Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • NPI Medicare & Medicaid
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty Drugsmoda_health_plan_inc Phesgo Coverage & Prior Auth …
    Ask Trek AI about this page
    Currentmoda_health_plan_incPolicy N/A

    Phesgo (pertuzumab, trastuzumab and hyaluronidase-zzxf) — subcutaneous

    Customize your policy alerts

    Sign up for all moda_health_plan_inc policy alerts

    Know when moda_health_plan_inc releases new policies or updates existing guidance.

    Monitor payer policy activity

    Receive email alerts as soon as relevant payer policies are published or updated.

    Defines prior authorization, dosing, administration, and medical necessity criteria for use of Phesgo (subcutaneous pertuzumab/trastuzumab/hyaluronidase) for HER2-positive breast cancer for Moda Health Plan members and providers submitting authorization requests.

    Policy Summary
    Payermoda_health_plan_inc
    PolicyPhesgo (pertuzumab, trastuzumab and hyaluronidase-zzxf) — subcutaneous
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Last ReviewJun 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization for Phesgo; initial approvals are valid 6 months and may be renewed every 6 months (neoadjuvant/adjuvant up to 1 year).
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 monthsInitial prior authorization validity
    6 monthsRenewal prior authorization interval
    1 yearMax authorization (neoadjuvant/adjuvant)
    J9316HCPCS code

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    1200/600 mgInitial vs maintenance dosing
    Appendix ANQTL checklist

    Coverage and Medical Necessity Criteria

    Initial Approval Criteria

    Covered when ALL of the following are met:

    Age: Member is at least 18 years of age
    Cardiac function: Left ventricular ejection fraction (LVEF) is within normal limits prior to initiating therapy and will be assessed at regular intervals (e.g., every 3 months)

    Specific LVEF thresholds for renewal provided in Renewal Criteria

    HER2 status: Member has HER2-positive disease determined by an FDA-approved or CLIA-compliant test

    HER2 IHC/ISH criteria detailed in Definitions

    Product formulation: Therapy will not be used in combination with pertuzumab or any trastuzumab-based formulation and will not be substituted for or with pertuzumab or any trastuzumab-based formulation
    Indication - Breast cancer contexts: One of the following indication-specific conditions is met: neoadjuvant/preoperative, adjuvant, recurrent unresectable/regional/metastatic, inflammatory, first-line metastatic, subsequent therapy, or single-agent use in specific post-surgical/pCR contexts

    Sub-conditions include tumor staging (e.g., ≥T1c, node positive, inflammatory), combination with taxane or other chemotherapy per guidance, prior trastuzumab exposure and no prior pertuzumab

    Renewal Criteria

    Authorization may be renewed when ALL of the following are met:

    Continued eligibility: Member continues to meet the universal and indication-specific relevant criteria (including concomitant therapy requirements and performance status)
    Duration not exceeded: Duration of authorization has not been exceeded per policy limits (see Dosage/Administration)

    Neoadjuvant/adjuvant use limited to total of 1 year (up to 18 cycles)

    Disease response with treatment is demonstrated (stabilization of disease or decrease in tumor size or tumor spread)
    Tolerable toxicity: Absence of unacceptable toxicity from the drug (examples include cardiotoxicity, pulmonary toxicity, neutropenia/febrile neutropenia, severe administration-related reactions)

    Uses not listed in the approved indications have inadequate data to support efficacy and are excluded from prior authorization validity. Other treatment options (for example, radiation therapy, surgery, traditional chemotherapy, clinical trials, or supportive care) may be appropriate alternatives depending on the clinical scenario.

    Indications not specified in this policy are considered to have inadequate evidence and are excluded as not medically necessary for those uses. Providers should document and justify any alternative therapy through established coverage exception processes or by referencing available compendia or clinical trial enrollment when appropriate.

