ModifiedColorado Rocky Mountain Health PlansPolicy 2025 P 1502-1

Inluriyo (imlunestrant) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Defines UnitedHealthcare Commercial prior authorization and notification criteria for Inluriyo (imlunestrant) for treatment of adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, including initial authorization, reauthorization, pediatric (<19) rule, NCCN recognition, and additional clinical/billing rules.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyInluriyo (imlunestrant) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1502-1

Change TypeNew prior authorization program

Effective DateFeb 1, 2026

Next Review Date

Key ActionSubmit prior authorization/notification requests for Inluriyo with documentation demonstrating ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer and prior endocrine therapy; approvals are issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

New prior authorization/notification program established for Inluriyo (imlunestrant).

12 monthsAuthorization Duration

Adults ER+ HER2- ESR1-mutCovered Population

<19Pediatric Rule

Coverage Summary

UnitedHealthcare Commercial prior authorization/notification criteria apply to Inluriyo (imlunestrant) for the treatment of adults with ER-positive (ER+), HER2-negative (HER2-), ESR1-mutated advanced or metastatic breast cancer. Coverage is covered_with_criteria and approvals are issued for 12 months when the criteria are met. The policy references the Inluriyo package insert (September 2025) and notes recognition by the NCCN Drugs and Biologics Compendium.

Initial Therapy Criteria

Initial Authorization

Inluriyo will be approved based on all of the following criteria:

ALL of the following

Diagnosis of breast cancer
Breast cancer is all of the following
- Estrogen receptor-positive (ER+)
- Human epidermal growth factor receptor 2-negative (HER2-)
- Estrogen receptor 1 (ESR1)-mutated
Disease is advanced or metastatic
Disease progression has occurred following at least one line of endocrine therapy

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Pediatric Criteria (<19 years)

Patients less than 19 years of age

Inluriyo will be approved based on the following criterion:

Patient is less than 19 years of age

Continuation / Reauthorization Criteria

Reauthorization

Inluriyo will be approved for reauthorization based on the following criterion:

Patient does not show evidence of progressive disease while on Inluriyo therapy

NCCN Recognition

Supportive recognition for coverage:

Drug is recognized for the treatment of the cancer indication by The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Provider Actions & Authorization Rules

Prior Authorization

Prior authorization required

Prior authorization/notification program applies to Inluriyo (imlunestrant). Approvals are issued for 12 months when criteria are met.

Documentation Required

Clinical documentation required

Documentation should support ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, evidence of disease progression following at least one line of endocrine therapy for initial approval, and for reauthorization there must be no evidence of disease progression while on Inluriyo therapy.

Billing Rule

Automated approval possible

UnitedHealthcare may approve initial and reauthorization based solely on prior claim or medication history, diagnosis codes (ICD-10), and/or claim logic using automated approval processes.

Billing Rule

Authorization duration

Authorizations—including initial approvals, pediatric approvals, NCCN-based approvals, and reauthorizations—are issued for 12 months.

Applicable Codes

ICD-10 Diagnosis Codes (general reference)ICD-10

No codes listed

Clinical Evidence & References

P&T Approval Date: 11/2025.

Package Insert: Inluriyo [package insert]. Lilly, LLC. September 2025.

NCCN recognition is referenced in the coverage criteria and supportive guidance from the NCCN Drugs and Biologics Compendium.

Background & Definitions

Inluriyo (imlunestrant) is indicated for the treatment of adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, per the product labeling (September 2025). The drug is also recognized by the NCCN Drugs and Biologics Compendium for this cancer indication.

ESR1-mutated: Presence of mutation in the estrogen receptor 1 gene (ESR1) as documented in clinical or genetic testing.

Revision History

11/2025P&T approval

New prior authorization/notification program established for Inluriyo (imlunestrant).

2026-02-01effectiveLatest

New prior authorization/notification program established for Inluriyo (imlunestrant).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyInluriyo (imlunestrant) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1502-1

Change TypeNew prior authorization program

Effective DateFeb 1, 2026

Next Review Date

SourceLink

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