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, Waldenstrom’s Macroglobulinemia (Lymphoplasmacytic Lymphoma) and Systemic Light Chain Amylooidosis.

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

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

Multiple Myeloma

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

2)    For previously treated multiple myeloma for relaps

3)    Prescribed by or in consultation with an oncologist;

4)    For primary therapy, Kyprolis is prescribed in one of the following ways:

a.    In combination with dexamethasone and lenalidomide;

b.    In combination with Darzalex (daratumumab), lenalidomide, and dexamethasone;

5)    For previously treated multiple myeloma for relapsed or refractory disease, Kyprolis is prescribed in one of the following ways:

a.    In combination with dexamethasone or with lenalidomide plus dexamethasone in patients who have received one or 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) or Darzalex Faspro™ (daratumumab/hyaluronidase-fihj) and dexamethasone in patients who have received one or three lines of therapy;

d.    In combination with Sarclisa (isatuximab-irfc) and dexamethasone in patients who have received one or three lines of therapy;

e.    In combination with Xpovio (Selinexor) and dexamethasone for relapse or progressive disease;

f.     In combination with dexamethasone and cyclophosphamide, with or without thalidomide, for relapse or progressive disease;

g.    In combination with pomalidomide and dexamethasone for patients who have received at least two prior therapies, including an immunomodulatory agent and a proteasome inhibitor and who have demonstrated disease progression on or within 60 days of completion of the last therapy;

6)     Request meets one of the following (a, b, c, d, or e):*

a. Monotherapy: dose does not exceed 56 mg/m2 twice weekly each 28-day cycle;

b. With dexamethasone and lenalidomide: dose does not exceed 27 mg/m2 twice weekly 3 out of 4 weeks for twelve 28-day cycles, then 27 mg/m2 twice weekly 2 out of 4 weeks for the next six 28-day cycles for up to a total of 18 cycles;

c. With dexamethasone ± Darzalex: dose does not exceed (i or ii):

i. 70 mg/m2 once weekly each 28-day cycle;

ii. 56 mg/m2 twice weekly each 28-day cycle;

d. With dexamethasone and Sarclisa: 56 mg/m2 twice weekly each 28-day cycle;

e. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Waldenstrom’s Macroglobulinemia (lymphoplasmacytic Lymphoma) (off label)

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

5)    Dosing is consistent with FDA labeling or NCCN

Systemic Light Chain Amyloidosis (off label)

1. Diagnosis of Systemic Light Chain Amyloidosis;

2. Prescribed by or in consultation with an oncologist;

3. Age ≥ 18 years;

4. Request is for relapsed/refractory non-cardiac disease;

5. Prescribed in one of the following ways (a or b):

a. As a single agent;

b. In combination with dexamethasone;

6. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Approval Duration: 6 months

Continued Therapy

A. Multiple Myeloma (must meet all):

1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Kyprolis for a covered indication and has received this medication for at least 30 days;

2. Member is responding positively to therapy;

3. If request is for a dose increase, request meets one of the following (a, b, c, d, or e):*

a. Monotherapy: new dose does not exceed 56 mg/m2 twice weekly each 28-day cycle;

b. With dexamethasone and lenalidomide: new dose does not exceed 27 mg/m2 twice weekly 3 out of 4 weeks for twelve 28-day cycles, then 27 mg/m2 twice weekly 2 out of 4 weeks for the next six 28-day cycles for up to a total of 18 cycles;

c. With dexamethasone ± Darzalex: new does not exceed (i or ii):

i. 70 mg/m2 once weekly each 28-day cycle;

ii. 56 mg/m2 twice weekly each 28-day cycle;

d. With dexamethasone and Sarclisa: 56 mg/m2 twice weekly each 28-day cycle;

e. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: 12 months

Waldenstrom’s Macroglobulinemia (Lymphoplasmacytic Lymphoma) (off-label) (must meet all):

1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Kyprolis for a covered indication and has received this medication for at least 30 days;

2. Member is responding positively to therapy;

3. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).*

*Prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: 12 months

C. Systemic Light Chain Amyloidosis (off-label) (must meet all):

1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Kyprolis for a covered indication and has received this medication for at least 30 days;

2. Member is responding positively to therapy;

3. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).*

*Prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: 12 months

Codes Used In This BI:

J9047 Injection, carfilzomib, 1mg

1)    Kyprolis prescribing information.  Onyx Pharmaceuticals, Inc., South San Francisco, CA.  June 2022.

2)    National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed July 12, 2022.

3)    3. National Comprehensive Cancer Network. Multiple Myeloma Version 05.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Accessed July 12, 2022.National Comprehensive Cancer Network. Waldenstrom’s macroglobulinemia-lymphoplasmacytic lymphoma Version 01.2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/waldenstroms.pdf. Accessed July 12, 2022.

4)    5. National Comprehensive Cancer Network. Systemic Light Chain Amyloidosis Version 1.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/amyloidosis.pdf. Accessed July 12, 2022.

Addendum:

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

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

Effective 01/01/2024: Updated MM and Waldenstrom’s Macroglobulinemia criteria and added criteria for systemic light chain amyloidosis.