    Coding, Codes and Quantity Limits

    Covered HCPCS CodesHCPCSCovered
    J9316Injection, pertuzumab, trastuzumab, and hyaluronidase-zzxf, per 10 mg; 1 billable unit = 10 mg
    NDCsNDC
    50242-0245-xxPhesgo 1,200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase per 15 mL single-dose vial
    50242-0260-xxPhesgo 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase per 10 mL single-dose vial
    Covered ICD-10 Diagnosis CodesICD-10Covered
    C50.011Malignant neoplasm of nipple and areola, right female breast.
    C50.012Malignant neoplasm of nipple and areola, left female breast.
    C50.019Malignant neoplasm of nipple and areola, unspecified female breast.
    C50.021Malignant neoplasm of nipple and areola, right female breast.
    C50.022Malignant neoplasm of nipple and areola, left female breast.
    C50.029Malignant neoplasm of nipple and areola, unspecified female breast.
    C50.111Malignant neoplasm of central portion of right female breast.
    C50.112Malignant neoplasm of central portion of left female breast.
    C50.119Malignant neoplasm of central portion of unspecified female breast.
    C50.121Malignant neoplasm of central portion of right male breast.
    1–10 of 58
    1/6
    Max units per dose — Initial and maintenance
    Initial dose180 billable units per dose (one-time initial administration)
    Maintenance dose120 billable units every 21 days (per maintenance dose)
    Unit definition1 billable unit = 10 mg (HCPCS J9316 billed per 10 mg)
    N/A (placeholder)
    StatusN/A (no threshold or quantity limit specified)
    NotesNo additional coding thresholds provided in Appendix 1; see covered diagnosis codes for applicable indications.

    Provider Requirements, Prior Authorization and Documentation

    Prior Authorization

    Prior authorization validity and renewal intervals

    Prior authorization is required for Phesgo. Initial authorizations are valid for 6 months (180 days); renewals may be issued every 6 months (180 days). For neoadjuvant/preoperative and adjuvant therapy, prior authorization may be renewed up to a total of 1 year (up to 18 cycles).

    Prior Authorization

    Prior authorization consideration per NQTL checklist

    Prior authorization is considered an appropriate utilization management approach for this drug based on factors in the NQTL checklist (indication, safety/efficacy, cost); document the rationale when applying PA in accordance with the plan's NQTL considerations.

    Step Therapy

    Fourth‑line use restricted — prerequisite alternatives required

    Initial Dosing and Administration Criteria

    Initial dosing

    Dosing and initial administration

    Initial dose: Administer 1,200 mg pertuzumab / 600 mg trastuzumab / 30,000 units hyaluronidase subcutaneously as the initial dose

    To be administered by a health care professional subcutaneously in the thigh; do not administer intravenously

    Quantity limit - initial dose: Initial dose maximum: 180 billable units (1 billable unit = 10 mg)

    Refer to Max Units per dose

    Continuation and Maintenance Therapy

    Continuation and maintenance

    Continuation/maintenance therapy rules and fourth-line restrictions

    First-line metastatic use: Used as first-line therapy in combination with either paclitaxel or docetaxel
    Maintenance with endocrine therapy: May be used as first-line maintenance therapy in combination with an aromatase inhibitor, with or without palbociclib, if initial treatment included chemotherapy and chemotherapy was stopped

    Requires hormone receptor–positive disease and postmenopausal status or ovarian suppression in premenopausal patients; males require testicular suppression when AI used

    Fourth-line restriction: Use as fourth-line therapy and beyond is restricted to members with contraindication or intolerance to lapatinib/capecitabine or to a regimen containing trastuzumab hyaluronidase plus a generically available agent/regimen; see NCCN for alternative regimens

    Step Therapy Requirements

    Required prior alternative(s)Notes
    Contraindication or intolerance to lapatinib and capecitabine (lapatinib/capecitabine)Member has contraindication or intolerance to lapatinib/capecitabine prior to use beyond fourth-line
    Contraindication or intolerance to a regimen containing trastuzumab hyaluronidase plus a generically available agent (e.g., trastuzumab/capecitabine)Must have trial and intolerance/contraindication to trastuzumab hyaluronidase combined with a generically available agent per NCCN alternatives

    Administration Site and Medicare Notes

    Note

    Subcutaneous administration in office (thigh only)

    Administer Phesgo subcutaneously in the thigh by a healthcare professional; do not administer intravenously.

    Billing Rule

    Hospital outpatient / Medicare Part B determinations follow CMS guidance

    Medicare Part B outpatient coverage determinations follow CMS guidance; local NCDs, LCDs, or LCAs may apply to Part B claims — verify and comply with applicable CMS coverage and local policies.

    Definitions and Evidence Sources

    HER2-positive overexpression criteria
    IHC criterionImmunohistochemistry (IHC) assay 3+
    ISH ratio criterionDual-probe ISH HER2/CEP17 ratio ≥ 2.0 with average HER2 copy number ≥ 4.0 signals/cell
    Concurrent IHC/ISH combinationsSpecified concurrent results also qualify (eg, ratio ≥2.0 with copy number <4.0 plus IHC 3+; ratio <2.0 with copy number ≥6.0 plus IHC 2+ or 3+; ratio <2.0 with copy number ≥4.0 and <6.0 plus IHC 3+)
    Key evidence sources
    Key clinical trialsNeoSphere, TRYPHAENA, CLEOPATRA and related pivotal trials cited in references
    Guideline sourcesESMO Clinical Practice Guideline and ASCO/CAP HER2 testing guideline (Wolff et al. 2018)

    Background

    Phesgo is a fixed‑dose subcutaneous combination product containing pertuzumab, trastuzumab, and hyaluronidase indicated for treatment of HER2‑positive breast cancer in neoadjuvant, adjuvant, and metastatic settings as specified in this policy. It is administered subcutaneously by a healthcare professional (typically in the thigh) and should not be given intravenously; dosing and administration details, including initial and maintenance dose rules, are provided in the Dosage and Quantity Limits sections.

