BlueCross BlueShield of Tennessee Medical Policy Manual

Daratumumab

NDC CODE(S)

57894-0502-XX Darzalex 100 MG/5ML SOLN (Janssen)

 

57894-0502-XX Darzalex 400 MG/20 ML SOLN (Janssen)

DESCRIPTION

Daratumumab is an immunoglobulin G1 kappa human monoclonal antibody against CD38 antigen, produced in a mammalian cell line using recombinant DNA technology. Daratumumab binds to CD38 and inhibits the growth of CD38 expressing tumor cells by inducing apoptosis directly through Fc mediated cross linking as well as by immune-medicated tumor cell lysis through complement dependent cytotoxicity, antibody dependent cell mediated cytotoxicity and antibody dependent cellular phagocytosis.  Myeloid derived suppressor cells and a subset of regulatory T cells express CD38 and are susceptible to daratumumab mediated cell lysis.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Multiple myeloma monotherapy and in combination with lenalidomide or pomalidomide and dexamethasone

16 mg/kg body weight given as an IV infusion:

Weekly                        Weeks 1 to 8

Every two weeks         Weeks 9 to 24

Every four weeks        Week 25 onwards
Multiple myeloma in combination with bortezomib and dexamethasone

16 mg/kg body weight given as an IV infusion:

Weekly                         Weeks 1 to 9

Every three weeks       Weeks 10 to 24

Every four weeks         Week 25 onwards

 

LENGTH OF AUTHORIZATION

Coverage will be provided for 6 months and may be renewed

Click here to view DOSAGE 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.

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, the express terms of the health plan will govern.

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).

No controlled studies were found in the published literature that validate the use of daratumumab for the treatment or prevention of other conditions or diseases.

SOURCES

Lexicomp Online. (2018). AHFS DI. Daratumumab. Retrieved February 22, 2018 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, January). Daratumumab. Retrieved February 22, 2018 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Daratumumab. Retrieved February 22, 2018 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2017, June). Center for Drug Evaluation and Research. Darzalex™ (daratumumab) injections, for intravenous use. Retrieved February 22, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761036s005lbl.pdf.

ORIGINAL EFFECTIVE DATE:  1/6/2016

MOST RECENT REVIEW DATE:  5/8/2018

ID_MRx

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.

 

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 10 mg

Regimen

MAXIMUM UNITS

Lenalidomide/Pomalidomide Regimen

180 billable units per dose (Weekly in weeks 1 to 8, then every two weeks in weeks 9-24, then every four weeks in week 25 onwards)

Bortezomib Regimen

180 billable units per dose (Weekly in weeks 1 to 9, then every three weeks in weeks 10-24, then every four weeks in week 25 onwards)