CurrentHealth NetPolicy CP PHAR.702

Clinical Policy: Inavolisib (Itovebi)

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

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.

1Covered Indications (FDA-approved combination)

9 mg/dayStandard maximum daily dose

6 moInitial approval duration

12 moContinuation approval duration

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)
- HER2-negative
- Locally advanced or metastatic disease
- Positive for PIK3CA mutation (as detected by an FDA-approved test)
Itovebi is prescribed in combination with palbociclib and fulvestrant
Disease progression or recurrence on or after adjuvant endocrine therapy
See Appendix B
If member is premenopausal or perimenopausal female, member has been treated with ovarian ablation or is receiving ovarian suppression
See Appendix D
Member must use inavolisib (Itovebi), if available, unless contraindicated or clinically significant adverse effects are experienced
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)

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

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.

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

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

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

Tablets: 3 mg	Inavolisib tablet strength available
Tablets: 9 mg	Inavolisib tablet strength available

OpenPayer

Clinical Policy: Inavolisib (Itovebi)

Coverage Summary

Initial Therapy Criteria - Breast Cancer

Initial Therapy Criteria - Other Indications

Continuation Therapy Criteria - Breast Cancer

Continuation Therapy Criteria - Other Indications

Diagnoses / Indications Not Authorized

Provider Actions & Authorization Requirements

Applicable Codes

Clinical Evidence & Guideline Sources

Definitions

Revision History