BCBST MEDICAL POLICY MANUAL

Daratumumab

NDC CODE(S)

57894-0502-05 Darzalex 100 mg/5 mL (Janssen)

 

57894-0502-20 Darzalex 400 mg/20 mL (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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

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

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 of other conditions or diseases.

SOURCES

Lexicomp Online. (2016, October). AHFS DI. Daratumumab. Retrieved February 20, 2017 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, February). Daratumumab. Retrieved February 20, 2017 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®. Daratumumab. Retrieved February 20, 2017 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2016, November). Center for Drug Evaluation and Research. Darzalex™ (daratumumab) injections, for intravenous use. Retrieved February 21, 2017 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761036s004lbl.pdf.

ORIGINAL EFFECTIVE DATE:  1/6/2016

MOST RECENT REVIEW DATE:  4/11/2017

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

Pharmaceutical Decision Support Tree

Daratumumab (Darzalex™)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #5

  1. Is the individual 18 years of age or older with a diagnosis of multiple myeloma requesting treatment as a single agent and ANY ONE of the following?

If yes, go to question #4

If no, go to question #3

  1. Is the individual 18 years of age or older with a diagnosis of multiple myeloma and a minimum of one prior therapy requesting combination therapy with either bortezomib and dexamethasone or lenalidomide and dexamethasone?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 180 billable units or less for dosage of 16 mg/kg body weight given as an IV infusion for an authorization period of 6 months per the dosage table below?

Multiple myeloma monotherapy and in combination with lenalidomide 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

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 2 through 4?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is effectiveness evidenced by stabilization of disease and/or absence of progression of disease?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the drug including infusion reactions, fatigue, nausea, back pain, pyrexia, cough, and upper respiratory tract infection?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

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