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    v1.0.28
    OpenPayerPolicy UpdatesReimbursement/Payment PolicyAloha Care Phesgo Coverage Prior Auth | OpenPayer
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    CurrentAloha CarePolicy N/A

    Phesgo (pertuzumab-trastuzumab-hyaluronidase-zzxf) coverage

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    This policy defines medical benefit coverage, authorization, dosing, and Medicare Part B rules for Phesgo (pertuzumab-trastuzumab-hyaluronidase-zzxf) for AlohaCare Medicaid and Medicare members.

    Policy Summary
    PayerAloha Care
    PolicyPhesgo (pertuzumab-trastuzumab-hyaluronidase-zzxf) coverage
    Policy CodePolicy N/A
    Change TypeNew policy (created 9/19/23)
    Effective DateOct 1, 2020
    Last ReviewSep 19, 2023
    Next Review DateN/A
    Key ActionMedical benefit requires prior authorization; pharmacy benefit refer to Drug Finder and Carelon PA criteria.
    SourceLink
    POLICY UPDATE CHANGES

    Policy created (New).

    J9316HCPCS code for Phesgo
    Initial 3m / Reauth 12mDuration of approval
    Initial IM doseFDA initial dosing
    Maintenance q3wFDA maintenance dosing
    Medicaid & Medicare

    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.

    Plans covered

    Coverage Criteria and Medicare Rules

    Coverage Criteria Set

    Coverage and Medicare Part B-specific rules and general coverage criteria for Phesgo.

    Review using the most current Local Coverage Determination (LCD), National Coverage Determination (NCD), or Local Coverage Article (LCA) that applies to the Hawaii region; if none found, apply the General Coverage Criteria below.

    Medicare Part B transitional rule

    • For new Medicare members, a 90-day transition period applies during which an active course of the requested treatment is continued without applying Coverage and Step Therapy; after 90 days Coverage and Step Therapy Criteria must be met.
    Step therapy: For new starts, Medicare Part B Step Therapy Criteria must be met in addition to Coverage Criteria before a request may be approved; currently no step therapy is specified.

    Initial Therapy — Medical Necessity Criteria

    INITIAL THERAPY CRITERIA

    Covered when ALL of the following are met:

    Diagnosis of HER2-positive breast cancer (IHC 3+ or ISH positive).
    Use of Phesgo consistent with an FDA-indicated regimen: initial IM dosing as specified below.

    Initial dosing

    • Initial IM dose: 1,200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase in 15 mL.

    Authorization

    • Initial authorization duration: 3 months for the initial request.
    Benefit assignment: Medical benefit requires prior authorization (HCPCS J9316).

    Continuation Therapy and Reauthorization

    CONTINUATION CRITERIA

    Continuation and transition rules for ongoing therapy:

    During the first 90 days after Medicare enrollment, members on an active course may continue Phesgo without applying Coverage and Step Therapy; after 90 days, Coverage and Step Therapy Criteria must be met for continued coverage.

    Maintenance dosing

    • Maintenance IM dose: 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase every 3 weeks; continue until disease progression for metastatic disease when used after initial combination therapy with docetaxel or as monotherapy post-docetaxel discontinuation.

    Authorization duration for continuation

    • Continuation of care/Reauthorization duration: 12 months (per policy thresholds for reauthorization).

    Billing Codes, Authorization Duration, and Quantity Limits

    HCPCSHCPCSCovered
    J9316Injection pertuzumab, trastuzumab, and hyaluronidase-zzxf 10 mg (Phesgo)
    Related oncology HCPCSHCPCS
    J9171Docetaxel (mentioned as combination option)
    J9306Intravenous pertuzumab (referenced as alternative IV product)
    J9355Intravenous trastuzumab (referenced as alternative IV product)
    Authorization duration
    Initial approval durationInitial request: 3 months
    Continuation of care / ReauthorizationCOC/Reauthorization: 12 months
    Benefit assignmentMedical Benefit: Authorization Required; Pharmacy Benefit: refer to Drug Finder and Carelon PA criteria
    Phesgo — dosing reference and quantity limits
    HCPCS codeJ9316 — Injection pertuzumab, trastuzumab, and hyaluronidase-zzxf 10 mg (Phesgo)
    How supplied / vial strengthsPhesgo 1,200 mg / 600 mg / 30,000 unit per 15 mL SDV; 600 mg / 600 mg / 20,000 unit per 10 mL SDV

