vp-0351
print Print Back Back

Bortezomib* (Intravenous Only)

Policy Number: VP-0351

Last Review Date: 09/03/2019

Date of Origin: 02/06/2018

Dates Reviewed: 02/2018, 05/2018, 09/2018, 10/2018, 12/2018, 03/2019, 06/2019, 09/2019

 

I. Length of Authorization

Coverage will be provided for 6 months and may be renewed. For use as maintenance therapy in multiple myeloma, coverage may be renewed up to 2 years of total therapy.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [Pharmacy Benefit]:
  • Bortezomib 3.5 mg powder for injection: 4 vials per 14 day supply
  1. Max Units (per dose and over time) [Medical Benefit]:
  • Multiple Myeloma – Maintenance Therapy Only
    • 140 billable units every 14 days
  • All Other Indications
    • 140 billable units every 21 days

III. Initial Approval Criteria

Coverage is provided in the following conditions:

  • Patient aged 18 years or older; AND
  • Will not be administered intrathecally; AND

Multiple myeloma †

  • Patient has not received in excess of 2 years of maintenance therapy with a bortezomib product; AND
  • Used in combination with a corticosteroid containing regimen as primary therapy for active (symptomatic) disease or for relapse after 6 months following primary induction therapy with the same regimen; OR
  • Used as maintenance therapy as a single agent; OR
  • Used as therapy for relapse or progressive disease in combination with a dexamethasone containing regimen

Mantle cell lymphoma †

  • Used as initial therapy as a component of  VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone) in patients who are not candidates for high-dose therapy/autologous stem cell rescue; OR
  • Used as second-line therapy after partial or better response to induction therapy or for extended response to prior chemoimmunotherapy; AND
    • Used as a single agent or in combination with rituximab

Systemic Light Chain Amyloidosis ‡

  • Patient is newly diagnosed; AND
    • Used in combination with cyclophosphamide and dexamethasone; OR
    • Used as a single agent; OR
    • Used in combination with dexamethasone with or without melphalan; OR
  • Patient has relapsed or refractory disease§; AND
    • Used as a single agent; OR
    • Used in combination with dexamethasone with or without melphalan

§Consider repeating initial therapy if relapse-free for several years

Waldenström’s macroglobulinemia/Lymphoplasmacytic Lymphoma ‡

  • Used in combination with dexamethasone and rituximab; OR
  • Used as a single agent or in combination with rituximab; OR
  • Used in combination with dexamethasone; OR

Multicentric Castleman’s Disease ‡

  • Must be used as subsequent therapy; AND
  • Patient has progressed following treatment for relapsed/refractory or progressive disease; AND
  • Used as a single agent or in combination with rituximab

Adult T-Cell Leukemia/Lymphoma ‡

  • Must be used as a single agent for non-responders to first-line therapy for acute disease or lymphoma

Pediatric Acute Lymphoblastic Leukemia ‡

  • Patient is at least 1 year of age or older: AND
  • Patient has relapsed or refractory Philadelphia chromosome negative disease: OR
  • Patient has relapsed or refractory T-cell disease (T-ALL); AND
    • Used in combination with a corticosteroid, vincristine, doxorubicin, and pegaspargase

*Bortezomib was approved by the FDA as a 505(b) (2) NDA of the innovator product, Velcade (bortezomib) for Injection, for intravenous use only and thus should NOT be considered therapeutically interchangeable (i.e. not suitable for substitution) for other non-approved indications.

FDA Approved Indication(s); Compendia recommended indication(s)

IV. Renewal Criteria

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet the criteria identified in section III; AND
  • Tumor response with stabilization of disease or decrease in size of tumor or tumor spread; AND
  • Absence of unacceptable toxicity from the drug. Example of unacceptable toxicity include peripheral neuropathy, hypotension, cardiac toxicity, pulmonary toxicity, posterior reversible encephalopathy syndrome, gastrointestinal toxicity, thrombocytopenia, neutropenia, tumor lysis syndrome, hepatic toxicity, thrombotic microangiopathy, etc.
  • For maintenance therapy of multiple myeloma: patient has not received over 2 years of therapy.

V. Dosage/Administration

Indication

Dose

Multiple myeloma - previously untreated

1.3 mg/m2 IV in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles. In cycles 1-4, bortezomib is given twice weekly (days 1, 4, 8, 11, 22, 25, 29, and 32). In cycles 5-9, bortezomib is given once weekly (days 1, 8, 22, and 29).

Multiple myeloma – maintenance therapy

1.3 mg/m² IV every two weeks for up to 2 years

Multiple myeloma & Mantle Cell Lymphoma- relapsed

1.3 mg/m² IV twice weekly x 4 doses (days 1, 4, 8, and 11) followed by a 10-day rest period (days 12-21).

