BlueCross BlueShield of Tennessee Medical Policy Manual

Daratumumab and hyaluronidase-fihj (Darzalex Faspro®)

IMPORTANT REMINDER

 

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

 

POLICY         

INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered covered benefits provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications

Compendial Uses

All other indications are considered experimental/investigational and not medically necessary.

DOCUMENTATION

Submission of the following information is necessary to initiate the prior authorization review:

Documentation of testing or laboratory results confirming t(11:14) translocation, where applicable.

COVERAGE CRITERIA

Multiple Myeloma

Authorization of 12 months may be granted for the treatment of multiple myeloma when used in combination with cyclophosphamide, bortezomib, and dexamethasone

Authorization of 12 months may be granted for the treatment of multiple myeloma as primary therapy when any of the following criteria is met:

Authorization of 12 months may be granted for the treatment of previously treated multiple myeloma when any of the following criteria is met:

Authorization of 12 months may be granted for maintenance therapy of symptomatic multiple myeloma for transplant candidates when used in combination with lenalidomide.

POEMS (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes) Syndrome

Authorization of 12 months may be granted for the treatment of POEMS syndrome when used in combination with lenalidomide and dexamethasone as induction therapy for transplant eligible member.

Systemic Light Chain Amyloidosis

Authorization of 12 months may be granted for the treatment of systemic light chain amyloidosis if either of the following criteria is met:

CONTINUATION OF THERAPY

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section when any of the following criteria are met:

MEDICATION QUANTITY LIMITS

Drug Name

Diagnosis

Maximum Dosing Regimen

Daratumumab and hyaluronidase-fihj (Darzalex Faspro)

Multiple Myeloma

Route of Administration: Subcutaneous

1800/30,000mg-units per dose (dosing schedule varies by regimen)

Daratumumab and hyaluronidase-fihj (Darzalex Faspro)

Systemic Light Chain Amyloidosis

Route of Administration: Subcutaneous

1800/30,000mg-units every week for 8 doses, followed by every 2 weeks for 8 doses, then every 4 weeks

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

REFERENCES    

  1. Darzalex Faspro [package insert]. Horsham, PA: Janssen Biotech, Inc.; July 2024.
  2. The NCCN Drugs & Biologics Compendium® ©2024 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed October 2, 2024.
  3. The NCCN Clinical Practice Guidelines in Oncology Multiple Myeloma (Version 1.2025) 2024 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed October 2, 2024.

ORIGINAL EFFECTIVE DATE: 7/31/2020

MOST RECENT REVIEW DATE: 8/30/2025

ID_CHS

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.