vp-0130
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Bendamustine: Treanda®; Bendeka®; Belrapzo®; Vivimusta™; Bendamustine Ψ (Intravenous)

Policy Number: VP-0130

Last Review Date: 02/02/2023

Date of Origin: 01/01/12

Dates Reviewed: 12/2011, 02/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 09/2018, 12/2018, 03/2019, 06/2019, 09/2019, 12/2019, 03/2020, 06/2020, 09/2020, 03/2021, 03/2022, 06/2022, 01/2023, 02/2023

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

I. Length of Authorization 1-6,9,14,18

  • Waldenström’s Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL):
    • Coverage will be provided for six months and may NOT be renewed, unless otherwise specified.
      • May be renewed for an additional six months for relapsed disease if previously used as primary therapy.
  • Non-Hodgkin Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL), Hodgkin Lymphoma, Systemic Light Chain Amyloidosis: 
    • Coverage will be provided for six months and may NOT be renewed.
  • Multiple Myeloma: 
    • Coverage will be provided for eight months and may NOT be renewed.
  • HSCT Conditioning: 
    • Coverage will be provided for one time only and may NOT be renewed.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Treanda 100 mg single-dose vial: 6 vials every 21 days
  • Treanda 25 mg single-dose vial: 3 vials every 21 days
  • Bendeka 100 mg/4 mL multi-dose vial: 6 vials every 21 days
  • Belrapzo 100 mg/4 mL RTD multi-dose vial: 6 vials every 21 days
  • Vivimusta 100 mg/4 mL multi-dose vial: 6 vials every 21 days
  1. Max Units (per dose and over time) [HCPCS Unit]:

NHL:

  • 600 billable units every 21 days

WM/LPL:

  • 450 billable units every 28 days

Hodgkin Lymphoma:

  • 600 billable units every 28 days

CLL/SLL, Systemic Light Chain Amyloidosis & Multiple Myeloma:

  • 500 billable units every 28 days

HSCT Conditioning:

  • 1000 billable units one time only

III. Initial Approval Criteria 1-4

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age, unless otherwise specified; AND
  • Patient must not have received bendamustine in a previous line of therapy, unless otherwise specified; AND

Non-Hodgkin Lymphoma (NHL) † Ф 1-5,16

  • Coverage is provided for B-Cell Lymphomas when:
  • Used as subsequent therapy †; AND
      • In combination with rituximab for:
        •  
        • AIDS-Related Diffuse Large B-cell Lymphoma (DLBCL), primary effusion lymphoma, or HHV8-positive DLBCL, not otherwise specified (NOS)
        • Follicular Lymphoma (grade 1-2)
        • Gastric MALT Lymphoma
          • High-grade B-cell Lymphomas
          • Mantle Cell Lymphoma (may also be used as a component of RBAC500 [rituximab, bendamustine, and cytarabine])
          • Nodal Marginal Zone Lymphoma
          • Non-Gastric MALT Lymphoma (Noncutaneous)
          • Monomorphic Post-Transplant Lymphoproliferative Disorder (B-cell type)
          • Splenic Marginal Zone Lymphoma; OR
      • Used as a single agent for:
          • AIDS-Related B-cell Lymphomas (i.e., DLBCL, primary effusion lymphoma, HHV8-positive DLBCL NOS, or plasmablastic lymphoma in non-candidates for transplant)
          • Follicular Lymphoma (grade 1-2)
          • High-grade B-cell Lymphomas
          • Monomorphic Post-Transplant Lymphoproliferative Disorder (B-cell type); OR
      • In combination with obinutuzumab for:
          • Follicular Lymphoma (grade 1-2)
          • Gastric MALT Lymphoma
          • Nodal Marginal Zone Lymphoma
          • Non-Gastric MALT Lymphoma (Noncutaneous)
          • Splenic Marginal Zone Lymphoma; OR
      • In combination with polatuzumab (with or without rituximab) for:
          • AIDS-Related DLBCL, primary effusion lymphoma, or HHV8-positive DLBCL, NOS
          • AIDS-Related plasmablastic lymphoma in non-candidates for transplant (excluding use with rituximab)
          • DLBCL
          • Follicular Lymphoma (grade 1-2)
          • Histologic transformation of indolent lymphomas to DLBCL
          • High-grade B-cell Lymphomas
          • Monomorphic Post-Transplant Lymphoproliferative Disorder (B-cell type); OR
  • Used as first line therapy ‡; AND
      • In combination with rituximab for:
        •  
        • Follicular Lymphoma (grade 1-2)
          • Gastric MALT Lymphoma
          • Mantle Cell Lymphoma (may also be used as a component of RBAC500 [rituximab, bendamustine, and cytarabine])
          • Nodal Marginal Zone Lymphoma
          • Non-Gastric MALT Lymphoma (Noncutaneous)
          • Splenic Marginal Zone Lymphoma; OR
        • In combination with obinutuzumab for:
          •  
          • Follicular Lymphoma
          • Nodal Marginal Zone Lymphoma
  • Used as CAR T-cell bridging therapy after leukapheresis ‡; AND
      • In combination with polatuzumab (with or without rituximab) for:
        •  
        • AIDS-Related DLBCL, primary effusion lymphoma, or HHV8-positive DLBCL, NOS
        • AIDS-Related plasmablastic lymphoma in non-candidates for transplant (excluding use with rituximab)
        • High-grade B-cell Lymphomas
        • DLBCL
        • Monomorphic Post-Transplant Lymphoproliferative Disorder (B-cell type)
  • Coverage is provided for the following T-Cell Lymphomas ‡
    • Adult T-Cell Leukemia/Lymphoma
      • Used as subsequent therapy for non-responders to first-line therapy as a single agent for acute or lymphoma subtypes
    • Breast Implant-Associated Anaplastic Large Cell Lymphoma (ALCL)
      • Used as subsequent therapy as a single agent for relapsed or refractory disease
    • Hepatosplenic T-Cell Lymphoma
      • Used as subsequent therapy as a single agent for refractory disease after two first-line therapy regimens
    • Peripheral T-Cell Lymphoma (includes peripheral T-cell not otherwise specified, enteropathy-associated T-cell, monomorphic epitheliotropic intestinal T-cell, angioimmunoblastic T-cell, nodal peripheral T-cell with TFH phenotype, follicular T-cell, or anaplastic large cell lymphomas)
      • Used as a single agent; AND
      • Used as subsequent therapy for relapsed or refractory disease; OR
      • Used as initial palliative intent therapy in transplant ineligible patients

