ModifiedMass General Brigham Health PlanPolicy N/A

Breast Cancer Therapies Datroway (datopotamab deruxtecan-dlnk) Enhertu (fam-trastuzumab deruxtecan-nxki) Faslodex (fulvestrant) Halaven (eribulin) Kadcyla (ado-trastuzumab) Margenza (margetuximab-cmkb) Perjeta (pertuzumab) Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) Trodelvy (sacituzumab govitecan-hziy)

Pharmacy and medical benefit prior authorization and coverage criteria for multiple breast cancer therapies (Datroway, Enhertu, Faslodex, Halaven, Kadcyla, Margenza, Perjeta, Phesgo, Trodelvy) detailing diagnoses, prescriber, prior therapy requirements, dosing requirements, continuation/reauthorization and limitations. Applies to commercial/exchange plans of Mass General Brigham Health Plan / MassHealth drug program.

Policy Summary

PayerMass General Brigham Health Plan

PolicyBreast Cancer Therapies Datroway (datopotamab deruxtecan-dlnk) Enhertu (fam-trastuzumab deruxtecan-nxki) Faslodex (fulvestrant) Halaven (eribulin) Kadcyla (ado-trastuzumab) Margenza (margetuximab-cmkb) Perjeta (pertuzumab) Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) Trodelvy (sacituzumab govitecan-hziy)

Policy CodePolicy N/A

Change TypeMultiple material updates (added agent, revised indications, benefit routing, reauth changes)

Effective DateJan 1, 2022

Next Review DateJun 11, 2025

Key ActionPrior authorization is required; provide documentation of diagnoses, prior therapies, oncologist prescriber and appropriate dosing.

SourceLink

POLICY UPDATE CHANGES

Datroway added to criteria

Enhanced indication for Enhertu to include unresectable or metastatic HER2-positive (IHC 3+) solid tumors with prior systemic treatment and no satisfactory alternative

Trodelvy criteria updated and benefit routing clarified

Appendix removal and reauthorization criteria alignment with MassHealth

10Agents covered in policy

12 monthsInitial/reauthorization duration

multipleIndications covered

Coverage Summary

This policy provides pharmacy and medical benefit prior authorization and coverage criteria for multiple breast cancer therapies including Datroway (datopotamab deruxtecan-dlnk), Enhertu (fam-trastuzumab deruxtecan-nxki), Faslodex, Halaven, Kadcyla, Margenza, Perjeta, Phesgo, and Trodelvy. It applies to Commercial/Exchange plans of Mass General Brigham Health Plan and the MassHealth drug program and details required diagnoses, prescriber restrictions, prior therapy and dosing requirements, benefit routing, continuation/reauthorization, and limitations. Status: MODIFIED.

Initial Therapy Criteria (by agent and indication)

Datroway (datopotamab deruxtecan-dlnk) — HR-positive, HER2-negative unresectable locally advanced or metastatic breast cancer

Authorization may be granted when ALL of the following are met, and documentation is provided:

ALL of the following

Datroway (datopotamab deruxtecan-dlnk): Diagnosis of HR-positive, HER2-negative unresectable locally advanced or metastatic breast cancer
Prescriber is an oncologist

Policy Summary

PayerMass General Brigham Health Plan

Policy CodePolicy N/A

Change TypeMultiple material updates (added agent, revised indications, benefit routing, reauth changes)

Effective DateJan 1, 2022

Next Review DateJun 11, 2025

Key ActionPrior authorization is required; provide documentation of diagnoses, prior therapies, oncologist prescriber and appropriate dosing.

SourceLink

On This Page

Inadequate response or adverse reaction to ONE or contraindication to ALL endocrine-based therapies

Inadequate response or adverse reaction to TWO prior non-endocrine-based systemic therapies in the metastatic setting

If HER2 IHC 0+, 1+, or 2+/ISH- (HER2-low) breast cancer, inadequate response, adverse reaction, or contraindication to Enhertu (fam-trastuzumab deruxtecan-nxki)

Enhertu (fam-trastuzumab deruxtecan-nxki) — General Authorization Conditions

Enhertu (fam-trastuzumab deruxtecan-nxki) may be authorized when ALL of the following general conditions are met:

