Daratumumab (Darzalex) and Daratumumab and Hyaluronidase-fihj (Darzalex Faspro)

Policy ID: I-150-010

Section: Injections

Effective Date: October 01, 2019

Revised Date: September 16, 2022

Revision Effective Date: November 01, 2022

Last Reviewed: September 28, 2022

Applies To: Commercial and Medicaid Expansion

Description

Daratumumab (Darzalex™) is an immunoglobulin G1 kappa (IgG1k) human monoclonal antibody against CD38 antigen indicated for the treatment of individuals with multiple myeloma.

Hyaluronan is a polysaccharide found in the extracellular matrix of the subcutaneous tissue. It is depolymerized by the naturally occurring enzyme hyaluronidase. Unlike the stable structural components of the interstitial matrix, hyaluronan has a half-life of approximately 0.5 days. Hyaluronidase increases permeability of the subcutaneous tissue by depolymerizing hyaluronan. In the doses administered, hyaluronidase in daratumumab and hyaluronidase-fihj (Darzalex Faspro^TM) acts locally. The effects of hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Daratumumab (Darzalex)

Daratumumab (Darzalex) may be considered medically necessary for the treatment of multiple myeloma in individuals 18 years of age or older who meet ANY of the following criteria:

As combination therapy with lenalidomide and dexamethasone in newly diagnosed individuals who are ineligible for autologous stem cell transplant; or
As combination therapy with lenalidomide and dexamethasone in individuals with relapsed or refractory disease who have received at least one (1) prior therapy; or
As combination therapy with bortezomib, melphalan and prednisone in newly diagnosed individuals who are ineligible for autologous stem cell transplant; or
As combination therapy with bortezomib, thalidomide, and dexamethasone in newly diagnosed individuals who are eligible for autologous stem cell transplant; or
As combination therapy with dexamethasone and bortezomib in individuals who have received at least one (1) prior therapy; or
As combination therapy with pomalidomide and dexamethasone in individuals who have received at least two (2) prior therapies including lenalidomide and a proteasome inhibitor; or
As monotherapy, in individuals who have received at least three (3) 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; or
As combination therapy with carfilzomib and dexamethasone in individuals with relapsed or refractory disease who have received one (1) to three (3) prior lines of therapy.

The use of daratumumab (Darzalex) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9145

Daratumumab and Hyaluronidase-fihj (Darzalex Faspro)

Daratumumab and hyaluronidase-fihj (Darzalex Faspro) may be considered medically necessary for the treatment of individuals 18 years of age or older with multiple myeloma who meet ANY of the following criteria:

As combination therapy with bortezomib, melphalan and prednisone in newly diagnosed individuals who are ineligible for autologous stem cell transplant; or
As combination therapy with lenalidomide and dexamethasone in newly diagnosed individuals who are ineligible for autologous stem cell transplant; or
As combination therapy with lenalidomide and dexamethasone in individuals with relapsed or refractory multiple myeloma who have received at least one (1) prior therapy; or
As combination therapy with bortezomib and dexamethasone in individuals who have received at least one prior therapy; or
As combination therapy with pomalidomide and dexamethasone in individuals who have received at least one (1) prior therapy including lenalidomide and a proteasome inhibitor; or
As combination therapy with carfilzomib and dexamethasone in individuals with relapsed or refractory disease who have received one (1) to three (3) prior lines of therapy; or
As monotherapy, in individuals who have received at least three (3) 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; or
In combination with bortezomib, thalidomide and dexamethasone in newly diagnosed individuals who are eligible for autologous stem cell transplant; or

Daratumumab and hyaluronidase-fihj (Darzalex Faspro) may be considered medically necessary for the treatment of light chain (AL) amyloidosis in individuals 18 years of age or older who meet the following criteria:

As combination therapy with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed individuals.

