69639-0102-XX - Akynzeo (235 MG FOSNETUPITANT/0.25 MG PALONOSETRON) SOLR (HELSINN THERAPEUTICS U.S.)
Fosnetupitant and Palonosetron is a combination of palonosetron, a serotonin-3 (5-HT3) receptor antagonist, and fosnetupitant, substance P/neurokinin-1 (NK-1) receptor antagonists: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.
Fosnetupitant/Palonosetron for the treatment of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Fosnetupitant/Palonosetron for the treatment of other conditions/diseases is considered investigational.
Fosnetupitant/Palonosetron is considered medically appropriate for the prevention of chemotherapy induced nausea and vomiting (CINV) if ALL of the following criteria are met:
Individual is 18 years of age or older
Used in combination with dexamethasone
Individual has failed (failure is defined as: Two or more documented episodes of vomiting attributed to the current chemotherapy regimen) with another generically available 5-HT3 receptor antagonist (e.g. ondansetron, granisetron or palonosetron) and NK1 receptor antagonist (e.g. aprepitant, fosaprepitant or rolapitant) while receiving the current chemotherapy regimen
Receiving highly emetogenic chemotherapy (HEC) including but not limited to carboplatin, cisplatin, dacarbazine, etc.
Fosnetupitant/Palonosetron WILL NOT be used for ALL of the following:
Repeat dosing in multiday emetogenic chemotherapy regimens
Prevention of CINV related to an anthracycline plus cyclophosphamide chemotherapy regimen
Fosnetupitant and Palonosetron is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Absence of unacceptable toxicity from the agent. Examples of unacceptable toxicity include: severe hypersensitivity reactions, serotonin syndrome, etc.
|INDICATION(S)||DOSAGE & ADMINISTRATION|
Prevention of chemotherapy-induced nausea and vomiting in adults
|Administer the contents of 1 vial, intravenously, approximately 30 minutes prior to the start of chemotherapy|
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed
Refer to DOSAGE LIMITS below
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
No controlled studies were found in the published literature that validate the use of Fosnetupitant and Palonosetron for the treatment or prevention of other conditions or diseases.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (July, 2018). Fosnetupitant/Palonosetron. Retrieved August 2,, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Fosnetupitant/Palonosetron Retrieved August 2, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2018, April). Center for Drug Evaluation and Research. AKYNZEO® (fosnetupitant and palonosetron) for injection, for intravenous use Retrieved August 2, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210493s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 7/10/2018
MOST RECENT REVIEW DATE: 9/11/2018
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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Maximum billable units per dose and over time by indication as a Medical Benefit