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) † Ф  1-5,17

  • Used as first-line therapy; AND
    • Used as a single agent †; OR
    • Used in combination with rituximab or obinutuzumab for disease without del(17p)/TP53 mutations (excluding use in frail patients [i.e., not able to tolerate purine analogs]); OR
  • Used as subsequent therapy, after prior Bruton Tyrosine Kinase inhibitor- and venetoclax-based regimens; AND
    • Used in combination with rituximab for disease without del(17p)/TP53 mutations in patients <65 years of age without significant comorbidities

Waldenström’s Macroglobulinemia/Lymphoplasmacytic Lymphoma (WM/LPL) ‡ 5

  • Used as a single agent or in combination with rituximab; AND
    • Used as primary therapy; OR
    • Used for relapse, if previously used as primary therapy that was well tolerated and elicited a prolonged response; OR
    • Used as alternative therapy for previously treated disease that does not respond to primary therapy; OR
    • Used for progressive or relapsed disease

Adult Hodgkin Lymphoma ‡ 5,6

  • Patient has classic Hodgkin Lymphoma (cHL); AND
    • Used as second-line or subsequent therapy for relapsed or refractory disease; AND
      • Used in combination with gemcitabine and vinorelbine; OR
      • Used in combination with brentuximab vedotin; OR
    • Used as subsequent fourth-line therapy for relapsed or refractory disease; AND
      • Used as a single agent; OR
      • Used in combination with carboplatin and etoposide; OR
    • Used as palliative therapy as a single agent for relapsed or refractory disease in patients >60 years of age; OR
  • Patient has Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL); AND
    • Used as subsequent therapy for progressive, relapsed, or refractory disease; AND
    • Used in combination with rituximab

Pediatric Hodgkin Lymphoma ‡ 5,6

  • Patient age is 18 years and under*; AND
  • Used as re-induction therapy or subsequent therapy for relapsed or refractory disease; AND
  • Used in combination with brentuximab vedotin

* Pediatric Hodgkin Lymphoma may be applicable to adolescent and young adult (AYA) patients up to the age of 39 years.

Multiple Myeloma ‡ 5

  • Used for relapsed or progressive (after at least 3 prior therapies) disease; AND
  • Used as a single agent; OR
  • Used in combination with dexamethasone and either lenalidomide or bortezomib

Systemic Light Chain Amyloidosis ‡ 5,18

  • Patient has relapsed or refractory disease; AND
  • Used in combination with dexamethasone

Hematopoietic Cell Transplantation‡ 5,19

  • Used as conditioning for autologous transplant; AND
  • Used in combination with etoposide, cytarabine and melphalan (BEAM); AND
  • Patient has Non-Hodgkin Lymphoma without CNS disease or Hodgkin Lymphoma

† FDA-labeled indication(s); ‡ Compendia recommended indication(s); Ф Orphan Drug

IV. Renewal Criteria 1-5

Coverage may be renewed based upon the following criteria:

  • Patient continues to meet the indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe myelosuppression, infections, progressive multifocal leukoencephalopathy (PML), anaphylaxis, severe infusion reactions, tumor lysis syndrome (TLS), fatal and serious skin reactions, fatal and serious hepatotoxicity, secondary malignancies, extravasation injury, etc.; AND

Waldenström’s Macroglobulinemia/Lymphoplasmacytic Lymphoma (if bendamustine was previously used as primary therapy)

  • Refer to Section III for criteria (see WM/LPL)

All Other Indications

  • Coverage may not be renewed.

V. Dosage/Administration 1-6,9,14,18

Indication

Dose

Non-Hodgkin Lymphoma

Up to 120 mg/m² intravenously on days 1 and 2 of a 21-day cycle, up to 8 cycles

CLL/SLL & Systemic Light Chain Amyloidosis

Up to 100 mg/m² intravenously on days 1 and 2 of a 28-day cycle, up to 6 cycles

Waldenström’s Macroglobulinemia/ Lymphoplasmacytic Lymphoma

Up to 90 mg/m2 intravenously on days 1 and 2 of a 28-day cycle, up to 6 cycles

*May be repeated for relapsed disease if primary therapy was well tolerated and elicited a prolonged response.

