Natalizumab*Medical Policy: 05.01.12 This policy applies to all products unless specific contract limitations, exclusions or exceptions apply. Please refer to the member's coverage manual for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply. 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®. Prior approval is recommended. Submit a prior approval/treatment request now. 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, 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 has not experienced therapeutic benefit by 12 weeks of induction therapy. All other indications and uses of natalizumab are considered investigational. Procedure Codes and Billing Guidelines:
New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
*Prior Approval is recommended for this policy. **Current Procedural Terminology © 2008 American Medical Association. All Rights Reserved. Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice. |
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