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         

1. 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.

1. FDA-Approved Indications

1. Darzalex Faspro is indicated for the treatment of adult patients with multiple myeloma:
   1. in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant.
   2. in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
   3. in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant.
   4. in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy.
   5. in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.
   6. in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
   7. 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. 

2. Darzalex Faspro is indicated for the treatment of adult patients with newly diagnosed light chain  amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone.

2. Compendial Uses

1. For multiple myeloma, may be used as a single agent or in combination with other systemic therapies where intravenous daratumumab is recommended
2. Systemic light chain amyloidosis

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

2. 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.

3. CRITERIA FOR INITIAL APPROVAL

A.   Multiple Myeloma

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

2. Authorization of 12 months may be granted for the treatment of multiple myeloma as primary therapy when any of the following criteria is met:
   1. The member is ineligible for a transplant and the requested medication will be used in combination with either:
      1. Lenalidomide and dexamethasone
      2. Bortezomib, melphalan, and prednisone
   2. The member is eligible for transplant and the requested medication will be used in combination with any of the following:
      1. Bortezomib, thalidomide, and dexamethasone for a maximum of 16 doses
      2. Bortezomib, lenalidomide, and dexamethasone
      3. Carfilzomib, lenalidomide, and dexamethasone
      4. Ixazomib, lenalidomide, and dexamethasone

3. Authorization of 12 months may be granted for the treatment of previously treated multiple myeloma when any of the following criteria is met:
   1. The requested medication will be used in combination with lenalidomide and dexamethasone in members who have received at least one prior therapy
   2. The requested medication will be used in combination with bortezomib and dexamethasone in members who have received at least one prior therapy
   3. The requested medication will be used in combination with carfilzomib and dexamethasone in members who have received at least one prior therapy
   4. The requested medication will be used in combination with pomalidomide and dexamethasone in members who have received at least one prior therapy including a proteasome inhibitor (PI) and an immunomodulatory agent.
   5. The requested medication will be used in combination with selinexor and dexamethasone
   6. The requested medication will be used in combination with venetoclax and dexamethasone for members with documented t(11:14) translocation
   7. The requested medication will be used as a single agent in members who have received at least three prior therapies, including a PI and an immunomodulatory agent
   8. The requested medication will be used as a single agent in members who are double refractory to a PI and an immunomodulatory agent

4. Authorization of 12 months may be granted for maintenance therapy of symptomatic multiple myeloma for transplant candidates when either of the following criteria is met:
   1. The requested medication will be used as a single agent
   2. The requested medication will be used in combination with lenalidomide in members who have high risk disease

2. Light Chain Amyloidosis

Authorization of 12 months may be granted for the treatment of light chain amyloidosis in either of the following settings:

1. For newly diagnosed members when used in combination with bortezomib, cyclophosphamide and dexamethasone or as a single agent.
2. For relapsed or refractory disease.

4. CONTINUATION OF THERAPY

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

1. All members (including new members) requesting the requested medication in combination with bortezomib, thalidomide, and dexamethasone for multiple myeloma must meet all initial criteria.
2. For members requesting reauthorization for newly diagnosed light chain amyloidosis, the maximum treatment duration is 24 months and there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
3. For all other regimens and indications listed in Section III, there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

MEDICATION QUANTITY LIMITS

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.; November 2022.
2. The NCCN Drugs & Biologics Compendium^® ©2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed December 14, 2023.
3. The NCCN Clinical Practice Guidelines in Oncology Multiple Myeloma (Version 1.2024) 2023 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed October 2, 2023.

ORIGINAL EFFECTIVE DATE: 7/31/202

MOST RECENT REVIEW DATE: 12/31/2024

IID_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.