Datroway (datopotamab deruxtecan-dlnk) and related breast cancer therapies — Medical benefit prior authorization criteria
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Medical benefit prior authorization criteria for Datroway and several HER2-directed and other breast cancer therapies for Mass General Brigham Health Plan (MassHealth UPPL). Applies to prescribers and oncology providers requesting authorization for these agents.
Added expanded labeling for Datroway for adult patients with locally advanced or metastatic EGFR-mutated NSCLC and specified EGFR mutations within Datroway criteria.
Trodelvy criteria updated and availability/benefit source clarified historically; Enhertu moved to medical benefit-only with PA in prior updates.
Coverage Criteria for Listed Agents
Datroway for EGFR-mutated NSCLC
Covered when ALL of the following are met
Datroway for HR-positive, HER2-negative breast cancer
Covered when ALL of the following are met
Enhertu for HER2-positive metastatic breast cancer
Covered when ALL of the following are met
Enhertu for gastric/GEJ adenocarcinoma
Covered when ALL of the following are met
Enhertu for HER2-low metastatic breast cancer
Covered when ALL of the following are met
Enhertu for NSCLC with HER2 mutations
Covered when ALL of the following are met
Enhertu for other HER2-positive solid tumors
Covered when ALL of the following are met
Refer to latest NCCN guidance for prior systemic therapy options.
Halaven for metastatic/recurrent breast cancer
Covered when ALL of the following are met
Halaven for liposarcoma
Covered when ALL of the following are met
Kadcyla
Covered when ALL of the following are met
Margenza
Covered when ALL of the following are met
Perjeta
Covered when ALL of the following are met
Phesgo
Covered when ALL of the following are met
Perjeta (pertuzumab) — Initial/line-specific criteria
Pertuzumab (Perjeta) covered when ALL of the following are met:
From Perjeta criteria
Phesgo — Early and metastatic use
Phesgo (pertuzumab/trastuzumab/hyaluronidase) covered when ALL of the following are met:
From Phesgo criteria
Trodelvy — Indication-specific criteria and step through
Trodelvy (sacituzumab govitecan) covered when ALL of the following are met (separate branches for indications):
TNBC branch
HR+/HER2- branch
Authorizations will not be processed for product supplied as free samples or obtained through a manufacturer's patient assistance program; such supplies are excluded from automatic coverage review. For members new to the plan who are currently receiving treatment, authorizations may be reviewed on a case‑by‑case basis, but exclusion of samples or manufacturer assistance program supplies remains applicable.
Review history documents that the diagnosis of adults with locally advanced or metastatic urothelial cancer was removed from Trodelvy due to indication withdrawal. This change is recorded in the policy review log under prior updates and reflects historical adjustment to Trodelvy's covered indications.
Provider Actions, Prior Authorization, and Documentation
Prior authorization required for Datroway and listed agents
Prior authorization is required under the medical benefit for Datroway and the listed agents; requests for members who are new to the plan and currently receiving the medication will be reviewed on a case‑by‑case basis.
- Program type: Prior Authorization (medical benefit).
- Case‑by‑case review available for members new to plan receiving requested medication; excludes products obtained as samples or via manufacturer patient assistance programs.
Initial and reauthorization approvals — 12 months
Initial authorizations and reauthorizations are granted for a 12‑month period; a request for reauthorization will be interpreted as the prescriber attesting the member has had a positive response to therapy.
- Duration: Initial approvals and reauthorizations — 12 months.
- Reauthorization implies the prescriber is confirming ongoing benefit/clinical response.
Document prior lines of therapy or inadequate response/intolerance
Coverage requires prior lines of therapy or documentation of inadequate response or intolerance as specified in the indication‑specific criteria (requirements vary by agent and indication).
- Examples: inadequate response or intolerance to endocrine therapy and two prior non‑endocrine systemic therapies for HR+/HER2‑ breast cancer (Datroway).
- EGFR‑mutated NSCLC requires inadequate response or contraindication to one EGFR‑directed therapy and one platinum‑based chemotherapy.
Step therapy requirements for Trodelvy (sacituzumab govitecan)
For sacituzumab govitecan (Trodelvy), the prescriber must document inadequate response or adverse reaction to the required prior systemic therapies per the indication: for TNBC ≥2 prior systemic therapies (at least one for metastatic disease); for HR+, HER2‑ disease prior endocrine therapy failure/contraindication plus two prior non‑endocrine systemic therapies, and if HER2‑low, inadequate response/adverse reaction/contraindication to Enhertu.
- TNBC branch: inadequate response or adverse reaction to at least two prior systemic therapies, at least one for metastatic disease.
- HR+/HER2‑ branch: inadequate response/adverse reaction to one or contraindication to all endocrine therapies, plus inadequate response/adverse reaction to two prior non‑endocrine systemic therapies; if HER2‑low, trial/contraindication to Enhertu required.
Required documentation to support the request
Submit documentation that supports the diagnosis, prior therapies, and inadequate response or intolerance to required prior treatments, and that the prescriber is an oncologist.
- Diagnosis documentation (e.g., histology, HER2 IHC/ISH, EGFR mutation results) as applicable to the requested indication.
- Clinical notes showing inadequate response, adverse reaction, or contraindication to required prior therapies.
