ORSERDU (elacestrant)

ORSERDU (elacestrant)

Self-Administration – oral tablets

Diagnosis considered for coverage:

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.

Coverage Criteria:

For diagnosis of breast cancer:

• 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 one of the following:
  • An FDA-approved test
  • 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)]; AND
• Prescribed by or in consultation with an oncologist.

Reauthorization Criteria:

For diagnosis of breast cancer:

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

Dosing:

• 345 mg tablet taken orally, once daily.
  • If Grade 3 toxicity occurs (severe and undesirable adverse event), interrupt Orserdu until recovery to Grade ≤ 1 or baseline. Then resume Orserdu reduced by one dose level. If a Grade 3 or toxicity recurs, then recover to Grade ≤ 1 or baseline followed by Orserdu reduced by another dose level.
    • First-dose reduction: 258 mg once daily (three 86 mg tablets)
    • Second-dose reduction: 172 mg once daily (two 86 mg tablets)
  • If Grade 4 toxicity occurs (life-threatening or disabling adverse event), interrupt Orserdu until recovery to Grade ≤ 1 or baseline. Then resume Orserdu reduced by one dose level. If a Grade 4 or intolerable adverse reaction recurs, permanently discontinue Orserdu.

Coverage Duration:

• 1 year

Authorization is not covered for the following:

• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in combination with aromatase inhibitors (AIs) or in combination with fulvestrant are the preferred treatment regimens for ER- and/or HR-positive HER2-negative breast cancer. Disease progression, however, may occur due to acquired or de novo resistance to endocrine therapies.
• Mutations in ESR1 have been associated with endocrine resistance. These mutations are estimated to occur in 20 to 40% of patients exposed to an AI. ESR1 mutations result in resistance to AIs, but not ER inhibitors (e.g., selective estrogen receptor degraders [SERDs] and selective estrogen receptor modulators [SERMs]). (Bidard et al 2022).
• Orserdu (elacestrant) is an oral SERD that is the first treatment approved specifically for patients with ESR1 mutations. It was FDA-approved in January 2023.
• Information on FDA-approved tests for detection of ESR1 mutations in breast cancer is available at: http://www.fda.gov/CompanionDiagnostics

Policy Updates:

• 09/01/2023 – New program for Orserdu approved by P&T. (P&T 08/15/2023)

References:

1. Orserdu Prescribing Information. Stemline Therapeutics, Inc., New York, NY. January 2023.
2. Bidard FC, Kaklamani V, Neven P, et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor-positive human epidermal growth factor receptor 2-negative advanced breast cancer: Results from the randomized phase III EMERALD trial. J Clin Oncol. 2022;40:3246-3256.
3. Cancer Therapy Evaluation Program (CTEP). (2020). Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. [PDF] https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcv20_4-30-992.pdf. Accessed June 29, 2023.
4. 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/study/NCT03778931?term=nct03778931&rank=1. Accessed June 29, 2023.
5. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Breast Cancer. V4.2023. Available at https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf . Accessed June 29, 2023.