Oscar Commercial Clinical Policy

Oscar Exemestane (PG084) Form

Effective Date

NA

Last Reviewed

NA

Original Document

  Reference



Exemestane (Brand Name: Aromasin)

is an aromatase inhibitor medication typically used in the treatment of certain types of breast cancer in postmenopausal women. By reducing the production of estrogen, a hormone which some breast cancers rely on for growth, exemestane can help inhibit disease progression. Similar agents used for hormone receptor-positive breast cancers include anastrozole, letrozole, and tamoxifen.

In addition to its primary use in treating breast cancer, exemestane can also be prescribed for other cancer types, such as endometrial carcinoma, fallopian tube cancer, persistent or recurrent epithelial ovarian cancer, primary peritoneal cancer, and various forms of uterine sarcoma. This medicine may also be used in combination with other treatments or interventions, such as ovarian suppression in premenopausal women or a gonadotropin-releasing hormone analogue in men with hormone receptor- positive breast cancer.

Definitions

Adjuvant hormonal therapy is therapy where medications are used alongside other anticancer therapies to suppress hormones that contribute to the growth of breast tissue.

Menopause is clinically defined by the National Comprehensive Cancer Network (NCCN) as the absence of a menstrual period for 12 months without another medical cause. It is when a woman stops having monthly periods, the ovaries stop releasing eggs and making the hormones estrogen and progesterone. NCCN states natural menopause usually occurs between the ages of 42-58 years.

Clinical Indications

Medical Necessity Criteria for Initial Authorization

The Plan considers exemestane (Aromasin) medically necessary when ALL the following criteria are met for the applicable indication listed below:

Breast cancer:
  1. The requested medication is being prescribed for ONE (1) of the following:
    • A postmenopausal woman for ONE (1) of the following:
      1. advanced breast cancer whose disease has progressed following tamoxifen therapy; or
      2. estrogen receptor–positive early breast cancer; or
      3. reducing the risk of invasive breast cancers (at increased risk of developing breast cancer); or
    • A premenopausal woman and BOTH of the following:
      1. for use in combination with ovarian suppression (e.g., triptorelin injection, bilateral oophorectomy, or bilateral ovarian irradiation); and
      2. the member has ONE (1) of the following:
        1. early-stage hormone receptor-positive breast cancer at higher risk of disease recurrence (i.e., younger age, larger or high-grade tumor, increased risk of lymph node involvement); or
        2. received prior adjuvant chemotherapy (e.g., trastuzumab with or without pertuzumab); or
    • A male with hormone receptor-positive breast cancer in combination with a gonadotropin-releasing hormone analogue; AND
  2. Chart documentation and supporting laboratory test results are provided for review to substantiate the above listed requirements.
Other Cancers:
  1. The requested medication is prescribed by or in consultation with an oncologist; AND
  2. The member is 18 years of age or older; AND
  3. The member has a diagnosis of ONE of the following:
    • endometrial carcinoma; or
    • fallopian tube cancer; or
    • persistent or recurrent epithelial ovarian cancer; or
    • primary peritoneal cancer; or
    • uterine sarcoma, including:
      1. Adenosarcoma; or
      2. Endometrial stromal sarcoma (ESS); or
      3. PEComa; or
      4. Undifferentiated uterine sarcoma (UUS); or
      5. Uterine leiomyosarcoma (uLMS); or
    • The use is supported by The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium with a level of evidence category of 1, 2A, or 2B; AND

Chart documentation and supporting laboratory test results are provided for review to substantiate the above listed requirements.

If the above prior authorization criteria are met, exemestane (Aromasin) will be approved for 12 months.

Medical Necessity Criteria for Reauthorization

Reauthorization for 12 months will be granted if BOTH of the following are met:

  1. the member still meets the applicable initial criteria; AND
  2. recent chart documentation (within the last 12 months) shows the member has experienced a clinical benefit (e.g., disease or recurrence free survival, time to tumor progression).

Experimental or Investigational / Not Medically Necessary

Exemestane for any other indication is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.

References
  1. Aromasin (exemestane) [prescribing information]. New York, NY: Pfizer; November 2021.
  2. Bellet M, Gray KP, Francis PA, et al. Twelve-month estrogen levels in premenopausal women with hormone receptor-positive breast cancer receiving adjuvant triptorelin plus exemestane or tamoxifen in the Suppression of Ovarian Function Trial (SOFT): the SOFT-EST Substudy. J Clin Oncol. 2016;34(14):1584-1593. doi:10.1200/JCO.2015.61.2259
  3. Burris, H. A., Chan, A., Bardia, A., Thaddeus Beck, J., Sohn, J., Neven, P., ... & Yardley, D. A. (2021). Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2,-3 and-7 trials in hormone receptor-positive, HER2-negative advanced breast cancer. British journal of cancer, 125(5), 679-686.
  4. Burstein HJ, Lacchetti C, Anderson H, et al. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: ASCO clinical practice guideline focused update. J Clin Oncol. 2019;37(5):423-438. doi:10.1200/JCO.18.01160
  5. Burstein HJ, Lacchetti C, Anderson H, et al. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: ASCO clinical practice guideline update on ovarian suppression. J Clin Oncol. 2016;34(14):1689-1701. doi:10.1200/JCO.2015.65.9573
  6. Burstein HJ, Somerfield MR, Barton DL, et al. Endocrine treatment and targeted therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer: ASCO guideline update. J Clin Oncol. 2021;39(35):3959-3977. doi:10.1200/JCO.21.01392
  7. Finn, R. S., Cristofanilli, M., Ettl, J., Gelmon, K. A., Colleoni, M., Giorgetti, C., ... & Rugo, H. S. (2020). Treatment effect of palbociclib plus endocrine therapy by prognostic and intrinsic subtype and biomarker analysis in patients with bone-only disease: a joint analysis of PALOMA-2 and PALOMA-3 clinical trials. Breast Cancer Research and Treatment, 184(1), 23-35.
  8. Francis PA, Pagani O, Fleming G, et al. Tailoring adjuvant endocrine therapy for premenopausal breast cancer. N Engl J Med. 2018;379(2):122-137. doi:10.1056/NEJMoa1803164
  9. Goss PE, Ingle JN, Pritchard KI, et al. Extending aromatase-inhibitor adjuvant therapy to 10 years. N Engl J Med. 2016;375(3):209-219.
  10. Hassett MJ, Somerfield MR, Baker ER, et al. Management of male breast cancer: ASCO guideline. J Clin Oncol. 2020;38(16):1849-1863. doi:10.1200/JCO.19.03120
  11. Henry, N. L., Giles, J. T., & Stearns, V. (2008). Aromatase inhibitor-associated musculoskeletal symptoms: etiology and strategies for management. Oncology, 22(12), 1401.
  12. National Comprehensive Cancer Network: NCCN Clinical Practice Guidelines in Oncology: Breast Cancer Risk Reduction. Version 1.2023. NCCN website. Updated October 12, 2022. Accessed September, 2023. https://www.nccn.org/
  13. National Comprehensive Cancer Network: NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 4.2023. NCCN website. Updated March 23, 2023. Accessed September, 2023. https://www.nccn.org/
  14. National Comprehensive Cancer Network: NCCN Clinical Practice Guidelines in Oncology:Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer. Version 2.2023. NCCN website.
  1. National Comprehensive Cancer Network: NCCN Clinical Practice Guidelines in Oncology: Uterine Neoplasms. Version 2.2023. NCCN website. Updated April 28, 2023. Accessed September, 2023. https://www.nccn.org/
  2. Pagani O, Regan MM, Walley BA, et al; TEXT and SOFT Investigators; International Breast Cancer Study Group. Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. 2014;371(2):107-118. doi:10.1056/NEJMoa1404037
  3. Piccart, M., Hortobagyi, G. N., Campone, M., Pritchard, K. I., Lebrun, F., Ito, Y., ... & Baselga, J. (2014). Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2. Annals of oncology, 25(12), 2357-2362.
  4. Tamoxifen [package insert]: Raleigh NC. Midatech Pharma US Inc. 2018
  5. Toi, M., Inoue, K., Masuda, N., Iwata, H., Sohn, J., Hae Park, I., ... & Sledge Jr, G. W. (2021). Abemaciclib in combination with endocrine therapy for East Asian patients with HR+, HER2− advanced breast cancer: MONARCH 2 & 3 trials. Cancer science, 112(6), 2381-2392.
  6. Visvanathan K, Fabian CJ, Bantug E, et al. Use of endocrine therapy for breast cancer risk reduction: ASCO clinical practice guideline update. J Clin Oncol. 2019;37(33):3152-3165. doi:10.1200/JCO.19.01472

Clinical Guideline Revision / History Information
Original Date: 11/05/2020
Reviewed/Revised: 03/11/2021, 10/14/2021, 12/01/2021, 9/15/2022, 9/21/2023