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Date Printed: August 18, 2017: 10:14 AM

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09-J2000-40

Original Effective Date: 06/15/14

Reviewed: 06/14/17

Revised: 07/15/17

Subject: Bendamustine HCl (Bendeka®, Treanda®) Injection

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Bendamustine (Bendeka®, Treanda®) is an alkylating agent; similar to other alkylating agents (e.g., cisplatin), it exerts its antineoplastic activity by cross-linking DNA and ultimately resulting in DNA single-strand and double-strand breaks. Bendamustine was originally developed in 1963 and has been used in Germany since 1971; however, Treanda was not approved by the US Food and Drug Administration (FDA) until March 2008. In December 2015, a new formulation of bendamustine, Bendeka, was approved by the FDA. Compared to Treanda, Bendeka has the advantages of allowing for a lower infusion volume (50 mL vs. 500 mL) and a faster infusion time (10 minutes vs. 30 to 60 minutes). Bendeka contains different solubilizes including monothioglycerol, and polyethylene glycol 400. Currently, bendamustine is FDA-approved for the treatment of chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL). In addition to these FDA-approved indications, use in the treatment of a variety of other oncologic indications is supported by standard reference compendia (e.g., National Comprehensive Cancer Network [NCCN]). Bendamustine was granted orphan designation by the FDA for the treatment of CLL in 2007 and for the treatment of indolent B-cell NHLs in 2013.

POSITION STATEMENT:

Initiation of bendamustine (Treanda, Bendeka) meets the definition of medical necessity when used for the treatment of an indication listed in Table 1 AND the indication-specific criteria and maximum allowable dosage criteria are met.

Table 1

Indications and Specific Criteria

Indication

Specific Criteria

Maximum Allowable Dosage

Adult T-cell leukemia/lymphoma

BOTH of the following (“1” and “2”):

1. Bendamustine will be used as a single agent

2. Bendamustine is being used as second-line or later therapy for a member who did not respond to initial chemotherapy

120 mg/ m2 given twice (e.g., days 1 and 2) during every 21-day or 28-day cycle

AIDS-related B-cell lymphoma

ALL of the following (“1”, “2”, “3”, and “4”):

1. Bendamustine is being used as second-line or later therapy

2. Bendamustine will be used as a single agent or in combination with rituximab

3. Member has ANY of the following disease subtypes (“a”, “b”, or “c”):

a. Diffuse large B-cell lymphoma

b. Primary effusion lymphoma

c. HHV8-positive diffuse large B-cell lymphoma, not otherwise specified (NOS)

4. The member is NOT a candidate for high-dose therapy

120 mg/ m2 given twice (e.g., days 1 and 2) during every 21-day or 28-day cycle

Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)

BOTH of the following (“1” and “2”):

1. Bendamustine will be used as a single agent or in combination with rituximab

2. The member does NOT have the del(17p) mutation, or the del(17p) mutation status is unknown

100 mg/ m2 given twice (e.g., days 1 and 2) during every 28-day cycle

Classical Hodgkin’s lymphoma (CHL)

BOTH of the following (“1” and “2”):

1. Bendamustine will be used as a single agent

2. Bendamustine is being used as second-line or later therapy for relapsed or refractory disease

120 mg/ m2 given twice (e.g., days 1 and 2) of every 28-day cycle

Diffuse large B-Cell lymphoma (DLBCL)

ALL of the following (“1”, “2”, and “3”):

5. Bendamustine is being used as second-line or later therapy

6. Bendamustine will be used as a single agent or in combination with rituximab

7. The member is NOT a candidate for high-dose therapy

120 mg/ m2 given twice (e.g., days 1 and 2) of every 21-day or 28-day cycle

Follicular lymphoma

EITHER of the following (“1” or “2”):

1. BOTH of the following (“a” and “b”):

a. Bendamustine is being used as first-line therapy

b. Bendamustine will be used in combination with either rituximab or obinutuzumab (Gazyva)

2. BOTH of the following (“a” and “b”):

a. Bendamustine is being used as second-line or later therapy for relapsed or refractory disease

b. Bendamustine will be used as a single agent, or in combination with either rituximab or obinutuzumab

