Natalizumab (Tysabri®)
Medical Policy: 05.01.12
Original Effective Date: June 2006
Reviewed: October 2011
Revised: January 2008
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Natalizumab is a monoclonal antibody that binds to a protein called alpha-4-integrin. Integrins are found primarily on the surface of white blood cells and play a role in immune system activity. While its function is not completely clear, research suggests natalizumab prevents immune cells from migrating from the bloodstream into the brain, where they can cause inflammation leading to damage to nerve fibers and their insulation.
Natalizumab is administered as an intravenous infusion once every 28 days in the office or outpatient setting and is available only through a distribution program known as TOUCHTM administered by Biogen Idec, Inc. TOUCHTM is designed to assess the risk of progressive multifocal leukoencephalopathy (PML) associated with natalizumab, minimize the risk of PML, minimize death and disability due to PML, and promote informed decision-making regarding natalizumab use. Safety and efficacy of treatment with natalizumab beyond two years are not known.
Natalizumab is currently marketed under the trade name Tysabri®.
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Prior Approval:
Not applicable
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Policy:
Natalizumab may be considered medically necessary as monotherapy in patients 18 years of age or older with an established diagnosis of a relapsing form of multiple sclerosis who have failed or cannot tolerate an interferon beta product (such as Avonex®, Rebif®, or Betaseron®) or Copaxone®.
Natalizumab may be considered medically necessary to induce and maintain clinical response and remission in patients 18 years of age or older with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate conventional Crohn’s therapies including immunosuppressants, aminosalicylates, NSAIDs and Cox-2 inhibitors, inhibitors of TNF-alpha, and corticosteroids.
For patients with Crohn’s disease that start natalizumab while on chronic oral corticosteroids, steroid tapering should commence as soon as a therapeutic benefit of natalizumab has occurred; if the patient with Crohn’s disease cannot be fully tapered off of corticosteroids within 6 months of starting natalizumab, natalizumab should be discontinued.
Natalizumab should be discontinued for patients with Crohn’s disease that have not experienced therapeutic benefit by 12 weeks of induction therapy.
All other indications and uses of natalizumab are considered investigational.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- J2323 Injection, natalizumab, per 1 mg
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Selected References:
- Meyer MA. Natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006 Jun 1;354(22):2387-9.
- Niino M, Bodner C, Simard ML Natalizumab effects on immune cell responses in multiple sclerosis. Ann Neurol. 2006 May;59(5):748-54.
- Goodin D. The return of natalizumab: weighing benefit against risk. Lancet Neurol. 2006 May;5(5):375-7.
- Polman CH, O'Connor PW, Havrdova E, AFFIRM Investigators. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):899-910.
- Fox RJ, Bethoux F, Goldman MD, Cohen JA. Multiple sclerosis: advances in understanding, diagnosing, and treating the underlying disease. Cleve Clin J Med. 2006 Jan;73(1):91-102.
- MacDonald JK, McDonald JW. Natalizumab for induction of remission in Crohn’s disease. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD006097.
- Targan SR, Feagan BG, Fedorak RN et al. Natalizumab for the treatment of active Crohn’s disease: results of the ENCORE trial. Gastroenterology. 2007 May;132(5):1672-83.
- Feagan BG, Sandborn WJ, Hass S et al. Health-related quality of life during natalizumab maintenance therapy for Crohn’s disease. Am J gastroenterol. 2007 Dec;102(12):2737-46.
- Sands BE, Kozarek R, Spainhour J et al. Safety and tolerability of concurrent natalizumab treatment for patients with Crohn’s disease not in remission while receiving infliximab. Inflamm Bowel Dis 2007 Jan;13(1):2-11.
- Kerbrat A, Le Page E, Leray E et al. Natalizumab and drug holiday in clinical practice: an observational study in very active relapsing remitting multiple sclerosis patients. J Neurol Sci. 2011 Sep 15; 308(1-2):98-102. Epub 2011 Jun 12.
- Hellwig K, Gold R. Progressive multifocal leukoencephalopathy and natalizumab. J Neurol. 2011 Jun 7. [Epub ahead of print].
- Vermersch P, Kappos L, Gold R et al. Clinical outcomes of natalizumab-associated progressive multifocal leukoencephalopathy. Neurology. 2011 May 17; 76(20):1697-704.
- O’Connor PW, Goodman A, Kappos L et al. Disease activity return during natalizumab treatment interruption in patients with multiple sclerosis. Neurology. 2011 May 31; 76(22):1858-65. Epub 2011 May 4.
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Policy History:
Date Reason Action
October 2011 Annual review Policy renewed
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drugs, etc. They are developed to
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.
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