CurrentmhnPolicy CP.PHAR.702

Clinical Policy: Inavolisib (Itovebi)

Defines medical necessity and prior authorization criteria for coverage of inavolisib (Itovebi) for adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer, and continuation criteria for members currently receiving therapy. Affects providers prescribing Itovebi and payer prior authorization staff for applicable lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Inavolisib (Itovebi)

Policy CodePolicy CP.PHAR.702

Change TypeMaterial operational updates (criteria clarifications and approval duration change)

Effective DateDec 1, 2024

Next Review Date

Key ActionPrior authorization is required; requests must show all initial or continued therapy criteria are met and include supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

Added option for regionally advanced disease or recurrent disease per NCCN.

Clarified ovarian ablation or ovarian suppression is required if members are premenopausal or perimenopausal.

Added requirement that male members be prescribed in combination with an agent that suppresses testicular steroidogenesis.

Extended initial approval duration from 6 months to 12 months for this maintenance medication.

9 mg/daymaximum recommended dose

2/daytablet limit

12 monthsapproval duration

Policy Summary

Payermhn

PolicyClinical Policy: Inavolisib (Itovebi)

Policy CodePolicy CP.PHAR.702

Change TypeMaterial operational updates (criteria clarifications and approval duration change)

Effective DateDec 1, 2024

Next Review Date

Key ActionPrior authorization is required; requests must show all initial or continued therapy criteria are met and include supporting clinical documentation.

SourceLink

On This Page

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Coverage Criteria for Inavolisib (Itovebi)

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) Advanced (local or regional), recurrent, or metastatic; 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 member is a premenopausal or perimenopausal female, member has been treated with ovarian ablation or is receiving ovarian suppression; 8. If member is male, prescribed in combination with an agent that suppresses testicular steroidogenesis (e.g., gonadotropin-releasing hormone agonists); 9. For Itovebi requests, member must use inavolisib, if available, unless contraindicated or clinically significant adverse effects are experienced; 10. Request meets one of the following: a) Dose does not exceed both: i) 9 mg per day; ii) 2 tablets per day; OR b) 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. Approval duration: 12 months.

Continuation Therapy

Covered when ALL of the following are met:

Continued Therapy - Breast Cancer: 1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Itovebi for breast cancer and has received this medication for at least 30 days; 2. Member is responding positively to therapy; 3. For Itovebi requests, member must use inavolisib, if available, unless contraindicated or clinically significant adverse effects are experienced; 4. If request is for a dose increase, request meets 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 (prescriber must submit supporting evidence).

Prescribed regimen must be FDA‑approved or recommended by NCCN. Approval duration: 12 months.

This policy applies only to the FDA‑approved indication(s) and uses explicitly described in the coverage criteria for inavolisib (Itovebi). Requests for therapy for diagnoses or indications that are not FDA‑approved and are not specifically addressed in this policy will not be authorized unless they include sufficient supporting documentation consistent with off‑label use policies. Providers should follow the referenced off‑label policies when seeking coverage for non‑FDA indications.

For non‑FDA or off‑label uses, the prescriber must submit clinical evidence demonstrating the safety and efficacy of inavolisib for the requested indication. Coverage for such uses will be considered only when documentation meets the requirements of the applicable off‑label use policies (e.g., CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid) or when there is clear evidence in the member’s evidence of coverage. Requests lacking adequate supporting evidence are subject to denial.

Initial Therapy — Authorization Conditions

Initial Therapy

Covered when ALL of the following are met:

Initial Therapy - Itovebi (consistent placement): 1. Diagnosis of breast cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Disease is HR-positive, HER2-negative, and is advanced (local or regional), recurrent, or metastatic; 5. Tumor is positive for PIK3CA mutation; 6. Itovebi is prescribed in combination with palbociclib and fulvestrant; 7. Disease progression or recurrence on or after adjuvant endocrine therapy; 8. Premenopausal or perimenopausal females must have ovarian ablation or be receiving ovarian suppression; 9. Males must receive concomitant suppression of testicular steroidogenesis (e.g., GnRH agonist); 10. Member must use inavolisib if available unless contraindicated; 11. Dose does not exceed both: i) 9 mg per day; ii) 2 tablets per day, OR 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. Approval duration: 12 months.