ALL of the following

Prescriber is an oncologist
Appropriate dosing (weight required where specified)
Documentation of HER2 testing appropriate to the indication (IHC and/or ISH or an FDA‑approved companion diagnostic where required)
Inadequate response or adverse reaction to prior relevant therapies as specified per indication (see indication-specific criteria)
For members new to the plan currently receiving Enhertu, authorization may be reviewed case-by-case if documentation of ongoing treatment is provided (excluding samples or manufacturer patient assistance program supply)

Enhertu — HER2-Positive Metastatic Breast Cancer

Authorization may be granted when ALL of the following are met for HER2‑positive metastatic breast cancer:

ALL of the following

Diagnosis of unresectable or metastatic HER2-positive breast cancer
Prescriber is an oncologist
Appropriate dosing (weight required)
Inadequate response or adverse reaction to ONE anti-HER2-based regimen (e.g., trastuzumab, ado‑trastuzumab emtansine [Kadcyla], pertuzumab; agents used in combination count as one regimen)

Enhertu — Metastatic Gastric or GEJ Adenocarcinoma

Authorization may be granted when ALL of the following are met for locally advanced or metastatic HER2‑positive gastric or GEJ adenocarcinoma:

ALL of the following

Diagnosis of locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma
Prescriber is an oncologist
Appropriate dosing (weight required)
Inadequate response or adverse reaction to a trastuzumab-based regimen

Enhertu — HER2‑Low Metastatic Breast Cancer

Authorization may be granted when ALL of the following are met for HER2‑low metastatic breast cancer:

ALL of the following

Diagnosis of unresectable or metastatic HER2‑low breast cancer (IHC 1+ or IHC 2+/ISH-)
Prescriber is an oncologist
Appropriate dosing (weight required)
Inadequate response or adverse reaction to ONE prior chemotherapy regimen (examples: anthracyclines [doxorubicin, liposomal doxorubicin], taxanes [paclitaxel], antimetabolites [capecitabine, gemcitabine], microtubule inhibitors [vinorelbine, eribulin])

Enhertu — NSCLC with ERBB2 (HER2) Mutations

Authorization may be granted when ALL of the following are met for NSCLC with activating ERBB2 (HER2) mutations:

ALL of the following

Diagnosis of unresectable or metastatic non-small cell lung cancer (NSCLC) with tumors harboring activating HER2 (ERBB2) mutations as detected by an FDA‑approved test
Prescriber is an oncologist
Appropriate dosing (weight required)
Inadequate response or adverse reaction to ONE prior systemic therapy

Enhertu — HER2‑Positive Solid Tumors (IHC 3+)

Authorization may be granted when ALL of the following are met for HER2‑positive (IHC 3+) unresectable or metastatic solid tumors:

ALL of the following

Diagnosis of unresectable or metastatic HER2‑positive solid tumor (IHC 3+)
Prescriber is an oncologist
Appropriate dosing (weight required)
ONE of the following
- Inadequate response or adverse reaction to ONE prior systemic therapy (refer to latest NCCN guidelines for guidance of prior systemic therapy options)
- Member has no satisfactory alternative treatment options

Faslodex (fulvestrant) — Indications and Therapy‑Specific Conditions

Faslodex (fulvestrant) may be authorized when ALL of the following are met for FDA‑approved breast cancer indications:

ALL of the following

Diagnosis of HR‑positive advanced or metastatic breast cancer or other FDA‑approved indication
Prescriber is an oncologist
Appropriate dosing
Diagnosis options
- Advanced or metastatic breast cancer with progression following endocrine therapy (e.g., tamoxifen, anastrozole, letrozole, exemestane)
- HR‑positive, HER2‑negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy
Therapy‑specific conditions
- Requested agent will be used in combination with a CDK4/6 inhibitor (e.g., abemaciclib, palbociclib, ribociclib)
- Requested agent will be used as monotherapy
- Concomitant therapy with anastrozole or letrozole
- For HER2‑positive disease: requested agent will be used in combination with trastuzumab

Halaven (eribulin) — Indications

Halaven (eribulin) may be authorized when ALL of the following are met for its indications:

ALL of the following

Indication options
- Diagnosis of unresectable or metastatic liposarcoma and inadequate response, adverse reaction, or contraindication to an anthracycline‑containing regimen
- Diagnosis of metastatic breast cancer and prior receipt of at least two chemotherapeutic regimens for metastatic disease
Prescriber is an oncologist
Appropriate dosing (height and weight or BSA as required)

Kadcyla (ado‑trastuzumab emtansine) — Criteria

Kadcyla (ado‑trastuzumab emtansine) may be authorized when ALL of the following are met:

