ModifiedQualChoicePolicy CP.PHAR.715

Datopotamab Deruxtecan-dlnk (Datroway)

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Policy governing medical necessity, prior authorization, and coverage criteria for datopotamab deruxtecan-dlnk (Datroway) across Commercial, HIM/ICHRA, and Medicaid lines of business for approved oncology indications.

Policy Summary

PayerQualChoice

PolicyDatopotamab Deruxtecan-dlnk (Datroway) — Clinical/Medical Policy

Policy CodePolicy CP.PHAR.715

Change TypeMaterial revision — TNBC indication addedcoding and attestation updates

Effective DateJun 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation showing member meets indication-specific criteria and, for PD-L1 positive TNBC, include provider attestation of ineligibility for PD-1/PD-L1 therapy.

SourceLink

POLICY UPDATE CHANGES

Added criteria for TNBC per NCCN and extended initial approval duration for Medicaid and HIM.

Updated FDA approved indications to include additional use in adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy; updated TNBC requirements to allow use in PD-L1 negative tumors and modified requirements for PD-L1 positive tumors to require provider attestation of ineligibility for PD-1/PD-L1 inhibitor treatment.

HCPCS/J-code changes: J9011 was added and C9174 removed previously; historical adds/removes noted in coding implications.

3FDA indications

J9011Drug billing code

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ModifiedQualChoicePolicy CP.PHAR.715

Datopotamab Deruxtecan-dlnk (Datroway)

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Policy Summary

PayerQualChoice

PolicyDatopotamab Deruxtecan-dlnk (Datroway) — Clinical/Medical Policy

Policy CodePolicy CP.PHAR.715

Change TypeMaterial revision — TNBC indication addedcoding and attestation updates

Effective DateJun 1, 2025

Next Review Date

SourceLink

POLICY UPDATE CHANGES

Added criteria for TNBC per NCCN and extended initial approval duration for Medicaid and HIM.

HCPCS/J-code changes: J9011 was added and C9174 removed previously; historical adds/removes noted in coding implications.

3FDA indications

J9011Drug billing code

12 moApproval duration (govt)

6 moApproval duration (commercial)

6 mg/kg / 540 mgDose limit

6 mg/kg q3wDosing regimen

Coverage Criteria

Initial Therapy — Breast Cancer

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

Breast cancer initial criteria: 1. Diagnosis of unresectable or metastatic breast cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age >= 18 years; 4. Documentation of one of the following: a) TNBC (estrogen receptor-, progesterone receptor-, and HER2-negative) and one of the following: i) tumor is PD-L1 negative; OR ii) tumor expresses PD-L1 and provider attestation that member is ineligible for PD-1/PD-L1 inhibitor treatment (see Appendix D); OR b) HR-positive and HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) disease and both of the following: i) member received prior endocrine-based therapy; AND ii) member received prior chemotherapy for unresectable or metastatic disease; 5. Prescribed as a single agent; 6. Request meets one of the following: a) dose does not exceed both 6 mg/kg and 540 mg once every 3 weeks (21-day cycle); OR b) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Therapy — Non-Small Cell Lung Cancer

Covered when ALL of the following are met for NSCLC:

NSCLC initial criteria: 1. Diagnosis of locally advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC); 2. Prescribed by or in consultation with an oncologist; 3. Age >= 18 years; 4. Documentation of EGFR mutation–positive disease; 5. Member received prior EGFR-directed therapy and platinum-based chemotherapy; 6. Prescribed as a single agent; 7. Request meets one of the following: a) dose does not exceed both 6 mg/kg and 540 mg once every 3 weeks (21-day cycle); OR b) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Coverage criteria (partial — windowed)

Covered when criteria specific to indication are met as described in policy (extracted items in this window):

Dosing and indication basics: Datopotamab deruxtecan-dlnk dosing for breast cancer and NSCLC is 6 mg/kg IV once every 3 weeks (21-day cycle) with a maximum dose of 540 mg per 3 weeks; product available as 100 mg single-dose vial lyophilized powder.

TNBC specific requirement: For unresectable or metastatic triple-negative breast cancer (TNBC), use is limited to adult patients who are not candidates for PD-1/PD-L1 inhibitor therapy. For PD-L1 positive tumors, provider attestation of ineligibility for PD-1/PD-L1 inhibitors is required; PD-L1 negative tumors may be eligible per updated policy.

Policy updated per NCCN and FDA changes.

Other Diagnoses/Indications

Other/Off-label uses

Other uses: 1. If this drug has had a label change within the last 6 months that is not yet reflected in this policy, follow the no coverage or non-formulary policies for the relevant line of business per policy references (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16); OR 2. If the requested use is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient supporting documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for HIM/ICHRA, and CP.PMN.53 for Medicaid) or applicable evidence‑of‑coverage documents.

