HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
I-150-011
Topic:
Daratumumab (Darzalex) and Daratumumab and Hyaluronidase-fihj (Darzalex Faspro)
Section:
Injections
Effective Date:
October 9, 2023
Issued Date:
October 9, 2023
Last Revision Date:
August 2023
Annual Review:
August 2023
 
 

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 FasproTM) acts locally. The effects of hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours.

Policy Position

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 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 bortzomib 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 patients with relapse 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 not medically necessary.

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 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 (1) prior therapy; or
  • As combination therapy with bortezomib and dexamethasone in patients who have received at least one (1) prior therapy; or
  • As combination therapy with pomalidomide and dexamethasone in individuals who have received at least one (1) prior therapy including lenalidomide and proteasome inhibitor; or 
  • As combination therapy with carfilzomib and dexamethasone in patients with relapsed or refractory disease who have received one (1) to three (3) prior lines of therapy, or
  • As monotherapy, in patients 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. 
  • 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 not medically necessary.

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, 2A, or 2B 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 not medically necessary.

J9145

J9144

  

 

 

 

 


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. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

NOTE: 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.

Related Policies

Refer to Medical Policy I-249, Pennsylvania Cancer Treatment Mandate, for additional information. 


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

E85.3

E85.4

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

 


Place of Service: Outpatient

Daratumumab (Darzalex) or daratumumab and hyaluronidase-fihj (Darzalex Faspro) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.




Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
    • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.