Coverage Policies

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Effective Date: 01/01/2013 Title: Kyprolis (Carfilzomib)
Revision Date: 12/01/2021 Document: BI385:00
CPT Code(s): J9047
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Kyprolis requires prior authorization.

2)    Kyprolis is used to treat multiple myeloma and Waldenstrom’s Macroglobulinemia (Lymphoplasmacytic Lymphoma).

3)    Kyprolis is an injectable product covered under the medical benefit as a specialty drug.

Medical Statement

Kyprolis is considered medically necessary for patients who meet all of the following criteria:

1)    Diagnosis of multiple myeloma (C90.00, C90.02)   AND

2)    For previously treated multiple myeloma for relapsed and refractory disease, Kyprolis is prescribed in one of the following ways (a, b, or c):

a.    In combination with dexamethasone or with Revlimid (lenalidomide) plus dexamethasone in patients who have received oneo r three lines of therapy;

b.    As a single agent in patients who have received one or more lines of therapy;

c.    In combination with Darzalex (daratumumab) and dexamethasone in patients who have received one or three lines of therapy;




3)     Will be used with Revlimid (lenalidomide) and dexamethasone as first-line treatment of multiple myeloma.  OR

4)    Will be used with dexamethasone and cyclophosphamide as first-line treatment of multiple myeloma.


Kyprolis is also considered medically necessary for patients who meet all the following critera:

1)    Diagnosis of Waldenstrom’s macroglobulinemia (i.e., lymphoplasmacytic lymphoma) (WM/LP);

2)    Prescribed by or in consultation with an oncologist;

3)    Age 18 years or older;

4)    Prescribed as a component of CaRD (carfilzomib, Rituxan [rituximab), and dexamethasone regimen as primary or Kyprolis-relapsed therapy


Codes Used In This BI:


J9047 Injection, carfilzomib, 1mg


1)    Kyprolis prescribing information.  Onyx Pharmaceuticals, Inc., South San Francisco, CA.  July 2012.

2)    Clinical Pharmacology.  Accessed online November 26, 2012.

3)    National Comprehensive Cancer network (NCCN) Guidelines.  Version 1.2012 Multiple Myeloma.

4)    NCCN Drugs & Biologics Compendium. Accessed online 10-08-2021.


Effective 12/01/2021: Added coverage criteria for Waldenstrom’s macroglobulinemia

Effective 01/01/2023” Updated criteria for multiple myeloma.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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