00024-5824-XX Jevtana 60MG/1.5ML SOLN (SANOFI PHARMACEUTICALS)
Cabazitaxel is an antineoplastic agent in the taxane class. It is a semi-synthetic agent prepared with a precursor (10-deacetyl baccatin III) extracted from the needles of certain yew trees. Its antineoplastic activity is as a microtubule inhibitor. Cabazitaxel binds to cellular tubulin which promotes the assembly of microtubules but inhibits microtubular function and breakdown. This halts the cellular mitotic and interphase functions and leads to apoptosis.
Cabazitaxel for the treatment of prostate cancer is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Cabazitaxel for the treatment of other conditions/diseases is considered investigational.
Cabazitaxel is considered medically appropriate if ALL of the following criteria are met:
Individual is diagnosed with hormone-refractory metastatic prostate cancer
Prior treatment with docetaxel-based chemotherapy regimen (unless contraindicated or intolerant to docetaxel)
Administration is in combination with a corticosteroid (e.g., prednisone or dexamethasone)
May not be used with other chemotherapy agents
Continuation of treatment with cabazitaxel is considered medically appropriate if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Disease response as defined by lack of disease progression, improvement in tumor size and/or improvement in symptoms
Absence of unacceptable toxicity from the drug, including, but not limited to, neutropenia, anemia, leukopenia, thrombocytopenia, severe hypersensitivity reactions, severe diarrhea, nausea, vomiting, severe hemorrhagic cystitis, renal or hepatic toxicity, interstitial lung disorders, etc.
|INDICATION(S)||DOSAGE & ADMINISTRATION|
· 20 – 25 mg/m2 every 3 weeks in combination with oral corticosteroid
PVC equipment should not be used
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).
Lexi-Comp Online. (2019. AHFS DI. Cabazitaxel. Retrieved February 21, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, February). Cabazitaxel. Retrieved February 21, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Cabazitaxel. Retrieved February 21, 2019 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2018, January). Center for Drug Evaluation and Research. Jevtana® (cabazitaxel). Retrieved February 21, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201023s021lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 4/9/2019
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.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 1 mg