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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsClover Health Rybrevant Faspro Coverage | OpenPaye…
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    CurrentClover HealthPolicy 7331-A

    Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) Coverage Criteria

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    Medicare Part B prior authorization and coverage for Rybrevant Faspro in adults with advanced, recurrent, or metastatic NSCLC, including specified EGFR mutation-positive disease and combination regimens.

    Policy Summary
    PayerClover Health
    PolicyRybrevant Faspro (amivantamab and hyaluronidase-lpuj) Coverage Criteria
    Policy CodePolicy 7331-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionDocument applicable EGFR exon 20 insertion, exon 19 deletion, or exon 21 L858R mutation results for initial requests.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 monthsAuthorization duration
    4FDA-approved pathways
    4Compendial uses
    2Mutation categories requiring testing

    Covered Treatment Pathways

    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.

    First-line EGFR exon 20 insertion NSCLC

    Authorization of 12 months may be granted when all criteria in this pathway are met.

    • Disease setting: Advanced, recurrent, or metastatic nonsquamous NSCLC
    • Molecular criterion: EGFR exon 20 insertion mutation-positive disease
    • Regimen: Rybrevant Faspro used in combination with carboplatin and pemetrexed

    EGFR exon 19 or L858R with lazertinib

    Authorization of 12 months may be granted when all criteria in this pathway are met.

    EGFR exon 19 deletion or exon 21 L858R NSCLC with lazertinib

    • Disease and molecular criterion: Advanced, recurrent, or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutation-positive disease
    • Regimen: Rybrevant Faspro used in combination with lazertinib (Lazcluze)

    Subsequent treatment pathways

    Authorization of 12 months may be granted for subsequent treatment when either pathway is satisfied.

    Subsequent NSCLC treatment pathways

    • EGFR exon 20 insertion pathway

      • Disease and molecular criterion: Advanced, recurrent, or metastatic NSCLC with EGFR exon 20 insertion mutation-positive disease
      • Prior treatment: Disease has progressed on or after platinum-based chemotherapy
      • Regimen: Rybrevant Faspro used as a single agent

    • EGFR exon 19 deletion or exon 21 L858R pathway

    Authorization and Documentation Requirements

    Prior Authorization

    First-Line EGFR Exon 20 Insertion Regimen

    Prior authorization may be granted for 12 months for first-line treatment of advanced, recurrent, or metastatic nonsquamous NSCLC with EGFR exon 20 insertion mutations when Rybrevant Faspro is used in combination with carboplatin and pemetrexed.

    • Document advanced, recurrent, or metastatic nonsquamous NSCLC.
    • Document EGFR exon 20 insertion mutation-positive disease.
    • Confirm combination use with carboplatin and pemetrexed.
    Prior Authorization

    EGFR Exon 19 or L858R With Lazertinib

    Prior authorization may be granted for 12 months for advanced, recurrent, or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutation-positive disease when Rybrevant Faspro is used in combination with lazertinib (Lazcluze).

    • Document advanced, recurrent, or metastatic NSCLC.
    • Document EGFR exon 19 deletion or exon 21 L858R substitution mutation-positive disease.
    • Confirm combination use with lazertinib (Lazcluze).
    Prior Authorization

    Subsequent EGFR Exon 20 Insertion Therapy

    Prior authorization may be granted for 12 months for subsequent treatment of advanced, recurrent, or metastatic NSCLC with EGFR exon 20 insertion mutation-positive disease when the disease has progressed on or after platinum-based chemotherapy and Rybrevant Faspro will be used as a single agent.

    • Document disease progression on or after platinum-based chemotherapy.
    • Confirm Rybrevant Faspro will be used as monotherapy.
    Prior Authorization

    Subsequent EGFR Exon 19 or L858R Therapy

    Prior authorization may be granted for 12 months for subsequent treatment of advanced, recurrent, or metastatic nonsquamous NSCLC with EGFR exon 19 deletion or exon 21 L858R mutations when disease has progressed on or after Tagrisso (osimertinib) and Rybrevant Faspro will be used in combination with carboplatin and pemetrexed.

    • Document nonsquamous NSCLC with EGFR exon 19 deletion or exon 21 L858R mutations.
    • Document disease progression on or after Tagrisso (osimertinib).
    • Confirm combination use with carboplatin and pemetrexed.
    Documentation Required

    Document EGFR Mutation Test Results

    For all initial requests, make the applicable mutation test results available upon request.

