BlueCross BlueShield of Tennessee Medical Policy Manual

Natalizumab

NDC CODE(S)

64406-0008 - Tysabri 300 MG/15 ML CONC (BIOGEN IDEC)

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. 

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

** Risk factors for the development of Progressive Multifocal Leukoencephalopathy (PML)
  • Presence of anti-JCV antibodies

  • Prior treatment with an immunosuppressant

  • Natalizumab treatment, especially beyond 2 years

  • Elevated levels of anti-JCV antibody response index (i.e., index > 0.9)*

*In those using natalizumab for 25–36 months with no prior use of immunosuppressants, the PML risk is 0.2 per 1,000 in those with an index of 0.9 or less, 0.3 per 1,000 in those with an index of 0.9–1.5, and 3 per 1,000 in those with an index greater than 1.5.
 

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

All Indications

300 mg intravenous infusion over one hour every four weeks

LENGTH OF AUTHORIZATION

Crohn’s Disease:

Multiple Sclerosis:

Refer to DOSAGE LIMITS below

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).

SOURCES

Lexi-Comp Online. (2018). AHFS DI. Natalizumab. Retrieved November 5, 2018 from Lexi-Comp Online with AHFS.

Lichtenstein GR, Loftus EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol 2018; 113:481–517; doi: 10.1038/ajg.2018.27.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, September). Natalizumab. Retrieved November 5, 2018 from MICROMEDEX Healthcare Series.

Rae-Grant, A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis. Report of the Guideline Development, Dissemination, and  Implementation Subcommittee of the American Academy of Neurology. Neurology® 2018;90:777-788. doi:10.1212/WNL.0000000000005347.

Thompson AJ, Banwell BL, Barkhof F, et al. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2.

U. S. Food and Drug Administration. (2018, April). Center for Drug Evaluation and Research. Tysabri® (natalizumab). Retrieved November 5, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125104s953s955lbl.pdf.

ORIGINAL EFFECTIVE DATE:  1/13/2007

MOST RECENT REVIEW DATE:  3/2/2019

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 = 1mg

DIAGNOSIS

MAXIMUM UNITS

All indications

300 billable units every 28 days