Hodgkin Lymphoma

Up to 120 mg/m² intravenously on days 1 and 2 of a 28-day cycle, up to 6 cycles

Multiple Myeloma

Up to 100 mg/m² intravenously on days 1 and 2 of a 28-day cycle, up to 8 cycles

Conditioning for HSCT

Up to 200 mg/m² intravenously on days –7 and –6 leading up to transplant.

VI. Billing Code/Availability Information

HCPCS Code:

  • J9033 – Injection, bendamustine hcl (treanda), 1 mg; 1 billable unit = 1 mg
  • J9034 – Injection, bendamustine hcl (bendeka), 1 mg; 1 billable unit = 1 mg
  • J9036 – Injection, bendamustine hcl, (belrapzo/bendamustine), 1 mg; 1 billable unit = 1 mg
  • J9999 – Not otherwise classified, antineoplastic drugs (Applicable to other unclassified 505(b)(2) NDA not listed, inclusive of Vivimusta, ONLY) Ψ
  • C9399 – Unclassified drugs or biologicals (Applicable to other unclassified 505(b)(2) NDA not listed, inclusive of Vivimusta, ONLY) Ψ

NDC(s):

  • Treanda 100 mg lyophilized powder in a single-dose vial for reconstitution: 63459-0391-xx
  • Treanda 25 mg lyophilized powder in a single-dose vial for reconstitution: 63459-0390-xx
  • Treanda 45 mg/0.5 mL solution in a single dose vial: 63459-0395-xx * §
  • Treanda 180 mg/2 mL solution in a single dose vial: 63459-0396-xx * §
  • Bendeka 100 mg/4 mL solution in a multi-dose vial: 63459-0348-xx § Ψ
  • Belrapzo 100 mg/4 mL ready-to-dilute multi-dose vial: 42367-0521-xx Ψ
  • Vivimusta 100 mg/4 mL solution in a multi-dose vial: 71225-0120-xx Ψ
  • * No longer commercially available;
  • § Available generically from various manufacturers;

Ψ Designated products approved by the FDA as a 505(b)(2) NDA of the innovator product. These products are not rated as therapeutically equivalent to their reference listed drug in the Food and Drug Administration’s (FDA) Orange Book and are therefore considered single source products based on the statutory definition of “single source drug” in section 1847A(c)(6) of the Act. For a complete list of all approved 505(b)(2) NDA products please reference the latest edition of the Orange Book:  

 Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book | FDA

  1. References
  1. Treanda [package insert]. North Wales, PA; Cephalon, Inc; October 2022. Accessed December 2022.
  2. Bendeka [package insert]. North Wales, PA; Teva Pharmaceuticals USA, Inc.; October 2021. Accessed December 2022.
  3. Belrapzo [package insert]. Woodcliff, NJ; Eagle Pharmaceuticals, Inc; June 2022. Accessed December 2022.
  4. Vivimusta [package insert]. Princeton, NJ; Slayback Pharma, Inc; December 2022. Accessed December 2022.
  1. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for bendamustine. National Comprehensive Cancer Network, 2022. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed December 2022.
  2. Moskowitz AJ, Hamlin PA Jr, Perales MA, et al. Phase II study of bendamustine in relapsed and refractory Hodgkin lymphoma. J Clin Oncol. 2013;31(4):456-460.
  3. Kahl BS, Bartlett NL, Leonard JP, et al. Bendamustine is effective therapy in patients with rituximab-refractory, indolent B-cell non-Hodgkin lymphoma: results from a Multicenter Study. Cancer. 2010;116(1):106-114. doi:10.1002/cncr.24714.
  4. 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;159(1):67-77. doi:10.1111/bjh.12000.
  5. Rummel MJ, Niederle N, Maschmeyer G, et al. 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 [published correction appears in Lancet. 2013 Apr 6;381(9873):1184]. Lancet. 2013;381(9873):1203-1210. doi:10.1016/S0140-6736(12)61763-2.
  6. O'Connor OA, Lue JK, Sawas A, et al. Brentuximab vedotin plus bendamustine in relapsed or refractory Hodgkin's lymphoma: an international, multicentre, single-arm, phase 1-2 trial. Lancet Oncol 2018; 19:257-266.
  7. Santoro A, Mazza R, Pulsoni A, et al. Bendamustine in Combination With Gemcitabine and Vinorelbine Is an Effective Regimen As Induction Chemotherapy Before Autologous Stem-Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma: Final Results of a Multicenter Phase II Study. J Clin Oncol 2016; 34:3293.
  8. Budde LE, Wu D, Martin DB, et al. Bendamustine with rituximab, etoposide and carboplatin (T(R)EC) in relapsed or refractory aggressive lymphoma: a prospective multicentre phase 1/2 clinical trial. Br J Haematol. 2018;183(4):601-607. doi:10.1111/bjh.15585.
  9. 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;123(7):985-991. doi:10.1182/blood-2013-08-521468.
  10. Lentzsch S, O'Sullivan A, Kennedy RC, et al. Combination of bendamustine, lenalidomide, and dexamethasone (BLD) in patients with relapsed or refractory multiple myeloma is feasible and highly effective: results of phase 1/2 open-label, dose escalation study. Blood. 2012;119(20):4608-4613. doi:10.1182/blood-2011-12-395715.
  11. Knop S, Straka C, Haen M, Schwedes R, Hebart H, Einsele H. The efficacy and toxicity of bendamustine in recurrent multiple myeloma after high-dose chemotherapy. Haematologica. 2005;90(9):1287-1288.
  12. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas 5.2022. National Comprehensive Cancer Network, 2022. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed December 2022.
  13. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma 1.2023. National Comprehensive Cancer Network, 2022. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed December 2022.
  14. Lentzsch S, Lagos G, Comenzo R, et.al. Bendamustine With Dexamethasone in Relapsed/Refractory Systemic Light-Chain Amyloidosis: Results of a Phase II Study. J Clin Oncol. 2020 May 1;38(13):1455-1462. doi: 10.1200/JCO.19.01721. Epub 2020 Feb 21.
  15. Frankiewicz A, Saduś-Wojciechowska M, Najda J, et al. Comparable safety profile of BeEAM (bendamustine, etoposide, cytarabine, melphalan) and BEAM (carmustine, etoposide, cytarabine, melphalan) as conditioning before autologous haematopoietic cell transplantation. Contemp Oncol (Pozn) 2018;22:113-117

