CurrentCentenePolicy CP PHAR.702

Clinical Policy: Inavolisib (Itovebi)

Defines medical necessity and prior authorization criteria for inavolisib (Itovebi) use in combination with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA‑mutated, HR‑positive, HER2‑negative locally advanced or metastatic breast cancer; applies to Centene lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerCentene

PolicyClinical Policy: Inavolisib (Itovebi)

Policy CodePolicy CP PHAR.702

Change TypeNo material changes

Effective DateDec 1, 2024

Next Review Date

Key ActionPrior authorization is required and providers must submit documentation that all initial approval criteria are met for Itovebi in combination with palbociclib and fulvestrant.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

9 mgspecified daily dose

2max tablets/day

6 moinitial approval

12 mocontinuation approval

3 mg, 9 mgavailable strengths

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Coverage Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met

Initial Approval - Breast Cancer: 1) Diagnosis of breast cancer; 2) Prescribed by or in consultation with an oncologist; 3) Age >= 18 years; 4) Disease has ALL of the following characteristics: a) HR-positive (estrogen or progesterone receptor [ER/PR]-positive); b) HER2-negative; c) Locally advanced or metastatic disease; d) Positive for PIK3CA mutation; 5) Itovebi is prescribed in combination with palbociclib and fulvestrant; 6) Disease progression or recurrence on or after adjuvant endocrine therapy; 7) If premenopausal or perimenopausal female, treated with ovarian ablation or receiving ovarian suppression; 8) For Itovebi requests, member must use inavolisib if available unless contraindicated or clinically significant adverse effects are experienced; 9) Request meets one of the following dosing options: (a) 9 mg per day and dose does not exceed both of the following: i) 9 mg per day; ii) 2 tablets per day, and prescribed regimen must be FDA-approved or recommended by NCCN; OR (b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use with supporting evidence provided.

Approval duration: 6 months

inv-02: Continuation Therapy

Covered when ALL of the following are met

Continuation Therapy - Breast Cancer: 1) Currently receiving medication via Centene benefit OR documentation supports current Itovebi use for breast cancer with at least 30 days of therapy; 2) Member is responding positively to therapy; 3) If request is for a dose increase, the new dose must meet one of the following: (a) new dose does not exceed both: i) 9 mg per day; ii) 2 tablets per day; OR (b) new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use with supporting evidence provided; 4) For Itovebi requests, member must use inavolisib if available unless contraindicated or clinically significant adverse effects are experienced; 5) Prescribed regimen must be FDA-approved or recommended by NCCN or supported by practice guidelines/peer-reviewed literature for the indication.

Approval duration: 12 months

Requests for use of Inavolisib (Itovebi) for non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid).

Use of Itovebi for non‑FDA approved indications without adequate supporting evidence per the referenced off‑label policies is considered not authorized/not covered. Providers requesting coverage for off‑label uses must provide documentation meeting the requirements of the applicable off‑label policy to demonstrate sufficient evidence of efficacy and safety.

Initial Therapy

inv-15: Initial authorization criteria for Itovebi in combination with palbociclib and fulvestrant

Initial authorization criteria for Itovebi in combination with palbociclib and fulvestrant

Initial: 1) Diagnosis of breast cancer; 2) Prescribed by or in consultation with an oncologist; 3) Age >= 18 years; 4) Disease characteristics ALL: HR-positive (ER/PR-positive), HER2-negative, locally advanced or metastatic, and positive for PIK3CA mutation; 5) Itovebi prescribed in combination with palbociclib and fulvestrant; 6) Disease progression or recurrence on or after adjuvant endocrine therapy; 7) If premenopausal/perimenopausal female, treated with ovarian ablation or receiving ovarian suppression; 8) For Itovebi requests, use inavolisib if available unless contraindicated; 9) Dose criteria: either (a) 9 mg per day and does not exceed 2 tablets per day and prescribed regimen must be FDA-approved or recommended by NCCN OR (b) dose supported by practice guidelines or peer-reviewed literature for the relevant use (prescriber must submit supporting evidence).