120 mg/ m2 given twice (e.g., days 1 and 2) of every 21-day or 28-day cycle

Gastric MALT lymphoma

EITHER of the following (“1” or “2”):

1. ALL of the following (“a”, “b”, and “c”):

a. Bendamustine is being used as first-line therapy

b. Member has stage IV disease (i.e., T1-4 N3 M0, or T1 N0-3 M1)

c. Bendamustine will be used in combination with rituximab

2. BOTH of the following (“a” and “b”):

a. Bendamustine is being used as second-line or later therapy for recurrent or progressive disease

b. Bendamustine will be used as a single agent, or in combination with either rituximab or obinutuzumab

120 mg/ m2 given twice (e.g., days 1 and 2) of every 21-day or 28-day cycle

Mantle cell lymphoma

EITHER of the following (“1” or “2”):

1. BOTH of the following (“a” and “b”):

a. Bendamustine is being used as less aggressive induction therapy

b. Bendamustine will be used in combination with rituximab

2. BOTH of the following (“a” and “b”):

a. Bendamustine is being used as second-line or later therapy for members with a partial response to induction therapy or for relapsed, refractory, or progressive disease

b. Bendamustine will be used as a single agent or in combination with rituximab

120 mg/ m2 given twice (e.g., days 1 and 2) of every 21-day or 28-day cycle

Multiple myeloma (MM)

ALL of the following (“1”. “2”, and “3”):

1. The member has previously-treated relapsed, refractory, or progressive disease

2. ANY of the following (“a”, “b”, or “c”):

a. Bendamustine will be used as a single agent

b. Bendamustine will be used as triplet therapy in combination with both lenalidomide (Revlimid) and dexamethasone

c. Bendamustine will be used as triplet therapy in combination with both bortezomib (Velcade) and dexamethasone

3. Laboratory documentation of the member’s baseline (i.e., within 60 days prior to initiating treatment with bendamustine) serum monoclonal protein (M-protein), as detected by serum protein electrophoresis (SPEP), is provided*

*If the M-protein is undetectable by SPEP, documentation of a baseline serum free light chain assay (SFLCA) must also be provided

Single-agent therapy:

100 mg/ m2 given twice (e.g., days 1 and 2) during every 28-day cycle

Combination therapy:

75 mg/ m2 given twice (e.g., days 1 and 2; days 1 and 8) during every 28-day cycle

Mycosis Fungoides (MF)/Sézary Syndrome (SS)

BOTH of the following (“1” and “2”):

1. Bendamustine will be used as a single-agent

2. ANY of the following (“a”, “b” or “c”):

a. Stage IB to IIA disease with histologic evidence of folliculotropic or large cell transformation

b. Stage IIB disease with generalized tumor lesions (with or without skin-directed therapy)

c. Stage IV non-Sézary or visceral disease

120 mg/ m2 given twice (e.g., days 1 and 2) during every 21-day or 28 day cycle

Nodal marginal zone lymphoma

EITHER of the following (“1” or “2”):

1. ALL of the following (“a”, “b”, and “c”):

a. Bendamustine is being used as first-line therapy

b. Member has stage III or IV disease

c. Bendamustine will be used in combination with rituximab

2. BOTH of the following (“a” and “b”):

a. Bendamustine is being used as second-line or later therapy for refractory or progressive disease

b. Bendamustine will be used as a single agent, or in combination with either rituximab or obinutuzumab

120 mg/ m2 given twice (e.g., days 1 and 2) of every 21-day or 28-day cycle

Non-gastric MALT lymphoma

EITHER of the following (“1” or “2”):

1. ALL of the following (“a”, “b”, and “c”):

a. Bendamustine is being used as first-line therapy

b. Member has stage IV disease

c. Bendamustine will be used in combination with rituximab

2. BOTH of the following (“a” and “b”):

a. Bendamustine is being used as second-line or later therapy for refractory or progressive disease

b. Bendamustine will be used as a single agent, or in combination with either rituximab or obinutuzumab

120 mg/ m2 given twice (e.g., days 1 and 2) of every 21-day or 28-day cycle

Peripheral T-cell lymphoma (PTCL)

