vp-0535
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Darzalex Faspro™ (daratumumab and hyaluronidase-fihj) (Subcutaneous)

Policy Number: VP-0535

Last Review Date: 06/02/2020

Date of Origin: 06/02/2020

Dates Reviewed: 06/2020

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

Coverage will be provided for 6 months and may be renewed.   

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Darzalex Faspro 1,800 mg/30,000 unit single-dose vial for injection: 1 vial 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
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • Bortezomib/Melphalan/Prednisone Regimen
    • 1800 mg/30,000 units (1 vial) per dose

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

  • Bortezomib/dexamethasone Regimen
    • 1800 mg/30,000 units (1 vial) per dose

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

  • Monotherapy OR lenolidomide/dexamethasone Regimen
    • 1800 mg/30,000 units (1 vial) per dose

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

III. Initial Approval Criteria

Coverage is provided in the following conditions:

  • Patient is 18 years or older; AND

Universal Criteria

  • Will not be used in combination with other anti-CD38 therapies (i.e., daratumumab, isatuximab, etc.); AND

Multiple myeloma †/Ф                                                 

  • 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 as subsequent therapy in combination with dexamethasone and either lenalidomide or bortezomib; OR
    • Used as 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), Compendia recommended indication(s); Ф Orphan Drug

IV. Renewal Criteria

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. 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: severe infusion reactions including anaphylactic reactions, neutropenia, thrombocytopenia, etc.

V. Dosage/Administration

Indication

Dose

Multiple Myeloma

Administer 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) as a 15 mL injection subcutaneously into the abdomen over approximately 3-5 minutes.

Treatment as one of the following:

  • Combination therapy with: bortezomib, melphalan and prednisone (D-VMP) (6-week cycle)
  • Weekly                        Weeks 1 to 6 (six doses; cycle 1)
  • Every three weeks      Weeks 7 to 54 (16 doses; cycles 2 to 9)
  • Every four weeks        Week 55 onwards until disease progression (cycle 10 and beyond)
    • Monotherapy OR in combination with lenalidomide and dexamethasone (D-Rd) (4-week cycle)
  • Weekly                        Weeks 1 to 8 (eight doses; cycles 1 and 2)
  • Every two weeks         9 to 24 (eight doses; cycles 3 to 6)
  • Every four weeks        Week 25 onwards until disease progression (cycle 7 and beyond)
  • Combination therapy with bortezomib and dexamethasone (D-Vd) (3-week cycle)
  • Weekly                        Weeks 1 to 9 (nine doses; cycles 1 to 3)
  • Every three weeks      Weeks 10 to 24 (five doses; cycles 4 to 8)
  • Every four weeks        Week 25 onwards until disease progression (cycle 9 and beyond)

*Keep refrigerated. Darzalex Faspro should only be administered subcutaneously by a healthcare professional. Do NOT administer Darzalex Faspro intravenously.

Note: Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week after starting Darzalex and continue for 3 months following treatment. Refer to the PI for other pre- and post-medication therapies.

VI. Billing Code/Availability Information

HCPCS code:

  • J9999 - Not otherwise classified, antineoplastic drugs
  • C9399 - Unclassified drugs or biologicals (hospital outpatient use)

NDC(s):

  • Darzalex Faspro 1,800 mg of daratumumab and 30,000 units of hyaluronidase per 15 mL single-dose vial: 57894-0503-xx

VII. References

  1. Darzalex Faspro [package insert]. Horsham, PA; Janssen Biotech, Inc; May 2020. Accessed May 2020.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for daratumumab and hyaluronidase-fihj. National Comprehensive Cancer Network, 2020. 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 May 2020.
  3. Chari A, San Miguel J, McCarthy H, et al. Subcutaneous Daratumumab Plus Standard Treatment Regimens in Patients with Multiple Myeloma across Lines of Therapy: Pleiades Study Update. Blood (2019) 134 (Supplement_1): 3152.
  4. Mateos MV, Nahi H, Legier W, et al. Efficacy and safety of the randomized, open-label, non-inferiority, phase 3 study of subcutaneous (SC) versus intravenous (IV) daratumumab (DARA) administration in patients (pts) with relapsed or refractory multiple myeloma (RRMM): COLUMBA. JCO 2019 37:15_suppl, 8005-8005.
  5. Lancman G, Arinsburg S, Jhang J, et al. Blood Transfusion Management for Patients Treated With Anti-CD38 Monoclonal Antibodies. Front. Immunol.9:2616. Doi: 10.3389/fimmu.2018.02616.

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), Local Coverage Determinations (LCDs), and Articles 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/Article): 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