BlueCross BlueShield of Tennessee Medical Policy Manual
Daratumumab (Darzalex®)
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
Darzalex is indicated for the treatment of adult patients with multiple myeloma:
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:
T-cell Acute Lymphoblastic Leukemia (T-ALL)
Authorization of 12 months may be granted for the treatment of T-cell acute lymphoblastic leukemia (T-cell) when the member has relapsed or refractory disease and the requested medication will be used in combination with any of the following:
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 either of the following regimen or indication-specific criteria is met:
MEDICATION QUANTITY LIMITS
|
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
|
Daratumumab (Darzalex®)
|
Multiple Myeloma |
Route of Administration: Intravenous 16mg/kg per dose (dosing schedule varies by regimen) |
|
Daratumumab (Darzalex®)
|
Systemic Light Chain Amyloidosis |
Route of Administration: Intravenous 16mg/kg every week for 8 doses, followed by every 2 weeks for 8 doses, then every 4 weeks |
|
Daratumumab (Darzalex®)
|
T-cell Acute Lymphoblastic Leukemia (T-ALL) |
Route of Administration: Intravenous 16mg/kg every week for 8 doses, followed by every 2 weeks for 8 doses, then every 4 weeks |
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).
ORIGINAL EFFECTIVE DATE: 1/6/2016
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.