CurrentNeighborhood Health Plan of Rhode IslandPolicy 6696-A

Itovebi (inavolisib) for PIK3CA‑mutated HR+/HER2‑ breast cancer — Coverage Criteria

Covers medical necessity criteria and prior authorization requirements for Itovebi (inavolisib) when used 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 members of Neighborhood Health Plan of Rhode Island under the payer's medical benefit when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyItovebi (inavolisib) for PIK3CA‑mutated HR+/HER2- breast cancer — Coverage Criteria

Policy CodePolicy 6696-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit documentation of PIK3CA mutation and HR/HER2 status for coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moinitial authorization duration

12 mocontinuation duration

1FDA-approved indication referenced

2compendia ref (NCCN)

Coverage Criteria

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyItovebi (inavolisib) for PIK3CA‑mutated HR+/HER2- breast cancer — Coverage Criteria

Policy CodePolicy 6696-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit documentation of PIK3CA mutation and HR/HER2 status for coverage.

SourceLink

On This Page

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inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial authorization criteria: 1) Patient is an adult with locally advanced or metastatic breast cancer; 2) Tumor is hormone receptor (HR)-positive and HER2-negative; 3) Tumor harbors a PIK3CA mutation detected by an FDA‑approved test; 4) Disease is endocrine-resistant and the request is for combination therapy with Itovebi (inavolisib) plus palbociclib and fulvestrant following recurrence on or after completing adjuvant endocrine therapy; 5) Documentation of the PIK3CA mutation and HR/HER2 status is submitted; 6) Member has no exclusions to the prescribed therapy.

Authorization may be granted for 12 months.

inv-02: Continuation Therapy

Covered when ALL of the following are met for reauthorization:

Continuation criteria: 1) Current treatment aligns with an indication in the coverage criteria; 2) There is no evidence of disease progression while on the current regimen; 3) There is no unacceptable toxicity from the regimen; 4) Documentation supports ongoing clinical benefit or stability.

Authorization of 12 months may be granted for continued treatment.

All uses of Itovebi (inavolisib) beyond the FDA‑approved indication (in combination with palbociclib and fulvestrant for endocrine‑resistant, PIK3CA‑mutated, HR‑positive, HER2‑negative locally advanced or metastatic breast cancer) and the compendial recurrent breast cancer indication are considered experimental/investigational. Such uses do not meet medical necessity criteria and are not eligible for coverage under this policy.

Use of Itovebi (inavolisib) for any indication other than the FDA‑approved setting and the compendial recurrent breast cancer indication is not medically necessary and may be denied.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Itovebi (alpelisib) is subject to prior authorization for coverage when used for the FDA‑approved indication — adults with endocrine‑resistant, PIK3CA‑mutated, HR‑positive, HER2‑negative locally advanced or metastatic breast cancer in combination with palbociclib and fulvestrant, following recurrence on or after completing adjuvant endocrine therapy. Authorization may be granted for up to 12 months when clinical criteria are met.

Drug must be used in combination with palbociclib and fulvestrant.
FDA‑approved PIK3CA mutation must be documented by an FDA‑approved test.

Denial Risk

Non‑Covered Indications

Non‑covered / Experimental Uses: Use of Itovebi for indications other than the FDA‑approved indication and compendial recurrent breast cancer is considered experimental and investigational and not medically necessary.

Coverage limited to FDA‑approved indication and compendial recurrent breast cancer; all other indications are not covered.

Documentation Required

Required Documentation

Documentation Required for Prior Authorization: Submit documentation confirming presence of a PIK3CA mutation and documentation of hormone receptor (HR) and HER2 status. Include the test name, date, and results; clinical history demonstrating endocrine resistance and prior adjuvant endocrine therapy with timing of recurrence; and the plan to use in combination with palbociclib and fulvestrant.

Provide copy of PIK3CA mutation test (test name, date, result).
Provide pathology or receptor testing confirming HR‑positive and HER2‑negative status.
Provide clinical history showing endocrine resistance and prior adjuvant endocrine therapy with dates.
Specify concomitant palbociclib and fulvestrant in the treatment plan.

Note

Provider Action

Provider Action / Alert: Ensure prior authorization is requested before initiating Itovebi and include all required documentation to avoid denial. For questions about coverage determination, contact the plan’s clinical review team.

Covered Regimens

Regimen	Indication	Authorization duration
Itovebi (inavolisib) in combination with palbociclib and fulvestrant
Endocrine-resistant, PIK3CA‑mutated, HR‑positive, HER2‑negative locally advanced or metastatic breast cancer following recurrence on or after completing adjuvant endocrine therapy (PIK3CA mutation detected by an FDA‑approved test)
Authorization of 12 months may be granted

Line of Therapy

inv-12: first-line

Line of therapy: Use is indicated for endocrine-resistant disease following recurrence on or after completing adjuvant endocrine therapy; Itovebi (inavolisib) is used in combination with palbociclib and fulvestrant in this setting.

FDA‑approved setting as specified.

Biomarker Requirements

PIK3CA — detected by an FDA-approved test

PIK3CA biomarker requirementTumor must harbor a PIK3CA mutation detected by an FDA-approved test.

PurposeRequired for eligibility for Itovebi in combination with palbociclib and fulvestrant for endocrine-resistant HR-positive, HER2-negative locally advanced or metastatic breast cancer.

Documentation to submitProvide documentation of the test confirming presence of the PIK3CA mutation as part of prior authorization.

Definitions

endocrine-resistant — definition per FDA indication

DefinitionEndocrine-resistant: disease that progressed following or recurred on adjuvant endocrine therapy (per FDA indication).

Context of useIndication applies to adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer receiving Itovebi with palbociclib and fulvestrant after recurrence on or after completing adjuvant endocrine therapy.

Implication for authorizationRequests must document prior adjuvant endocrine therapy with evidence of recurrence or progression to meet the endocrine-resistant criterion.

PIK3CA-mutated — requirement that mutation be detected by an FDA-approved test

Coverage requirementA PIK3CA mutation detected by an FDA-approved test is required for coverage of Itovebi in the indicated regimen.

How to documentSubmit the test report confirming presence of the PIK3CA mutation with the prior authorization request.

Link to regimenThis requirement applies when Itovebi is requested in combination with palbociclib and fulvestrant for endocrine-resistant HR-positive, HER2-negative advanced or metastatic breast cancer.

Background

Itovebi (inavolisib) is indicated for use in combination with palbociclib and fulvestrant for adults with endocrine‑resistant, PIK3CA‑mutated, HR‑positive, HER2‑negative locally advanced or metastatic breast cancer; compendial use includes recurrent breast cancer. Other clinical uses beyond these specified indications are considered experimental/investigational and are not medically necessary under this policy.