    Policy Revision History

    2026-06-01Policy reviewLatest

    Policy underwent routine review (last_review date updated).

    Policy Summary
    Payermoda_health_plan_inc
    PolicyPhesgo (pertuzumab, trastuzumab and hyaluronidase-zzxf) — subcutaneous
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Last ReviewJun 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization for Phesgo; initial approvals are valid 6 months and may be renewed every 6 months (neoadjuvant/adjuvant up to 1 year).
    SourceLink
    On This Page
    Coverage and Medical Necessity CriteriaCoding, Codes and Quantity LimitsProvider Requirements, Prior Authorization and DocumentationInitial Dosing and Administration CriteriaContinuation and Maintenance TherapyStep Therapy RequirementsAdministration Site and Medicare NotesDefinitions and Evidence SourcesBackgroundPolicy Revision History
    LVEF thresholds:
    LVEF obtained within the previous 3 months meets criteria: for neoadjuvant/adjuvant LVEF ≥ 50% or absolute decrease < 10% from baseline; for all other indications LVEF > 45% or 40–45% with absolute decrease < 10% from baseline

    LVEF must be obtained within previous 3 months

    Phesgo quantity limits
    Phesgo — Initial quantity limit180 billable units per dose (initial administration)
    Phesgo — Maintenance quantity limit120 billable units every 21 days for maintenance dosing
    Billing unitLimits expressed in HCPCS billable units (1 unit = 10 mg); use J9316 for billing per 10 mg

    Use of Phesgo beyond fourth-line therapy is restricted; continuation beyond fourth-line requires documentation that the member has a contraindication or intolerance to lapatinib/capecitabine or to a regimen containing trastuzumab hyaluronidase plus a generically available agent.

    • Refer to NCCN Breast Cancer guidelines for acceptable alternative regimens.
    Note

    Provide clinical rationale for utilization review/prior authorization

    When submitting requests, include documentation supporting the choice of Phesgo and relevant clinical context (indication, prior therapies, contraindications/intolerances) so utilization review can assess benefit duration and extent consistent with policy criteria.

    • Document prior therapy history and rationale if seeking use beyond fourth‑line.
    • Ensure indication aligns with covered settings (neoadjuvant, adjuvant, metastatic, etc.).
    Documentation Required

    Submit HER2 test results and LVEF data

    Required clinical documentation must include evidence of HER2‑positive disease determined by an FDA‑approved or CLIA‑compliant test and left ventricular ejection fraction (LVEF) data as specified for initiation and renewal.

    • Include the HER2 test type and result (IHC/ISH per policy definitions).
    • Provide baseline LVEF and follow‑up LVEF measurements as required for renewal (within previous 3 months).
    Note

    Follow CMS/NCD/LCD/LCA requirements for Medicare Part B

    For Medicare Part B members, coverage determinations are governed by CMS manuals and any applicable NCDs, LCDs, or LCAs; comply with those Medicare policies where applicable.

    • Use the CMS Medicare Coverage Database to identify applicable NCD/LCD/LCA guidance.
    Denial Risk

    Excluded: indications not specified in policy

    Uses not listed in the policy’s approved indications, or those with inadequate data to support efficacy, are excluded from prior authorization validity and will not be approved.

    Denial Risk

    PA and utilization review may restrict benefit duration/extent

    Utilization review methods such as prior authorization may limit how long or to what extent benefits are provided; factors considered for PA include indication, safety and efficacy, and drug cost.

    • PA may be applied comparably across MH/SUD and M/S drugs as noted in the NQTL appendix.
    Maintenance quantity limit: Maintenance dose: 600 mg pertuzumab / 600 mg trastuzumab / 20,000 units hyaluronidase subcutaneously every 3 weeks until disease progression or unacceptable toxicity

    Maintenance dose maximum: 120 billable units every 21 days

    Additional referencesPHranceSCa preference study and other supportive literature listed in Standard and Enhanced reference sections