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C81.00

Nodular lymphocyte predominant Hodgkin lymphoma, unspecified site

C81.01

Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.02

Nodular lymphocyte predominant Hodgkin lymphoma, intrathoracic lymph nodes

C81.03

Nodular lymphocyte predominant Hodgkin lymphoma, intra-abdominal lymph nodes

C81.04

Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.05

Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.06

Nodular lymphocyte predominant Hodgkin lymphoma, intrapelvic lymph nodes

C81.07

Nodular lymphocyte predominant Hodgkin lymphoma, spleen

C81.08

Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of multiple sites

C81.09

Nodular lymphocyte predominant Hodgkin lymphoma, extranodal and solid organ sites

C81.10

Nodular sclerosis Hodgkin lymphoma, unspecified site

C81.11

Nodular sclerosis Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.12

Nodular sclerosis Hodgkin lymphoma, intrathoracic lymph nodes

C81.13

Nodular sclerosis Hodgkin lymphoma, intra-abdominal lymph nodes

C81.14

Nodular sclerosis Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.15

Nodular sclerosis Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.16

Nodular sclerosis Hodgkin lymphoma, intrapelvic lymph nodes

C81.17

Nodular sclerosis Hodgkin lymphoma, spleen

C81.18

Nodular sclerosis Hodgkin lymphoma, lymph nodes of multiple sites

C81.19

Nodular sclerosis Hodgkin lymphoma, extranodal and solid organ sites

C81.20

Mixed cellularity Hodgkin lymphoma, unspecified site

C81.21

Mixed cellularity Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.22

Mixed cellularity Hodgkin lymphoma, intrathoracic lymph nodes

C81.23

Mixed cellularity Hodgkin lymphoma, intra-abdominal lymph nodes

C81.24

Mixed cellularity Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.25

Mixed cellularity Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.26

Mixed cellularity Hodgkin lymphoma, intrapelvic lymph nodes

C81.27

Mixed cellularity Hodgkin lymphoma, spleen

C81.28

Mixed cellularity Hodgkin lymphoma, lymph nodes of multiple sites

C81.29

Mixed cellularity Hodgkin lymphoma, extranodal and solid organ sites

C81.30

Lymphocyte depleted Hodgkin lymphoma, unspecified site

C81.31

Lymphocyte depleted Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.32

Lymphocyte depleted Hodgkin lymphoma, intrathoracic lymph nodes

C81.33

Lymphocyte depleted Hodgkin lymphoma, intra-abdominal lymph nodes

C81.34

Lymphocyte depleted Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.35

Lymphocyte depleted Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.36

Lymphocyte depleted Hodgkin lymphoma, intrapelvic lymph nodes

C81.37

Lymphocyte depleted Hodgkin lymphoma, spleen

C81.38

Lymphocyte depleted Hodgkin lymphoma, lymph nodes of multiple sites

C81.39

Lymphocyte depleted Hodgkin lymphoma, extranodal and solid organ sites

C81.40

Lymphocyte-rich Hodgkin lymphoma, unspecified site

C81.41

Lymphocyte-rich Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.42

Lymphocyte-rich Hodgkin lymphoma, intrathoracic lymph nodes

C81.43

Lymphocyte-rich Hodgkin lymphoma, intra-abdominal lymph nodes

C81.44

Lymphocyte-rich Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.45

Lymphocyte-rich Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.46

Lymphocyte-rich Hodgkin lymphoma, intrapelvic lymph nodes

C81.47

Lymphocyte-rich Hodgkin lymphoma, spleen

C81.48

Lymphocyte-rich Hodgkin lymphoma, lymph nodes of multiple sites

C81.49

Lymphocyte-rich Hodgkin lymphoma, extranodal and solid organ sites

C81.70

Other Hodgkin lymphoma unspecified site

C81.71

Other Hodgkin lymphoma lymph nodes of head, face, and neck

C81.72

Other Hodgkin lymphoma intrathoracic lymph nodes

C81.73

Other Hodgkin lymphoma intra-abdominal lymph nodes

C81.74

Other Hodgkin lymphoma lymph nodes of axilla and upper limb

C81.75

Other Hodgkin lymphoma lymph nodes of inguinal region and lower limb

C81.76

Other Hodgkin lymphoma intrapelvic lymph nodes

C81.77

Other Hodgkin lymphoma spleen

C81.78

Other Hodgkin lymphoma lymph nodes of multiple sites

C81.79

Other Hodgkin lymphoma extranodal and solid organ sites

C81.90

Hodgkin lymphoma, unspecified, unspecified site

C81.91

Hodgkin lymphoma, unspecified, lymph nodes of head, face, and neck

C81.92

Hodgkin lymphoma, unspecified, intrathoracic lymph nodes

C81.93

Hodgkin lymphoma, unspecified, intra-abdominal lymph nodes

C81.94

Hodgkin lymphoma, unspecified, lymph nodes of axilla and upper limb

C81.95

Hodgkin lymphoma, unspecified, lymph nodes of inguinal region and lower limb

C81.96

Hodgkin lymphoma, unspecified, intrapelvic lymph nodes

C81.97

Hodgkin lymphoma, unspecified, spleen

C81.98

Hodgkin lymphoma, unspecified, lymph nodes of multiple sites

C81.99

Hodgkin lymphoma, unspecified, extranodal and solid organ sites

C82.00

Follicular lymphoma grade I, unspecified site

C82.01

Follicular lymphoma grade I, lymph nodes of head, face and neck

C82.02

Follicular lymphoma, grade I, intrathoracic lymph nodes

C82.03

Follicular lymphoma grade I, intra-abdominal lymph nodes

C82.04

Follicular lymphoma grade I, lymph nodes of axilla and upper limb

C82.05

Follicular lymphoma grade I, lymph nodes of inguinal regional and lower limb

C82.06

Follicular lymphoma grade I, intrapelvic lymph nodes

C82.07

Follicular lymphoma grade I, spleen

C82.08

Follicular lymphoma grade I, lymph nodes of multiple sites

C82.09

Follicular lymphoma grade I, extranodal and solid organ sites

C82.10

Follicular lymphoma grade II, unspecified site

C82.11

Follicular lymphoma grade II, lymph nodes of head, face and neck

C82.12

Follicular lymphoma, grade II, intrathoracic lymph nodes

C82.13

Follicular lymphoma grade II, intra-abdominal lymph nodes

C82.14

Follicular lymphoma grade II, lymph nodes of axilla and upper limb

C82.15

Follicular lymphoma grade II, lymph nodes of inguinal region and lower limb

C82.16

Follicular lymphoma grade II, intrapelvic lymph nodes

C82.17

Follicular lymphoma grade II, spleen

C82.18

Follicular lymphoma grade II, lymph nodes of multiple sites

C82.19

Follicular lymphoma grade II, extranodal and solid organ sites

C82.20

Follicular lymphoma grade III, unspecified, unspecified site

C82.21

Follicular lymphoma grade III, unspecified, lymph nodes of head, face and neck

C82.22

Follicular lymphoma, grade III, unspecified, intrathoracic lymph nodes

C82.23

Follicular lymphoma grade III, unspecified, intra-abdominal lymph nodes

C82.24

Follicular lymphoma grade III, unspecified, lymph nodes of axilla and upper limb

C82.25

Follicular lymphoma grade III, unspecified, lymph nodes of inguinal region and lower limb

