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Darzalex Faspro® (daratumumab and hyaluronidase-fihj)

Policy Number: VP-90535

Subcutaneous

 

Last Review Date: 09/05/2024

Date of Origin: 06/02/2020

Dates Reviewed: 06/2020, 09/2020, 01/2021, 02/2021, 08/2021, 03/2022, 03/2023, 03/2024, 09/2024

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.
  1. Length of Authorization 1,19,20,23,28

Coverage will be provided for 6 months and may be renewed unless otherwise specified.   

      •  
    • Use for newly diagnosed multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone may not be renewed.
    • Use for newly diagnosed multiple myeloma when used as part of the Induction and Consolidation Therapy Regimen in combination with bortezomib, lenalidomide and dexamethasone may not be renewed.
    • Use for newly diagnosed multiple myeloma when used as part of the Induction, Consolidation, and Maintenance Therapy Regimen in combination with bortezomib, lenalidomide and dexamethasone may be renewed for up to a maximum of 2 years of maintenance therapy.
    • Use for newly diagnosed OR relapsed or refractory/progressive multiple myeloma in combination with cyclophosphamide, bortezomib and dexamethasone may be renewed for up to a maximum of 80 weeks (32 weeks of induction therapy and 48 weeks of maintenance therapy).
    • Use for newly diagnosed multiple myeloma in combination with carfilzomib, lenalidomide, and dexamethasone may be renewed for a maximum of 32 weeks.
    • Use as maintenance therapy for multiple myeloma in combination with lenalidomide may be renewed for up to a maximum of 2 years.
    • Use for newly diagnosed OR repeat of initial therapy for relapsed/refractory (after being relapse-free for several years) systemic light chain amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone may be renewed for up to a maximum of 2 years.

II. Dosing Limits

   A. 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 8, then every two weeks Weeks 9-24, then every four weeks Week 25 onwards

  B. Max Units (per dose and over time) [HCPCS Unit]:

  • Up to 180 billable units per dose
  • Weekly Weeks 1 to 8, then every two weeks Weeks 9-24, then every four weeks Week 25 onwards
  1. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND

         Universal Criteria 1

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

Multiple Myeloma † ‡ 1,2,17                                                     

  • 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
    • Cyclophosphamide, bortezomib, and dexamethasone; OR
  • Used in the treatment of newly diagnosed disease in patients who are eligible for autologous stem cell transplant (ASCT) in combination with ONE of the following regimens:
    • Bortezomib, lenalidomide, and dexamethasone; OR
    • Bortezomib, thalidomide, and dexamethasone (VTd); OR
    • Carfilzomib, lenalidomide, and dexamethasone (ixazomib may be substituted for carfilzomib); OR
    • Cyclophosphamide, bortezomib, and dexamethasone; OR
  • Used for disease relapse after 6 months following primary induction therapy with the same regimen in combination with ONE of the following regimens:
    • Lenalidomide and dexamethasone for non-transplant candidates; OR
    • Cyclophosphamide, bortezomib, and dexamethasone; OR
  • Used as subsequent therapy for relapsed or refractory/progressive disease in combination with dexamethasone and ONE of the following:
    • Lenalidomide; OR
    • Bortezomib; OR
    • Carfilzomib; OR
    • Cyclophosphamide and bortezomib; OR
    • Selinexor; OR
    • Venetoclax (for patients with t(11:14) ONLY); OR
  • Used in combination with pomalidomide and dexamethasone after prior therapy with lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib, etc.); OR
  • Used as single agent therapy; AND
    • Patient received at least three prior 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; OR
  • Used as maintenance therapy for symptomatic disease in transplant candidates; AND
    • Used as single agent therapy or in combination with lenalidomide; AND
      • Used after response to primary myeloma therapy; OR
      • Used for response or stable disease following an autologous hematopoietic cell transplant (HCT); OR
      • Used for response or stable disease following a tandem autologous or allogeneic HCT for high risk* patients

*High-risk as defined by the Revised International Staging System for Multiple Myeloma is the presence of del(17p) and/or translocation t(4;14) and/or translocation t(14;16). This is not an all-inclusive list. Refer to the NCCN Multiple Myeloma Guidelines for additional risk factors.

Systemic Light Chain Amyloidosis † ‡ Ф 1,2,18

  • Patient must NOT have NYHA Class IIIB or Class IV, or Mayo Stage IIIB cardiac disease; AND
    • Used in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd); AND
      • Used for newly diagnosed disease; OR
      • Used as a repeat of initial therapy for relapsed/refractory disease if the patient has been relapse-free for several years; AND
        • Patient has no significant neuropathy; OR
    • Used as single agent therapy; AND
      • Used for the treatment of relapsed/refractory disease; OR
      • Used for newly diagnosed disease; AND
        • Patient has stage IIIb disease with no significant neuropathy; OR
        • Patient has significant neuropathy

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

  1. Renewal Criteria 1,2

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: hypersensitivity and other administration reactions (e.g., systemic administration-related reactions, local injection-site reactions, etc.), neutropenia, thrombocytopenia, cardiac toxicity, etc.; AND

Multiple Myeloma 1,19,20,23,28

  • Use for newly diagnosed disease in combination with bortezomib, thalidomide and dexamethasone may not be renewed.
  • Use for newly diagnosed multiple myeloma when used as part of the Induction and Consolidation Therapy Regimen in combination with bortezomib, lenalidomide and dexamethasone may not be renewed.
  • Use for newly diagnosed disease when used as part of the Induction, Consolidation, and Maintenance Therapy Regimen in combination with bortezomib, lenalidomide and dexamethasone may be renewed for up to a maximum of 2 years of maintenance therapy.
  • Use for newly diagnosed OR relapsed or refractory/progressive disease in combination with cyclophosphamide, bortezomib and dexamethasone may be renewed for up to a maximum of 80 weeks (32 weeks of induction therapy and 48 weeks of maintenance therapy).
  • Use for newly diagnosed disease in combination with carfilzomib, lenalidomide, and dexamethasone may be renewed for a maximum of 32 weeks.
  • Use as maintenance therapy for multiple myeloma in combination with lenalidomide may be renewed for up to a maximum of 2 years.

Systemic Light Chain Amyloidosis 1

  • Use for newly diagnosed disease OR repeat of initial therapy for relapsed/refractory disease (after being relapse-free for several years) in combination with bortezomib, cyclophosphamide, and dexamethasone may be renewed for a maximum of 2 years of therapy.
  1. Dosage/Administration 1,15,19,20,23-26,28

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. Treatment as one of the following:

Newly diagnosed disease in patients ineligible for ASCT in combination 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 (cycle 10 and beyond)

Treat until disease progression or unacceptable toxicity.

Newly diagnosed disease in patients eligible for ASCT in combination with bortezomib, thalidomide and dexamethasone (4-week cycle):

Induction –

  • Weekly                        Weeks 1 to 8 (eight doses; cycles 1 and 2)
  • Every two weeks        Weeks 9 to 16 (four doses; cycles 3 and 4)

Stop for high dose chemotherapy and ASCT.

Consolidation –

  • Every two weeks        Weeks 1 to 8 (four doses; cycles 5 and 6)

Newly diagnosed disease in patients eligible for ASCT in combination with carfilzomib, lenalidomide, and dexamethasone (4-week cycle):

  • Weekly                        Weeks 1 to 8 (eight doses; cycles 1 and 2)
  • Every two weeks        Weeks 9 to 24 (eight doses; cycles 3 to 6)
  • Every four weeks       Weeks 25 to 32 (two doses; cycles 7 and 8)

Newly diagnosed disease in patients eligible for ASCT in combination with bortezomib, lenalidomide and dexamethasone:

Induction, Consolidation, and Maintenance Therapy Regimen:

Induction – 3 week cycle

  • Weekly                    Weeks 1 to 12 (twelve doses; cycles 1 to 4)

Consolidation – (after ASCT) – 3 week cycle

  • Every 3 weeks              Weeks 13 to 18 (two doses; cycles 5 and 6)

Maintenance – 4 week cycle

  • Every 4 or 8 weeks      Weeks 1 to 104 for a maximum of 2 years of maintenance treatment

-OR-

Induction and Consolidation Therapy Regimen ONLY:

Induction – 4 week cycle

  • Weekly                        Weeks 1 to 8 (eight doses; cycles 1 and 2)
  • Every two weeks        Weeks 9 to 16 (four doses; cycles 3 and 4)

Stop for high dose chemotherapy and ASCT.

Consolidation – 4 week cycle

  • Every two weeks          Weeks 1 to 8 (four doses; cycles 5 and 6)

Newly diagnosed OR relapsed or refractory/progressive disease in combination with cyclophosphamide, bortezomib and dexamethasone (4-week cycle):

Induction –

  • Weekly                         Weeks 1 to 8 (eight doses; cycles 1 and 2)
  • Every two weeks          Weeks 9 to 24 (eight doses; cycles 3 to 6)
  • Every four weeks         Week 25 to 32 (two doses; cycles 7 and 8)

Maintenance (after ASCT) –

  • Every 4 weeks for up to 12 cycles (48 weeks)

Treatment as one of the following:

  • Monotherapy for patients with relapsed/refractory multiple myeloma (4-week cycle)
  • Combination therapy with lenalidomide and dexamethasone for newly diagnosed patients ineligible for ASCT (4-week cycle)
  • Combination therapy with lenalidomide, pomalidomide, selinexor, or carfilzomib AND dexamethasone in patients with relapsed or refractory/progressive disease (4-week cycle)
  • Weekly                        Weeks 1 to 8 (eight doses; cycles 1 and 2)
  • Every two weeks         Weeks 9 to 24 (eight doses; cycles 3 to 6)
  • Every four weeks        Week 25 onwards (cycle 7 and beyond)

Treat until disease progression or unacceptable toxicity.

Combination therapy with bortezomib and dexamethasone for relapsed or refractory/progressive disease (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 (cycle 9 and beyond)

Treat until disease progression or unacceptable toxicity.

Combination therapy with venetoclax and dexamethasone for relapsed or refractory/progressive t(11;14) disease (4-week cycle):

  • Weekly                        Weeks 1 to 8 (eight doses; cycles 1 and 2)
  • Every two weeks        Weeks 9 to 24 (eight doses; cycles 3 to 6)
  • Every four weeks        Week 25 onwards (cycle 7 and beyond)

Monotherapy as maintenance treatment for transplant candidates

  • Every 4 weeks until disease progression or unacceptable toxicity.

In combination with lenalidomide as maintenance treatment for transplant candidates

  • Every 4 or 8 weeks until disease progression or unacceptable toxicity. For a maximum of 2 years of maintenance treatment.

Systemic Light Chain Amyloidosis

Newly diagnosed disease OR repeat of initial therapy for relapsed/refractory disease (after being relapse-free for several years) in combination therapy with bortezomib, cyclophosphamide and dexamethasone (D-VCd) (4-week cycle):

  • Weekly                        Weeks 1 to 8 (eight doses; cycles 1 and 2)
  • Every two weeks         Weeks 9 to 24 (eight doses; cycles 3 to 6)
  • Every four weeks        Week 25 onwards (cycle 7 and beyond)

Treat until disease progression or unacceptable toxicity or a maximum of 2 years

Single agent therapy for relapsed/refractory disease OR newly diagnosed disease (4-week cycle):

  • Weekly                        Weeks 1 to 8 (eight doses; cycles 1 and 2)
  • Every two weeks         Weeks 9 to 24 (eight doses; cycles 3 to 6)
  • Every four weeks        Week 25 onwards (cycle 7 and beyond)

Treat until disease progression or unacceptable toxicity

*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 Faspro and continue for 3 months following the end of treatment. Refer to the PI for other pre- and post-medication therapies.
  1. Billing Code/Availability Information

HCPCS Code:

  • J9144 – Injection, daratumumab, 10 mg and hyaluronidase-fihj; 1 billable unit=10 mg

NDC:

  • Darzalex Faspro 1,800 mg of daratumumab and 30,000 units of hyaluronidase per 15 mL single-dose vial: 57894-0503-xx
  1. References
  1. Darzalex Faspro [package insert]. Horsham, PA; Janssen Biotech, Inc; July 2024. Accessed August 2024.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for daratumumab and hyaluronidase-fihj. National Comprehensive Cancer Network, 2024. 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 2024.
  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.
  6. Chari A, Martinez-Lopez J, Mateos MV, et al. Daratumumab plus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma. Blood. 2019 Aug 1;134(5):421-431. doi: 10.1182/blood.2019000722. Epub 2019 May 21.
  7. Facon T, Kumar S, Plesner T, et al. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med. 2019 May 30;380(22):2104-2115. doi: 10.1056/NEJMoa1817249.
  8. Mateos MV, Dimopoulos MA, Cavo M, et al. Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma. N Engl J Med. 2018 Feb 8;378(6):518-528. doi: 10.1056/NEJMoa1714678. Epub 2017 Dec 12.
  9. Moreau P, Attal M, Hulin C, et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. Lancet. 2019 Jul 6;394(10192):29-38. doi: 10.1016/S0140-6736(19)31240-1. Epub 2019 Jun 3.
  10. Dimopoulos MA, Oriol A, Nahi H, et al. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016 Oct 6;375(14):1319-1331.
  11. Palumbo A, Chanan-Khan A, Weisel K, et al. Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016 Aug 25;375(8):754-66. doi: 10.1056/NEJMoa1606038.
  12. Chari A, Suvannasankha A, Fay JW, et al. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood. 2017 Aug 24;130(8):974-981. doi: 10.1182/blood-2017-05-785246. Epub 2017 Jun 21.
  13. Lonial S, Weiss BM, Usmani SZ, et al. Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial. Lancet. 2016 Apr 9;387(10027):1551-1560. doi: 10.1016/S0140-6736(15)01120-4. Epub 2016 Jan 7.
  14. Lokhorst HM, Plesner T, Laubach JP, et al. Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma. N Engl J Med. 2015 Sep 24;373(13):1207-19. doi: 10.1056/NEJMoa1506348. Epub 2015 Aug 26.
  15. Kaufman GP, Schrier SL, Lafayette RA, et al. Daratumumab yields rapid and deep hematologic responses in patients with heavily pretreated AL amyloidosis. Blood. 2017 Aug 17;130(7):900-902. doi: 10.1182/blood-2017-01-763599. Epub 2017 Jun 14.
  16. Dimopoulous M, Quach H, Mateos MV, et al. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): results from a randomised, multicentre, open-label, phase 3 study. Lancet. 2020 July 18;396(10245):186-197.
  17. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma Version 4.2024. National Comprehensive Cancer Network, 2024. 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 August 2024.
  18. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Systemic Light Chain Amyloidosis Version 2.2024. National Comprehensive Cancer Network, 2024. 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 February 2024.
  19. Voorhees PM, Kaufman JL, Laubach J, et al. Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial. Blood. 2020 Aug 20;136(8):936-945.
  20. Yimer H, Melear J, Faber E, et al. Daratumumab, bortezomib, cyclophosphamide and dexamethasone in newly diagnosed and relapsed multiple myeloma: LYRA study. Br J Haematol. 2019 May;185(3):492-502.
  21. Palladini G, Kastritis E, Maurer M, et al Daratumumab plus CyBorD for patients with newly diagnosed AL amyloidosis: safety run-in results of ANDROMEDA. Blood 2020 Jul 2;136(1):71-80. doi: 10.1182/blood.2019004460.
  22. Dimopoulos MA, Terpos E, Boccadoro M, et al; APOLLO Trial Investigators. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Jun;22(6):801-812. doi: 10.1016/S1470-2045(21)00128-5.
  23. Landgren O, Hultcrantz M, Diamond B, et al. Safety and Effectiveness of Weekly Carfilzomib, Lenalidomide, Dexamethasone, and Daratumumab Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma: The MANHATTAN Nonrandomized Clinical Trial. JAMA Oncol. 2021 Jun 1;7(6):862-868. doi: 10.1001/jamaoncol.2021.0611.
  24. Gasparetto C, Lentzsch S, Schiller G, et al. Selinexor, daratumumab, and dexamethasone in patients with relapsed or refractory multiple myeloma. eJHaem. 2020;1-10. https://doi.org/10.1002/jha2.122.
  25. Kastritis E, Minnema MC, Dimopoulos MA, et al. Daratumumab Monotherapy in Previously Untreated High-Risk Patients with Stage 3B Light Chain (AL) Amyloidosis: A Phase II Multicenter Study By European Myeloma Network (EMN). Blood 2019; 134 (Supplement_1): 1868. doi: https://doi.org/10.1182/blood-2019-126524.
  26. Bahlis NJ, Baz R, Harrison SJ, et al. Phase I Study of Venetoclax Plus Daratumumab and Dexamethasone, With or Without Bortezomib, in Patients With Relapsed or Refractory Multiple Myeloma With and Without t(11;14). J Clin Oncol. 2021 Nov 10;39(32):3602-3612. doi: 10.1200/JCO.21.00443. Epub 2021 Aug 13. PMID: 34388020; PMCID: PMC8577687.
  27. Moreau P, Hulin C, Perrot A, et al. Maintenance with daratumumab or observation following treatment with bortezomib, thalidomide, and dexamethasone with or without daratumumab and autologous stem-cell transplant in patients with newly diagnosed multiple myeloma (CASSIOPEIA): an open-label, randomised, phase 3 trial. Lancet Oncol 2021;22:1378-1390.
  28. Laubach JP, Kaufman JL, Sborov DW, et al. Daratumumab (DARA) Plus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Patients (Pts) with Transplant-Eligible Newly Diagnosed Multiple Myeloma (NDMM): Updated Analysis of Griffin after 24 Months of Maintenance. Blood 2021; 138 (Supplement 1): 79. doi: https://doi.org/10.1182/blood-2021-149024.
  29. Sonneveld P, Dimopoulos MA, Boccadoro M, et al; PERSEUS Trial Investigators. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Jan 25;390(4):301-313. doi: 10.1056/NEJMoa2312054. Epub 2023 Dec 12. PMID: 38084760.

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

E85.3

Secondary systemic amyloidosis

E85.4

Organ-limited amyloidosis

E85.81

Light chain (AL) amyloidosis

E85.89

Other amyloidosis

E85.9

Amyloidosis, unspecified

Z85.79

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

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

The preceding information is intended for non-Medicare coverage determinations. 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 Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied 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

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA

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