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)    All bendamustine products require pre-authorization.

2)    Bendamustine) is an intravenous medication used to treat Chronic Lymphocytic leukemia and some forms of lymphoma.

3)    All bendamustine products are covered under the medical benefit as a specialty drug.

I.     Initial Approval Criteria

A.   Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (must meet all):

1.    Diagnosis of chronic lymphocytic leukemia (CLL) (i.e., small lymphocytic lymphoma [SLL]);

2.    Prescribed by or in consultation with an oncologist or hematologist;

3.    Age ≥ 18 years;

4.    Prescribed in combination with rituximab, Arzerra®, or Gazyva®;

5.    Request meets one of the following (a or b):*

a.    Dose does not exceed 100 mg/m2 on Days 1 and 2 of a 28-day cycle, up to 6 cycles;

b.    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: 6 months

B.   Non-Hodgkin B-Cell Lymphomas (must meet all):

1.    One of the following diagnoses (a through k):

a.    Indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen;

b.    Follicular lymphoma;

c.    Gastric MALT lymphoma;

d.    Nongastric MALT lymphoma;

e.    Nodal marginal zone lymphoma;

f.     Splenic marginal zone lymphoma;

g.    Mantle cell lymphoma;

h.    Diffuse large B-cell lymphoma (DLBCL) (as subsequent therapy);*

i.      AIDS-related B-cell lymphoma (as subsequent therapy);*

j.      Monomorphic post-transplant lymphoproliferative disorder (PTLD) (B-cell type) (as subsequent therapy);*

k.    High-grade B-cell lymphomas: not otherwise specified or with translocations of MYC and BCL2 and/or BCL6 (double/triple hit lymphoma) (as subsequent therapy);*

*See Appendix B - prior authorization may be required for prior therapies

2.    Prescribed by or in consultation with an oncologist or hematologist;

3.    Age ≥ 18 years;

4.    For nodal/splenic marginal zone lymphoma or gastric/nongastric MALT lymphoma, prescribed in combination with rituximab or Gazyva*;

5.    For mantle cell lymphoma, prescribed in combination with rituximab;

6.    Request meets one of the following (a or b):*

a.    Dose does not exceed 120 mg/m2 on Days 1 and 2 of a 21-day cycle, up to 8 cycles;

b.    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: 6 months

C.   NCCN Recommended Uses (off-label) (must meet all):

1.    Diagnosis of one of the following (a, b, c, d, e, f, or g):

a.    Classic or nodular lymphocyte-predominant Hodgkin lymphoma (HL) (as subsequent therapy);*

b.    Pediatric HL (as re-induction or subsequent therapy);*

c.    Multiple myeloma (MM);

d.    T-cell lymphomas (i, ii, iii, or iv):

i.      Hepatosplenic T-cell lymphoma (HSTCL) (as subsequent therapy);*

ii.    Adult T-cell leukemia/lymphoma (ATLL) (as subsequent therapy);*

iii.   Peripheral T-cell lymphoma (PTCL) (as subsequent therapy)*: relapsed/refractory ALCL, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, enteropathy-associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype, or follicular T-cell lymphoma;

iv.   Breast implant-associated ALCL (as subsequent therapy);*

e.    Waldenstrom’s macroglobulinemia (i.e., lymphoplasmacytic lymphoma);

f.     Systemic light chain amyloidosis (SLCA) in combination with dexamethasone (as subsequent therapy);*

g.    Hematopoietic cell transplantation in combination with etoposide, cytarabine, and melphalan for NHL without central nervous system (CNS) disease or for HL;

2.    Prescribed by or in consultation with an oncologist or hematologist;

3.    Age ≥ 18 years, unless diagnosis is pediatric HL;

4.    Dose is within FDA maximum limit for any FDA-approved indication or 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: 6 months

II.    Continued Therapy

A.   All Indications in Section I (must meet all):

1.    Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Belrapzo, Bendeka, Treanda, or Vivimusta 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 (a or b):*

a.    New dose does not exceed (i or ii):

i.      CLL/SLL: 100 mg/m2 on Days 1 and 2 of a 28-day cycle, up to 6 cycles;

ii.    Non-Hodgkin indolent B-cell lymphoma: 120 mg/m2 on Days 1 and 2 of a 21-day cycle, up to 8 cycles;

b.    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:

J9033             Injection, Bendamustine HCl, 1 mg (Treanda)

J9034             Injection, Bendamustine HCl, 1mg (Bendeka)

J9036             Injection, bendamustine HCl, 1mg (Belrapzo)

1)    Belrapzo Prescribing Information. Woodcliff Lake, NJ: Eagle Pharmaceuticals, Inc; June 2022. Available at: www.belrapzo.com. Accessed June 24, 2022.

2)    Bendeka Prescribing Information. North Wales, PA: Teva Pharmaceuticals USA, Inc.; October 2021. Available at: http://www.bendeka.com/. Accessed June 24, 2022.

3)    Treanda Prescribing Information. North Wales, PA: Teva Pharmaceuticals USA, Inc.; June 2021. Available at: http://treandahcp.com/. Accessed June 24, 2022.

4)    Vivimusta Prescribing Information. Princeton, NJ: Slayback Pharma; December 2022. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212209s000lbl.pdf. Accessed December 27, 2022.

5)    National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed June 24, 2022.

6)    National Comprehensive Cancer Network. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Version 3.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cll.pdf. Accessed June 24, 2022.

7)    National Comprehensive Cancer Network. B-cell Lymphomas Version 4.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed June 24, 2022.

8)    National Comprehensive Cancer Network. Hodgkin Lymphoma Version 2.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/hodgkins.pdf. Accessed June 24, 2022.

9)    National Comprehensive Cancer Network. Multiple Myeloma Version 5.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Accessed June 24, 2022.

10) National Comprehensive Cancer Network. T-cell Lymphomas Version 2.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/t-cell.pdf. Accessed June 24, 2022.

National Comprehensive Cancer Network. Waldenstrom Macroglobulinemia/Lymphoplasmacytic Lymphoma Version 3.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/waldenstroms.pdf. Accessed June 24, 2022

Addendum:

Effective 08/01/2017:  Added J9034 (Bendeka) to covered codes and added additional diagnoses

Effective 10/01/2019: Added coverage criteria for Non-Hodgkins T-cell lymphoma, Hodgkin’s Lymphoma, Multiple Myeloma, and Waldenstrom’s Macroglobulinemia.

Effective 01/01/2023: Added J9036 to policy as covered with pre-authorization

Effective 03/01/2023: Added Vivimusta to coverage criteria; updated all coverage criteria.

Resource Document:

 BI036 Treanda RD

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.