ALL of the following (“1”, “2”, and “3”):

1. Bendamustine will be used as a single agent

2. Bendamustine will be used as second-line or later therapy for relapsed or refractory disease

3. The member has ANY of the following disease subtypes:

a. Anaplastic large cell lymphoma (ALCL)

b. Angioimmunoblastic T-cell lymphoma (AITL)

c. Enteropathy-associated T-cell lymphoma (EATL)

d. Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)

e. Peripheral T-cell lymphoma, not otherwise specified (NOS)

120 mg/ m2 given twice (e.g., days 1 and 2) during every 21-day or 28-day cycle

Primary cutaneous B-cell lymphomas

Bendamustine will be used for treatment of EITHER of the following disease subtypes (“1” or “2”):

1. Primary cutaneous marginal zone lymphoma or follicle center lymphoma and ANY of the following (“a”, “b”, or “c”):

a. First-line therapy for newly diagnosed generalized extracutaneous disease in combination with rituximab

b. Second-line therapy for refractory generalized cutaneous disease as a single agent or in combination with either rituximab or obinutuzumab

c. Second-line or later therapy for relapsed generalized extracutaneous disease as a single agent or in combination with either rituximab or obinutuzumab

2. Primary cutaneous diffuse large B-cell lymphoma, leg type and ALL of the following:

a. Bendamustine will be used as second-line or later therapy for relapsed or refractory disease

b. Bendamustine will be used as a single agent or in combination with rituximab

c. The member is NOT a candidate for high-dose therapy

120 mg/ m2 given twice (e.g., days 1 and 2) of every 21-day or 28-day cycle

Primary cutaneous CD30+ T-cell lymphoproliferative disorders

BOTH of the following (“1” and “2”):

1. Bendamustine will be used as a single agent

2. The member has EITHER of the following disease subtypes (“a” or “b”):

a. Relapsed or refractory primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions

b. Relapsed or refractory cutaneous ALCL with regional nodes (excludes systemic ALCL)

120 mg/ m2 given twice (e.g., days 1 and 2) of every 21-day or 28-day cycle

Splenic marginal zone lymphoma

EITHER of the following (“1” or “2”):

1. ALL of the following (“a”, “b”, or “c”):

a. Member has had disease progression following splenectomy, or is not a surgical candidate

b. Bendamustine is being used as first-line medical therapy

c. Bendamustine will be used combination with rituximab

2. BOTH of the following (“a” and “b”):

a. Bendamustine is being used as second-line or later medical therapy for progressive or refractory disease

b. Bendamustine will be used as a single agent, or in combination with either rituximab or obinutuzumab

120 mg/m2 given twice (e.g., days 1 and 2) of every 21-day or 28-day cycle

Waldenström’s macroglobulinemia (a.k.a., lymphoplasmacytic lymphoma)

ALL of the following (“1”, “2”, and “3”):

1. EITHER of the following (“a” or “b”):

a. Member is symptomatic (e.g., hyperviscosity, neuropathy, symptomatic adenopathy or organomegaly, amyloidosis, cryoglobulinemia, cold agglutinin disease, presence of cytopenia), AND treatment is being used as primary therapy

b. Treatment is for previously-treated relapsed or progressive disease

2. Bendamustine will be used as either single agent therapy OR in combination with rituximab

3. Documentation of the member’s baseline (i.e., within 60 days prior to initiating treatment with bendamustine) serum IgM level is provided

90 mg/m2 given twice (e.g., days 1 and 2) during every 28-day cycle

Approval duration: 6 months

Continuation of bendamustine meets the definition of medical necessity when ALL of the following criteria are met:

1. An authorization/reauthorization for bendamustine has been previously approved by Florida Blue or another health plan in the past 2 years for anindication listed in Table 1, OR the member previously met ALL indication-specific initiation criteria

2. Member’s disease has not progressed during treatment with bendamustine

3. The dose of bendamustine does not exceed the maximum allowable dosage listed in Table 1 for the member’s indication, UNLESS a higher dosage was previously authorized by Florida Blue

Approval duration: 12 months

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved: bendamustine is indicated for the treatment of CLL, and indolent B-Cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The recommended dosing for bendamustine is based on indication and is described in Table 2.

