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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsHealth Net Itovebi coverage & prior auth | OpenPay…
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    CurrentHealth NetPolicy CP PHAR.702

    Clinical Policy: Inavolisib (Itovebi)

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    Defines medical necessity criteria, initial and continuation approval requirements, dosing limits, and coverage limitations for Inavolisib (Itovebi) in combination with palbociclib and fulvestrant for adults with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer; applies to Commercial, HIM, and Medicaid lines of business.

    Policy Summary
    PayerHealth Net
    PolicyClinical Policy: Inavolisib (Itovebi)
    Policy CodePolicy CP PHAR.702
    Change TypeInitial creation
    Effective DateDec 1, 2024
    Last ReviewNov 1, 2024
    Next Review Date
    Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.
    SourceLink
    POLICY UPDATE CHANGES

    Policy created 10.15.24 and effective 12.01.24 with criteria for Inavolisib (Itovebi) use in PIK3CA-mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer.

    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.

    1Covered Indications (FDA-approved combination)
    9 mg/dayStandard maximum daily dose
    6 moInitial approval duration
    12 moContinuation approval duration

    Coverage Summary

    Background: Itovebi (inavolisib) is indicated in combination with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence on or after completing adjuvant endocrine therapy. Scope: defines medical necessity criteria, initial and continuation approval requirements, dosing limits, and coverage limitations for Inavolisib (Itovebi) in combination with palbociclib and fulvestrant for PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer and applies to Commercial, HIM, and Medicaid lines of business. Coverage stance: covered_with_criteria with specified initial and continuation criteria and dose limits.

    Quick Facts / Key Thresholds
    Age requirement≥ 18 years
    Standard maximum daily dose9 mg per day (and not to exceed 2 tablets per day)
    Initial approval duration6 months
    Continuation approval duration12 months
    Prior exposure required for continuationAt least 30 days of Itovebi
    Strengths availableTablets: 3 mg and 9 mg

    Initial Therapy Criteria - Breast Cancer

    Initial Approval Criteria - Breast Cancer

    Covered when ALL of the following are met:

    ALL of the following

    • Diagnosis of breast cancer
    • Prescribed by or in consultation with an oncologist
    • Age ≥ 18 years

    • Disease characteristics (all required)

      • Hormone receptor (HR)-positive (estrogen or progesterone receptor [ER/PR]-positive)

    Initial Therapy Criteria - Other Indications

    Initial Approval Criteria - Other diagnoses/indications

    If the requested indication is not the primary breast cancer criteria, must meet one of:

    ANY of the following

    • For drugs on formulary/PDL: follow no coverage criteria policy for relevant line of business

      CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, CP.PMN.255 for Medicaid

    • For drugs not on formulary/PDL: follow non-formulary policy for relevant line of business

      CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, CP.PMN.16 for Medicaid

    • If requested use (diagnosis, age, dosing) is not listed and criterion above does not apply, refer to off-label use policy for relevant line of business

      CP.CPA.09 commercial, HIM.PA.154 marketplace, CP.PMN.53 Medicaid

    Continuation Therapy Criteria - Breast Cancer

    Continuation Therapy - Breast Cancer

    Covered when ALL of the following are met:

    ALL of the following

    • Member is currently receiving medication via Centene benefit; OR documentation supports member has been receiving Itovebi for breast cancer and has received it for at least 30 days
    • Member is responding positively to therapy
    • Member must use inavolisib (Itovebi), if available, unless contraindicated or clinically significant adverse effects are experienced

    • Dose increase requests (one of)

      • New dose does not exceed both of the following: 9 mg per day

    Continuation Therapy Criteria - Other Indications

    Continuation Therapy - Other diagnoses/indications

    If continuation for other indications, must meet one of:

    ANY of the following

    • For drugs on formulary/PDL: follow no coverage criteria policy for relevant line of business

      CP.CPA.190 for commercial, HIM.PA.33 marketplace, CP.PMN.255 Medicaid

    • For drugs not on formulary/PDL: follow non-formulary policy for relevant line of business

      CP.CPA.190 for commercial, HIM.PA.103 marketplace, CP.PMN.16 Medicaid

    • If requested use not listed and criterion above does not apply, refer to off-label use policy

      CP.CPA.09 commercial, HIM.PA.154 marketplace, CP.PMN.53 Medicaid

    Diagnoses / Indications Not Authorized

    Diagnoses/Indications Not Authorized

    Not covered unless exceptions per off-label policies apply:

    Non‑FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety according to the off-label use policies or evidence of coverage documents

    CP.CPA.09 commercial, HIM.PA.154 marketplace, CP.PMN.53 Medicaid

    Provider Actions & Authorization Requirements

    Prior Authorization

    Documentation submission required

    Provider must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, laboratory results, or other clinical information demonstrating that the member meets all approval criteria (diagnosis, PIK3CA mutation status, prior endocrine therapy history, concurrent palbociclib and fulvestrant use, menopausal/ovarian suppression status when applicable, and dosing).

