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Bendamustine (Treanda, Bendeka, Belrapzo™)

Section: Injections
Effective Date: October 01, 2019
Revised Date: September 30, 2019

Description

Bendamustine (Treanda, Bendeka, Belrapzo™) is used in treating certain types of cancers, classified as a bifunctional alkylating agent and is a nitrogen mustard analogue. It can be used as a single agent or in combination with other cancer treating agents in certain types of cancers.

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.

Food and Drug Administration (FDA) Indications:

The use of bendamustine (Treanda, Bendeka, Belrapzo) may be considered medically necessary for the following conditions:

Chronic Lymphocytic Leukemia (CLL)

  • As treatment of individuals with CLL; or

Non-Hodgkin Lymphoma (NHL)

  • Indolent B-cell NHL as therapy that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

The use of bendamustine (Treanda, Bendeka, Belrapzo) for all other indications is considered experimental/investigational, and therefore, non-covered. Scientific evidence does not support its use for any other indication.

Procedure Codes

J9033 J9034 J9036

National Comprehensive Cancer Network (NCCN) Recommendations:

Hodgkin lymphoma

  • Classical Hodgkin lymphoma as:
    • Additional therapy as a single agent for refractory or relapsed disease; or
    • Palliative therapy as a single agent for older adults (age greater than 60).

Multiple myeloma:

  • Therapy for previously treated myeloma for disease relapse or for progressive or refractory disease as;
    • A single agent or in combination with lenalidomide and dexamethasone; or
    • In combination with bortezomib and dexamethasone.

Non-Hodgkin lymphoma (NHL)

  • Adult T-Cell Leukemia/Lymphoma as:
    • Therapy for non-responders to first-line therapy for acute disease or lymphoma.
  • AIDS-Related B-Cell Lymphoma as:
    • Second-line or subsequent therapy with or without rituximab for relapse of AIDS related:
      • Diffuse large B-cell lymphoma; or
      • Primary effusion lymphoma; or
      • Lymphoma associated with Castleman's disease in non-candidates for high-dose therapy.
  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) as:
    • First-line therapy with or without rituximab for CLL/SLL without del(17p)/TP53 mutation with or without del(11q)/TP53 mutation and with or without del(11q) in patients age greater than or equal to 65 years or for younger patients with or without significant comorbidities who have indications for treatment; or
    • Therapy for relapsed or refractory disease with or without del(17p)/TP53 mutation with or without del(11q)/TP53 mutation and with or without del(11q) as a single agent or in combination with rituximab.
  • Diffuse Large B-Cell Lymphoma as a:
    • Second-line or subsequent therapy with or without rituximab for relapsed or refractory disease in non-candidates for high-dose therapy.
  • Follicular Lymphoma as a:
    • First-line therapy in combination with rituximab for stage I or II disease or for patients indications for treatment with stage II bulky, III, or IV disease; or
    • Second-line or subsequent therapy as a single agent or in combination with rituximab for refractory or progressive disease.
  • Gastric MALT Lymphoma used in patients with indications for treatment as:
    • First-line therapy in combination with rituximab for stage IIIE-IV disease; or
    • Additional therapy in combination with rituximab for stage IE-IIE disease; or
    • Second-line or subsequent therapy for recurrent or progressive disease with rituximab with or without rituximab.
  • Mantle Cell Lymphoma used for stage I-II disease or aggressive stage II bulky, III, or IV disease as:
    • A less aggressive induction therapy with rituximab; or
    • A second-line therapy with or without rituximab for relapsed, refractory, or progressive disease.
  • Mycosis Fungoides (MF)/Sezary Syndrome (SS) single-agent therapy for tumors with aggressive growth rate for:
    • Stage IB-IIA MF with histologic evidence of folliculotropic; or
    • Large cell transformation or stage IIB with generalized extent tumor; or
    • Transformed, and/or folliculotropic disease with or without skin-directed therapy; or
    • Stage IV non-Sezary or visceral disease.
  • Non-Gastric MALT Lymphoma as a:
    • First-line therapy for stage IV disease or recurrent stage I-II disease in combination with rituximab; or
    • Second-line or subsequent therapy for refractory or progressive disease as a single agent or in combination with rituximab.
  • Peripheral T-Cell Lymphoma as a second-line or subsequent therapy for:
    • Relapsed or refractory angioimmunoblastic T-cell lymphoma; or
    • Peripheral T-cell lymphoma not otherwise specified; or
    • Anaplastic large cell lymphoma; or
    • Enteropathy-associated T-cell lymphoma.
  • Primary Cutaneous B-Cell Lymphoma, primary cutaneous marginal zone, or follicle center lymphoma used in combination with rituximab as a:
    • First-line therapy for generalized extracutaneous disease; or
    • Therapy for very extensive or refractory generalized T3 cutaneous disease; or
    • Second-line or subsequent therapy for refractory or progressive generalized extracutaneous disease; or
    • Second-line or subsequent therapy with or without rituximab for relapsed or refractory primary cutaneous diffuse large B-cell lymphoma, leg type in non-candidates for high dose therapy.
  • Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders as a single-agent therapy for relapsed or refractory disease for:
    • Primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions; or
    • Cutaneous ALCL with regional nodes (excludes systemic ALCL).
  • Splenic Marginal Zone Lymphoma as a:
    • First-line therapy in combination with rituximab for progressive disease following initial treatment for splenomegaly; or
    • Second-line or subsequence therapy for refractory or progressive disease as a single agent or in combination with rituximab.

