I-150-009

HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

Medical Policy:

I-150-009

Topic:

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

Section:

Injections

Effective Date:

May 31, 2021

Issued Date:

May 31, 2021

Last Revision Date:

May 2021

Annual Review:

April 2021

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.

Policy Position

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 bortzomib 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; or

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.

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.
In combination with bortezomib, thalidomide and dexmethasone 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 or

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.

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, thalidomide and dexamethasone (useful in certain circumstances*); or
- As primary therapy for symptomatic multiple myeloma in combination with bortezomib, melphalan, and prednisone for non-transplant candidates; 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.

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.

Covered Diagnosis Codes for Procedure Codes J1944 and J1945

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

Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

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

Links

Link to Provider Resource Center for the Medical Policy Update

06/2020, Coverage Guidelines Established for Daratumab Hyaluronidase-fihj (Darzalex Faspro)

Link to References

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, and subject to the applicable laws of your state.

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.

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.

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.