Pharmacy Prior Authorization Criteria

Inluriyo (imlunestrant)

Indications for Prior Authorization

Inluriyo (imlunestrant)

• For diagnosis of Breast Cancer
  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.

Criteria

Inluriyo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of breast cancer
AND
• Disease is one of the following:
• Advanced
• Metastatic
AND
• Disease is estrogen receptor (ER)-positive
AND
• Disease is human epidermal growth factor receptor 2 (HER2)-negative
AND
• Presence of estrogen receptor-1 (ESR1) mutation(s) as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Disease has progressed following at least one line of endocrine therapy [e.g., Faslodex (fulvestrant), Arimidex (anastrozole), Femara (letrozole), Aromasin (exemestane)] [A]

Inluriyo

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

P & T Revisions

2025-12-02, 2024-03-08, 2023-06-26, 2023-05-10, 2023-03-21

References

1. Inluriyo Prescribing Information. Lilly USA, LLC., Indianapolis, IN. September 2025.
2. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Breast Cancer. v5.2025. Available at https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed December 2, 2025.
3. Jhaveri KL, Neven P, Casalnuovo ML, et al; EMBER-3 study group. Imlunestrant with or without abemaciclib in advanced breast cancer. N Engl J Med. 2025; 392(12):1189-1202.

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End Notes

1. Estrogen receptor-1 (ESR1) activating mutations are frequently detected in patients with prior aromatase inhibitor (AI) (e.g., anastrozole, letrozole, exemestane) exposure. Tumors with ESR1 mutations are often resistant to both AIs and tamoxifen, while some retain fulvestrant sensitivity. [2] The pivotal study included patients previously treated with an AI, alone or with a CDK4/6 inhibitor, who progressed within 12 months of neoadjuvant/adjuvant AI therapy with no systemic therapy for recurrent disease, or more than 12 months after neoadjuvant/adjuvant endocrine therapy or de novo metastatic disease and had progressed on only one line of AI therapy. [1, 3]

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Revision History

• 2025-12-02: New Program for Inluriyo
• 2024-03-08: 2024 Annual Review
• 2023-06-26: Removed specialist requirement.
• 2023-05-10: update guideline
• 2023-03-21: New PA Criteria

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