Pharmacy Prior Authorization Criteria

Orserdu (elacestrant)

Indications for Prior Authorization

Orserdu (elacestrant)

• For diagnosis of Breast Cancer
  Indicated for the treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

Criteria

Orserdu

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 (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, 1, 3]

Orserdu

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

P & T Revisions

2024-03-08, 2023-06-26, 2023-05-10, 2023-03-21

References

1. Orserdu Prescribing Information. Stemline Therapeutics, Inc., New York, NY. January 2023.
2. Clinicaltrials.gov. Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer (EMERALD). Available at https://www.clinicaltrials.gov/ct2/results?cond=&term=nct03778931&cntry=&state=&city=&dist=. Accessed March 7, 2023.
3. Clinical Consult with an oncologist. March 16, 2023.
4. National Comprehensive Cancer Network(NCCN) Clinical Practice Guidelines in Oncology. Breast Cancer. V3.2023. Available at https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed March 16, 2023.

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End Notes

1. Per clinical consult, treatment can be with an aromatase inhibitor, with or without fulvestrant, with or without CD4/6 inhibitors, as not all patients are candidates for CD4/6 inhibitors [3]

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Revision History

• 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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