    Provider Actions, Medicare Part B Notes, and Billing Guidance

    Prior Authorization

    Authorization and benefit assignment — prior authorization required

    Medical benefit administration of Phesgo requires prior authorization; pharmacy benefit requests should be directed to the Drug Finder and follow Carelon PA criteria. Initial authorization is granted for 3 months; continuation/COC or reauthorization requests are for 12 months. Refer to HCPCS J9316 for billing the product and to dosing guidance for quantity limits.

    • Medical Benefit: Authorization Required.
    • Pharmacy Benefit: Refer to Drug Finder, use Carelon PA criteria.
    • Authorization duration — Initial Request: 3 months; COC/Reauthorization: 12 months.
    • Quantity limits: See dosing information; bill using HCPCS J9316.
    Documentation Required

    Medicare Part B transitional and coverage review

    Follow the most current LCD/NCD/LCA that applies to the Hawaii region when reviewing Medicare Part B requests; if no applicable LCD/NCD/LCA exists, apply the policy's general coverage criteria. For new Medicare members, a 90-day transition period applies during which active ongoing treatment continues and Coverage and Step Therapy do not apply; after 90 days, the Coverage and Step Therapy criteria must be met for continued coverage.

    Administration Site and Billing Considerations

    Billing Rule

    Infusion center: medical-benefit administration and billing

    Phesgo administered in an infusion/clinic setting is billed under HCPCS J9316 and is considered medical-benefit IM administration; ensure dosing and billing align with J9316.

    • Bill administration/medication using HCPCS code J9316 (Injection pertuzumab, trastuzumab, and hyaluronidase-zzxf 10 mg).
    • Follow the policy dosing guidance for IM administration when billing the medical benefit.

    Dosing Definitions

    Initial IM dose
    Initial IM dose (FDA)1,200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase in 15 mL
    RouteSubcutaneous (IM) administration as supplied
    Indication contextFor HER2-positive breast cancer per FDA labeling
    Maintenance IM dose
    Maintenance IM dose (FDA)Every 3 weeks: 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase
    Dosing intervalEvery 3 weeks (q3w)
    Use in continuation therapy

    Step Therapy Requirements

    StepRequirement
    1No step therapy specified; for new starts Medicare Part B step therapy criteria must be met in addition to Coverage Criteria before approval.
    Policy Summary
    PayerAloha Care
    PolicyPhesgo (pertuzumab-trastuzumab-hyaluronidase-zzxf) coverage
    Policy CodePolicy N/A
    Change TypeNew policy (created 9/19/23)
    Effective DateOct 1, 2020
    Last ReviewSep 19, 2023
    Next Review DateN/A
    Key ActionMedical benefit requires prior authorization; pharmacy benefit refer to Drug Finder and Carelon PA criteria.
    SourceLink
    On This Page
    Coverage Criteria and Medicare RulesInitial Therapy — Medical Necessity CriteriaContinuation Therapy and ReauthorizationBilling Codes, Authorization Duration, and Quantity LimitsProvider Actions, Medicare Part B Notes, and Billing GuidanceAdministration Site and Billing ConsiderationsDosing DefinitionsStep Therapy Requirements
    If member was transitioned from IV pertuzumab/trastuzumab, therapy may continue under the coverage criteria when Phesgo is serving as the substitute for the IV combination (J9306 + J9355).
    Quantity limits guidanceQuantity limits: see dosing information (follow FDA dosing for initial and maintenance IM doses)
    • Review using current LCD/NCD/LCA for Hawaii; if none, use General Coverage Criteria.
    • New Medicare members: 90-day transition where active course continues without applying Coverage and Step Therapy; thereafter criteria apply.
    Continue q3w maintenance until disease progression or per treatment plan