- Prescriber specialty: documentation that prescriber is an oncologist.
Examples of required supporting documentation
Provide supporting records such as pathology or biomarker reports (HER2 IHC/ISH, EGFR mutation testing), prior treatment records or clinic notes showing prior regimens and response, and dosing/administration records to confirm the requested regimen meets combination or dosing requirements.
- Pathology/biomarker reports: HER2 IHC/ISH results or EGFR mutation test report.
- Prior treatment records or clinic notes documenting prior regimens and clinical response or toxicity.
- Dosing and administration documentation to confirm appropriate dosing and that combination therapy requirements (e.g., pertuzumab with trastuzumab + taxane) are met.
Case‑by‑case review for members new to the plan receiving ongoing therapy
For members new to the plan who are already receiving the requested agent, the request will be reviewed on a case‑by‑case basis and approval is not automatic — include prior authorization history and recent treatment documentation to support continuation.
- Provide recent clinical notes and prior authorization/coverage history to demonstrate ongoing therapy and response.
- Exclude products obtained as samples or via manufacturer's patient assistance programs from automatic coverage review.
Denial risk for missing prescriber specialty or dosing/combination documentation
Requests that do not document the prescriber specialty (oncologist) or that lack dosing/combination regimen details required by the criteria (for example, pertuzumab not shown to be given with trastuzumab + docetaxel/paclitaxel when required) risk denial.
- Common denial triggers: missing prescriber specialty, missing biomarker/pathology reports, absent prior therapy documentation, or dosing/combination regimen not shown to meet listed requirements.
Line/Timing Specifications
second-line
See individual agent criteria for the exact number/type of required prior therapies.
first-line
See Phesgo criteria for details.
mixed
Refer to individual product criteria for specific combination and line restrictions.
Biomarker and Diagnostic Requirements
Allowed Drug Combinations and Sequence
| Regimen | Indication / Requirement | Coverage status |
|---|---|---|
| Margetuximab (Margenza) plus capecitabine, eribulin, gemcitabine, or vinorelbine | HER2-positive metastatic breast cancer; used in combination with one of the listed chemotherapies; inadequate response or adverse reaction to at least TWO prior anti‑HER2–based regimens | Covered |
| Regimen | Indication / Requirement | Coverage status |
|---|---|---|
| Pertuzumab (Perjeta) + trastuzumab + docetaxel or paclitaxel (or pertuzumab + trastuzumab + chemotherapy) | HER2-positive breast cancer; for recurrent or stage IV disease used in combination with trastuzumab AND docetaxel or paclitaxel; for adjuvant/neoadjuvant use, used in combination with trastuzumab AND chemotherapy | Covered |
| Regimen | Indication / Requirement | Coverage status |
|---|---|---|
| Pertuzumab in combination with trastuzumab AND docetaxel or paclitaxel | Recurrent or stage IV HER2‑positive breast cancer; used in combination with trastuzumab AND a taxane | Covered |
| Regimen | Indication / Requirement | Coverage status |
|---|---|---|
| Phesgo (pertuzumab/trastuzumab/hyaluronidase) in combination with chemotherapy | Early (early-stage) HER2‑positive breast cancer; requested agent used in combination with chemotherapy | Covered |
| Regimen | Indication / Requirement | Coverage status |
|---|---|---|
| Phesgo (pertuzumab/trastuzumab/hyaluronidase) in combination with docetaxel | Metastatic HER2‑positive breast cancer (first‑line); used in combination with docetaxel as first‑line metastatic treatment (member should not have received prior anti‑HER2 therapy) | Covered |
| Regimen | Indication / Requirement | Coverage status |
|---|---|---|
| Trodelvy (sacituzumab govitecan) after ≥2 prior systemic therapies (≥1 for metastatic disease) | Unresectable locally advanced or metastatic triple‑negative breast cancer; inadequate response or adverse reaction to at least TWO prior systemic therapies, at least one for metastatic disease | Covered with criteria |
| Regimen | Indication / Requirement | Coverage status |
|---|---|---|
| Trodelvy (sacituzumab govitecan) after endocrine therapy failure and after two prior non‑endocrine systemic therapies; step through Enhertu if HER2‑low | HR‑positive, HER2‑negative unresectable locally advanced or metastatic breast cancer: inadequate response or contraindication to ONE or all endocrine therapies, and inadequate response to TWO prior non‑endocrine systemic therapies; if HER2 IHC 0+, 1+, or 2+/ISH‑ (HER2‑low), inadequate response/adverse reaction/contraindication to Enhertu is required | Covered with criteria |
Definitions and Key Terms
Datroway (datopotamab deruxtecan‑dlnk) is included in this medical benefit prior authorization policy for use in selected advanced solid‑tumor indications. The policy covers Datroway for HR‑positive, HER2‑negative unresectable locally advanced or metastatic breast cancer after prior endocrine‑based therapy and subsequent systemic therapy, and for locally advanced or metastatic EGFR‑mutated non‑small cell lung cancer (NSCLC) when specified activating EGFR mutations are present. Prior authorization is required and requests must document diagnosis, oncologist prescriber specialty, appropriate dosing, and that required prior lines of therapy or documented intolerance/contraindication have been tried as specified in the criteria.
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