CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 1502-1

Inluriyo (imlunestrant) prior authorization

Prior authorization and notification requirements for Inluriyo (imlunestrant) for treatment of adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, including initial and reauthorization criteria and pediatric (<19) handling. Affects providers prescribing and pharmacies dispensing Inluriyo under Colorado Rocky Mountain Health Plans/UnitedHealthcare commercial programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyInluriyo (imlunestrant) prior authorization

Policy CodePolicy 2025 P 1502-1

Change TypeNo material changes

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization showing diagnosis of ER+, HER2-, ESR1‑mutated advanced/metastatic breast cancer with progression after ≥1 line of endocrine therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization duration

Adults ESR1-mutprimary population

11/2025P&T date

NCCNcompendium

Coverage Criteria for Inluriyo (imlunestrant)

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Initial Authorization

Covered when ALL of the following are met

Initial Authorization for Adults: Diagnosis of breast cancer; tumor is estrogen receptor-positive (ER+); tumor is human epidermal growth factor receptor 2-negative (HER2-); tumor is estrogen receptor 1 (ESR1)-mutated; disease is advanced or metastatic; disease progression has occurred following at least one line of endocrine therapy.all conditions required

Authorization will be issued for 12 months

Initial Therapy

Initial therapy coverage criteria

Initial Therapy: Diagnosis of breast cancer; tumor is estrogen receptor-positive (ER+); tumor is human epidermal growth factor receptor 2-negative (HER2-); tumor is estrogen receptor 1 (ESR1)-mutated; disease is advanced or metastatic; progression after at least one line of endocrine therapy.all required

Authorization 12 months

Reauthorization

Covered when ALL of the following are met

Reauthorization: Patient does not show evidence of progressive disease while on Inluriyo therapy.no progression

Authorization will be issued for 12 months

Continuation Therapy

Reauthorization criteria

Continuation: Patient does not show evidence of progressive disease while on Inluriyo therapy.no progression

Authorization for 12 months

Pediatric Authorization

Covered when the following criterion is met

Pediatric Approval: Patient is less than 19 years of age.age <19

Authorization will be issued for 12 months

Coverage is not provided when the listed diagnostic or disease-state requirements are not met. Specifically, Inluriyo is not covered if the tumor is not estrogen receptor–positive (ER+), not HER2–negative (HER2–), or not ESR1–mutated. Coverage also requires that disease be advanced or metastatic, and that there has been disease progression after at least one line of endocrine therapy; absence of any of these elements precludes approval.

For reauthorization, treatment with Inluriyo will be denied if there is evidence of disease progression while the patient is receiving Inluriyo. Continued approval requires documentation that the patient does not show evidence of progressive disease while on Inluriyo therapy.

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization required for Inluriyo. Initial approval is granted when all specified clinical criteria are met (see coverage criteria). Authorization period: 12 months for approved requests.

Initial authorization required
Authorization period: 12 months

Step Therapy

Step Therapy: Prior Endocrine Therapy Required

Requires prior endocrine therapy failure: disease progression following at least one line of endocrine therapy is required for approval.

Must have progressed following ≥1 line of endocrine therapy

Denial Risk

Coverage Criteria Not Met — Denial Risk

Denial risk if diagnostic and disease criteria are not met. Coverage requires: breast cancer that is ER+, HER2-, and ESR1‑mutated, and disease must be advanced or metastatic. Requests that do not meet these criteria may be denied.

Diagnosis must be breast cancer
Must be ER+, HER2-, and ESR1‑mutated
Disease must be advanced or metastatic

Prior Authorization

Pediatric Handling

For patients less than 19 years of age: authorization will be issued when the patient is <19 years old. Approval period for pediatric patients: 12 months.

Pediatric approvals issued for patients <19 years of age
Authorization period: 12 months

Documentation Required

Supporting Documentation

Supporting documentation may include prior claim/medication history, diagnosis codes (ICD-10), and other claim logic. The Inluriyo package insert is referenced for additional clinical details. Supply limits may apply.

Document prior claim/medication history as available
Include relevant ICD-10 diagnosis codes
Reference: Inluriyo package insert (September 2025)

Step Therapy Requirements

Step	Requirement
1	Disease progression following at least one line of endocrine therapy is required prior to approval.

Quantity Limits and Supply

Inluriyo (imlunestrant) — Quantity / Supply limits

Supply limitsSupply limits may be in place for Inluriyo (imlunestrant).

Quantity limit periodPer month (program may apply monthly limits).

Program discretionUnitedHealthcare programs may apply automated approval/re-approval processes that include supply limits.

ReferenceSee Additional Clinical Rules for supply-limit statement and program variability.

Definitions

ESR1‑mutated — definition and relevance

DefinitionPresence of mutation(s) in the estrogen receptor 1 (ESR1) gene identified on tumor testing.

Clinical relevanceESR1 mutation status is required to meet diagnosis criteria for Inluriyo coverage (ER-positive, HER2-negative, ESR1‑mutated).

Source indicationInluriyo is indicated for adults with ER-positive, HER2-negative, ESR1‑mutated advanced or metastatic breast cancer after progression on endocrine therapy.

DocumentationTumor testing results demonstrating ESR1 mutation should be included in prior authorization documentation.

Background

Inluriyo (imlunestrant) is an estrogen receptor antagonist indicated for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. Authorization for initial therapy is contingent on a documented diagnosis of breast cancer meeting those tumor characteristics, evidence the disease is advanced or metastatic, and documented progression following at least one line of endocrine therapy. When approved, authorizations are issued for 12 months.

Coding and Supporting Resources

Billing Rule

Claims/coding guidance and references

For coding and claims processing, UnitedHealthcare may approve based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic; the Inluriyo package insert is listed as a reference and supply limits may apply.

Claims/medication history may be sufficient for automated approval
Include ICD-10 diagnosis codes that substantiate ER+, HER2-, ESR1-mutated advanced/metastatic disease
Refer to the Inluriyo package insert for clinical details

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyInluriyo (imlunestrant) prior authorization

Policy CodePolicy 2025 P 1502-1

Change TypeNo material changes

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization showing diagnosis of ER+, HER2-, ESR1‑mutated advanced/metastatic breast cancer with progression after ≥1 line of endocrine therapy.

SourceLink

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