WHA

Darzalex (daratumumab), Darzalex Faspro (daratumumab and hyaluronidase-fihj) - PA, NF

Indications for Prior Authorization

Darzalex (daratumumab)
  • For diagnosis of Multiple Myeloma - Monotherapy
    Indicated as monotherapy for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

  • For diagnosis of Multiple Myeloma - Combination therapy
    Indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.

  • For diagnosis of Multiple Myeloma - Combination therapy
    Indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

  • For diagnosis of Multiple Myeloma - Combination therapy
    Indicated in combination with carfilzomib and dexamethasone in adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.

  • For diagnosis of Multiple Myeloma - Combination therapy
    Indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

  • For diagnosis of Newly Diagnosed Multiple Myeloma
    Indicated in combination with bortezomib, melphalan, and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

  • For diagnosis of Newly Diagnosed Multiple Myeloma
    Indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

  • For diagnosis of Newly Diagnosed Multiple Myeloma
    Indicated in combination with bortezomib, thalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

Darzalex Faspro (daratumumab and hyaluronidase-fihj)
  • For diagnosis of Multiple Myeloma - Monotherapy
    Indicated as monotherapy for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

  • For diagnosis of Multiple Myeloma - Combination
    Indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.

  • For diagnosis of Multiple Myeloma - Combination
    Indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

  • For diagnosis of Multiple Myeloma - Combination
    Indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.

  • For diagnosis of Multiple Myeloma - Combination
    Indicated in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.

  • For diagnosis of Newly Diagnosed Multiple Myeloma
    Indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

  • For diagnosis of Newly Diagnosed Multiple Myeloma
    Indicated in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

  • For diagnosis of Newly Diagnosed Multiple Myeloma
    Indicated in combination with bortezomib, thalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

  • For diagnosis of Newly Diagnosed Multiple Myeloma
    Indicated in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant.

  • For diagnosis of Smoldering Multiple Myeloma
    Indicated for the treatment of adult patients with high-risk smoldering multiple myeloma as monotherapy.

  • For diagnosis of Light Chain (AL) Amyloidosis
    Indicated in combination with bortezomib, cyclophosphamide, and dexamethasone for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis. Limitations of Use: DARZALEX FASPRO is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

Criteria

Darzalex

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Relapsed/Refractory Multiple Myeloma

  • Diagnosis of multiple myeloma
    • AND
  • One of the following:
    • Both of the following:
      • Used as monotherapy
        • AND
      • One of the following:
        • Patient has received at least three prior treatment regimens which included both of the following:
          • Proteasome inhibitor (e.g., bortezomib [Velcade], carfilzomib [Kyprolis])
          • Immunomodulatory agent (e.g., lenalidomide [Revlimid], thalidomide [Thalomid])
          OR
        • Patient is double-refractory to a proteasome inhibitor and an immunomodulatory agent
      OR
    • Both of the following:
      • Used in combination with one of the following treatment regimens:
        • lenalidomide and dexamethasone
        • bortezomib and dexamethasone
        • carfilzomib and dexamethasone
        AND
      • Patient has received at least one prior therapy (e.g., bortezomib [Velcade], carfilzomib [Kyprolis], ixazomib [Ninlaro], lenalidomide [Revlimid], thalidomide [Thalomid]) [3]
      OR
    • Both of the following:
      • Used in combination with both of the following:
        • pomalidomide
        • dexamethasone
        AND
      • Patient has received at least two prior therapies including lenalidomide and a proteasome inhibitor (e.g., bortezomib [Velcade], carfilzomib [Kyprolis])
Darzalex

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Newly Diagnosed Multiple Myeloma

  • Newly diagnosed multiple myeloma
    • AND
  • One of the following:
    • Both of the following:
      • Patient is ineligible for autologous stem cell transplant
        • AND
      • One of the following:
        • Used in combination with all of the following:
          • bortezomib
          • melphalan
          • prednisone
          OR
        • Used in combination with both of the following:
          • lenalidomide
          • dexamethasone
      OR
    • Both of the following:
      • Patient is eligible for autologous stem cell transplant
        • AND
      • Used in combination with all of the following:
        • bortezomib
        • thalidomide
        • dexamethasone
Darzalex Faspro

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Relapsed/Refractory Multiple Myeloma

  • Diagnosis of multiple myeloma
    • AND
  • One of the following:
    • Both of the following:
      • Used as monotherapy
        • AND
      • One of the following:
        • Patient has received at least three prior treatment regimens which included both of the following:
          • Proteasome inhibitor (e.g., bortezomib [Velcade], carfilzomib [Kyprolis])
          • Immunomodulatory agent (e.g., lenalidomide [Revlimid], thalidomide [Thalomid])
          OR
        • Patient is double-refractory to a proteasome inhibitor and an immunomodulatory agent
      OR
    • Both of the following:
      • Used in combination with one of the following treatment regimens:
        • lenalidomide and dexamethasone
        • bortezomib and dexamethasone
        • carfilzomib and dexamethasone
        AND
      • Patient has received at least one prior therapy (e.g., bortezomib [Velcade], carfilzomib [Kyprolis], ixazomib [Ninlaro], lenalidomide [Revlimid], thalidomide [Thalomid]) [3]
      OR
    • Both of the following:
      • Used in combination with both of the following:
        • pomalidomide
        • dexamethasone
        AND
      • Patient has received at least one prior line of therapy including lenalidomide and a proteasome inhibitor (e.g., bortezomib [Velcade], carfilzomib [Kyprolis])
Darzalex Faspro