ALL of the following

Diagnosis of HER2‑positive breast cancer
Prescriber is an oncologist
Appropriate dosing
Prior therapy options
- Prior reaction to trastuzumab and a taxane, separately or in combination
- Prior trastuzumab‑based treatment

Margenza (margetuximab‑cmkb) — Criteria

Margenza (margetuximab‑cmkb) may be authorized when ALL of the following are met:

ALL of the following

Diagnosis of HER2‑positive metastatic breast cancer
Prescriber is an oncologist
Appropriate dosing
Requested agent will be used in combination with chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine)
Inadequate response or adverse reaction to at least TWO prior anti‑HER2‑based regimens (e.g., trastuzumab, ado‑trastuzumab emtansine, pertuzumab; combination agents count as one regimen)

Perjeta (pertuzumab) — Use Settings

Perjeta (pertuzumab) may be authorized when ALL of the following are met:

ALL of the following

Diagnosis of HER2‑positive breast cancer
Prescriber is an oncologist
Appropriate dosing
Use settings
- For recurrent or stage IV disease: requested agent will be used in combination with trastuzumab AND docetaxel or paclitaxel
- For adjuvant or neoadjuvant chemotherapy: requested agent will be used in combination with trastuzumab AND chemotherapy

Phesgo (pertuzumab/trastuzumab/hyaluronidase‑zzxf) — Use Settings

Phesgo (pertuzumab/trastuzumab/hyaluronidase‑zzxf) may be authorized when ALL of the following are met:

ALL of the following

Diagnosis of HER2‑positive breast cancer
Prescriber is an oncologist
Appropriate dosing
Use settings
- For early breast cancer: requested agent will be used in combination with chemotherapy
- For metastatic breast cancer: requested agent will be used in combination with docetaxel as first‑line treatment in the metastatic setting (members should not have received prior anti‑HER2 therapy)

Trodelvy (sacituzumab govitecan‑hziy) — Indications (TNBC and HR‑positive/HER2‑negative)

Trodelvy (sacituzumab govitecan‑hziy) may be authorized when ALL of the following are met for each indication:

ALL of the following

Indication: TNBC
- Diagnosis of unresectable locally advanced or metastatic triple‑negative breast cancer
Prescriber is an oncologist
Appropriate dosing
Inadequate response or adverse reaction to at least TWO prior systemic therapies, at least one for metastatic disease (see Appendix for acceptable previous therapies)

ALL of the following

Indication: HR‑positive, HER2‑negative unresectable locally advanced or metastatic breast cancer
- Diagnosis of HR‑positive, HER2‑negative unresectable locally advanced or metastatic breast cancer
Prescriber is an oncologist
Appropriate dosing
Inadequate response or adverse reaction to ONE or contraindication to ALL endocrine‑based therapies (see Appendix for acceptable previous therapies)
If HER2 IHC 0+, 1+, or 2+/ISH- (HER2‑low), inadequate response, adverse reaction, or contraindication to Enhertu (fam‑trastuzumab deruxtecan‑nxki)

Continuation Therapy & Limitations

Continuation of Therapy

Reauthorization conditions

Reauthorization by prescriber will infer a positive response to therapy

Limitations

Authorization duration limits

Initial approvals and reauthorizations will be granted for 12 months12 months

Operational note: Initial approvals and reauthorizations will be granted for 12 months. Reauthorization must be requested prior to continuation of therapy, and reauthorization by the prescriber will be taken to infer a positive clinical benefit from the therapy (prescriber attestation expected).

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for the listed agents; authorizations may be reviewed case-by-case for members new to the plan currently receiving treatment; documentation of diagnoses, prior therapies, oncologist prescriber and appropriate dosing must be provided.

Authorizations may be reviewed case-by-case for members new to the plan who are currently receiving treatment (excluding samples or manufacturer patient assistance programs).
Documentation must include diagnoses.
Documentation must include prior therapies.
Documentation must include oncologist prescriber specialty.
Documentation must include appropriate dosing.

Documentation Required

Documentation of prior therapies and HER2 status

Providers must document prior systemic therapy regimens (number and class), endocrine therapy history or contraindications, and HER2 status (IHC and ISH results where applicable) and weight when dosing requires it.

