76075-0103-XX Kyprolis 10 MG SOLR (AMGEN)
76075-0102-XX Kyprolis 30 MG SOLR (AMGEN)
76075-0101-XX Kyprolis 60 MG SOLR (AMGEN)
Carfilzomib is a proteasome inhibitor. Proteasomes are found in the nucleus and cytoplasm of cells and are essential for cellular survival. They play a role in several complex cellular functions including the degradation of abnormal and misfolded proteins in the cell, involvement in the cell’s stress response, cell cycle regulation, and cellular differentiation and also play a role in the immune system by generating antigenic peptides. Carfilzomib irreversibly binds to active sites of the core particle of the 26S proteasome. This action inhibits proteosome activity in blood and tissue leading to growth delay and cellular destruction in solid and hematologic tumor cells.
Carfilzomib for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Waldenström's macroglobulinemia / lymphoplasmacytic lymphoma
Carfilzomib for the treatment of other conditions/diseases is considered investigational.
Carfilzomib is considered medically appropriate if ALL of the following:
Individual is 18 years of age or older
Request is for a diagnosis of ANY ONE of the following:
Multiple Myeloma if ANY ONE of the following:
Used as primary chemotherapy or for disease relapse after 6 months following primary chemotherapy with this same regimen in individuals with active (symptomatic) disease and ANY ONE of the following:
Used in combination with lenalidomide and dexamethasone
Used in combination with dexamethasone and cyclophosphamide in NON stem-cell transplant candidates
Used for previously treated myeloma for disease relapse or for progressive or refractory disease and ANY ONE of the following:
Used as a single agent for subsequent therapy
In combination with dexamethasone with or without lenalidomide
In combinations with dexamethasone and cyclophosphamide
In combination with panobinostat; and individual has received at least 2 prior regimens, including bortezomib and an immunomodulatory agent
In combination with pomalidomide and dexamethasone and ALL of the following:
Individual has received at least 2 prior therapies, including a proteasome inhibitor and an immunomodulatory agent
Individual has progressed on or within 60 days of completion of the last therapy
Waldenström's macroglobulinemia/lymphoplasmacytic lymphoma in combination with rituximab and dexamethasone (component of CaRD regimen) and ANY ONE of the following:
As primary therapy
For Relapsed disease if ALL of the following:
This regimen was used as primary therapy
Individual achieved a response that lasted for at least 24 months
Carfilzomib is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet the initial approval criteria
Disease response as indicated by stabilization and/or absence or progress of disease
Absence of unacceptable toxicity from the agent, including cardiac events (heart failure and ischemia), pulmonary toxicity, pulmonary hypertension, dyspnea, infusion reactions, tumor lysis syndrome, thrombocytopenia, hepatic toxicity/failure, thrombotic microangiopathy (TTP/HUS), acute renal failure, severe hypertension, posterior reversible encephalopathy syndrome (PRES), venous thromboembolic events, hemorrhage, etc.
|INDICATION(S)||DOSAGE & ADMINISTRATION|
20/27 regimen (single agent):
20/56 regimen (single agent):
20/27 regimen (combination with lenalidomide and dexamethasone):
20/27 regimen (combination with pomalidomide and dexamethasone):
20/45 regimen (combination with panobinostat and dexamethasone):
20/56 regimen (combination with dexamethasone):
20/70 regimen (combination with dexamethasone):
20/36 regimen (combination with cyclophosphamide and dexamethasone):
|Waldenström’s Macroglobulinemia/ Lymphoplasmacytic Lymphoma||
CaRD regimen (carfilzomib, rituximab, dexamethasone)
|Note: Calculate the Kyprolis dose using the patient’s actual body surface area at baseline. In patients with a body surface area greater than 2.2 m2, calculate the dose based upon a body surface area of 2.2 m2|
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).
Lexicomp Online. (2018). AHFS DI. Carfilzomib. Retrieved December 17, 2018 from Lexicomp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, October). Carfilzomib. Retrieved December 17, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Carfilzomib. Retrieved December 13, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2018, September). Center for Drug Evaluation and Research. Kyprolis® (carfilzomib) for injection. Retrieved December 13, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s013lbl.pdf.
ORIGINAL EFFECTIVE DATE: 8/13/2012
MOST RECENT REVIEW DATE: 1/8/2019
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 1mg = 1 billable unit