Small Cell Lung Cancer (SCLC)

  • Subsequent chemotherapy for patients with performance status 0-2 as a single agent for:
    • Relapses within 6 months following complete or partial response or stable disease with initial treatment; or
    • For primary progressive disease.

Waldenstr m’s Macroglobulinemia/Lymphoplasmacytic Lymphoma

  • Used with rituximab or as a single agent as ANY of the following:
    • Primary therapy; or
    • Therapy for previously treated disease that does not respond to primary therapy; or
    • For progressive or relapsed disease.

The use of bendamustine (Treanda, Bendeka, Belrapzo) for all other indications is considered experimental/investigational, and therefore, non-covered. Scientific evidence does not support its use for any other indication.

Procedure Codes

J9033 J9034 J9036

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. BCBSND may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Covered Diagnosis codes for Procedure Codes J9033, J9034, and J9036

B20 C7A.1 C33 C34.00 C34.01 C34.02 C34.10
C34.11 C34.12 C34.2 C34.30 C34.31 C34.32 C34.80
C34.81 C34.82 C34.90 C34.91 C34.92 C78.00 C78.01
C78.02 C79.31 C79.51 C79.52 C81.10 C81.11 C81.12
C81.13 C81.14 C81.15 C81.16 C81.17 C81.18 C81.19
C81.20 C81.21 C81.22 C81.23 C81.24 C81.25 C81.26
C81.27 C81.28 C81.29 C81.30 C81.31 C81.32 C81.33
C81.34 C81.35 C81.36 C81.37 C81.38 C81.39 C81.40
C81.41 C81.42 C81.43 C81.44 C81.45 C81.46 C81.47
C81.48 C81.49 C81.70 C81.71 C81.72 C81.73 C81.74
C81.75 C81.76 C81.77 C81.78 C81.79 C81.90 C81.91
C81.92 C81.93 C81.94 C81.95 C81.96 C81.97 C81.98
C81.99 C82.00 C82.01 C82.02 C82.03 C82.04 C82.05
C82.06 C82.07 C82.08 C82.09 C82.10 C82.11 C82.12
C82.13 C82.14 C82.15 C82.16 C82.17 C82.18 C82.19
C82.20 C82.21 C82.22 C82.23 C82.24 C82.25 C82.26
C82.27 C82.28 C82.29 C82.30 C82.31 C82.32 C82.34
C82.35 C82.36 C82.37 C82.38 C82.39 C82.40 C82.41
C82.42 C82.43 C82.44 C82.45 C82.46 C82.47 C82.48
C82.49 C82.50 C82.51 C82.52 C82.53 C82.54 C82.55
C82.56 C82.57 C82.58 C82.59 C82.60 C82.61 C82.62
C82.63 C82.64 C82.65 C82.66 C82.67 C82.68 C82.69
C82.80 C82.81 C82.82 C82.83 C82.84 C82.85 C82.86
C82.87 C82.88 C82.89 C82.90 C82.92 C82.93 C82.94
C82.95 C82.96 C82.97 C82.98 C82.99 C83.00 C83.01
C83.02 C83.03 C83.04 C83.05 C83.06 C83.07 C83.08
C83.09 C83.10 C83.11 C83.12 C83.13 C83.14 C83.15
C83.16 C83.17 C83.18 C83.19 C83.30 C83.31 C83.32
C83.33 C83.34 C83.35 C83.36 C83.37 C83.38 C83.39
C83.51 C83.52 C83.53 C83.54 C83.55 C83.56 C83.57
C83.58 C83.59 C83.80 C83.81 C83.82 C83.83 C83.84
C83.85 C83.86 C83.87 C83.88 C83.89 C83.90 C83.91
C83.92 C83.93 C83.94 C83.95 C83.96 C83.97 C83.98
C83.99 C84.00 C84.01 C84.02 C84.03 C84.04 C84.05
C84.06 C84.07 C84.08 C84.09 C84.10 C84.11 C84.12
C84.13 C84.14 C84.15 C84.16 C84.17 C84.18 C84.19
C84.40 C84.41 C84.42 C84.43 C84.44 C84.45 C84.46
C84.47 C84.48 C84.49 C84.60 C84.61 C84.62 C84.63
C84.64 C84.65 C84.66 C84.67 C84.68 C84.69 C84.70
C84.71 C84.72 C84.73 C84.74 C84.75 C84.76 C84.77
C84.78 C84.79 C84.90 C84.91 C84.92 C84.93 C84.94
C84.95 C84.96 C84.97 C84.98 C84.99 C84.A0 C84.A1
C84.A2 C84.A3 C84.A4 C84.A5 C84.A6 C84.A7 C84.A8
C84.A9 C84.Z0 C84.Z1 C84.Z2 C84.Z3 C84.Z4 C84.Z5
C84.Z6 C84.Z7 C84.Z8 C84.Z9 C85.10 C85.11 C85.12
C85.13 C85.14 C85.15 C85.16 C85.17 C85.18 C85.19
C85.20 C85.21 C85.22 C85.23 C85.24 C85.25 C85.26
C85.27 C85.28 C85.29 C85.80 C85.81 C85.82 C85.83
C85.84 C85.85 C85.86 C85.87 C85.88 C85.89 C86.0
C86.1 C86.2 C86.3 C86.4 C86.5 C86.6 C88.0
C88.2 C88.3 C88.4 C88.8 C88.9 C90.00 C90.02
C90.10 C90.12 C90.20 C90.22 C90.30 C90.32 C91.00
C91.02 C91.10 C91.12 C91.50 C91.52 D47.Z1 Z85.110
Z85.118 Z85.71 Z85.72 Z85.79