Coding lists included in this policy are provided for informational purposes only; the presence of a code on a list does not by itself establish coverage. Providers must follow applicable plan documents and current professional coding guidance when submitting claims.

Codes referenced in this clinical policy are informational and do not guarantee that a service or item will be covered. Inclusion or exclusion of any code should not be used alone to determine medical necessity or benefits—claims should be evaluated against the full policy criteria and payer coding rules.

Initial Therapy Criteria

Initial Therapy

Initial therapy criteria per indication

Initial therapy: See Initial Therapy — Breast Cancer and Initial Therapy — Non-Small Cell Lung Cancer entries which require age >= 18 years, oncologist prescriber or consultation, indication-specific prior therapy documentation (EGFR-directed and platinum-based chemotherapy for NSCLC; prior endocrine and chemotherapy for HR-positive, HER2-negative breast cancer), single-agent use, and adherence to dose limits (≤ 6 mg/kg and ≤ 540 mg every 3 weeks) or guideline-supported alternative dosing.

Initial therapy — dosing and codes

Initial therapy dosing and code requirements referenced:

Initial dosing: Administer datopotamab deruxtecan-dlnk 6 mg/kg IV every 3 weeks (maximum 540 mg per 3-week cycle).≤ 6 mg/kg and ≤ 540 mg per 21-day cycle

Product supplied as 100 mg single-dose vial; use HCPCS J9011 for billing (injection, datopotamab deruxtecandlnk, 1 mg).

Continuation / Renewal Criteria

Continued Therapy

Covered when ALL of the following are met for continuation:

Continued therapy criteria: 1. Currently receiving medication via Centene benefit, or documentation supports current receipt of Datroway for a covered indication and at least 30 days of therapy; 2. Member is responding positively to therapy; 3. If request is for a dose increase, the new dose must either not exceed both 6 mg/kg and 540 mg every 3 weeks OR be supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Continuation Therapy — requirements

Continuation therapy requirements

Continuation: Member must have been receiving Datroway for at least 30 days via the Centene benefit or have documentation of current therapy; member must be responding positively to treatment; dose increases must meet the dose limits (≤ 6 mg/kg and ≤ 540 mg every 3 weeks) or be supported by practice guidelines/peer-reviewed literature with prescriber-submitted evidence. Prior authorization and documentation supporting ongoing benefit are required.

Coding and Dose Limits

Drug HCPCS CodesHCPCSCovered

J9011

Injection, datopotamab deruxtecandlnk, 1 mg

Removed / historical codesHCPCS

C9174	historical/previous HCPCS (removed)
J3490	historical miscellaneous HCPCS (removed)
J3590	historical miscellaneous HCPCS (removed)
C9399	historical miscellaneous HCPCS (removed)
J9999	historical miscellaneous HCPCS (removed)

Dose limits per 21-day cycle — maximum dosing (inv-11)

Dose limit (weight-based)≤ 6 mg/kg every 21-day cycle

Dose limit (absolute)≤ 540 mg every 21-day cycle

Dosing intervalOnce every 3 weeks (21-day cycle)

Maximum dose per cycle — 540 mg per 3 weeks (inv-12)

Maximum dose per cycle540 mg per 3 weeks

Usual dosing regimen6 mg/kg IV once every 3 weeks

Product dosing context

Provider Actions and Requirements

Prior Authorization

Prior authorization required — demonstrate criteria for initial & continued therapy

Prior authorization is required for both initial and continued therapy; the provider must demonstrate that the member meets all applicable approval criteria in Sections I (Initial Approval Criteria) and II (Continued Therapy) of the policy (e.g., diagnosis, prescriber specialty, age, prior therapies, dosing limits or guideline-supported dosing).

Provider must show criteria for initial approval (see Section I) and for continuation (see Section II).
Dose limits: must not exceed 6 mg/kg and 540 mg every 3 weeks unless supported by guidelines/literature.

Billing Rule

Use HCPCS J9011 for authorization and billing

When requesting prior authorization or submitting claims for datopotamab deruxtecan-dlnk, use HCPCS code J9011 (Injection, datopotamab deruxtecandlnk, 1 mg) per the coding guidance; follow the policy’s coding/billing instructions and referenced coding guidance.