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Relapsed/Refractory Multiple Myeloma

  • Submission of medical records (e.g., chart notes) confirming diagnosis of multiple myeloma
    • AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming one of the following:
    • Both of the following:
      • Used as monotherapy
        • AND
      • One of the following:
        • Patient has received at least three prior treatment regimens which included both of the following:
          • Proteasome inhibitor (e.g., bortezomib [Velcade], carfilzomib [Kyprolis])
          • Immunomodulatory agent (e.g., lenalidomide [Revlimid], thalidomide [Thalomid])
          OR
        • Patient is double-refractory to a proteasome inhibitor and an immunomodulatory agent
      OR
    • Both of the following:
      • Used in combination with one of the following treatment regimens:
        • lenalidomide and dexamethasone
        • bortezomib and dexamethasone
        • carfilzomib and dexamethasone
        AND
      • Patient has received at least one prior therapy (e.g., bortezomib [Velcade], carfilzomib [Kyprolis], ixazomib [Ninlaro], lenalidomide [Revlimid], thalidomide [Thalomid]) [3]
      OR
    • Both of the following:
      • Used in combination with both of the following:
        • pomalidomide
        • dexamethasone
        AND
      • Patient has received at least one prior line of therapy including lenalidomide and a proteasome inhibitor (e.g., bortezomib [Velcade], carfilzomib [Kyprolis])
Darzalex Faspro

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Newly Diagnosed Multiple Myeloma

  • Newly diagnosed multiple myeloma
    • AND
  • One of the following:
    • Both of the following:
      • Patient is ineligible for autologous stem cell transplant
        • AND
      • One of the following:
        • Used in combination with all of the following:
          • bortezomib
          • melphalan
          • prednisone
          OR
        • Used in combination with both of the following:
          • lenalidomide
          • dexamethasone
      OR
    • Both of the following:
      • Patient is eligible for autologous stem cell transplant
        • AND
      • One of the following:
        • Used in combination with all of the following:
          • bortezomib
          • thalidomide
          • dexamethasone
          OR
        • Used in combination with all of the following: [3]
          • bortezomib
          • lenalidomide
          • dexamethasone
Darzalex Faspro

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Newly Diagnosed Multiple Myeloma

  • Submission of medical records (e.g., chart notes) confirming newly diagnosed multiple myeloma
    • AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming one of the following:
    • Both of the following:
      • Patient is ineligible for autologous stem cell transplant
        • AND
      • One of the following:
        • Used in combination with all of the following:
          • bortezomib
          • melphalan
          • prednisone
          OR
        • Used in combination with both of the following:
          • lenalidomide
          • dexamethasone
      OR
    • Both of the following:
      • Patient is eligible for autologous stem cell transplant
        • AND
      • One of the following:
        • Used in combination with all of the following:
          • bortezomib
          • thalidomide
          • dexamethasone
          OR
        • Used in combination with all of the following: [3]
          • bortezomib
          • lenalidomide
          • dexamethasone
Darzalex Faspro

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Smoldering Multiple Myeloma

  • Diagnosis of smoldering (asymptomatic) multiple myeloma [A]
    • AND
  • Disease is high risk, defined as TWO of the following: [B]
    • Serum M-protein (IgG or IgA) level greater than 2 g/dL
    • Involved to uninvolved serum free light-chain ratio (FLCr) greater than 20
    • Bone marrow plasma cell (BPMC) infiltration greater than 20%
    AND
  • Used as monotherapy
Darzalex Faspro

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Smoldering Multiple Myeloma

  • Submission of medical records (e.g., chart notes) confirming diagnosis of smoldering (asymptomatic) multiple myeloma [A]
    • AND
  • Submission of medical records (e.g., chart notes) confirming disease is high risk, defined as TWO of the following: [B]
    • Serum M-protein (IgG or IgA) level greater than 2 g/dL
    • Involved to uninvolved serum free light-chain ratio (FLCr) greater than 20
    • Bone marrow plasma cell (BPMC) infiltration greater than 20%
    AND
  • Requested drug will be used as monotherapy
Darzalex Faspro

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Light Chain Amyloidosis

  • Newly diagnosed light chain (AL) amyloidosis
    • AND
  • Used in combination with ALL of the following:
    • Bortezomib
    • Cyclophosphamide
    • Dexamethasone
    AND
  • All of the following: [2]
    • Patient does not have New York Heart Association (NYHA) Class IIIB disease
    • Patient does not have New York Heart Association (NYHA) Class IV disease
    • Patient does not have Mayo Stage IIIB disease
Darzalex Faspro

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Light Chain Amyloidosis

  • Submission of medical records (e.g., chart notes) confirming newly diagnosed light chain (AL) amyloidosis
    • AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming medication is being used in combination with ALL of the following:
    • Bortezomib
    • Cyclophosphamide
    • Dexamethasone
    AND
  • All of the following: [2]
    • Patient does not have New York Heart Association (NYHA) Class IIIB disease
    • Patient does not have New York Heart Association (NYHA) Class IV disease
    • Patient does not have Mayo Stage IIIB disease
Darzalex, Darzalex Faspro

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All Indications listed above

  • Patient does not show evidence of progressive disease while on therapy

  • Guideline ID
    GL-457202

  • Formulary
    Premium

  • Effective date
    Jan 1, 2026

  • P&T approval date
    Jan 27, 2016

P & T Revisions

2025-12-08, 2025-02-24, 2024-09-04, 2024-02-20, 2023-07-18, 2023-02-28, 2022-02-01, 2021-12-16, 2021-08-24, 2021-05-19, 2021-04-06, 2021-03-09, 2020-06-30, 2020-05-20, 2020-02-27, 2019-11-18, 2019-08-27

  1. Darzalex Prescribing Information. Janssen Biotech, Inc. Horsham, PA. April 2025.
  2. Darzalex Faspro Prescribing Information. Janssen Biotech, Inc. Horsham, PA. November 2025.
  3. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Multiple Myeloma v3.2026. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Accessed November 17, 2025.
  4. Dimopoulos MA, Voorhees PM, Schjesvold F, et al. Daratumumab or active monitoring for high-risk smoldering multiple myeloma. N Engl J Med. 2025; 392(18):1777-1788.
  5. Rajkumar SV, Dimopoulos MA, Palumbo A, et al. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014 Nov; 15(12):e538-548.
  6. Mateos M, Kumar S, Dimopoulos MA, et al. International Myeloma Working Group risk stratification model for smoldering multiple myeloma (SMM). Blood Cancer J. 2020; 10(10): 102.
  1. Smoldering (asymptomatic) myeloma is a stage of myeloma with no symptoms and no related organ or tissue impairment. Smoldering myeloma is a precursor to multiple myeloma. In the pivotal study, the International Myeloma Working Group (IMWG) criteria for smoldering multiple myeloma were used to determine study inclusion. Per IMWG, a diagnosis of smoldering myeloma is confirmed if the patient demonstrates both of the following: 1) a serum monoclonal protein (IgG or IgA) of 30 g/L (3 g/dL) or more or urinary monoclonal protein of 500 mg/24hr or more and/or clonal bone marrow plasma cells of 10-60%; and 2) absence of myeloma-defining events or amyloidosis. [3-5]
  2. The National Comprehensive Cancer Network (NCCN) recommends the Mayo 2018/IMWG 20/2/20 criteria to stratify patients’ risk of progression from smoldering to active multiple myeloma. Based on the 20/2/20 criteria, patients are high risk if they have at least two of the following: bone marrow plasma cell (BMPC) infiltration greater than 20%, serum M-protein greater than 2 g/dL, and involved to uninvolved free light-chain ratio (FLCr) greater than 20. As the 20/2/20 criteria were published after the pivotal AQUILA study was initiated, 40.5% of included participants were retrospectively classified as having high-risk disease. Darzalex Faspro is only indicated for patients with high-risk smoldering multiple myeloma due to the high likelihood of progression to multiple myeloma (i.e., ~46%); it is not indicated for other risk categories which have lower estimated 2-year progression risk (i.e., 5% for low risk and 17% for intermediate risk). [3, 4, 6]
  • 2025-12-08: Criteria update for Darzalex Faspro new indication of smoldering MM. Incorporated reference & background updates for 2026 annual review.
  • 2025-02-24: 2025 annual review: no criteria changes, background updates.
  • 2024-09-04: Created criteria for new indication. Updated non-formulary criteria. Background updates
  • 2024-02-20: 2024 annual review: no criteria changes. Updated some verbiages and formats in criteria with no change to clinical intent. Updated indications, references.
  • 2023-07-18: Removed oncologist specialist requirement
  • 2023-02-28: 2023 UM Annual Review. Updated NF criteria to require submission of medical records or paid claims. Updated references.
  • 2022-02-01: Addition of new FDA indication for Darzalex Faspro
  • 2021-12-16: Addition of NF Criteria
  • 2021-08-24: Addition of new FDA indication for Darzalex Faspro
  • 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-04-06: GPI Reclassification
  • 2021-03-09: Added new indications for Darzalex Faspro
  • 2020-06-30: Added Darzalex Faspro criteria
  • 2020-05-20: Removed reference to drug name in reauthorization criteria.
  • 2020-02-27: 2020 Annual Review
  • 2019-11-18: Updated for new indication
  • 2019-08-27: Updated guideline to include new indication of in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant.