Glossary of Terms - ZEJULA® (niraparib)

Glossary

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Advanced Beneficiary Notice (ABN) – A notice that you could receive if Medicare is expected to deny payment. You may be responsible for the cost of services that Medicare does not cover.1

Adverse Event – An unexpected medical issue, such as a side effect, that occurs during or following a treatment. May also be called an adverse effect or an adverse reaction.2,3

Allowable Charges – The dollar amount that an insurance company will pay for something like a medical visit or procedure.1

Anemia – When your blood has a low number of red blood cells or when the red blood cells don’t have enough hemoglobin, which is the protein that helps carry oxygen through the body.4,5

Annual Maximum – The maximum amount that an insurance company will cover for each patient per year. This may be a dollar amount, or it can be a limit on the number of treatments that insurance will cover.6

Appeal – If your insurance company denies payment for a service or medicine, you or your doctor can file an appeal, a written notice to the insurance company stating that you and your doctor disagree with the decision to deny the service or medication coverage and providing medically justified reasoning.1

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References: 1. Glossary. Centers for Medicare and Medicaid Services. https://www.cms.gov/apps/glossary/. Accessed May 4, 2018. 2. NCI Dictionary of Cancer Terms: Adverse Event. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/adverse-event. Accessed May 4, 2018. 3. Merriam-Webster Dictionary: Side Effect. Merriam-Webster website. https://www.merriam-webster.com/dictionary/side+effect. Accessed May 4, 2018. 4. Anemia. National Heart, Lung, and Blood Institute. https://www.nhlbi.nih.gov/health-topics/anemia. Accessed May 4, 2018. 5. NCI Dictionary of Cancer Terms: Hemoglobin. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/hemoglobin. Accessed May 4, 2018. 6. U.S. Centers for Medicare & Medicaid Services Glossary: Annual Limit. HealthCare.gov. https://www.healthcare.gov/glossary/annual-limit/. Accessed May 4, 2018. 7. Data on file, Together with TESARO Benefits. TESARO, Inc. 8. NCI Dictionary of Cancer Terms: Biomarker. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/biomarker. Accessed May 4, 2018. 9. NCI Dictionary of Cancer Terms: BRCA. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/search?contains=false&q=brca. Accessed May 4, 2018. 10. Merriam-Webster Dictionary: Status. Merriam-Webster website. https://www.merriam-webster.com/dictionary/status. Accessed May 4, 2018. 11. BRCA Mutations: Cancer Risk & Genetic Testing. National Cancer Institute website. https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-factsheet. Accessed May 4, 2018. 12. NCI Dictionary of Cancer Terms: Germline Mutation. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/germline-mutation. Accessed May 4, 2018. 13. NCI Dictionary of Cancer Terms: Somatic Mutation. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/somatic-mutation. Accessed May 4, 2018. 14. ZEJULA [package insert]. Waltham, MA: TESARO, Inc.; October 2019. 15. NCI Dictionary of Cancer Terms: Complete Blood Count. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/complete-blood-count. Accessed May 4, 2018. 16. U.S. Centers for Medicare & Medicaid Services Glossary: Copayment. HealthCare.gov. https://www.healthcare.gov/glossary/co-payment/. Accessed May 4, 2018. 17. U.S. Centers for Medicare & Medicaid Services Glossary: Deductible. HealthCare.gov. https://www.healthcare.gov/glossary/deductible/. Accessed May 4, 2018. 18. U.S. Centers for Medicare & Medicaid Services. Internal appeals. HealthCare.gov. https://www.healthcare.gov/appeal-insurance/internal-appeals/. Accessed May 4, 2018. 19. Data on file, PR-30-5011-C. TESARO, Inc. 20. NCI Dictionary of Cancer Terms: Explanation of Benefits. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/explanation-of-benefits. Accessed May 4, 2018. 21. NCI Dictionary of Cancer Terms: Food and Drug Administration. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/fda. Accessed May 4, 2018. 