BlueCross BlueShield of Tennessee Medical Policy Manual

Carfilzomib

NDC CODE(S)

76075-0103-XX Kyprolis 10 MG SOLR (AMGEN)

 

76075-0102-XX Kyprolis 30 MG SOLR (AMGEN)

 

76075-0101-XX Kyprolis 60 MG SOLR (AMGEN)

DESCRIPTION

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. 

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

 

 

 

INDICATION(S) DOSAGE & ADMINISTRATION
Multiple Myeloma

20/27 regimen (single agent):

  • Cycle 1: 20 mg/m2 on days 1 and 2; if tolerated, increase to 27 mg/m2 on days 8, 9, 15, and 16 of a 28-day treatment cycle
  • Cycles 2 to 12: 27 mg/m2 on days 1, 2, 8, 9, 15, and 16 of a 28-day treatment cycle
  • Cycle 13 and beyond: 27 mg/m2 on days 1, 2, 15, and 16 of a 28-day treatment cycle; continue until disease progression or unacceptable toxicity

20/56 regimen (single agent):

  • Cycle 1: 20 mg/m2 on days 1 and 2; if tolerated, increase to 56 mg/m2 on days 8, 9, 15, and 16 of a 28-day treatment cycle.
  • Cycles 2 to 12: 56 mg/m2 on days 1, 2, 8, 9, 15, and 16 of a 28-day treatment cycle.
  • Cycle 13 and beyond: 56 mg/m2 on days 1, 2, 15, and 16 of a 28-day treatment cycle; continue until disease progression or unacceptable toxicity.

20/27 regimen (combination with lenalidomide and dexamethasone):

  • Cycle 1: 20 mg/m2 on days 1 and 2; if tolerated, increase to 27 mg/m2 on days 8, 9, 15, and 16 of a 28-day treatment cycle.
  • Cycles 2 to 12: 27 mg/m2 on days 1, 2, 8, 9, 15, and 16 of a 28-day treatment cycle.
  • Cycles 13 to 18: 27 mg/m2 on days 1, 2, 15, and 16 of a 28-day treatment cycle; discontinue carfilzomib after Cycle 18

20/27 regimen (combination with pomalidomide and dexamethasone):

  • Cycle 1: 20 mg/m2 on days 1 and 2; if tolerated, increase to 27 mg/m2 on days 8, 9, 15, and 16 of a 28-day treatment cycle.
  • Cycles 2 and beyond: 27 mg/m2 on days 1, 2, 8, 9, 15, and 16 of a 28-day treatment cycle.

20/45 regimen (combination with panobinostat and dexamethasone):

  • Cycle 1: 20 mg/m2 on days 1 and 2; if tolerated, increase to 45 mg/m2 on days 8, 9, 15, and 16 of a 28-day treatment cycle.
  • Cycles 2 and beyond: 45 mg/m2 on days 1, 2, 8, 9, 15, and 16 of a 28-day treatment cycle.

20/56 regimen (combination with dexamethasone):

  • Cycle 1: 20 mg/m2 on days 1 and 2; if tolerated, increase to 56 mg/m2 on days 8, 9, 15, and 16 of a 28-day treatment cycle.
  • Cycle 2 and beyond: 56 mg/m2 on days 1, 2, 8, 9, 15, and 16 of a 28-day treatment cycle; continue until disease progression or unacceptable toxicity.

20/70 regimen (combination with dexamethasone):

  • Cycle 1: 20 mg/m2 on day 1; if tolerated increase to 70 mg/m2 on day 8 and 15 of a 28-day treatment cycle.
  • Cycle 2 and beyond: 70 mg/m2 on days 1, 8 and 15 of a 28-day treatment cycle; continue until disease progression or unacceptable toxicity.

20/36 regimen (combination with cyclophosphamide and dexamethasone):

  • Cycle 1: 20 mg/m2 on days 1 and 2; increase to 36 mg/m2 days 8, 9, 15, and 16 of a 28-day treatment cycle
  • Cycle 2 through 9: 36 mg/m2 days 1, 2, 8, 9, 15, and 16 of a 28-day treatment cycle
Waldenström’s Macroglobulinemia/ Lymphoplasmacytic Lymphoma

CaRD regimen (carfilzomib, rituximab, dexamethasone)

Induction

  • Cycle 1: 20 mg/m2 on days 1, 2, 8, and 9 of a 21-day treatment cycle.
  • Cycle 2-6: 36 mg/m2 on days 1, 2, 8, and 9 of a 21-day treatment; begin maintenance 8 weeks later.

Maintenance

  • 36 mg/m2 on days 1 and 2 every 8 weeks for 8 cycles
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.

IMPORTANT REMINDER

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.

ADDITIONAL INFORMATION 

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).

SOURCES 

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

ID_MRx

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.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit 1mg = 1 billable unit

DIAGNOSIS

MAXIMUM UNITS

Multiple Myeloma

720 billable units every 28 days

Waldenström’s Macroglobulinemia/ Lymphoplasmacytic Lymphoma

320 billable units every 21 days