Criteria for Continued Coverage

Continued Therapy

Covered when ALL of the following are met:

Continued Therapy - Itovebi: 1. Currently receiving Itovebi via Centene benefit, or documentation shows at least 30 days of Itovebi administration for breast cancer; 2. Member is responding positively to therapy; 3. Member must use inavolisib if available unless contraindicated or clinically significant adverse effects are experienced; 4. If request is for a dose increase, new dose must either: a) not exceed both: i) 9 mg per day; ii) 2 tablets per day; OR b) be 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. Approval duration: 12 months.

Coding and Dosing Information

Policy coding notesmixed

N/A	No specific CPT/HCPCS/NDC codes listed in policy text.

Maximum daily dose

Maximum daily dose9 mg/day

Tablet limit2 tablets/day

Approval duration12 months

Itovebi (inavolisib) — quantity limit / strength

Product strength (per tablet)9 mg

Maximum daily amount9 mg/day

Tablet daily limit2 tablets/day

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Itovebi (Itolvib?) requests. Requests must meet the clinical criteria in this policy and receive prior authorization before coverage is provided.

Prior authorization required for new and continuing therapy
Requests must meet all applicable approval criteria in this policy

Documentation Required

Required Documentation

Providers must submit documentation supporting that the member meets all approval criteria. Acceptable documentation includes office chart notes, relevant laboratory results (including PIK3CA mutation testing), imaging reports, prior therapy records (adjuvant endocrine therapy, ovarian suppression/ablation, or testicular suppression when applicable), and treatment history showing progression or recurrence.

Office chart notes summarizing diagnosis and treatment plan
Laboratory results (e.g., PIK3CA mutation report)

Therapeutic Alternatives and Step Therapy

Therapeutic alternative	Dosing / notes
Endocrine therapies (aromatase inhibitors: anastrozole, letrozole, exemestane)	Anastrozole: 1 mg PO once daily; Letrozole: 2.5 mg PO once daily; Exemestane: 25 mg PO once daily.
Fulvestrant	500 mg IM per regimen (two 5 mL injections, one in each buttock); follow regimen dosing per prescriber/NCCN guidance.
CDK4/6 inhibitors (to be used in combination per regimen, e.g., with fulvestrant)	Use per product labeling and treatment plan; may require prior authorization. (Alternatives listed in Appendix B may not be formulary for all lines of business.)

Definitions

PIK3CA

TermPIK3CA

Definitionphosphatidylinositol 3-kinase catalytic subunit alpha

ContextReferenced in diagnostic requirement for PIK3CA-mutated disease

HR (hormone receptor)

TermHR

Definitionhormone receptor (estrogen or progesterone receptor)

Clinical contextRequired HR-positive disease characteristic for initial approval

Background

Inavolisib is a PI3K inhibitor used in combination therapy for a specific breast cancer population. This policy governs coverage for inavolisib when prescribed for adults with endocrine‑resistant, PIK3CA‑mutated, hormone receptor‑positive (HR+) / HER2‑negative locally advanced or metastatic breast cancer following recurrence on or after adjuvant endocrine therapy. Premenopausal or perimenopausal females require ovarian ablation or suppression and males require concurrent suppression of testicular steroidogenesis when indicated; dosing limits and other clinical requirements are described in the coverage criteria. Non‑FDA indications are not authorized unless sufficient off‑label evidence is provided per the referenced policies.

Quantity Limits and Tablet Strengths

Itovebi — strength / limit

Product strength9 mg

Dosing regimen (breast cancer)9 mg PO QD

Maximum daily dose9 mg/day

Site of Care

Note

No site‑of‑care restriction

There are no specific site‑of‑care restrictions specified in this policy.