    • EGFR exon 20 insertion mutation test results, where applicable.
    • EGFR exon 19 deletion or exon 21 L858R mutation test results, where applicable.
    Denial Risk

    Indication or Regimen Outside Criteria

    Coverage applies only when the requested use meets the applicable FDA-approved or compendial criteria and the member has no exclusions to the prescribed therapy. Requests for an indication, disease setting, mutation status, combination, or treatment sequence outside the stated criteria may be denied.

    • Confirm the indication is advanced, recurrent, or metastatic NSCLC as applicable.
    • Confirm the required EGFR mutation and regimen criteria are met.
    • Confirm no exclusions to the prescribed therapy.
    Denial Risk

    Required Mutation Testing Not Documented

    Required EGFR mutation documentation must be available for all initial requests. Missing or unavailable results may delay review or result in denial when mutation testing is required for the requested regimen.

    • Provide EGFR exon 20 insertion mutation results when applicable.
    • Provide EGFR exon 19 deletion or exon 21 L858R mutation results when applicable.
    Prior Authorization

    Continuation Requires Ongoing Clinical Benefit

    For continuation requests, authorization may be granted for 12 months when the member is currently receiving Rybrevant Faspro for NSCLC and is receiving clinical benefit. Benefit requires no unacceptable toxicity; for the general NSCLC continuation criterion, there must also be no evidence of disease progression on the current regimen.

    • The member is currently receiving the requested medication.
    • The medication is being used to treat NSCLC.
    • For general NSCLC continuation: document no unacceptable toxicity and no evidence of disease progression on the current regimen.
    • For continuation in combination with lazertinib (Lazcluze): confirm the member is receiving the combination for NSCLC and has no evidence of unacceptable toxicity on the current regimen.

    Policy Background

    Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) is covered for selected adults with locally advanced, recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC) involving specified EGFR mutations. The policy distinguishes first-line from subsequent treatment and requires the applicable disease setting, mutation status, treatment regimen, and prior-therapy criteria.

    Initial Therapy

    Initial NSCLC therapy

    Authorization of 12 months may be granted when one of the applicable initial-treatment pathways is met.

    Initial NSCLC treatment pathways

    • EGFR exon 20 insertion pathway: The member has advanced, recurrent, or metastatic nonsquamous NSCLC with EGFR exon 20 insertion mutation-positive disease, and Rybrevant Faspro will be used in combination with carboplatin and pemetrexed.
    • EGFR exon 19 deletion or exon 21 L858R pathway: The member has advanced, recurrent, or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutation-positive disease, and Rybrevant Faspro will be used in combination with lazertinib (Lazcluze).

    Continuation Therapy

    General continuation therapy

    Authorization of 12 months may be granted for continuing therapy when all criteria are met.

    General NSCLC continuation

    • Current therapy: The member is currently receiving therapy with Rybrevant Faspro
    • Indication: Rybrevant Faspro is being used to treat non-small cell lung cancer (NSCLC)

    • Clinical benefit

      • No unacceptable toxicity: No evidence of unacceptable toxicity while on the current regimen
      • No disease progression: No evidence of disease progression while on the current regimen

    Continuation with lazertinib

    Authorization of 12 months may be granted for continuing combination therapy when all criteria are met.

    Lazertinib combination continuation

    • Current combination therapy: The member is currently receiving therapy with Rybrevant Faspro in combination with lazertinib (Lazcluze)
    • Indication: Rybrevant Faspro is being used to treat NSCLC
    • Clinical benefit: The member is receiving benefit from therapy, defined as no evidence of unacceptable toxicity while on the current regimen
    Policy Summary
    PayerClover Health
    PolicyRybrevant Faspro (amivantamab and hyaluronidase-lpuj) Coverage Criteria
    Policy CodePolicy 7331-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionDocument applicable EGFR exon 20 insertion, exon 19 deletion, or exon 21 L858R mutation results for initial requests.
    SourceLink
    On This Page
    Covered Treatment PathwaysAuthorization and Documentation RequirementsPolicy BackgroundInitial TherapyContinuation Therapy
    Disease and molecular criterion: Advanced, recurrent, or metastatic nonsquamous NSCLC with EGFR exon 19 deletion or exon 21 L858R mutations
  1. Prior treatment: Disease has progressed on or after treatment with Tagrisso (osimertinib)
  2. Regimen: Rybrevant Faspro used in combination with carboplatin and pemetrexed