Table 2: Approved Dosing and Administration

Indication

Dosing/Administration

Dose Modifications

CLL

100 mg/m2 IV over 30 minutes (for Treanda) or 10 minutes (for Bendeka) on days 1 and 2 of a 28 day cycle, up to 6 cycles

1. Hematologic toxicity

a. Grade 3 or greater: reduce to 50 mg/m2 on days 1 and 2 of each cycle

b. Recurrence of grade 3 or greater: reduce to 25 mg/m2 on days 1 and 2 of each cycle

2. Non-hematologic toxicity: clinically significant Grade 3 or greater, reduce to 50 mg/m2 on days 1 and 2 of each cycle

3. Dose re-escalation may be considered

NHL

120 mg/m2 IV over 60 minutes (for Treanda) or 10 minutes (for Bendeka) on days 1 and 2 of a 21 day cycle, up to 8 cycles

1. Hematologic toxicity

a. Grade 4: reduce the dose to 90 mg/m2 on days 1 and 2 of each cycle

b. Recurrence of grade 4: reduce dose to 60 mg/m2 on days 1 and 2 of each cycle

2. Non-hematologic toxicity

a. Grade 3 or greater: reduce the dose to 90 mg/m2 on days 1 and 2 of each cycle

b. Recurrence of grade 3 or greater: reduce dose to 60 mg/m2 on days 1 and 2 of each cycle

CLL, chronic lymphocytic leukemia; NHL, non-Hodgkin lymphoma; IV, intravenous

General dosing considerations: delay treatment for Grade 4 hematologic toxicity or clinical significant grade 2 or greater non-hematologic toxicity.

Renal impairment: Do not use if CRC is < 40 mL/min. Use with caution in lesser degrees of renal impairment.

Hepatic impairment: Do not use in moderate or severe hepatic impairment (Child-Pugh Category B or C). Use with caution in mild hepatic impairment.

Do NOT use bendamustine injection with devices that contain polycarbonate or acrylonitrile-butadiene-styrene (ABS), including most Closed System Transfer Devices (CSTDs).

Product Availability:

Treanda - 25 or 100 mg lyophilized powder in single-use vials that must be reconstituted prior to infusion, and 45 mg/0.5 mL and 180 mg/2 mL solution in single-use vials (90 mg/mL). The solutions must be stored refrigerated between 2°- 8°C (36°- 46°F) and protected from light. The powder may be stored up to 25°C (77°F) with excursions permitted up to 30°C (86°F) and protected from light.

Bendeka - 100 mg/4 mL solution in multiple-dose vials (25 mg/mL). Store refrigerated between 2°- 8°C (36°- 46°F) and protect from light

PRECAUTIONS:

Boxed Warning: none

Contraindications:

Prior history of hypersensitivity reactions to bendamustine (both Treanda and Bendeka), or polyethylene glycol 400, propylene glycol, or monothioglycerol (Bendeka only)

Warnings:

Myelosuppression:  Delay or reduce dose. Restart treatment based on ANC and platelet count recovery. Complications of myelosuppression may lead to death.

Infections:  Monitor for fever and other signs of infection and treat promptly.

Anaphylaxis and Infusion Reactions: Severe and anaphylactic reactions have occurred; monitor clinically and discontinue bendamustine. Pre-medicate in subsequent cycles for milder reactions.

Tumor Lysis Syndrome:  Acute renal failure and death; anticipate and use supportive measures.

Skin Reactions:  Discontinue for severe skin reactions. Cases of SJS and TEN, some fatal, have been reported when bendamustine was administered concomitantly with allopurinol and other medications known to cause these syndromes.

Hepatotoxicity: Fatal and serious cases of liver injury have been reported. Monitor liver chemistry tests prior to and during treatment

Other Malignancies: Pre-malignant and malignant diseases have been reported.

Extravasation: Assure good venous access and monitor infusion site during and after administration.

