑probe <4.0 signals/cell or dual‑probe ratio <2.0 with average <4.0 signals/cell)

Note on cell countingISH interpretations are observed in a homogeneous and contiguous population and counting is performed by counting at least 20 cells within the area

Line of Therapy

second-line

Line of therapy - Breast cancer (second-line): Prior endocrine-based therapy AND prior chemotherapy for unresectable or metastatic breast cancer are required before approval.

Document specifies both classes of prior therapy as prerequisites; considered second-line use.

second-line

Line of therapy - NSCLC (second-line): Prior EGFR-directed therapy AND prior platinum-based chemotherapy are required before approval.

Document indicates these prior therapies are required and correspond to second-line placement.

Biomarker Requirements

HER2 (IHC/ISH)

ASCO/CAP referenceHER2 test categories used for eligibility reference ASCO/CAP IHC and ISH criteria as detailed in the policy

HER2-negative for coverageEligible HER2-negative defined as IHC 0, IHC 1+, or IHC 2+ with ISH negative per ASCO/CAP criteria

Testing detailsISH positive/equivocal/negative thresholds (copy number and HER2/CEP17 ratio) follow ASCO/CAP definitions used in policy

EGFR mutation

Required biomarkerEGFR mutation is required for NSCLC eligibility (individual must have EGFR‑mutated disease)

Indication contextApplies to locally advanced or metastatic NSCLC under the updated labeled indication

Covered Regimens

Regimen	Indication	Coverage status
Datroway (datopotamab deruxtecan-dlnk) per labeled dosing (refer to product labeling)	Unresectable or metastatic, hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer after prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease	Covered with criteria

Regimen	Indication	Coverage status
Datroway (datopotamab deruxtecan-dlnk) per labeled dosing (refer to product labeling)	Locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-mutated disease after prior EGFR-directed therapy and platinum-based chemotherapy	Covered with criteria

Background

Datroway (datopotamab deruxtecan-dlnk) is a Trop-2–directed antibody-drug conjugate with a topoisomerase inhibitor payload indicated for unresectable or metastatic disease. The policy aligns use with labeled indications, including HR+, HER2‑negative unresectable or metastatic breast cancer after prior endocrine-based therapy and chemotherapy, and, per updated labeling, EGFR‑mutated locally advanced or metastatic NSCLC after prior EGFR‑directed therapy and platinum‑based chemotherapy.