CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 1502-1

Inluriyo (imlunestrant) prior authorization policy

Defines prior authorization criteria, initial and reauthorization requirements, and administrative rules for coverage of Inluriyo (imlunestrant) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer; includes pediatric (<19) approval pathway and references NCCN recognition. Authorization periods are 12 months.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyInluriyo (imlunestrant) prior authorization policy

Policy CodePolicy 2025 P 1502-1

Change TypeNew prior authorization program

Effective DateFeb 1, 2026

Next Review Date

Key ActionPrior authorization/notification is required for Inluriyo; approvals (initial, pediatric, and reauthorization) are issued for 12 months per the criteria.

POLICY UPDATE CHANGES

New prior authorization program for Inluriyo (imlunestrant) established with P&T approval 11/2025 and effective date 2/1/2026.

12Authorization duration

1+Required prior endocrine therapy lines (initial)

ER+, HER2-, ESR1Required tumor markers

Coverage Summary

Coverage policy 2025 P 1502-1: Inluriyo (imlunestrant) is covered with criteria as a prior authorization/notification program for adults with ER-positive, HER2-negative, ESR1‑mutated advanced or metastatic breast cancer. Initial approval requires disease progression following at least one line of endocrine therapy and meets tumor marker requirements (ER+, HER2-, ESR1‑mutated); pediatric pathway exists for patients <19 years. Authorization period is 12 months. P&T approval 11/2025; effective 02/01/2026.

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

Authorization will be issued for 12 months.

Patients less than 19 years of age

Pediatric pathway: Inluriyo will be approved based on the following criterion:

Pediatric approval (patients <19): Patient is less than 19 years of age

Authorization will be issued for 12 months.

NCCN Recognition

Supportive recognition

NCCN recognition: Drug is recognized for treatment of the cancer indication by the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Supporting note: This policy references the product labeling (Inluriyo [package insert], Lilly, September 2025) and recognizes NCCN Drugs and Biologics Compendium recognition per the policy criteria (Category of Evidence and Consensus 1, 2A, or 2B).

Provider Actions & Administrative Rules

Prior Authorization

Prior authorization required

Prior authorization/notification is required for Inluriyo (imlunestrant). Approvals (initial, pediatric, and reauthorization) are issued for 12 months per the program definitions.

Documentation Required

Clinical documentation to support criteria

Providers must document the clinical information that supports approval: diagnosis of estrogen receptor–positive (ER+), HER2‑negative (HER2‑) breast cancer with an ESR1 mutation and advanced or metastatic disease; prior endocrine therapy with evidence of disease progression for initial authorization; and absence of progressive disease while on therapy for reauthorization. Automated approval or reauthorization may be granted based on prior claims/medication history and diagnosis codes.

Diagnosis: breast cancer that is ER+, HER2‑, and ESR1‑mutated (advanced/metastatic)
Initial authorization: documentation of prior endocrine therapy and evidence of disease progression after at least one line of endocrine therapy
Reauthorization: documentation that the patient does not show evidence of progressive disease while on Inluriyo
Note: automated approval/re‑approval may be based on prior claim or medication history and diagnosis (ICD‑10) codes

Billing Rule

Supply limits may apply

Supply limits may be enforced by the plan and other utilization management rules may apply.

Background

Background: Inluriyo (imlunestrant) is an estrogen receptor antagonist indicated for adults with ER‑positive, HER2‑negative, ESR1‑mutated advanced or metastatic breast cancer after progression on at least one endocrine therapy. The policy aligns with the FDA/label context and was approved by P&T in 11/2025. The program is implemented as a prior authorization/notification with clinical documentation and administrative rules to support processing; approvals (initial, pediatric, and reauthorization) are issued for 12 months.

Definitions

Authorization periodApprovals (initial, pediatric, and reauthorization) will be issued for 12 months.