Embryo-fetal toxicity: Fetal harm can occur when administered to a pregnant woman. Women should be advised to avoid becoming pregnant when receiving bendamustine.

Drug Interactions: Concomitant CYP1A2 inducers or inhibitors have the potential to affect the exposure of bendamustine.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding (Treanda®)

J9033

Injection, bendamustine HCl (Treanda), 1 mg

HCPCS Coding (Bendeka®)

J9034

Injection, bendamustine HCl (Bendeka), 1 mg

ICD-10 Diagnoses Codes That Support Medical Necessity:

B20 w/ C83.39

Human immunodeficiency virus [HIV] disease; Diffuse large B-cell lymphoma, extranodal and solid organ sites

C81.00 – C81.09

Nodular lymphocyte predominant Hodgkin lymphoma

C81.10 – C81.19

Nodular sclerosis classical Hodgkin lymphoma

C81.20 – C81.29

Mixed cellularity classical Hodgkin lymphoma

C81.30 – C81.39

Lymphocyte depleted classical Hodgkin lymphoma

C81.40 – C81.49

Lymphocyte-rich classical Hodgkin lymphoma

C81.70 – C81.79

Other classical Hodgkin lymphoma

C81.90 – C81.99

Hodgkin lymphoma, unspecified

C82.90 – C82.99

Follicular lymphoma, unspecified

C83.10 – C83.19

Mantle Cell lymphoma

C83.30 – C83.39

Diffuse large B-cell lymphoma

C83.50 – C83.59

Lymphoblastic (diffuse) lymphoma

C83.80 – C83.89

Other non-follicular lymphoma

C84.40 – C84.49

Peripheral T-cell lymphoma, not classified

C84.60 – C84.69

Anaplastic large cell lymphoma, ALK-positive

C84.70 – C84.79

Anaplastic large cell lymphoma, ALK-negative

C85.80 – C85.89

Other specified types of non-Hodgkin lymphoma

C88.0

Waldenström macroglobulinemia

C88.8

Other malignant immunoproliferative diseases

C90.00

Multiple myeloma not having achieved remission

C90.02

Multiple myeloma in relapse

C90.10

Plasma cell leukemia not having achieved remission

C90.12

Plasma cell leukemia in relapse

C90.20

Extramedullary plasmacytoma not having achieved remission

C90.22

Extramedullary plasmacytoma in relapse

C90.30

Solitary plasmacytoma not having achieved remission

C90.32

Solitary plasmacytoma in relapse

C91.10

Chronic lymphocytic leukemia of B-cell type not having achieved remission

C91.12

Chronic lymphocytic leukemia of B-cell type in relapse

D47.Z9

Other specified neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) was found at the time of the last guideline review date. The following Local Coverage Determination (LCD) was reviewed on the last guideline review date: bendamustine hydrochloride (Treanda, Bendeka), (L33268) located at fcso.com.

DEFINITIONS:

None.

RELATED GUIDELINES:

Bortezomib (Velcade) Injection, 09-J0000-92
Doxorubicin HCl Liposome (Doxil) Injection, 09-J0000-91

Ibrutinib (Imbruvica), 09-J2000-09

Idelalisib (Zydelig) Oral Tablet - 09-J2000-23

Lenalidomide (Revlimid), 09-J0000-08

Obinutuzumab (Gazyva), 09-J2000-07

Procarbazine (Matulane) Capsules, 09-J1000-59

Rituximab (Rituxan), 09-J0000-59

Thalidomide (Thalomid) Capsules, 09-J1000-56

Vorinostat (Zolinza) Capsules, 09-J1000-54

OTHER:

None.