Approval duration: 6 months

Continuation Therapy

inv-16: Criteria for continuation of Itovebi

Criteria for continuation of Itovebi

Continuation: 1) Member is currently receiving Itovebi via Centene benefit or documentation supports current use with at least 30 days of therapy; 2) Member is responding positively to therapy; 3) If request is for a dose increase, the new dose must either: (a) not exceed 9 mg per day and not exceed 2 tablets per day; OR (b) be supported by practice guidelines or peer-reviewed literature for the relevant use with supporting evidence submitted; 4) For Itovebi requests, use inavolisib if available unless contraindicated or clinically significant adverse effects are experienced; 5) Prescribed regimen must be FDA-approved or recommended by NCCN or supported by guidelines/literature with evidence.

Approval duration: 12 months

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Itovebi. Provider must submit documentation demonstrating that the member meets all initial approval criteria prior to initiation. Approval duration: 6 months.

Policy: CP PHAR.702
Affected product: Itovebi
Approval duration: 6 months

Documentation Required

Supportive Clinical Documentation

Provider must submit supportive clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, pathology reports, relevant lab results, genetic testing confirming PIK3CA mutation, treatment history (including prior endocrine therapies and CDK4/6 use), and consultation notes from the prescribing oncologist.

Include evidence of diagnosis (breast cancer) and disease stage (locally advanced or metastatic)
Document HER2-negative and HR-positive status and PIK3CA mutation
If premenopausal/perimenopausal, document ovarian suppression or ablation
Document prior endocrine therapy and progression or recurrence on/after adjuvant endocrine therapy
If requesting an off-label dose/regimen, submit supporting peer-reviewed literature or guideline recommendation

Denial Risk

Non‑FDA Indications / Off‑Label Requests

Non‑FDA indications for Itovebi may be denied unless sufficient documentation is provided per the applicable off‑label use policies. Providers should include rationale and supporting evidence when requesting coverage for non‑FDA approved uses.

Off‑label requests must follow policies: CP CPA.09 (commercial), HIM.PA.154 (Health Insurance Marketplace), CP PMN.53 (Medicaid)
Provide peer‑reviewed literature or guideline support for off‑label use

Definitions

inv-12: HR definition — hormone receptor (estrogen or progesterone receptor)

DefinitionHormone receptor (HR) = estrogen or progesterone receptor

Abbreviations in appendixER = estrogen receptor; PR = progesterone receptor

Clinical relevanceHR‑positive is required disease characteristic for coverage

inv-13: HER2 definition — human epidermal growth factor receptor 2

DefinitionHER2 = human epidermal growth factor receptor 2

Clinical relevanceHER2‑negative is required disease characteristic for coverage

Source noteListed in Appendix A abbreviation/acronym key

inv-14: PIK3CA definition — phosphatidylinositol 3-kinase catalytic subunit alpha

DefinitionPIK3CA = phosphatidylinositol 3-kinase catalytic subunit alpha

Clinical relevancePositive PIK3CA mutation is required for coverage

Appendix referenceTerm appears in Appendix A abbreviation/acronym key

Step	Requirement	Notes / Rationale
1	Consider formulary alternatives (endocrine therapies and CDK4/6 inhibitors) before approving Itovebi	Appendix B lists endocrine therapy alternatives (e.g., anastrozole, letrozole, exemestane, fulvestrant, tamoxifen) and CDK4/6 inhibitors (ribociclib, abemaciclib, palbociclib); prescriber must document clinical rationale when Itovebi is requested instead of listed formulary options.

Quantity Limits

inv-18: Itovebi (inavolisib) specified daily dose — 9 mg

Specified daily dose9 mg per day

Available strengthsTablets available in 3 mg and 9 mg strengths

Use constraintDose of 9 mg/day specified in initial and continuation criteria (may not exceed dose limits unless guideline-supported)

inv-19: Itovebi (inavolisib) maximum tablets per day — 2

Maximum tablets per day2 tablets per day

Relation to dosingMaximum of 2 tablets/day applies alongside 9 mg/day maximum in initial and continuation criteria

Dose increase requestsAny requested increase must still not exceed 2 tablets/day unless supported by practice guidelines or peer‑reviewed literature

OpenPayer

Clinical Policy: Inavolisib (Itovebi)

Coverage Criteria

Initial Therapy

Continuation Therapy

Coding

Provider Actions

Background

Definitions

Step Therapy / Alternatives

Quantity Limits

Site of Care