Carfilzomib (Kyprolis)

Policy ID: I-41-009

Section: Injections

Effective Date: July 01, 2018

Revised Date: July 17, 2023

Revision Effective Date: September 01, 2023

Last Reviewed: July 26, 2023

Applies To: Commercial and Medicaid Expansion

Description

Carfilzomib (Kyprolis®) is a targeted therapy drug and is classified as a proteasome inhibitor. It exhibits antiproliferative and proapoptotic activity in sold and hematologic tumor cells.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Carfilzomib (Kyprolis) may be considered medically necessary when used for ANY of the following:

Multiple Myeloma

In combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab plus dexamethasone for the treatment of individuals with relapsed or refractory multiple myeloma who have received one to three lines of therapy; or
As a single agent for the treatment of individuals with relapsed or refractory multiple myeloma who have received one or more lines of therapy; or

Compendia Sources

Carfilzomib (Kyprolis) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of carfilzomib (Kyprolis) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9047

NOTE: In addition to the above criteria, product specific and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

C88.0

C90.00

C90.02

C90.10

C90.12

C90.20

C90.22

C90.30

C90.32

E85.3

E85.4

E85.81

E85.89

E85.9

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-14-2019

Updated codes

Internal Medical Policy Committee 11-19-2020

Updated FDA indications to also include regimen with daratumumab plus dexamethasone, and
Updated NCCN recommendations

Internal Medical Policy Committee 7-22-2021

Updated NCCN recommendations, and
Updated diagnosis codes

Internal Medical Policy Committee 7-21-2022

Added additional diagnosis codes, and
Removed diagnosis code Z85.79, and
Removed NCCN recommendations and added this statement 'Carfilzomib (Kyprolis) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.', and
Updated the experimental/investigational statement

Internal Medical Policy Committee 7-26-2023 - Effective September 01, 2023

Added diagnosis codes E85.3 and E85.4 to the policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-41-008

Section: Injections

Effective Date: July 01, 2018

Revised Date: July 05, 2022

Revision Effective Date: September 01, 2022

Last Reviewed: July 21, 2022

Archived Date: August 31, 2023

Applies To: Commercial and Medicaid Expansion

Description

Carfilzomib (Kyprolis®) is a targeted therapy drug and is classified as a proteasome inhibitor. It exhibits antiproliferative and proapoptotic activity in sold and hematologic tumor cells.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Carfilzomib (Kyprolis) may be considered medically necessary when used for ANY of the following:

Multiple Myeloma

In combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab plus dexamethasone for the treatment of individuals with relapsed or refractory multiple myeloma who have received one to three lines of therapy; or
As a single agent for the treatment of individuals with relapsed or refractory multiple myeloma who have received one or more lines of therapy; or

Compendia Sources

Carfilzomib (Kyprolis) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Carfilzomib (Kyprolis) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9047

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

C88.0

C90.00

C90.02

C90.10

C90.12

C90.20

C90.22

C90.30

C90.32

E85.81

E85.89

E85.9

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-14-2019 Updated codes

Internal Medical Policy Committee 11-19-2020 Updated FDA indications to also include regimen with daratumumab plus dexamethasone, updated NCCN recommendations

Internal Medical Policy Committee 7-22-2021 Updated NCCN recommendations and diagnosis codes

Internal Medical Policy Committee 7-21-2022 Added additional diagnosis codes and remove diagnosis code Z85.79, removed NCCN recommendations and added this statement "Carfilzomib (Kyprolis) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations." and updated the experimental/investigational statement

Links

References (PDF)

Disclaimer

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