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AETNA BETTER HEALTH® Non-Formulary Prior Authorization guideline for Capecitabine Authorization guidelines May be authorized when prescribed by an oncologist for patients who are at least 18 years old who have ANY of the following indications: • Metastatic colorectal cancer • Adjuvant (post-surgery) treatment of Dukes’ C colon cancer • Metastatic breast cancer that is refractory to both paclitaxel and an anthracycline-containing chemotherapy regimen • Metastatic breast cancer that is refractory to paclitaxel when the patient is not appropriate for anthracycline therapy • Metastatic breast cancer that has progressed on an anthracycline-containing chemotherapy when used in combination with docetaxel • • • Locally advanced anal/rectal cancer when used in combination with radiation Pancreatic cancer when used in combination with radiation HER2 positive advanced/recurrent or metastatic breast cancer: o Disease has progressed after receiving prior therapy with an anthracycline (doxorubicin, daunorubicin, epirubicin, idarubicin), a taxane (paclitaxel, docetaxel), AND trastuzumab (Herceptin) o Must be used in combination with Tykerb Authorization and Limitations Initial Approval: 1 year Extended Approval: 3 years Required documentation: • Crcl >30mL/min • neutrophils >1 × 109/L • platelets >50 × 109/L Additional Information: Capecitabine is NOT covered for members with the following criteria: • Use not approved by the FDA; AND • The use is unapproved and not supported by the literature or evidence as an accepted off-label use. Last Review: 12/2015 Previous PARP Approval: 10/1/2014 Current PARP Approval: 2/2016 Medically Necessary — A service or benefit is Medically Necessary if it is compensable under the MA Program and if it meets any one of the following standards: The service or benefit will, or is reasonably expected to, prevent the onset of an illness, condition or disability. The service or benefit will, or is reasonably expected to, reduce or ameliorate the physical, mental or developmental effects of an illness, condition, injury or disability. The service or benefit will assist the Member to achieve or maintain maximum functional capacity in performing daily activities, taking into account both the functional capacity of the Member and those functional capacities that are appropriate for Members of the same age. Determination of Medical Necessity for covered care and services, whether made on a Prior Authorization, Concurrent Review, Retrospective Review, or exception basis, must be documented in writing. The determination is based on medical information provided by the Member, the Member’s family/caretaker and the Primary Care Practitioner, as well as any other Providers, programs, agencies that have evaluated the Member. All such determinations must be made by qualified and trained Health Care Providers. A Health Care Provider who makes such determinations of Medical Necessity is not considered to be providing a health care service under this Agreement. References: 1. 2. 3. Xeloda [capecitabine] prescribing information. South San Francisco, CA: Genentech, inc. Updated: March, 2015. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Colon Cancer. http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Version 2.2016. Accessed December 17, 2015. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Anal Carcinoma. http://www.nccn.org/professionals/physician_gls/pdf/anal.pdf. Version 2.2015. Accessed November 4, 2015. 4. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Brest Cancer. http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Version 1.2016. Accessed December 17, 2015. 5. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Pancreatic Adenocarcinoma. http://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Version 2.2015. Accessed December 17, 2015. 6. Last Review: 12/2015 Previous PARP Approval: 10/1/2014 Current PARP Approval: 2/2016
