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Transcript
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