BlueCross BlueShield of Tennessee Medical Policy Manual

Belimumab

NDC CODE(S)

Benlysta 120 mg injection: 49401-0101-xx (Human Genome Sciences)

 

Benlysta 400 mg injection: 49401-0102-xx (Human Genome Sciences)

DESCRIPTION

Belimumab is a human IgG1 monoclonal antibody specific for soluble human B lymphocyte stimulator protein (BLyS), a B cell survival factor.  It is produced by recombinant DNA technology in a mammalian cell expression system.  Belimumab does not bind to B cells directly but blocks access of soluble BLyS to its receptors on B cells. This inhibits the survival of B cells and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.  Treatment with belimumab leads to reductions in circulating CD19+, CD20+, naïve and activated B cells along with plasmacytoid cells and the systemic lupus erythematosus (SLE) B-cell subset.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Systemic lupus erythematosus (SLE)

Loading Dose: 10 mg/kg every 2 week x 3 doses (days 1, 15 and 29)

Maintenance Dose: 10mg/kg 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.

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 belimumab for the treatment of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2016). AHFS DI. Belimumab. Retrieved September 19, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, August). Belimumab. Retrieved September 19, 2016 from MICROMEDEX Healthcare Series.  

U. S. Food and Drug Administration. (2014, April). Center for Drug Evaluation and Research. Benlysta® (belimumab) for injection, for intravenous use only. Retrieved September 19, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125370s053lbl.pdf.

ORIGINAL EFFECTIVE DATE:  8/13/2011

MOST RECENT REVIEW DATE:  2/6/2017

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 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.

Pharmaceutical Decision Support Tree

Belimumab (Benlysta®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #7

  1. Does the individual have a diagnosis of ANY ONE of the following?

If yes, this does not meet medical necessity and/or medical appropriateness criteria

If no, go to question #3

  1. Is the individual 18 years of age or older with a diagnosis of systemic lupus erythematosus (SLE) that is ALL of the following?

If yes, go to question #4

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

  1. Is the individual currently receiving standard therapy ((e.g., corticosteroids, antimalarials, nonsteroidal anti-inflammatories [NSAIDS], immunosuppressive agents [excluding intravenous cyclophosphamide]) with NO concomitant treatment with ANY ONE of the following?

If yes, go to question #5

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

  1. Does the individual show evidence of ALL of the following?

If yes, go to question #6

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

  1. Is the request for 360 billable units or less per 29 days for a loading dose and 120 billable units or less per 28 days for a maintenance dose for dosage of the following?

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 3 through 6?

If yes, go to question #8

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

  1. Is there adequate documentation of disease stability and/or improvement as indicated by ANY ONE of the following when compared to baseline?

If yes, go to question #9

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

  1. Is there absence of unacceptable toxicity from the drug, e.g., depression, suicidal thoughts, serious infections, malignancy?

If yes, this satisfies medical necessity and medical appropriateness criteria

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

This document has been classified as public information.