Step Therapy / Therapeutic Alternatives

Therapeutic alternative	Typical dosing / notes	May require prior authorization
Paclitaxel	Dosing regimen varies by formulation and indication; consult product labeling and Appendix B for examples
Abraxane (albumin-bound paclitaxel)	Dosing regimen varies; consult product labeling
Docetaxel (Taxotere)	Dosing regimen varies; consult product labeling
Doxorubicin / Liposomal doxorubicin (Doxil)	Examples: liposomal doxorubicin 50 mg/m2 IV day 1, cycled; other doxorubicin regimens vary
Capecitabine (Xeloda)	Example regimen: 1,000–1,250 mg/m2 PO BID on days 1–14 in a 21- or 28-day cycle (see Appendix B)
Gemcitabine (Gemzar)	Examples: 800–1,200 mg/m2 IV on days 1, 8 and 15 (varies by regimen)
Vinorelbine	Dosing regimens vary; see Appendix B for examples
Eribulin (Halaven)	Example: 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle
Ixabepilone (Ixempra)	Example: 40 mg/m2 IV on day 1 (maximum dose 40 mg/m2)
Endocrine therapies (tamoxifen, aromatase inhibitors: anastrozole, letrozole, exemestane)	Used for HR-positive disease; dosing varies by agent (see Appendix B)
EGFR-targeted therapies (for NSCLC examples: afatinib, erlotinib, dacomitinib, gefitinib, osimertinib, amivantamab ± lazertinib)	Dosing varies by agent and mutation subtype; see Appendix B for examples

Clinical scenario	Provider attestation required?	Supporting details / acceptable evidence
Adult patient with unresectable or metastatic TNBC whose tumor is PD-L1 positive	covered_with_criteria	Provider must attest that the member is ineligible for PD-1/PD-L1 inhibitor therapy (examples: prior (neo)adjuvant PD-1/PD-L1 use, comorbidity precluding use, or unavailability of PD-1/PD-L1 agent in patient's country) as described from trial enrollment criteria and policy updates
Adult patient with unresectable or metastatic TNBC whose tumor is PD-L1 negative	covered_with_criteria	Policy update allows PD-L1 negative tumors to be eligible; documentation of TNBC diagnosis and other initial criteria per policy required (attestation not required for PD-L1 negative per update)

Quantity Limits

Datopotamab deruxtecan-dlnk — quantity limit value (inv-33)

Quantity limit (mg per 3-week cycle)540 mg

Per-cycle unitMeasured as mg per 3-week (21-day) cycle

Associated dosingCorresponds to 6 mg/kg dosing with an absolute cap of 540 mg

Site of Care

Note

Infusion center / IV administration required

Administer IV infusions in an appropriate clinical setting (infusion center) consistent with the policy’s site‑of‑care guidance; no additional site‑of‑care restrictions are specified in this policy window.

Definitions

EGFR definition (inv-22)

TermEGFR = epidermal growth factor receptor

RelevanceEGFR mutation–positive disease is required for the NSCLC indication

Reference locationDefined in Appendix A and required in Initial Therapy — NSCLC criteria

TNBC — triple-negative breast cancer definition (inv-23)

DefinitionTriple‑negative breast cancer (TNBC) = estrogen receptor‑negative (ER‑), progesterone receptor‑negative (PR‑), and HER2‑negative

Policy relevanceTNBC patients addressed in initial therapy criteria; use limited to patients not candidates for PD‑1/PD‑L1 inhibitor therapy (policy exceptions apply)

Background

Datopotamab deruxtecan‑dlnk (Datroway) is a Trop‑2–directed antibody‑drug conjugate that delivers a topoisomerase inhibitor payload to Trop‑2–expressing tumor cells. It is approved for certain advanced or metastatic breast and non‑small cell lung cancer indications and, per the policy, is administered as an intravenous agent at a recommended dose of 6 mg/kg every 3 weeks with a maximum of 540 mg per 3‑week cycle. The policy notes approved uses include adult patients with EGFR‑mutated locally advanced or metastatic NSCLC after prior EGFR‑directed therapy and platinum‑based chemotherapy, and adult patients with unresectable or metastatic breast cancer subtypes (including TNBC and HR‑positive/HER2‑negative) meeting the specified prior therapy and eligibility criteria.

Policy Summary

PayerQualChoice

PolicyDatopotamab Deruxtecan-dlnk (Datroway) — Clinical/Medical Policy

Policy CodePolicy CP.PHAR.715

Change TypeMaterial revision — TNBC indication addedcoding and attestation updates

Effective DateJun 1, 2025

Next Review Date

SourceLink

On This Page

Continuation therapy (summary)

Continuation/renewal requirements referenced in broader policy but not detailed in this window.

Continuation summary: Policy history indicates initial approval durations and renewal practices vary by line of business; specific renewal intervals and administrative requirements are referenced elsewhere in the full policy. Providers should submit clinical documentation to support continued medical necessity.