    • Office chart notes
    • Laboratory results (including PIK3CA test results)
    • Other clinical information demonstrating prior endocrine therapy and current regimen
    Prior Authorization

    Prescriber specialty requirement

    Itovebi must be prescribed by or in consultation with an oncologist. Include evidence of the prescribing or consulting oncologist when submitting the request.

    Applicable Codes

    Drug Availability / StrengthsNDC
    Tablets: 3 mgInavolisib tablet strength available
    Tablets: 9 mgInavolisib tablet strength available

    Clinical Evidence & Guideline Sources

    Evidence: FDA Prescribing Information — Itovebi Prescribing Information, Genentech, October 2024; and NCCN Breast Cancer Version 5.2024 referenced for regimen recommendations.

    Definitions

    Definitions: HR = Hormone receptor (estrogen or progesterone receptor); HER2 = Human epidermal growth factor receptor 2; PIK3CA = Phosphatidylinositol 3-kinase catalytic subunit alpha; LHRH = Luteinizing hormone-releasing hormone.

    Revision History

    10.15.24creation

    Policy created 10.15.24 and effective 12.01.24 with criteria for Inavolisib (Itovebi) use in PIK3CA-mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer.

    12.01.24effective_dateLatest

    Policy effective 12.01.24 establishing coverage criteria: Itovebi indicated in combination with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence on or after completing adjuvant endocrine therapy; initial approval criteria, continuation criteria, age and dosing thresholds (≥18 years; max 9 mg/day and ≤2 tablets/day), and approval durations (initial 6 months; continuation 12 months).

    Policy Summary
    PayerHealth Net
    PolicyClinical Policy: Inavolisib (Itovebi)
    Policy CodePolicy CP PHAR.702
    Change TypeInitial creation
    Effective DateDec 1, 2024
    Last ReviewNov 1, 2024
    Next Review Date
    Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.
    SourceLink
    On This Page
    Coverage SummaryInitial Therapy Criteria - Breast CancerInitial Therapy Criteria - Other IndicationsContinuation Therapy Criteria - Breast CancerContinuation Therapy Criteria - Other IndicationsDiagnoses / Indications Not AuthorizedProvider Actions & Authorization RequirementsApplicable CodesClinical Evidence & Guideline SourcesDefinitionsRevision History
    HER2-negative
  1. Locally advanced or metastatic disease
  2. Positive for PIK3CA mutation (as detected by an FDA-approved test)
  3. Itovebi is prescribed in combination with palbociclib and fulvestrant
  4. Disease progression or recurrence on or after adjuvant endocrine therapy

    See Appendix B

  5. If member is premenopausal or perimenopausal female, member has been treated with ovarian ablation or is receiving ovarian suppression

    See Appendix D

  6. Member must use inavolisib (Itovebi), if available, unless contraindicated or clinically significant adverse effects are experienced

  7. Dose requirements (one of)

    • Prescribed dose is 9 mg per day9 mg/day
    • Prescribed regimen is FDA-approved or recommended by NCCN
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
    8. 9 mg/day
  8. New dose does not exceed both of the following: 2 tablets per day2 tablets/day
  9. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
  10. Prescribed regimen must be FDA-approved or recommended by NCCN
    11. Documentation Required

    PIK3CA mutation documentation

    Prescriber must provide evidence that the tumor is PIK3CA-mutated as detected by an FDA‑approved test. Submit the PIK3CA test report or laboratory documentation with the request.

    • FDA‑approved PIK3CA test report
    Documentation Required

    Ovarian suppression documentation for pre/perimenopausal females

    For premenopausal or perimenopausal females, document ovarian ablation or ongoing ovarian suppression (for example, an LHRH agonist such as goserelin or leuprolide) when applicable. Include surgical, radiation, or pharmacologic ovarian suppression records per NCCN recommendations.

    • Surgical oophorectomy or ovarian irradiation record (if ablation)
    • Documentation of LHRH agonist therapy (e.g., goserelin, leuprolide) if using ovarian suppression
    Billing Rule

    Dose limit enforcement

    Approvals are limited to doses that do not exceed both 9 mg per day and 2 tablets per day. If requesting doses outside these limits (initial or dose increase), the prescriber must submit supporting evidence from practice guidelines (e.g., NCCN) or peer‑reviewed literature to justify the higher dose.

    • Maximum allowed: ≤9 mg/day
    • Maximum allowed: ≤2 tablets/day
    • Prescriber must justify any dose outside these limits with guideline or literature support