Number and class of prior systemic regimens (e.g., chemotherapy, anti‑HER2 regimens).
Endocrine therapy history or documented contraindications to endocrine therapy.
HER2 testing results: IHC and ISH results where applicable.
Patient weight when dosing requires weight-based dosing.

Billing Rule

Benefit routing (pharmacy vs medical)

Trodelvy and Enhertu availability may be under pharmacy or medical benefit depending on plan and effective updates; check current benefit routing (policy notes indicate Enhertu moved to medical benefit and Trodelvy benefit routing updated in 2023–2024 updates).

Enhertu removed from pharmacy benefit and will only be available on the medical benefit with prior authorization (effective 3/4/24).
Trodelvy benefit routing has been updated multiple times; Trodelvy was clarified as available through pharmacy and medical benefits (effective 6/30/23) and further updates occurred in 2023–2024.
Check the plan's current benefit routing for Trodelvy and Enhertu before submitting a request.

Prior Authorization

Reauthorization infers benefit

Reauthorization by prescriber will infer a positive response to therapy and must be requested prior to continuation; initial approvals and reauthorizations are granted for 12 months.

Initial approvals and reauthorizations will be granted for 12 months.
Reauthorization requests should be submitted prior to continuation of therapy.
Reauthorization by the prescriber infers clinical benefit/positive response to therapy.

Applicable Codes

No codes explicitly listed in documentmixed

No codes listed

Clinical Evidence & Guidance Referenced

Evidence references: NCCN Clinical Practice Guidelines in Oncology (Breast Cancer and related tumor-specific guidelines, versions cited 2024) are referenced. Individual FDA prescribing information/prescribing documents for the agents are cited (prescribing information years cited range from 2020–2024). The policy notes that criteria align with FDA labels and NCCN guidance.

Background

Background: This multi-agent policy documents prior authorization criteria for several FDA-approved oncology agents used for breast cancer and other HER2-related indications, aligning criteria with FDA labels and NCCN guidance. The policy covers both pharmacy and medical benefit routing decisions (benefit routing for Trodelvy and Enhertu has been updated in recent reviews), includes prescriber restrictions (oncologist requirement for applicable agents), prior therapy requirements and dosing requirements (weight, height/BSA where specified), and applies to Mass General Brigham Health Plan / MassHealth drug program. Specific agent additions and routing/indication updates (for example Datroway added and Enhertu/Trodelvy routing updates) are noted in the review history.

Revision History

2021-11-17 (effective 01/01/2022)created

Policy created and reviewed for Nov P&T; matched with MH UPPL (effective 01/01/2022).

06/22/2022 (effective 08/01/22)revised

Criteria updated for expanded indication of Verzenio and removal of postmenopausal wording where appropriate.

03/15/2023 (effective 04/01/23)revised

Added criteria for Enhertu, Faslodex, Halaven, Kadcyla, Margenza, Perjeta, Phesgo, Trodelvy; added Appendix 'Previous Trials' for Trodelvy.

05/10/2023 (effective 06/05/23)revised

Orserdu (elacestrant) added for ER-positive, HER2-negative, ESR1-mutated advanced/metastatic breast cancer.

06/30/2023revised

Admin update: Clarified that Trodelvy is available through both pharmacy and medical benefits (dual).

07/31/23revised

MassHealth decision made to have Trodelvy be available under medical benefit only (benefit routing change).

02/14/24revised

Trodelvy criteria (medical benefit) updated to align with FDA-labeled indications; Appendix for Trodelvy acceptable previous trials updated; Enhertu removed from pharmacy benefit and will be available only on medical benefit with PA (effective 3/4/24).

12/11/24 (last_review; effective 01/06/25)revised

Separated criteria for pharmacy vs medical benefit drugs; Enhertu expanded indication added to include unresectable or metastatic HER2-positive (IHC 3+) solid tumors with prior systemic treatment and no satisfactory alternative (effective 1/6/25).

undatedadded

Datroway (datopotamab deruxtecan-dlnk) inclusion added to policy and criteria set.

undatedrevised

Trodelvy criteria updated and benefit routing clarified (multiple updates across 2023–2024).

06/11/25 (effective 07/01/25)revisedLatest

Removed urothelial cancer diagnosis from Trodelvy due to indication withdrawal; Datroway added to criteria; added an additional step-through with Enhertu for Trodelvy requests if HER2 IHC 0+, 1+, or 2+/ISH- (HER2-low); reauthorization criteria updated to align with MassHealth and Appendix removed (info to be found on NCCN).