| Mountain State Medical Policy Bulletin |
| Section: | Injections |
| Number: | I-85 |
| Topic: | Natalizumab (Tysabri®) |
| Effective Date: | January 14, 2008 |
| Issued Date: | May 19, 2008 |
| Date Last Reviewed: | 05/2008 |
Indications and Limitations of Coverage
Natalizumab (Tysabri® ) is eligible for patients who meet the following criteria: Multiple Sclerosis Members must have a documented diagnosis of relapsing-remitting or relapsing secondary progressive multiple sclerosis (340); and Natalizumab will only be approved as monotherapy (e.g., for treatment naive members or as a switch from an existing regimen); and Members must have at least one clinical relapse documented (e.g., functional disability, hospitalization, acute steroid therapy, etc.) during the prior year; and Coverage will be limited to one 300 mg intravenous infusion every four weeks. Because natalizumab increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability, natalizumab is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate multiple sclerosis therapies. Natalizumab has not been studied in patients with severe, disabling multiple sclerosis. The two main studies that appear in the FDA approved labeling only evaluated patients who had mild to moderate disability (Kurtzke Expanded Disability Status Scale scores between 0 and 5.0). Refer to the Text Attachment below for scale. Crohn's Disease Per prescribing information, moderate to severely active Crohn's disease is defined as ≥ 220 and ≤ 450 per the Crohn's Disease Activity Index. Refer to the Text Attachment below for index. Natalizumab should not be used in combination with immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-α (e.g., adalimumab, infliximab). Aminosalicylates may be continued during treatment with natalizumab. Coverage will be limited to one 300 mg intravenous infusion every four weeks. If the patient with Crohn's disease has not experienced therapeutic benefit by 12 weeks of induction therapy, discontinue natalizumab. For patients with Crohn's disease that start natalizumab while on chronic oral corticosteroids, commence steroid tapering as soon as a therapeutic benefit of natalizumab has occurred; if the patient with Crohn's disease cannot be tapered off to oral corticosteroids within six months of starting natalizumab, discontinue natalizumab. Other than the initial six-month taper, prescribers should consider discontinuing natalizumab for patients who require additional steroid use that exceeds three months in a calendar year to control their Crohn's disease. Natalizumab is not approved for use in patients under age 18. Natalizumab is available only through a special restricted distribution program called the TOUCH™ Prescribing Program. Natalizumab must be administered only to multiple sclerosis patients registered in the MS TOUCH™ Prescribing Program and Crohn's disease patients registered in the CD TOUCH™ Prescribing Program. The use of natalizumab for any other indication not listed in the coverage criteria above is considered experimental/investigational, and therefore, not covered. A participating, preferred, or network provider can bill the member for the denied service. Coverage for natalizumab is determined according to individual or group customer benefits. Natalizumab is not reimbursable under the prescription drug benefit. Description Natalizumab (Tysabri) is a recombinant humanized IgG4k monoclonal antibody produced in murine myeloma cells. Natalizumab contains human framework regions and the complementarity determining regions of a murine antibody that binds to a 4-integrin. |
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| J2323 |
Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious life-threatening condition and when medically necessary and appropriate for the patient’s condition. |
Development of a Crohn's Disease Activity Index, National Cooperative Crohn's Disease Study. Gastroenterology, Vol. 70, No. 3, 03/1976 Rating Neurologic Impairment in Multiple Sclerosis: An Expanded Disability Status Scale (EDSS), Neurology, Vol. 33, No. 11, 11/1983 A Controlled Trial of Natalizumab for Relapsing Multiple Sclerosis, The New England Journal of Medicine, Vol. 348, No. 1, 01/2003 US Food and Drug Administration (FDA). FDA issues public health advisory on Tysabri, a new drug for MS. FDA News. Rockville, MD: FDA; February 28, 2005 Progressive Multifocal Leukoencephalopathy After Natalizumab Therapy for Crohn's Disease, The New England Journal of Medicine, Vol. 353, No. 4, 07/2005 Progressive Multifocal Leukoencephalopathy Complicating Treatment with Natalizumab and Interferon Beta -1a for Multiple Sclerosis, The New England Journal of Medicine, Vol. 353, No. 4, 07/2005 Progressive Multifocal Leukoencephalopathy in a Patient Treated with Natalizumab, The New England Journal of Medicine, Vol. 353, No. 4, 07/2005 Progressive Multifocal Leukoencephalopathy and Natalizumab - Unforeseen Consequences, The New England Journal of Medicine, Vol. 353, No. 4, 07/2005 Natalizumab and Progressive Multifocal Leukoencephalopathy, The New England Journal of Medicine, Vol. 353, No. 4, 07/2005 Evaluation of Patients Treated with Natalizumab for Progressive Multifocal Leukoencephalopathy, The New England Journal of Medicine, Vol. 353, No. 4, 07/2005 Natalizumab Induction and Maintenance Therapy for Crohn's Disease, The New England Journal of Medicine, Vol. 353, No. 18, 11/2005 US Food and Drug Administration (FDA). FDA approves resumed marketing of Tysabri under a special distribution program. FDA News. Rockville, MD: FDA; June 5, 2006 Natalizumab Therapy for Moderate to Severe Crohn's Disease in Adolescents, Journal of Pediatric Gastroenterology and Nutrition: Vol. 44, No. 2, 02/2007 The Incidence and Significance of Anti-Natalizumab Antibodies, Neurology, Vol. 69, 2007 Natalizumab for the Treatment of Active Crohn's Disease: Results of the ENCORE Trial, Gastroenterology, Vol. 132, No. 5, 05/2007 US Food and Drug Administration (FDA). FDA approves Tysabri to treat moderate-to-severe Crohn's disease. FDA News. Rockville, MD: FDA; January 14, 2008 Elan Pharmaceuticals, Inc. Tysabri (natalizumab) injection for intravenous use. Prescribing Information. South San Francisco, CA, January 2008 FDA Issues Tysabri Warning www.fda.gov/medwatch/safety/2008/safety08/htm#Tysabri. Posted 02/28/2008 |
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| Term | Description |
|---|---|
Disease-modifying antirheumatic drug (DMARD) | Medicines classified as disease-modifying antirheumatic drugs (DMARDS) have the potential to reduce or prevent joint damage and preserve joint integrity and function. Commonly used traditional DMARDs include but are not limited to leflunomide, sulfasalazine, hydroxychloroquine, azathioprine, and methotrexate.
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Inhibitors of tumor necrosis factor alpha (TNF-α) | TNF-α inhibitors block the action of a protein in your body called tumor necrosis factor alpha (TNF-α). TNF-α is made by your body's immune system. People with certain diseases have too much TNF-α that can cause the immune system to attack normal healthy parts of the body (e.g., adalimumab [Humira®], infliximab[Remicade® ]). |