BlueCross BlueShield of Tennessee Medical Policy Manual

Natalizumab

NDC CODE(S)

64406-0008 - Tysabri 300 mg/15ml (Biogen Idec Inc)

DESCRIPTION

Natalizumab is a recombinant humanized IgG4κ monoclonal antibody produced in murine myeloma cells. It was the first member of a class of monoclonal antibodies referred to as selective adhesion molecule inhibitors. Natalizumab binds to the surface alpha-4 integrin receptor sites of all leukocytes except neutrophils, inhibiting the adhesion of leukocytes to their counter-receptors found on activated vascular endothelium cells and vascular endothelial cells of the gastrointestinal tract.  This prevents leukocytes from migrating across the endothelium into inflamed parenchymal tissue where they exacerbate the inflammatory process.

Additionally, natalizumab interferes with movement of potentially damaging immune cells across the blood-brain-barrier and into the brain and spinal cord.  It also likely inhibits further recruitment and inflammatory activity of activated immune cells.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

All Indications

300 mg intravenous infusion over one hour every four 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 natalizumab for the treatment of any other conditions or diseases.

SOURCES

Lexi-Comp Online. (2016). AHFS DI. Natalizumab. Retrieved November 10, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, October). Natalizumab. Retrieved November 10, 2016 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2016, May). Center for Drug Evaluation and Research. Tysabri® (natalizumab). Retrieved November 10, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125104s953s955lbl.pdf.

ORIGINAL EFFECTIVE DATE:  1/13/2007

MOST RECENT REVIEW DATE:  12/1/2016

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

Natalizumab (Tysabri ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #6

  1. Does the individual meet ALL of the following?

If yes, go to question #3

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

  1. Does the individual have a diagnosis of Multiple Sclerosis (MS) with ALL the following?

If yes, go to question #5

If no, go to question #4

  1. Does the individual have a diagnosis of Crohn’s disease (CD) with ALL of the following?

If yes, go to question #5

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

  1. Is the request for 300 billable units every 28 days (4 weeks) for dosage of 300 mg intravenous infusion over one hour every four weeks with an authorization period for MS of 6 months with renewal eligibility and for Crohn’s Disease for initial treatment of 12 weeks with renewal eligibility for 6 months?

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 initial approval criteria in questions 2 through 5?

If yes, go to question #7

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

  1. Does the individual have a diagnosis of MS with positive/acceptable results in continuous monitoring of response to therapy (manifestations of MS disease activity) which include, but are not limited to, the following?

If yes, this satisfies medical necessity and medical appropriateness criteria for renewal

If no, go to question #8

  1. Does the individual have a diagnosis of Crohn’s Disease with ALL of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria for renewal

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

This document has been classified as public information.