ModifiedCignaPolicy N/A

Itovebi (inavolisib) prior authorization for HR+, HER2- PIK3CA-mutated breast cancer

Cigna prior authorization policy for coverage of Itovebi (inavolisib tablets) in combination with palbociclib (Ibrance) and fulvestrant for adults with HR-positive, HER2-negative, PIK3CA-mutated, endocrine-resistant locally advanced or metastatic breast cancer meeting specified clinical criteria. Also states noncoverage for other uses.

Policy Summary

PayerCigna

PolicyItovebi (inavolisib) prior authorization for HR+, HER2- PIK3CA-mutated breast cancer

Policy CodePolicy N/A

Change TypeSelected revision (material changes)

Effective Date

Next Review DateNov 20, 2024

Key ActionPrior Authorization is recommended; document PIK3CA mutation status and prior endocrine therapy status, and for pre/perimenopausal females or males document ovarian suppression or surgical status.

POLICY UPDATE CHANGES

For pre/perimenopausal female or male added criterion to provide option of surgical bilateral oophorectomy or ovarian irradiation for females and orchiectomy for males in addition to GnRH agonist therapy.

Clarified criteria to state patient has disease progression while on adjuvant endocrine therapy or patient has had disease recurrence within 12 months after completing adjuvant endocrine therapy.

1Covered Indication (breast cancer)

0Other indications covered

12Authorization duration (months)

Coverage Summary

Medical Necessity Criteria

FDA-Approved Indication - Breast Cancer (Approve for 1 year)

Approve for 1 year if the patient meets ALL of the following (A, B, C, D, E, F, and G):

ALL of the following

Patient sex/menopausal status
- Postmenopausal female
  - Patient is ≥ 18 years of age>= 18 years
  - Patient is a postmenopausal female
    Defined in Policy Statement as an individual with the biological traits of a woman, regardless of gender identity or expression
- Pre/perimenopausal female or male
  - Patient is ≥ 18 years of age>= 18 years
  - ONE of the following (a or b)
    a: Patient is receiving a gonadotropin-releasing hormone (GnRH) agonist
    Examples of a GnRH agonist include leuprolide acetate, Lupron Depot, Trelstar, Zoladex
    b: Patient has had surgical bilateral oophorectomy or ovarian irradiation (female) or orchiectomy (male)
Disease characteristics
- HR-positive disease: Patient has locally advanced or metastatic hormone receptor (HR)-positive disease
- HER2-negative disease: Patient has human epidermal growth factor receptor 2 (HER2)-negative disease
- PIK3CA mutation: Patient has PIK3CA-mutated breast cancer as detected by an approved test
- Adjuvant endocrine therapy disease status
  - i: Patient has disease progression while on adjuvant endocrine therapy
    Examples of endocrine therapy include tamoxifen, anastrozole, letrozole, exemestane, toremifene

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Provider Actions

Prior Authorization

Prior authorization required

Prior Authorization is recommended for prescription benefit coverage of Itovebi; approvals are provided for the duration noted. Approvals for the FDA‑approved breast cancer indication are provided for 1 year.

Approve for 1 year

Documentation Required

Document PIK3CA mutation status

Provider must document PIK3CA‑mutated breast cancer as detected by an approved test.

Documentation Required

Document prior endocrine therapy status

Provider must document disease progression while on adjuvant endocrine therapy or disease recurrence within 12 months after completing adjuvant endocrine therapy.

Documentation Required

Document ovarian suppression or surgical status for pre/perimenopausal females or males

For pre/perimenopausal females or males, document receipt of a gonadotropin‑releasing hormone (GnRH) agonist or surgical bilateral oophorectomy/ovarian irradiation (female) or orchiectomy (male).

GnRH agonist examples: leuprolide acetate, triptorelin, goserelin
Surgical options: bilateral oophorectomy, ovarian irradiation (female); orchiectomy (male)

Denial Risk

Not covered for other uses

Itovebi is considered experimental, investigational or unproven for any use not listed in the Recommended Authorization Criteria; coverage is not recommended for other indications and claims for such uses may be denied.

Background and Evidence

Background: Itovebi is a kinase inhibitor indicated in combination with Ibrance (palbociclib) and fulvestrant for treatment of hormone receptor–positive, HER2-negative, PIK3CA‑mutated, endocrine‑resistant locally advanced or metastatic breast cancer in adults, per FDA labeling. The labeling recommends evaluating fasting plasma glucose/blood glucose and hemoglobin A1c (HbA1c) before initiating therapy, optimizing blood glucose prior to initiation, and monitoring glucose at regular intervals during treatment. NCCN guidance endorses the combination (category 1) for patients with disease progression on adjuvant endocrine therapy or relapse within 12 months of adjuvant endocrine therapy completion.

Source	Reference
NCCN recommendation
NCCN Breast Cancer Clinical Practice Guidelines in Oncology (version 6.2024) recommend Itovebi in combination with Ibrance and fulvestrant (category 1) for specified patients
Prescribing information
Itovebi tablets prescribing information, Genentech, October 2024

Definitions:

- postmenopausal female: Defined in the Policy Statement as an individual with the biological traits of a woman, regardless of the individual's gender identity or gender expression.

- woman / male (specified gender): Specified gender is defined as the biological traits of a woman or man, respectively, regardless of the individual's gender identity or gender expression. For pre/perimenopausal females or males, the policy allows ovarian suppression with a gonadotropin‑releasing hormone (GnRH) agonist (examples: leuprolide acetate, Lupron Depot, Trelstar, Zoladex) or surgical options (bilateral oophorectomy or ovarian irradiation for females; orchiectomy for males).

palbociclib	Ibrance (palbociclib capsules and tablets) - required combination agent
fulvestrant	Fulvestrant injection - required combination agent
leuprolide acetate / Lupron Depot	Example GnRH agonist
triptorelin pamoate / Trelstar	Example GnRH agonist
goserelin acetate / Zoladex	Example GnRH agonist

OpenPayer

Itovebi (inavolisib) prior authorization for HR+, HER2- PIK3CA-mutated breast cancer

Coverage Summary

Medical Necessity Criteria

Coding

Provider Actions

Background and Evidence

Revision History