  • For extended therapy of more than 8 cycles, bortezomib may be administered on the standard schedule or, for relapsed multiple myeloma, on a maintenance schedule of once weekly for 4 weeks (days 1, 8, 15, and 22), followed by a 13-day rest period (days 23 to 35)

Waldenström’s macroglobulinemia

  • 1.3 mg/m2 IV twice weekly for 2 weeks (days 1, 4, 8, and 11) in a 21 day cycle
  • In combination with rituximab alone: 1.6mg/m² days 1, 8, and 15 of a 28 day cycle

All Other Indications

1.3 mg/m² IV twice weekly (days 1, 4, 8, and 11) for 2 weeks of a 21 day cycle

VI. Billing Code/Availability Information

HCPCS code:

  • J9044 – Injection, bortezomib, not otherwise specified, 0.1 mg. 1 billable unit = 0.1 mg NDC(s):
  • Bortezomib 3.5 mg single-use vial powder for injection: 63323-0721-xx  

VII. References

  1. Bortezomib [package insert]. Lake Zurich, IL; Fresenius Kabi, Inc; July 2018. Accessed August 2019.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Bortezomib. National Comprehensive Cancer Network, 2019. 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 August 2019.
  3. Boccadoro M, Bringhen S, Gaidano G, et al, “Bortezomib, Melphalan, Prednisone, and Thalidomide (VMPT) Followed by Maintenance With Bortezomib and Thalidomide (VT) for Initial Treatment of Elderly Multiple Myeloma Patients,” J Clin Oncol, 2010, 28(7s):8013 [abstract 8013 from 2010 ASCO Annual Meeting].
  4. Palumbo A, Bringhen S, Rossi D, et al, “Bortezomib, Melphalan, Prednisone and Thalidomide (VMPT) Followed by Maintenance With Bortezomib and Thalidomide for Initial Treatment of Elderly Multiple Myeloma Patients,” Blood, 2009, 114(22):128 [abstract 128 from ASH 2009 Annual Meeting].
  5. Ghobrial IM, Hong F, Padmanabhan S, et al, “Phase II Trial of Weekly Bortezomib in Combination With Rituximab in Relapsed or Relapsed and Refractory Waldenstrom Macroglobulinemia,” J Clin Oncol, 2010, 28(8):1422-8.
  6. Sonneveld P, Schmidt-Wolf IG, van der Holt B, et al. Bortezomib induction and maintenance treatment in patients with newly diagnosed multiple myeloma: results of the randomized phase III HOVON-65/ GMMG-HD4 trial. J Clin Oncol. 2012 Aug 20;30(24):2946-55. doi: 10.1200/JCO.2011.39.6820. Epub 2012 Jul 1
  7. Horton, T. M., Whitlock, J. A., Lu, X. , et al. Bortezomib reinduction chemotherapy in highrisk ALL in first relapse: a report from the Children's Oncology Group. Br J Haematol 2019;186:274-285. doi:10.1111/bjh.15919
  8. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Systemic Light Chain Amyloidosis. Version 1.2019. National Comprehensive Cancer Network, 2019. 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 August 2019.
  9. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Waldenström’s Macroglobulinemia/Lymphoplasmacytic Lymphoma. Version 2.2019. National Comprehensive Cancer Network, 2019. 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 August 2019.
  10. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) B-Cell Lymphomas. Version 2.201 National Comprehensive Cancer Network, 2019. 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 August 2019
  11. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Multiple Myeloma. Version 1.2019. National Comprehensive Cancer Network, 2019. 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 August 2019.
  12. National Government Services, Inc. Local Coverage Article for Bortezomib – Related to LCD L33394 (A52371). Centers for Medicare & Medicaid Services, Inc. Updated on 12/18/2018 with effective date of 1/1/2019. Accessed August 2019.
  13. First Coast Options, Inc. Local Coverage Determination (LCD): Bortezomib (Velcade®) (L33273). Centers for Medicare & Medicaid Services, Inc. Updated on 01/04/2019 with effective date of 1/1/2019. Accessed August 2019.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

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

C88.0

Waldenstrom macroglobulinemia

C90.00

Multiple myeloma not having achieved remission

C90.01

Multiple myeloma in remission

C90.02

Multiple myeloma, in relapse

C90.10

Plasma cell leukemia not having achieved remission

C90.11

Plasma cell leukemia in remission

C90.12

Plasma cell leukemia in relapse

C90.20

Extramedullary plasmacytoma not having achieved remission

C90.21

Extramedullary plasmacytoma in remission

C90.22

Extramedullary plasmacytoma in relapse

C90.30

Solitary plasmacytoma not having achieved remission

C90.31

Solitary plasmacytoma in remission

C90.32

Solitary plasmacytoma in relapse

 C91.00 Acute lymphoblastic leukemia, not having achieved remission
 C91.02 Acute lymphoblastic leukemia, 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

D36.0

Benign neoplasm of lymph nodes

D47.Z2

Castleman disease

E85.81

Light chain (AL) amyloidosis

E85.89

Other amyloidosis

E85.9

Amyloidosis, unspecified

R59.0

Localized enlarged lymph nodes

R59.1

Generalized enlarged lymph nodes

R59.9

Enlarged lymph nodes, unspecified

Z85.72

Personal history of non-Hodgkin lymphomas

Z85.79

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

Dual coding requirements:

  • Codes Z85.72 & Z85.79 are secondary codes and must be billed in conjunction with a primary code

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) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-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):  

Jurisdiction(s): 6, K

NCD/LCD Document (s): A52371

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A52371&bc=gAAAAAAAAAAAAA==  

Jurisdiction(s): 9 (N)

NCD/LCD Document (s): L33273

https://www.cms.gov/medicare-coverage-database/search/lcd-date-search.aspx?DocID=L33273&bc=gAAAAAAAAAAA

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