vp-0266
print Print

Darzalex™ (daratumumab) (Intravenous)

Policy Number: VP-0266

Last Review Date: 10/01/2019

Date of Origin: 02/23/2016

Dates Reviewed: 02/2016, 12/2016, 02/2017, 05/2017, 06/2017, 11/2017, 02/2018, 05/2018, 06/2018, 09/2018, 12/2018, 03/2019, 06/2019, 08/2019, 10/2019

I. Length of Authorization

Coverage will be provided for 6 months and may be renewed.  Use for newly diagnosed disease in combination with bortezomib, thalidomide, and dexamethasone may not be renewed.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [Pharmacy Benefit]:

Darzalex 100 mg single-dose vial for injection: 3 vials per dose

  • Weekly Weeks 1 to 6, then every three weeks Weeks 7-54, then every four weeks Week 55 onwards OR
  • Weekly Weeks 1 to 8, then every two weeks Weeks 9-24, then every four weeks Week 25 onwards  OR
  • Weekly Weeks 1 to 9, then every three weeks Weeks 10-24, then every four weeks Week 25 onwards)
  • Weekly Weeks 1 to 8, then every two weeks Weeks 9-16 for induction therapy, then every two weeks Weeks 1 to 8 for consolidation therapy

Darzalex 400mg single dose vial for injection: 4 vials per dose

  • (Weekly Weeks 1 to 6, then every three weeks Weeks 7-54, then every four weeks Week 55 onwards OR
  • Weekly Weeks 1 to 8, then every two weeks Weeks 9-24, then every four weeks Week 25 onwards  OR
  • Weekly Weeks 1 to 9, then every three weeks Weeks 10-24, then every four weeks Week 25 onwards)
  • Weekly Weeks 1 to 8, then every two weeks Weeks 9-16 for induction therapy, then every two weeks Weeks 1 to 8 for consolidation therapy

  1. Max Units (per dose and over time) [Medical Benefit]:
  • Bortezomib/Melphalan/Prednisone Regimen
    • 180 billable units per dose

(Weekly Weeks 1 to 6, then every three weeks Weeks 7-54, then every four weeks Week 55 onwards)

  • Lenalidomide/Pomalidomide Regimen
    • 180 billable units per dose

(Weekly Weeks 1 to 8, then every two weeks Weeks 9-24, then every four weeks Week 25 onwards)

  • Bortezomib Regimen
    • 180 billable units per dose

(Weekly Weeks 1 to 9, then every three weeks Weeks 10-24, then every four weeks Week 25 onwards)

  • Bortezomib/Thalidomide Regimen
    • 180 billable units per dose

(Weekly Weeks 1 to 8, then every two weeks Weeks 9-16 for induction therapy, then every two weeks Weeks 1 to 8 for consolidation therapy)

III. Initial Approval Criteria

Coverage is provided in the following conditions:

  • Patient is 18 years or older; AND

Multiple myeloma †                                                     

Used in the treatment of newly diagnosed disease in patients who are ineligible for autologous stem cell transplant (ASCT) in combination with ONE of the following regimens:

    • Lenalidomide and dexamethasone; OR
    • Bortezomib, melphalan and prednisone; OR

Used in the treatment of newly diagnosed disease in patients who are eligible for autologous stem cell transplant (ASCT) in combination with bortezomib, thalidomide, and dexamethasone (VTd); OR

Used as subsequent therapy in combination with dexamethasone and either lenalidomide or bortezomib; OR

Used in combination with pomalidomide and dexamethasone after at least two prior therapies including an immunomodulatory agent (e.g., lenalidomide, pomalidomide, etc.) and a proteasome inhibitor (bortezomib, carfilzomib, etc.); OR

  •  

    Used as a single agent therapy; AND

  • Patient must have received at least three previous lines of therapy including a proteasome inhibitor (e.g., bortezomib, carfilzomib, etc.) and an immunomodulatory agent (e.g., lenalidomide, pomalidomide, etc.); OR
  • Patient is double-refractory to a proteasome inhibitor and an immunomodulatory agent

FDA Approved 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

Disease response with treatment as defined by stabilization of disease and decrease in size of tumor of tumor spread; AND

Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: severe infusion reactions, neutropenia, thrombocytopenia, etc. ; AND

Use for newly diagnosed disease in combination with bortezomib, thalidomide, and dexamethasone after 24 weeks of induction/consolidation therapy may not be renewed

V. Dosage/Administration

Indication

Dose

Multiple Myeloma

Newly diagnosed disease in combination with: bortezomib, melphalan and prednisone

  •  
  • 16 mg/kg body weight given as an intravenous infusion:
  • Weekly                        Weeks 1 to 6 (six doses)
  • Every three weeks      Weeks 7 to 54 (16 doses)
  • Every four weeks        Week 55 onwards until disease progression

Newly diagnosed disease in combination with bortezomib, thalidomide and dexamethasone

  •  
  • 16 mg/kg body weight given as an intravenous infusion
  • Induction: 
  • Weekly                        Weeks 1 to 8 (eight doses)
  • Every two weeks        Weeks 9 to 16 (four doses)

Stop for high dose chemotherapy and ASCT

  •  
  • Consolidation: 
  • Every two weeks        Week s 1 to 8 (four doses)

Treatment as one of the following:

  •  
  • Monotherapy
  • Combination therapy with lenalidomide and low-dose dexamethasone for newly diagnosed patients ineligible for ASCT and also in patients with relapsed/refractory disease
  • Combination therapy with lenalidomide or pomalidomide and low-dose dexamethasone
  •  
  • 16 mg/kg body weight given as an intravenous infusion:
  • Weekly                        Weeks 1 to 8 (eight doses)
  • Every two weeks         Weeks 9 to 24 (eight doses)
  • Every four weeks        Week 25 onwards until disease progression

Combination therapy with bortezomib and dexamethasone:

    • 16 mg/kg body weight given as an intravenous infusion:
  • Weekly                        Weeks 1 to 9 (nine doses)
  • Every three weeks      Weeks 10 to 24 (five doses)
  • Every four weeks        Week 25 onwards until disease progression

*To facilitate administration, the first prescribed 16 mg/kg dose at Week 1 may be split over two consecutive days i.e. 8 mg/kg on Day 1 and Day 2 respectively.

Note: Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week after starting Darzalex and continue for 3 months following treatment.

VI. Billing Code/Availability Information

Jcode:

J9145 - Injection, daratumumab, 10 mg; 1 billable unit = 10 mg

NDC(s):

Darzalex 100 mg/5 mL single-dose vial: 57894-0502-xx

Darzalex 400 mg/20 mL single-dose vial: 57894-0502-xx

VII. References

  1. Darzalex [package insert]. Horsham, PA; Janssen Biotech, Inc; September 2019. Accessed September 2019.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for daratumumab. 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 September 2019.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

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

Z85.79

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

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):  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