The use of daratumumab and hyaluronidase-fihj (Darzalex Faspro) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9144

Compendia Sources

Daratumumab (Darzalex) and daratumumab and hyaluronidase-fihj (Darzalex Faspro) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of daratumumab (Darzalex) and daratumumab and hyaluronidase-fihj (Darzalex Faspro) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9144

J9145

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

NOTE: Darzalex Faspro is not indicated and is not recommended for the treatment of individuals with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes J9144 and J9145

C90.00

C90.02

C90.10

C90.12

C90.20

C90.22

C90.30

C90.32

D47.2

E85.81

E85.89

E85.9

Additional Covered Diagnosis Codes for Procedure Codes J9145

C83.50

C83.51

C83.52

C83.53

C83.54

C83.55

C83.56

C83.57

C83.58

C83.59

C91.00

C91.01

C91.02

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 9-26-2019 Adopted new policy

Internal Medical Policy Committee 11-14-2019 Added 18 years of age or older to criteria

Internal Medical Policy Committee 5-19-2020 Changed J9145 to pre-certification drug

Internal Medical Policy Committee 7-22-2020

Added daratumumab and hyaluronidase-fihj (Darzalex Faspro) to policy, and
Added one additional daratumumab (Darzalex) FDA indication to policy

Internal Medical Policy Committee 9-21-2020 Added new code, C9062, to policy

Internal Medical Policy Committee 1-19-2021 - Effective January 01, 2021

Removed C9062, and
Added new code J9144

Internal Medical Policy Committee 5-21-2021

Updated FDA indications and
Updated NCCN recommendations for daratumumab (Darzalex) and daratumumab and hyaluronidase-fihj (Darzalex Faspro)

Internal Medical Policy Committee 5-24-2022 Annual review, no clinical content change

Internal Medical Policy Committee 9-28-2022

Removed NCCN recommendations, and
Added this statement "Daratumumab (Darzalex) and daratumumab and hyaluronidase-fihj (Darzalex Faspro) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.", and
Updated experimental/investigational statement, and
Added "NOTE: Darzalex Faspro is not indicated and is not recommended for the treatment of individuals with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.", and
Added additional criteria for Darzalex Faspro, and
Removed diagnosis codes Z85.79

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-150-009

Section: Injections

Effective Date: October 01, 2019

Revised Date: May 13, 2021

Revision Effective Date: July 01, 2021

Last Reviewed: May 24, 2022

Archived Date: October 31, 2022

Applies To: Commercial and Medicaid Expansion

Description

Daratumumab (Darzalex™) is an immunoglobulin G1 kappa (IgG1k) human monoclonal antibody against CD38 antigen indicated for the treatment of individuals with multiple myeloma.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Daratumumab (Darzalex)

Food and Drug Administration (FDA) Indications

Daratumumab (Darzalex) may be considered medically necessary for the treatment of multiple myeloma in individuals 18 years of age or older who meet ANY of the following criteria:

As combination therapy with lenalidomide and dexamethasone in newly diagnosed individuals who are ineligible for autologous stem cell transplant; or
As combination therapy with lenalidomide and dexamethasone in individuals with relapsed or refractory disease who have received at least one prior therapy; or
As combination therapy with bortezomib, melphalan and prednisone in newly diagnosed individuals who are ineligible for autologous stem cell transplant; or
As combination therapy with bortezomib, thalidomide, and dexamethasone in newly diagnosed individuals who are eligible for autologous stem cell transplant; or
As combination therapy with dexamethasone and bortezomib in individuals who have received at least one prior therapy; or
As combination therapy with pomalidomide and dexamethasone in individuals who have received at least two prior therapies including lenalidomide and a proteasome inhibitor; or
As monotherapy, in individuals who have received at least three (3) 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; or
In combination with carfilzomib and dexamethasone in patients who have received one to three prior lines of therapy.

The use of daratumumab (Darzalex) for and other indication is considered experimental/investigational, and therefore not covered. The safety and effectiveness cannot be established by review of the available published peer-reviewed literature.

Procedure Codes

J9145

Daratumumab and Hyaluronidase-fihj (Darzalex Faspro)

FDA Indications

Daratumumab and hyaluronidase-fihj (Darzalex Faspro) may be considered medically necessary for the treatment of individuals 18 years of age or older with multiple myeloma in ANY of the following treatment regimens:

As combination therapy with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant; or
As combination therapy with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant; or
As combination therapy with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; or
As combination therapy with bortezomib and dexamethasone in patients who have received at least one prior therapy; or
As monotherapy, in patients 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; or
In combination with bortezomib, thalidomide and dexamethasone in newly diagnosis individuals who are eligible for autologous stem cell transplant; or
In combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosis light chain (AL) amyloidosis individuals.