22. Office for Civil Rights. What does the HIPAA Privacy Rule do? HHS.gov. https://www.hhs.gov/hipaa/for-individuals/faq/187/what-does-the-hipaa-privacy-rule-do/index.html. Accessed May 4, 2018. 23. Fair Health Glossary: Health Insurance Portability and Accountability Act. Fair Health Consumer. http://www.fairhealthconsumer.org/glossary. Accessed May 4, 2018. 24. Chen Y, Zhang L, Liu WX, Liu XY. Prognostic significance of preoperative anemia, leukocytosis and thrombocytosis in chinese women with epithelial ovarian cancer. Asian Pac J Cancer Prev. 2015;16(3):933-939. 25. Health Insurance Glossary. California’s Valued Trust. https://www.cvtrust.org/sites/default/files/media/downloads/HealthInsuranceGlossary.pdf. Accessed May 4, 2018. 26. NCI Dictionary of Cancer Terms: Maintenance Treatment. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/maintenance-therapy. Accessed May 4, 2018. 27. Merriam-Webster Dictionary: Median. Merriam-Webster website. https://www.merriam-webster.com/dictionary/median. Accessed May 4, 2018. 28. Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: a meta-analytic review. J Consult Clin Psychol. 2010;78(2):169-183. 29. NCI Dictionary of Cancer Terms: Neutropenia. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/neutropenia. Accessed May 4, 2018. 30. American Cancer Society. Low white blood cell (neutrophil) counts and the risk of infection. American Cancer Society website. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/infections/infections-in-people-with-cancer/low-wbc-and-weak-immune-system.html. Accessed May 4, 2018. 31. NCI Dictionary of Cancer Terms: Off-label. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/off-label. Accessed May 4, 2018. 32. Thornton RG. Package inserts and the standard of care. Proc (Bayl Univ Med Cent). 2003;16(4):502-504. 33. NCI Dictionary of Cancer Terms: PARP Inhibitor. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/parp-inhibitor. Accessed May 4, 2018. 34. Sandhu SK, Schelman WR, Wilding G, et al. The poly(ADP-ribose) polymerase inhibitor niraparib (MK4827) in BRCA mutation carriers and patients with sporadic cancer: a phase 1 dose-escalation trial. Lancet Oncol. 2013;14(9):882-892. 35. NCI Dictionary of Cancer Terms: Pharmacist. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/pharmacist. Accessed May 4, 2018. 36. NCI Dictionary of Cancer Terms: Platelet. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/platelet. Accessed May 4, 2018. 37. Chemotherapy. Ovarian Cancer Research Fund Alliance. https://ocrfa.org/patients/about-ovarian-cancer/treatment/chemotherapy/. Accessed May 4, 2018. 38. NCI Dictionary of Cancer Terms: Platinum. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/platinum. Accessed May 4, 2018. 39. U.S. Centers for Medicare & Medicaid Services Glossary: Premium. HealthCare.gov. https://www.healthcare.gov/glossary/premium/. Accessed May 4, 2018. 40. NCI Dictionary of Cancer Terms: Progression-free Survival. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/progression-free-survival. Accessed May 4, 2018. 41. NCI Dictionary of Cancer Terms: Red Blood Cell. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/red-blood-cell. Accessed May 4, 2018. 42. NCI Dictionary of Cancer Terms: Remission. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/remission. Accessed May 4, 2018. 43. NCI Dictionary of Cancer Terms: Response. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/response. Accessed May 4, 2018. 44. Merriam-Webster Dictionary: Threshold. Merriam-Webster website. https://www.merriam-webster.com/dictionary/threshold. Accessed May 4, 2018. 45. NCI Dictionary of Cancer Terms: Thrombocytopenia. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/thrombocytopenia. Accessed May 4, 2018. 46. U.S. Centers for Medicare & Medicaid Services Glossary: UCR (Usual, Customary, and Reasonable). HealthCare.gov. https://www.healthcare.gov/glossary/ucr-usual-customary-and-reasonable/. Accessed May 4, 2018. 47. NCI Dictionary of Cancer Terms: Watchful Waiting. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/watchful-waiting. Accessed May 4, 2018. 48. NCI Dictionary of Cancer Terms: White Blood Cell. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/white-blood-cell. Accessed May 4, 2018.

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