REFERENCES:

  1. Bendeka (bendamustine) [package insert]. Teva Pharmaceuticals USA, Inc. North Wales (PA): February 2017.
  2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2017. Available at: www.clinicalpharmacilogy-ip.com. Accessed 4/20/17.
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  4. Eichhorst B, Fink AM, Bahlo J, et al; German CLL Study Group (GCLLSG). First-line chemoimmunotherapy with bendamustine and rituximab versus fludarabine, cyclophosphamide, and rituximab in patients with advanced chronic lymphocytic leukaemia (CLL10): an international, open-label, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2016 Jul;17(7):928-42.
  5. Fischer K, Cramer P, Busch R, et al. Bendamustine combined with rituximab in patients with relapsed and/or refractory chronic lymphocytic leukemia: a multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2011 Sep 10;29(26):3559-66.
  6. Fischer K, Cramer P, Busch R, et al. Bendamustine in combination with rituximab for previously untreated patients with chronic lymphocytic leukemia: a multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2012 Sep 10;30(26):3209-16.
  7. Gertz MA. Waldenström macroglobulinemia: 2017 update on diagnosis, risk stratification, and management. Am J Hematol. 2017 Feb;92(2):209-217.
  8. Knauf WU, Lissitchkov T, Aldaoud A, et al. Bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukaemia: updated results of a randomized phase III trial. Br J Haematol. 2012 Oct;159(1):67-77
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  11. Ludwig H, Kasparu H, Leitgeb C, et al. Bendamustine-bortezomib-dexamethasone is an active and well-tolerated regimen in patients with relapsed or refractory multiple myeloma. Blood. 2014 Feb 13;123(7):985-91.
  12. Michael M, Bruns I, Bölke E, et al. Bendamustine in patients with relapsed or refractory multiple myeloma. Eur J Med Res. 2010 Jan 29;15(1):13-9.
  13. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 4/20/17.
  14. Moskowitz AJ, Hamlin PA Jr, Perales MA, et al. Phase II study of bendamustine in relapsed and refractory Hodgkin lymphoma. J Clin Oncol. 2013 Feb 1;31(4):456-60.
  15. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed 4/20/17.
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  17. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (Version 2.2017) [cited2017 April 26]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/cll.pdf
  18. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Hodgkin Lymphoma (Version 1.2017) [cited 2017 April 26]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/hodgkins.pdf
  19. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Multiple Myeloma (Version 3.2017) [cited 2017 April 26]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf
  20. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Primary Cutaneous B-cell Lymphomas (Version 1.2017) [cited 2017 April 26]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/pcbcl.pdf
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  23. Offidani M, Corvatta L, Maracci L, et al. Efficacy and tolerability of bendamustine, bortezomib and dexamethasone in patients with relapsed-refractory multiple myeloma: a phase II study. Blood Cancer J. 2013 Nov 22;3:e162.
  24. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2017 [cited 2017 April 20]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  25. Rummel MJ, Niederle N, Maschmeyer G, et al.; Study group indolent Lymphomas (StiL). Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet. 2013 Apr 6;381(9873):1203-10
  26. Sehn LH, Chua N, Mayer J, et al. Obinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non-Hodgkin lymphoma (GADOLIN): a randomised, controlled, open-label, multicentre, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1081-93.
  27. Tedeschi A, Picardi P, Ferrero S, et al. Bendamustine and rituximab combination is safe and effective as salvage regimen in Waldenström macroglobulinemia. Leuk Lymphoma. 2015;56(9):2637-42.
  28. Treanda (bendamustine) [package insert]. Teva Pharmaceuticals USA, Inc. North Wales (PA): October 2016.
  29. Treon SP, Hanzis C, Tripsas C, et al. Bendamustine therapy in patients with relapsed or refractory Waldenström's macroglobulinemia. Clin Lymphoma Myeloma Leuk. 2011 Feb;11(1):133-5.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 6/14/17.

GUIDELINE UPDATE INFORMATION:

06/15/14

New Medical Coverage Guideline.

06/15/15

Review and revision to guideline; consisting of updating position statement, dosing/administration, coding, and references.

10/01/15

Revision consisting of update to Program Exceptions section.

03/15/16

Revision consisting of update to description, dosage/administration, coding/billing, and references.

06/15/16

Review and revision to guideline consisting of updating the position statement and references.

01/01/17

Revision: added HCPCS code J9034.

02/15/17

Revision to guideline consisting of updating the description, position statement, and references based on an update to the NCCN guidelines for B-cell lymphomas.

07/15/17

Review and revision to guideline consisting of updating and reformatting the position statement and updating the precautions and references.

Date Printed: August 18, 2017: 10:14 AM