Applies to breast cancer and NSCLC indications per dosing and administration section

Use HCPCS J9011 when requesting coverage for datopotamab deruxtecan-dlnk.
Refer to coding guidance in the policy for claim submission details.

Note

Therapeutic alternatives listed in Appendix B — may require PA

Therapeutic alternatives are listed in Appendix B and may be considered or required prior to approval; some alternatives may not be formulary agents for all lines of business and may themselves require prior authorization.

Appendix B lists alternative systemic and targeted therapies for breast cancer and NSCLC.
Alternatives may require PA depending on formulary status and line of business.

Documentation Required

Required documentation — clinical records, labs, prior therapy, dosing rationale

Submit office chart notes, laboratory results, and other clinical information to support that the member meets all approval criteria (diagnosis, prior therapies, age, prescriber specialty, dosing rationale, and treatment response for continuation requests).

Include documentation of diagnosis, prior therapies (see Appendix B), PD-L1 status or attestation when applicable, and evidence of treatment response for continuation.
If dose exceeds standard limits, include guideline or peer-reviewed literature supporting the dosing.

Denial Risk

Off‑label/non‑FDA indications may be denied without off‑label documentation

Requests for non‑FDA approved (off‑label) indications that are not addressed in this policy may be denied unless the provider supplies sufficient documentation of efficacy and safety per the referenced off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence-of-coverage documents.

Non‑FDA indications not addressed in this policy require supporting documentation per the applicable off‑label use policy.
Absence of such documentation may result in denial.

Denial Risk

Coding inclusion/exclusion does not guarantee coverage — incorrect or removed codes may trigger denial

Inclusion or exclusion of a code in this policy does not guarantee coverage; coding discrepancies or use of removed/historical codes may lead to denial — confirm the current HCPCS code (J9011) and consult professional coding guidance prior to claim submission.

Codes referenced are informational only; inclusion/exclusion does not guarantee coverage.
Use of removed or historical codes (e.g., C9174 previously removed) or incorrect coding may trigger claim denial.

Step Therapy

For TNBC: document patient is not a candidate for PD‑1/PD‑L1 inhibitor therapy

For TNBC, document that the patient is not a candidate for PD‑1/PD‑L1 inhibitor therapy as required by the TNBC criteria; prior PD‑1/PD‑L1 exposure, comorbidity precluding use, or unavailability may constitute ineligibility.

For unresectable or metastatic TNBC, policy limits use to adults who are not candidates for PD‑1/PD‑L1 inhibitor therapy.
Ineligibility reasons referenced in the TROPION‑Breast02 trial include prior (neo)adjuvant PD‑1/PD‑L1 therapy, comorbidity precluding use, or lack of availability.

Documentation Required

For PD‑L1 positive TNBC: include provider attestation of ineligibility for PD‑1/PD‑L1 therapy

If the tumor is PD‑L1 positive, include a provider attestation that the member is ineligible for PD‑1/PD‑L1 inhibitor treatment (per trial criteria such as prior PD‑1/PD‑L1 exposure, comorbidity, or unavailability) when requesting coverage for TNBC patients with PD‑L1 positive tumors.

Provider attestation of ineligibility for PD‑1/PD‑L1 inhibitors is required for PD‑L1 positive TNBC per the policy (see Appendix D).
PD‑L1 negative TNBC tumors may be eligible per updated policy language.

Dosed per standard regimen 6 mg/kg IV q3w with 540 mg maximum per cycle

Non‑small cell lung cancer (NSCLC) definition (inv-24)

DefinitionNon‑small cell lung cancer (NSCLC) = non‑small cell lung cancer

Clinical notePolicy requires documentation of EGFR mutation–positive disease for the NSCLC indication

DosingDatroway dosing for NSCLC is 6 mg/kg IV once every 3 weeks (max 540 mg)

TNBC — alternate key definition entry (inv-25)

DefinitionTriple‑negative breast cancer (TNBC) = ER‑, PR‑, and HER2‑negative

Policy requirementUse in unresectable or metastatic TNBC limited to adult patients not candidates for PD‑1/PD‑L1 inhibitor therapy; provider attestation required for some PD‑L1 positive tumors

Dose guidanceAdministered as single agent per policy with dose limits ≤6 mg/kg and ≤540 mg every 3 weeks

PD‑1 / PD‑L1 definition (inv-26)

TermPD‑1 = programmed cell death protein‑1; PD‑L1 = programmed cell death ligand‑1

Clinical relevanceEligibility for TNBC indication depends on candidacy for PD‑1/PD‑L1 inhibitor therapy; provider attestation may be required for PD‑L1 positive tumors

Appendix referencePD‑1/PD‑L1 abbreviations and notes appear in Appendix B and policy sections for TNBC