C82.26

Follicular lymphoma grade III, unspecified, intrapelvic lymph nodes

C82.27

Follicular lymphoma grade III, unspecified, spleen

C82.28

Follicular lymphoma grade III, unspecified, lymph nodes of multiple sites

C82.29

Follicular lymphoma grade III, unspecified, extranodal and solid organ sites

C82.30

Follicular lymphoma grade IIIa, unspecified site

C82.31

Follicular lymphoma grade IIIa, lymph nodes of head, face and neck

C82.32

Follicular lymphoma, grade IIIa, intrathoracic lymph nodes

C82.33

Follicular lymphoma grade IIIa, intra-abdominal lymph nodes

C82.34

Follicular lymphoma grade IIIa, lymph nodes of axilla and upper limb

C82.35

Follicular lymphoma grade IIIa, lymph nodes of inguinal region and lower limb

C82.36

Follicular lymphoma grade IIIa, intrapelvic lymph nodes

C82.37

Follicular lymphoma grade IIIa, spleen

C82.38

Follicular lymphoma grade IIIa, lymph nodes of multiple sites

C82.39

Follicular lymphoma grade IIIa, extranodal and solid organ sites

C82.40

Follicular lymphoma grade IIIb, unspecified site

C82.41

Follicular lymphoma grade IIIb, lymph nodes of head, face and neck

C82.42

Follicular lymphoma, grade IIIb, intrathoracic lymph nodes

C82.43

Follicular lymphoma grade IIIb, intra-abdominal lymph nodes

C82.44

Follicular lymphoma grade IIIb, lymph nodes of axilla and upper limb

C82.45

Follicular lymphoma grade IIIb, lymph nodes of inguinal region and lower limb

C82.46

Follicular lymphoma grade IIIb, intrapelvic lymph nodes

C82.47

Follicular lymphoma grade IIIb, spleen

C82.48

Follicular lymphoma grade IIIb, lymph nodes of multiple sites

C82.49

Follicular lymphoma grade IIIb, extranodal and solid organ sites

C82.50

Diffuse follicle center lymphoma unspecified site

C82.51

Diffuse follicle center lymphoma lymph nodes of head, face, and neck

C82.52

Diffuse follicle center lymphoma intrathoracic lymph nodes

C82.53

Diffuse follicle center lymphoma intra-abdominal lymph nodes

C82.54

Diffuse follicle center lymphoma lymph nodes of axilla and upper limb

C82.55

Diffuse follicle center lymphoma lymph nodes of inguinal region and lower limb

C82.56

Diffuse follicle center lymphoma intrapelvic lymph nodes

C82.57

Diffuse follicle center lymphoma spleen

C82.58

Diffuse follicle center lymphoma lymph nodes of multiple sites

C82.59

Diffuse follicle center lymphoma extranodal and solid organ sites

C82.60

Cutaneous follicle center lymphoma, unspecified site

C82.61

Cutaneous follicle center lymphoma, lymph nodes of head, face and neck

C82.62

Cutaneous follicle center lymphoma, intrathoracic lymph nodes

C82.63

Cutaneous follicle center lymphoma, intra-abdominal lymph nodes

C82.64

Cutaneous follicle center lymphoma, lymph nodes of axilla and upper limb

C82.65

Cutaneous follicle center lymphoma, lymph nodes of inguinal region and lower limb

