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Zofran® (ondansetron) (Intravenous) Document Number: IC-0150 Last Review Date: 02/24/2015 Date of Origin: 12/01/2011 Dates Reviewed: 03/2012, 06/19/2012, 09/06/2012, 12/06/2012, 03/07/2013, 06/06/2013, 09/05/2013, 12/05/2013, 03/25/2014, 02/24/2015 I. Length of Authorization Coverage is provided for 6 months and may be renewed. II. Dosing Limits A. Quantity Limit (max daily dose) [Pharmacy Benefit]: N/A B. Max Units (per dose and over time) [Medical Benefit]: Chemotherapy related nausea and vomiting: Male: 48 billable units per day Female: 48 billable units per day All other indications III. Male: 8 billable units per day Female: 8 billable units per day Initial Approval Criteria Coverage is provided in the following conditions: Prevention of chemotherapy induced Nausea and vomiting (CNIV)† • Patient is receiving emetogenic chemotherapy Prevention of post-operative nausea and vomiting † Breakthrough treatment for chemotherapy-induced nausea/vomiting Proprietary & Confidential © 2015 Magellan Health Services, Inc. Prevention of nausea and vomiting associated with radiation treatment †FDA Approved Indication(s) IV. Renewal Criteria Coverage can be renewed based upon the following criteria: V. VI. • Patient continues to meet criteria identified in section III; AND • Disease response; AND • Absence of unacceptable toxicity from the drug Dosage/Administration Indication Dose All other indications 0.15mg/kg IV x 3 doses on day of chemo up to a maximum of 16 mg per dose Prevention of Nausea and vomiting associated with radiation therapy 8 mg IV given prior to radiation Postoperative nausea and vomiting 4 mg IV given as a single dose Note: oral Ondansetron is typically recommended in these instances Billing Code/Availability Information JCode: • VII. J2405 – Zofran (GlaxoSmithKline) 4 mg, 40mg Injection: 1 billable unit = 1 mg References 1. Zofran [package insert]. Research Triangle Park, NJ; GlaxoSmithKline; September 2014. Accessed February 2015. 2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for ondansetron. National Comprehensive Cancer Network, 2015. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2015 Zofran® (ondansetron) Prior Auth Criteria Page 2 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. ©2015, Magellan Rx Management Appendix 1 – Covered Diagnosis Codes ICD-9 Codes Diagnosis 787.01 Nausea with vomiting 787.02 Nausea alone 787.03 Vomiting alone 909.2 Late effect of radiation 909.5 Late effect of poisoning due to drug, medicinal or biological substance 990 Effects of radiation, unspecified 995.20 Unspecified adverse effect of unspecified drug, medicinal and biological substance 995.22 Unspecified adverse effect of anesthesia 995.29 Unspecified adverse effect of other drug, medicinal and biological substance V58.0 Encounter for radiotherapy V58.11 Encounter for antineoplastic chemotherapy E933.1 Antineoplastic and immunosuppressive drugs causing adverse effects in therapeutic use E933.9 Unspecified systemic agent causing adverse effects in therapeutic use ICD-10 ICD-10 Description R11.0 Nausea R11.10 Vomiting, unspecified R11.11 Vomiting without nausea R11.12 Projectile vomiting R11.2 Nausea with vomiting, unspecified T41.0X5A Adverse effect of inhaled anesthetics, initial encounter T41.1X5A Adverse effect of intravenous anesthetics, initial encounter T41.205A Adverse effect of unspecified general anesthetics, initial encounter T41.295A Adverse effect of other general anesthetics, initial encounter T41.45XA Adverse effect of unspecified anesthetic, initial encounter T45.1X5A Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter T45.1X5S Adverse effect of antineoplastic and immunosuppressive drugs, sequela T45.95XA Adverse effect of unspecified primarily systemic and hematological agent, initial encounter T50.905A Adverse effect of unspecified drugs, medicaments and biological substances, initial encounter T50.995A Adverse effect of other drugs, medicaments and biological substances, initial Zofran® (ondansetron) Prior Auth Criteria Page 3 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. ©2015, Magellan Rx Management ICD-10 ICD-10 Description encounter T88.59XA Other complications of anesthesia, initial encounter Z51.0 Encounter for antineoplastic radiation therapy Z51.11 Encounter for antineoplastic chemotherapy Z51.12 Encounter for antineoplastic immunotherapy Appendix 2 – Centers for Medicare and Medicaid Services (CMS) Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicarecoverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan. Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD): N/A Medicare Part B Administrative Contractor (MAC) Jurisdictions Jurisdiction Applicable State/US Territory Contractor E CA,HI, NV, AS, GU, CNMI F AK, WA, OR, ID, ND, SD, MT, WY, Noridian Administrative Services (NAS) UT, AZ 5 KS, NE, IA, MO Wisconsin Physicians Service (WPS) 6 MN, WI, IL National Government Services (NGS) H LA, AR, MS, TX, OK, CO, NM Novitas Solutions 8 MI, IN Wisconsin Physicians Service (WPS) 9 (N) FL, PR, VI First Coast Service Options 10 (J) TN, GA, AL Cahaba Government Benefit Administrators 11 (M) NC, SC, VA, WV Palmetto GBA 12 (L) DE, MD, PA, NJ, DC Novitas Solutions K NY, CT, MA, RI, VT, ME, NH National Government Services (NGS) 15 KY, OH CGS Administrators, LLC Zofran® (ondansetron) Prior Auth Criteria Page 4 | Noridian Administrative Services (NAS) Proprietary Information. Restricted Access – Do not disseminate or copy without approval. ©2015, Magellan Rx Management