The use of daratumumab and hyaluronidase-fihj (Darzalex Faspro) for and other indication is considered experimental/investigational, and therefore not covered. The safety and effectiveness cannot be established by review of the available published peer-reviewed literature.

Procedure Codes

J9144

National Comprehensive Cancer Network (NCCN) Recommendations

Daratumumab (Darzalex)

Daratumumab (Darzalex) may be considered medically necessary for the treatment of systemic light chain amyloidosis when the following criteria are met:

As single agent treatment for relapsed/refractory disease; or

Daratumumab and Hyaluronidase-fihj (Darzalex Faspro)

Daratumumab and hyaluronidase-fihj (Darzalex Faspro) may be considered medically necessary for the treatment of systemic light chain amyloidosis when the following criteria are met:

As a single agent or in combination with other systemic therapies where intravenous daratumumab is recommended; or

Daratumumab (Darzalex) and Daratumumab and Hyaluronidase-fihj (Darzalex Faspro)

Daratumumab (Darzalex) or daratumumab and hyaluronidase-fihj (Darzalex Faspro) may be considered medically necessary for the treatment of individuals 18 years of age or older with the following:

Multiple Myeloma:
- As primary therapy for symptomatic multiple myeloma for transplant in combination with:
  - Bortezomib, lenalidomide and dexamethasone; or
  - Bortezomib, cyclophosphamide and dexamethasone (useful in certain circumstances*); or
- As primary therapy for symptomatic multiple myeloma for non-transplant candidates in combination with:
  - Bortezomib, melphalan, and prednisone; or
  - Cyclophosphamide, bortezomib and dexamethasone; or
- Primary therapy for symptomatic multiple myeloma or for disease relapse after 6 months following primary induction therapy with the same regimen in combination with;
  - Lenalidomide and dexamethasone for non-transplant candidates; or
  - Cyclophosphamide, bortezomib and dexamethasone; or
- Therapy for previously treated myeloma for relapse or for progressive disease:
  - In combination with dexamethasone and bortezomib; or
  - In combination with dexamethasone and lenalidomide; or
  - In combination with carfilzomib and dexamethasone; or
  - In combination with cyclophosphamide, bortezomib and dexamethasone; or
  - As a single agent in individuals who have received at least three (3) prior therapies, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a proteasome inhibitor and an immunomodulatory agent; or
  - In combination with selinexor and dexamethasone; or
  - In combination with pomalidomide and dexamethasone in individuals who have received at least two prior therapies including an immunomodulatory agent and a proteasome inhibitor.

The use of daratumumab (Darzalex) or daratumumab and hyaluronidase-fihj (Darzalex Faspro) for and other indication is considered experimental/investigational, and therefore not covered. The safety and effectiveness cannot be established by review of the available published peer-reviewed literature.

Procedure Codes

J9144

J9145

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes J9144 and J9145

C90.00

C90.02

C90.10

C90.12

C90.20

C90.22

C90.30

C90.32

D47.2

E85.81

E85.89

E85.9

Z85.79

Additional Covered Diagnosis Codes for Procedure Codes J9145

C83.50

C83.51

C83.52

C83.53

C83.54

C83.55

C83.56

C83.57

C83.58

C83.59

C91.00

C91.01

C91.02

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 9-26-2019 Adopted new policy

Internal Medical Policy Committee 11-14-2019 Added 18 years of age or older to criteria

Internal Medical Policy Committee 5-19-2020 Changed J9145 to pre-certification drug

Internal Medical Policy Committee 7-22-2020 Added daratumumab and hyaluronidase-fihj (Darzalex Faspro) to policy, added one additional daratumumab (Darzalex) FDA indication to policy

Internal Medical Policy Committee 9-21-2020 Added new code, C9062, to policy

Internal Medical Policy Committee 1-19-2021 Added new code J9144 and removed C9062 from policy effective 1-1-2021

Internal Medical Policy Committee 5-21-2021 Updated FDA indications and NCCN recommendations for daratumumab (Darzalex) and daratumumab and hyaluronidase-fihj (Darzalex Faspro)

Internal Medical Policy Committee 5-24-2022 Annual review, no clinical content change

Links

References (PDF)

Disclaimer

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