C82.66

Cutaneous follicle center lymphoma, intrapelvic lymph nodes

C82.67

Cutaneous follicle center lymphoma, spleen

C82.68

Cutaneous follicle center lymphoma, lymph nodes of multiple sites

C82.69

Cutaneous follicle center lymphoma, extranodal and solid organ sites

C82.80

Other types of follicular lymphoma unspecified site

C82.81

Other types of follicular lymphoma lymph nodes of head, face, and neck

C82.82

Other types of follicular lymphoma intrathoracic lymph nodes

C82.83

Other types of follicular lymphoma intra-abdominal lymph nodes

C82.84

Other types of follicular lymphoma lymph nodes of axilla and upper limb

C82.85

Other types of follicular lymphoma lymph nodes of inguinal region and lower limb

C82.86

Other types of follicular lymphoma intrapelvic lymph nodes

C82.87

Other types of follicular lymphoma spleen

C82.88

Other types of follicular lymphoma lymph nodes of multiple sites

C82.89

Other types of follicular lymphoma extranodal and solid organ sites

C82.90

Follicular lymphoma, unspecified, unspecified site

C82.91

Follicular lymphoma, unspecified, lymph nodes of head, face and neck

C82.92

Follicular lymphoma, unspecified, intrathoracic lymph nodes

C82.93

Follicular lymphoma, unspecified, intra-abdominal lymph nodes

C82.94

Follicular lymphoma, unspecified, lymph nodes of axilla and upper limb

C82.95

Follicular lymphoma, unspecified lymph nodes of inguinal region and lower limb

C82.96

Follicular lymphoma, unspecified, intrapelvic lymph nodes

C82.97

Follicular lymphoma, unspecified, spleen

C82.98

Follicular lymphoma, unspecified, lymph nodes of multiple sites

C82.99

Follicular lymphoma, unspecified, extranodal and solid organ sites

C83.00

Small cell B-cell lymphoma, unspecified site

C83.01

Small cell B-cell lymphoma, lymph nodes of head, face and neck

C83.02

Small cell B-cell lymphoma, intrathoracic lymph nodes

C83.03

small cell B-cell lymphoma, intra-abdominal lymph nodes

C83.04

Small cell B-cell lymphoma, lymph nodes of axilla and upper limb

C83.05

Small cell B-cell lymphoma, lymph nodes of inguinal region and lower limb

C83.06

Small cell B-cell lymphoma, intrapelvic lymph nodes

C83.07

Small cell B-cell lymphoma, spleen

C83.08

Small cell B-cell lymphoma, lymph nodes of multiple sites

C83.09

Small cell B-cell lymphoma, extranodal and solid organ sites

C83.10

Mantle cell lymphoma, unspecified site

C83.11

Mantle cell lymphoma, lymph nodes of head, face and neck

C83.12

Mantle cell lymphoma, intrathoracic lymph nodes

C83.13

Mantle cell lymphoma, intra-abdominal lymph nodes

C83.14

Mantle cell lymphoma, lymph nodes of axilla and upper limb

C83.15

Mantle cell lymphoma, lymph nodes of inguinal region and lower limb

C83.16

Mantle cell lymphoma, intrapelvic lymph nodes

C83.17

Mantle cell lymphoma, spleen

C83.18

Mantle cell lymphoma, lymph nodes of multiple sites

C83.19

Mantle cell lymphoma, extranodal and solid organ sites

C83.30

Diffuse large B-cell lymphoma, unspecified site

C83.31

Diffuse large B-cell lymphoma, lymph nodes of head, face and neck

C83.32

Diffuse large B-cell lymphoma intrathoracic lymph nodes

C83.33

Diffuse large B-cell lymphoma, intra-abdominal lymph nodes

C83.34

Diffuse large B-cell lymphoma, lymph nodes of axilla and upper limb

C83.35

Diffuse large B-cell lymphoma, lymph nodes of inguinal region and lower limb

C83.37

Diffuse large B-cell lymphoma, spleen

C83.38

Diffuse large B-cell lymphoma, lymph nodes of multiple sites

C83.39

Diffuse large B-cell lymphoma, extranodal and solid organ sites

C83.80

Other non-follicular lymphoma, unspecified site

C83.81

Other non-follicular lymphoma, lymph nodes of head, face and neck

C83.82

Other non-follicular lymphoma, intrathoracic lymph nodes

C83.83

Other non-follicular lymphoma, intra-abdominal lymph nodes

C83.84

Other non-follicular lymphoma, lymph nodes of axilla and upper limb

C83.85

Other non-follicular lymphoma, lymph nodes of inguinal region and lower limb

C83.86

Other non-follicular lymphoma, intrapelvic lymph nodes

