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L.2.03.400
Tamoxifen Raloxifene Anastrozole Exemestane
Breast cancer is the most commonly diagnosed cancer in American females. This emphasizes the importance of effective breast cancer screening and risk-reduction strategies. The National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology (ASCO), and the United States Preventive Services Task Force (USPSTF) suggest endocrine therapy for breast cancer prevention in women who are at an increased risk.
For an individual who does not have a personal history of breast cancer, the risk factors for the development of breast cancer can be grouped into categories, including familial/genetic factors, factors related to demographics, reproductive history, lifestyle factors, and other factors such as number of breast biopsies, history of ductal or lobular atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS), breast density, or thoracic irradiation before 30 years of age.
Risk-reducing medications (i.e., tamoxifen, raloxifene, anastrozole, exemestane) are recommended for patients ≥35 years of age only. The benefit of these agents in those younger than 35 years is unknown. All four medications may be used in women who are postmenopausal. Only tamoxifen is indicated for use on those who are premenopausal.
The NCCN concluded that tamoxifen, raloxifene, anastrozole, or exemestane substantially decrease the future risk for breast cancer providing an opportunity for a risk-reduction intervention. The risks and benefits with using these medications should be evaluated and discussed as part of a shared decision-making process.
Arimidex (anastrozole), Aromasin (exemastane), Evista (raloxifene), or Nolvadex (tamoxifen) may be considered medically necessary to reduce the risk of breast cancer development in women who meet ALL of the following criteria:
The individual is ≥35 years of age;
ONE of the following:
The individual has a ≥1.7% five-year risk for breast cancer based on validated risk estimation models (i.e., Gail Model, Tyrer-Cuzick);
The individual has a history of thoracic radiation administered prior to 30 years of age;
The individual has a history of lobular carcinoma in situ (LCIS);OR
The individual has atypical hyperplasia;
The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND
The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.
State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Assessment of Breast Cancer Risk The National Cancer Institute has developed a Breast Cancer Risk Assessment Tool (available at www.cancer.gov/bcrisktool) that is based on the Gail model and estimates the 5-year incidence of invasive breast cancer in women on the basis of characteristics entered into a risk calculator. This tool helps identify women who may be at increased risk for the disease. Other risk assessment models have been developed by the Breast Cancer Surveillance Consortium (BCSC), Rosner and Colditz, Chlebowski, Tyrer and Cuzick, and others.
Examples of risk factors elicited by risk assessment tools include patient age, race or ethnicity, age at menarche, age at first live childbirth, personal history of DCIS or LCIS, number of first-degree relatives with breast cancer, personal history of breast biopsy, body mass index, menopause status or age, breast density, estrogen and progestin use, smoking, alcohol use, physical activity, and diet.
Assessment of Risk for Adverse Effects In general, women taking medications for breast cancer risk reduction are less likely to experience a venous thromboembolic event if they are younger and have no other predisposition to thromboembolic events. Women with a personal or family history of venous thromboembolism are at higher risk for these adverse effects.
Women without a uterus are not at risk for tamoxifen-related endometrial cancer. Women with a uterus should have a baseline gynecologic examination prior to starting tamoxifen, with regular follow up after the end of treatment.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.
12/31/2014: Approved by Medical Policy Advisory Committee. Effective 01/01/2015.
07/23/2015: Code Reference section updated for ICD-10.
06/06/2016: Policy number L.2.03.400 added. Policy Guidelines updated to add medically necessary definition.
10/01/2020: Added aromatase inhibitor, anastrozole, as a breast cancer risk-reducing. USPSTF link updated in sources section. Policy title changed from "Risk-Reducing Medications for Primary Breast Cancer: Tamoxifen and Raloxifene" to "Risk-Reducing Medications for Primary Breast Cancer."
07/13/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated. Policy section updated to add brand name drugs and to revise medically necessary criteria. Policy Exceptions updated. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Added information regarding BCBSMS request for medical records. Sources updated. Code Reference section updated to remove table.
02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
06/03/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy updated to add Exemestane. Policy description revised. Policy statement updated to include Aromasin (exemastane) as medically necessary to reduce the risk of breast cancer development in women who meet ALL of the listed criteria. Medically necessary criteria updated regarding breast cancer risk, history of thoracic radiation, history of lobular carcinoma, and atypical hyperplasia. Policy Guidelines updated regarding breast cancer risk. Sources updated.
Anastrozole prescribing information. Avet Pharmaceuticals Inc. December 2024. Last accessed April 2025.
Breast Cancer Risk Assessment Tool. http://www.cancer.gov/bcrisktool/. Accessed April 9, 2025.
Exemestane prescribing information. Amneal Pharmaceuticals LLC. December 2024. Last accessed April 2025.
National Comprehensive Cancer Network. Breast Cancer Risk Reduction (Version 2.2025—January 30, 2025. https://www.nccn.org/professionals/physician_gls/pdf/breast_risk.pdf. Accessed April 9, 2025.
Raloxifene prescribing information. Cadila Pharmaceuticals Limited. January 2022. Last accessed April 2025.
Sharma, P. Selective estrogen receptor modulators and aromatase inhibitors for breast cancer prevention. UpToDate. https://www.uptodate.com/contents/selective-estrogen-receptor-modulators-and-aromatase-inhibitors-for-breast-cancer-prevention. Accessed April 9, 2025.
Tamoxifen prescribing information. Dr. Reddy’s Laboratories Inc. July 2024. Last accessed April 2025.
U.S. Preventive Services Task Force. Breast Cancer: Medication Use to Reduce Risk: Final Recommendation Statement. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/breast-cancer-medications-for-risk-reduction#fullrecommendationstart. Accessed April 9, 2025.
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