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, or 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 or 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 in 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 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. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).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])
- Patient is double-refractory to a proteasome inhibitor and an immunomodulatory agent
- Both of the following:
- Used in combination with one of the following treatment regimens:
- lenalidomide and dexamethasone
- bortezomib and dexamethasone
- carfilzomib and dexamethasone
- Patient has received at least one prior therapy (e.g., bortezomib [Velcade], carfilzomib [Kyprolis], ixazomib [Ninlaro], lenalidomide [Revlimid], thalidomide [Thalomid]) [2]
- Both of the following:
- Used in combination with both of the following:
- pomalidomide
- dexamethasone
- 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
- Used in combination with both of the following:
- lenalidomide
- dexamethasone
- 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])
- Patient is double-refractory to a proteasome inhibitor and an immunomodulatory agent
- Both of the following:
- Used in combination with one of the following treatment regimens:
- lenalidomide and dexamethasone
- bortezomib and dexamethasone
- carfilzomib and dexamethasone
- Patient has received at least one prior therapy (e.g., bortezomib [Velcade], carfilzomib [Kyprolis], ixazomib [Ninlaro], lenalidomide [Revlimid], thalidomide [Thalomid]) [2]
- Both of the following:
- Used in combination with both of the following:
- pomalidomide
- dexamethasone
- 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])
- Patient is double-refractory to a proteasome inhibitor and an immunomodulatory agent
- Both of the following:
- Used in combination with one of the following treatment regimens:
- lenalidomide and dexamethasone
- bortezomib and dexamethasone
- carfilzomib and dexamethasone
- Patient has received at least one prior therapy (e.g., bortezomib [Velcade], carfilzomib [Kyprolis], ixazomib [Ninlaro], lenalidomide [Revlimid], thalidomide [Thalomid]) [2]
- Both of the following:
- Used in combination with both of the following:
- pomalidomide
- dexamethasone
- 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
- Used in combination with both of the following:
- lenalidomide
- dexamethasone
- 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
- Used in combination with all of the following: (2)
- 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
- Used in combination with both of the following:
- lenalidomide
- dexamethasone
- 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
- Used in combination with all of the following: (2)
- bortezomib
- lenalidomide
- dexamethasone
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
- All of the following: [3]
- 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
- All of the following: [3]
- 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
P & T Revisions
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
References
- Darzalex Prescribing Information. Janssen Biotech, Inc. Horsham, PA. January 2023.
- National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Multiple Myeloma v4.2024. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Accessed August 13, 2024
- Darzalex Faspro Prescribing Information. Janssen Biotech, Inc. Horsham, PA. July 2024.
Revision History
- 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.
HEALTHY LIVING