C83.87

Other non-follicular lymphoma, spleen

C83.88

Other non-follicular lymphoma, lymph nodes of multiple sites

C83.89

Other non-follicular lymphoma, extranodal and solid organ sites

C83.90

Non-follicular (diffuse) lymphoma, unspecified site

C83.91

Non-follicular (diffuse) lymphoma, unspecified lymph nodes of head, face, and neck

C83.92

Non-follicular (diffuse) lymphoma, unspecified intrathoracic lymph nodes

C83.93

Non-follicular (diffuse) lymphoma, unspecified intra-abdominal lymph nodes

C83.94

Non-follicular (diffuse) lymphoma, unspecified lymph nodes of axilla and upper limb

C83.95

Non-follicular (diffuse) lymphoma, unspecified lymph nodes of inguinal region and lower limb

C83.96

Non-follicular (diffuse) lymphoma, unspecified intrapelvic lymph nodes         

C83.97

Non-follicular (diffuse) lymphoma, unspecified spleen

C83.98

Non-follicular (diffuse) lymphoma, unspecified lymph nodes of multiple sites

C83.99

Non-follicular (diffuse) lymphoma, unspecified extranodal and solid organ sites

C84.40

Peripheral T-cell lymphoma, not classified, unspecified site

C84.41

Peripheral T-cell lymphoma, not classified, lymph nodes of head, face, and neck

C84.42

Peripheral T-cell lymphoma, not classified, intrathoracic lymph nodes

C84.43

Peripheral T-cell lymphoma, not classified, intra-abdominal lymph nodes

C84.44

Peripheral T-cell lymphoma, not classified, lymph nodes of axilla and upper limb

C84.45

Peripheral T-cell lymphoma, not classified, lymph nodes of inguinal region and lower limb

C84.46

Peripheral T-cell lymphoma, not classified, intrapelvic lymph nodes

C84.47

 Peripheral T-cell lymphoma, not classified, spleen

C84.48

Peripheral T-cell lymphoma, not classified, lymph nodes of multiple sites

C84.49

Peripheral T-cell lymphoma, not classified, extranodal and solid organ sites

C84.60

Anaplastic large cell lymphoma, ALK-positive, unspecified site

C84.61

Anaplastic large cell lymphoma, ALK-positive, lymph nodes of head, face, and neck

C84.62

Anaplastic large cell lymphoma, ALK-positive, intrathoracic lymph nodes

C84.63

Anaplastic large cell lymphoma, ALK-positive, intra-abdominal lymph nodes

C84.64

Anaplastic large cell lymphoma, ALK-positive, lymph nodes of axilla and upper limb

C84.65

Anaplastic large cell lymphoma, ALK-positive, lymph nodes of inguinal region and lower limb

C84.66

Anaplastic large cell lymphoma, ALK-positive, intrapelvic lymph nodes

C84.67

Anaplastic large cell lymphoma, ALK-positive, spleen

C84.68

Anaplastic large cell lymphoma, ALK-positive, lymph nodes of multiple sites

C84.69

Anaplastic large cell lymphoma, ALK-positive, extranodal and solid organ sites

C84.7A

Anaplastic large cell lymphoma, ALK-negative, breast

C84.70

Anaplastic large cell lymphoma, ALK-negative, unspecified site

C84.71

Anaplastic large cell lymphoma, ALK-negative, lymph nodes of head, face, and neck

C84.72

Anaplastic large cell lymphoma, ALK-negative, intrathoracic lymph nodes

C84.73

Anaplastic large cell lymphoma, ALK-negative, intra-abdominal lymph nodes

C84.74

Anaplastic large cell lymphoma, ALK-negative, lymph nodes of axilla and upper limb

C84.75

Anaplastic large cell lymphoma, ALK-negative, lymph nodes of inguinal region and lower limb

C84.76

Anaplastic large cell lymphoma, ALK-negative, intrapelvic lymph nodes

C84.77

Anaplastic large cell lymphoma, ALK-negative, spleen

C84.78

Anaplastic large cell lymphoma, ALK-negative, lymph nodes of multiple sites

C84.79

Anaplastic large cell lymphoma, ALK-negative, extranodal and solid organ sites

C84.90

Mature T/NK-cell lymphomas, unspecified, unspecified site

C84.91

Mature T/NK-cell lymphomas, unspecified, lymph nodes of head, face and neck

C84.92

Mature T/NK-cell lymphomas, unspecified, intrathoracic lymph nodes

C84.93

Mature T/NK-cell lymphomas, unspecified, intra-abdominal lymph nodes

C84.94

Mature T/NK-cell lymphomas, unspecified, lymph nodes of axilla and upper limb

C84.95

Mature T/NK-cell lymphomas, unspecified, lymph nodes of inguinal region and lower limb

C84.96

Mature, T/NK-cell lymphomas, unspecified, intrapelvic lymph nodes

C84.97

Mature T/NK-cell lymphomas, unspecified, spleen

C84.98

Mature T/NK-cell lymphomas, unspecified, lymph nodes of multiple sites

C84.99

Mature T/NK-cell lymphomas, unspecified, extranodal and solid organ sites

C84.Z0

Other mature T/NK-cell lymphomas, unspecified site

C84.Z1

Other mature T/NK-cell  lymphomas, lymph nodes of head, face and neck

C84.Z2

Other mature T/NK-cell lymphomas, intrathoracic lymph nodes

C84.Z3

Other mature T/NK-cell lymphomas, intra-abdominal lymph nodes

C84.Z4

Other mature T/NK-cell lymphomas, lymph nodes of axilla and upper limb

C84.Z5

Other mature T/NK-cell lymphomas, lymph nodes of inguinal region and lower limb

C84.Z6

Other mature T/NK-cell lymphomas, intrapelvic lymph nodes

C84.Z7

Other mature T/NK-cell lymphomas, spleen

C84.Z8

Other mature T/NK-cell lymphomas, lymph nodes of multiple sites

C84.Z9

Other mature T/NK-cell lymphomas, extranodal and solid organ sites

C85.10 

Unspecified B-cell lymphoma, unspecified site

C85.11

Unspecified B-cell lymphoma, lymph nodes of head, face, and neck

C85.12

Unspecified B-cell lymphoma, intrathoracic lymph nodes

C85.13

Unspecified B-cell lymphoma, intra-abdominal lymph nodes

C85.14

Unspecified B-cell lymphoma, lymph nodes of axilla and upper limb

C85.15

Unspecified B-cell lymphoma, lymph nodes of inguinal region and lower limb

C85.16

Unspecified B-cell lymphoma, intrapelvic lymph nodes

C85.17

Unspecified B-cell lymphoma, spleen

C85.18

Unspecified B-cell lymphoma, lymph nodes of multiple sites

C85.19

Unspecified B-cell lymphoma, extranodal and solid organ sites

C85.20

Mediastinal (thymic) large B-cell lymphoma unspecified site

C85.21

Mediastinal (thymic) large B-cell lymphoma lymph nodes of head, face, and neck

C85.22

Mediastinal (thymic) large B-cell lymphoma intrathoracic lymph nodes

C85.23

Mediastinal (thymic) large B-cell lymphoma intra-abdominal lymph nodes

C85.24

Mediastinal (thymic) large B-cell lymphoma lymph nodes of axilla and upper limb

C85.25

Mediastinal (thymic) large B-cell lymphoma lymph nodes of inguinal region and lower limb

C85.26

Mediastinal (thymic) large B-cell lymphoma intrapelvic lymph nodes

C85.27

Mediastinal (thymic) large B-cell lymphoma spleen

C85.28

Mediastinal (thymic) large B-cell lymphoma lymph nodes of multiple sites

C85.29

Mediastinal (thymic) large B-cell lymphoma extranodal and solid organ sites

C85.80

Other specified types of non-Hodgkin lymphoma, unspecified site

C85.81

Other specified types of non-Hodgkin lymphoma, lymph nodes of head, face and neck

C85.82

Other specified types of non-Hodgkin lymphoma, intrathoracic lymph nodes

C85.83

Other specified types of non-Hodgkin lymphoma, intra-abdominal lymph nodes

C85.84

Other specified types of non-Hodgkin lymphoma, lymph nodes of axilla and upper limb

C85.85

Other specified types of non-Hodgkin lymphoma, lymph nodes of inguinal region of lower limb

C85.86

Other specified types of non-Hodgkin lymphoma, intrapelvic lymph nodes

C85.87

Other specified types of non-Hodgkin lymphoma, spleen

C85.88

Other specified types of non-Hodgkin lymphoma, lymph nodes of multiple sites

C85.89

Other specified types of non-Hodgkin lymphoma, extranodal and solid organ sites

C86.1

Hepatosplenic T-cell lymphoma

C86.2

Enteropathy-type (intestinal) T-cell lymphoma

C86.5

Angioimmunoblastic T-cell lymphoma

C88.0

Waldenström macroglobulinemia

C88.4

Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT-lymphoma)

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

C91.50

Adult T-cell lymphoma/leukemia (HTLV-1-associated) not having achieved remission

C91.52

Adult T-cell lymphoma/leukemia (HTLV-1-associated) in relapse

D47.Z1

Post-transplant lymphoproliferative disorder (PTLD)

E85.3

Secondary systemic amyloidosis

E85.4

Organ-limited amyloidosis

E85.81

Light chain (AL) amyloidosis

E85.89

Other amyloidosis

E85.9

Amyloidosis, unspecified

Z85.71

Personal history of Hodgkin lymphoma

Z85.79

Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues

Z94.81

Bone marrow transplant status

Z94.89

Other transplanted organ and tissue status

Z94.9

Transplanted organ and tissue status, unspecified

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC