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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty Drugsmoda_health_plan_inc Portrazza Coverage & Prior Au…
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    Currentmoda_health_plan_incPolicy IC-0475

    Portrazza (necitumumab) (Intravenous) Coverage Criteria

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    Defines prior authorization, dosing, coverage criteria, and billing for necitumumab (Portrazza) used for first-line treatment of metastatic squamous non-small cell lung cancer in adult patients.

    Policy Summary
    Payermoda_health_plan_inc
    PolicyPortrazza (necitumumab) (Intravenous) Coverage Criteria
    Policy CodePolicy IC-0475
    Change TypeNo material changes
    Effective DateJul 1, 2025
    Last ReviewSep 4, 2025
    Next Review DateJul 1, 2025
    Key ActionObtain prior authorization for initial coverage (approved for 6 months, renewable every 6 months).
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    800 mgper dose (Days 1 & 8 of each cycle)
    1600max billable units/21 days
    6 monthsinitial prior auth
    ≥18minimum age

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    Coverage Criteria

    Initial Therapy

    Covered when ALL of the following are met:

    Initial authorization requirements: Patient is at least 18 years of age; AND used as first-line therapy for metastatic disease; AND patient has squamous cell histology; AND used in combination with BOTH gemcitabine and cisplatin; AND use of necitumumab is restricted to patients with a contraindication or intolerance to a generically available regimen (e.g., carboplatin/docetaxel).

    Continuation Therapy

    Authorization renewal may be granted when ALL of the following are met:

    Renewal requirements: Patient continues to meet indication-specific relevant criteria (including concomitant therapy requirements and performance status as identified in initial criteria); AND disease response demonstrated by stabilization of disease or decrease in tumor size or spread; AND absence of unacceptable toxicity from necitumumab (examples include cardiopulmonary arrest, hypomagnesemia, severe dermatologic toxicity, severe infusion reactions, venous/arterial thromboembolic events).

    Coverage for necitumumab (Portrazza) is limited to use as first-line therapy for metastatic disease in adults and only when the agent is administered in combination with both gemcitabine and cisplatin. Requests for use outside these parameters — for example, as later-line therapy, in non‑metastatic settings, or without the specified combination chemotherapy — do not meet the indication criteria and may be denied. Additionally, necitumumab is reserved for patients who have a documented contraindication or intolerance to a generically available regimen (e.g., carboplatin/docetaxel) when such alternatives would otherwise be appropriate; NCCN guideline recommendations are considered when assessing alternative regimens.

    Necitumumab is not covered for patients with non‑squamous histology, for use outside the first‑line metastatic treatment setting, or when it would be given without the required combination of gemcitabine and cisplatin unless a documented contraindication or intolerance to appropriate generic alternatives exists. If a generic, guideline‑recommended regimen is appropriate and no contraindication is documented, the request is considered not medically necessary.

    Initial Therapy & Dosing

    Initial Therapy & Dosing

    Initial dosing and eligibility:

    Initial dosing and eligibility: Patient aged ≥18 years; metastatic squamous non-small cell lung cancer; intended as first-line systemic therapy; necitumumab administered in combination with gemcitabine and cisplatin; reserved for patients with contraindication or intolerance to generically available regimens when applicable; dosing 800 mg IV on Days 1 and 8 of each 3-week cycle prior to gemcitabine and cisplatin infusion, continued until disease progression or unacceptable toxicity.

    Continuation / Renewal Criteria

    Renewal

    Renewal requires ongoing benefit and tolerability:

    Renewal: Continued meeting of indication-specific criteria (including concomitant therapy requirements); documented disease stabilization or tumor reduction (stabilization of disease or decrease in size of tumor or tumor spread); and absence of unacceptable toxicity to necitumumab (examples: cardiopulmonary arrest, hypomagnesemia, severe dermatologic toxicity, severe infusion reactions, venous/arterial thromboembolic events).

    Coding and Billing

    Covered HCPCS CodesHCPCSCovered
    J9295Injection, necitumumab, 1 mg; 1 billable unit = 1 mg
    NDCNDC
    00002-7716-xxPortrazza 800 mg/50 mL single-dose vial NDC
    Covered ICD-10 Diagnosis CodesICD-10Covered
    C33Malignant neoplasm of trachea
    C34.00Malignant neoplasm of unspecified main bronchus
    C34.01Malignant neoplasm of right main bronchus
    C34.02Malignant neoplasm of left main bronchus
    C34.10Malignant neoplasm of upper lobe, unspecified bronchus or lung
    C34.11Malignant neoplasm of upper lobe, right bronchus or lung
    C34.12Malignant neoplasm of upper lobe, left bronchus or lung
    C34.2Malignant neoplasm of middle lobe, bronchus or lung
    C34.30Malignant neoplasm of lower lobe, unspecified bronchus or lung
    C34.31Malignant neoplasm of lower lobe, right bronchus or lung
    1–10 of 18
    1/2
    HCPCS unit maximum
    HCPCS unit maximum1600 billable units every 21 days (1 unit = 1 mg)
    Per-dose equivalencePolicy defines 1 billable HCPCS unit = 1 mg (J9295)
    Billing intervalLimit applies to each 21-day treatment cycle (q3 weeks)

    Provider Actions & Documentation

    Prior Authorization

    Prior authorization length and renewals

    Prior authorization is required. Initial prior authorization validity will be provided for 6 months; renewals may be granted every 6 months thereafter.

    Step Therapy

    Prerequisite therapy / alternatives required

    Necitumumab is reserved for use only after documenting a contraindication or intolerance to a generically available regimen (for example, carboplatin/docetaxel) when those alternatives would otherwise be appropriate.

    • Use must be first‑line for metastatic disease and in combination with both gemcitabine and cisplatin (prerequisite alternatives apply when appropriate).
    • Refer to NCCN NSCLC guidelines for the complete list of alternative regimens.
    Documentation Required

    Required supporting documentation

    Medical records must document the specific clinical elements that support coverage: patient age (≥18), squamous histology, metastatic first‑line intent, use in combination with gemcitabine and cisplatin, and when applicable documentation of contraindication or intolerance to generically available regimens; dosing and response/tolerability data are required for renewals.

    • Initial documentation: patient age ≥18; squamous NSCLC histology; first‑line metastatic intent; planned combination with gemcitabine and cisplatin; documented contraindication/intolerance to generic alternatives when applicable.
    • Dosing: 800 mg IV on Days 1 and 8 of each 3‑week cycle (administer prior to gemcitabine and cisplatin).
    • Renewal documentation: evidence of disease stabilization or tumor decrease and absence of unacceptable toxicity.
    Denial Risk

    Denial triggers for incomplete or non‑qualifying requests

    Requests missing indication‑specific criteria or the required contraindication/intolerance documentation may be denied.

    • Use in non‑squamous histology or outside the first‑line metastatic setting is a denial trigger.
    • Use without combination with both gemcitabine and cisplatin (when alternatives are appropriate) can lead to denial.
    • Failure to document contraindication or intolerance to generically available regimens when those alternatives apply may result in denial.

    Step Therapy

    StepRequirement
    1Necitumumab is reserved for patients with a documented contraindication or intolerance to a generically available regimen (e.g., carboplatin/docetaxel) when such alternatives would otherwise be appropriate.

    Quantity Limits

    necitumumab (Portrazza) — quantity limit (HCPCS units)
    Quantity limit (HCPCS units)1600 billable units per 21 days
    HCPCS code to billJ9295 — Injection, necitumumab, 1 mg (1 billable unit = 1 mg)
    Dose correspondenceStandard dosing is 800 mg IV on Days 1 and 8 of each 21-day cycle (total 1600 mg per cycle)

    Site of Care

    Note

    Infusion center administration and sequencing

    Administer necitumumab 800 mg IV on Days 1 and 8 of each 3‑week cycle prior to gemcitabine and cisplatin infusion; site of care is the infusion center and is not further restricted.

    • Continue treatment until disease progression or unacceptable toxicity.
    • Ensure dosing is given prior to gemcitabine and cisplatin as specified.

    Background

    Portrazza (necitumumab) is an intravenous monoclonal antibody indicated under this policy as part of initial systemic therapy for metastatic squamous non‑small cell lung cancer. Use is limited to adults and must be given in combination with gemcitabine and cisplatin; coverage is further restricted to patients with documented contraindication or intolerance to generically available alternative regimens when those alternatives would otherwise be appropriate. Renewal of authorization requires evidence of ongoing benefit (disease stabilization or tumor reduction) and acceptable tolerability.

    Definitions

    First-line therapy (metastatic squamous NSCLC) definition
    DefinitionAdministration of necitumumab in combination with gemcitabine and cisplatin as initial systemic therapy for metastatic squamous non-small cell lung cancer.
    Required combinationMust be used in combination with BOTH gemcitabine and cisplatin
    Patient populationAdults (≥18 years) with metastatic disease and squamous cell histology
    First-line intentUsed as initial (first-line) therapy for metastatic disease — not for later-line use
    Policy Summary
    Payermoda_health_plan_inc
    PolicyPortrazza (necitumumab) (Intravenous) Coverage Criteria
    Policy CodePolicy IC-0475
    Change TypeNo material changes
    Effective DateJul 1, 2025
    Last ReviewSep 4, 2025
    Next Review DateJul 1, 2025
    Key ActionObtain prior authorization for initial coverage (approved for 6 months, renewable every 6 months).
    SourceLink
    On This Page
    Coverage CriteriaInitial Therapy & DosingContinuation / Renewal CriteriaCoding and BillingProvider Actions & DocumentationStep TherapyQuantity LimitsSite of CareBackgroundDefinitions