Mountain State Medical Policy Bulletin
Section: Injections
Number: I-85
Topic: Natalizumab (Tysabri®)
Effective Date: July 17, 2006
Issued Date: July 17, 2006
Date Last Reviewed: 07/2006

General Policy Guidelines

Indications and Limitations of Coverage

Natalizumab (Tysabri®) is a monoclonal antibody indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations. The safety and efficacy of natalizumab beyond two years are unknown.

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.

Natalizumab will be covered when all the following criteria are met:

  1. Members must have a documented diagnosis of relapsing-remitting or relapsing secondary progressive multiple sclerosis (340); and

  2. Natalizumab will only be approved as monotherapy (e.g., for treatment naive members or as a switch from an existing regimen); and

  3. Members must have at least one clinical relapse documented (e.g., functional disability, hospitalization, acute steroid therapy, etc.) during the prior year; and

  4. Coverage will be limited to one 300 mg IV dose, once every 4 weeks.

Safety and efficacy in treating patients with a diagnosis of anything other than the relapsing forms of multiple sclerosis (chronic progressive multiple sclerosis, Crohn's disease, etc.) or the use of natalizumab in combination with any other drug therapy for multiple sclerosis have not been established and will not be covered. The use of natalizumab for any other diagnosis 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.


NOTE:
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Procedure Codes

Q4079     

Traditional Guidelines

Refer to General Policy Guidelines

FEP Guidelines

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.

PPO Guidelines

Refer to General Policy Guidelines

Managed Care POS Guidelines

Refer to General Policy Guidelines

Publications

References

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

Tysabri® (Natalizumab) drug label; Biogen Idec, Inc., Cambridge, MA, 06/2006

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

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Table Attachment

Text Attachment

Kurtzke Expanded Disability Status Scale (EDSS)

Rating

Status 
0  Normal Neurological Exam
1.0 No disability, minimal symptoms
1.5 No disability, minimal signs in more than one area
2.0  Slightly more disability in one area 
2.5  Slightly greater disability in two areas
3.0 Moderate disability in one area but still walking independently 
3.5  Walking independently but with moderate disability in one area and more than minimal disability in several others 
4.0  Walking without aid, self-sufficient, up and about some 12 hours a day despite relatively severe disability; able to walk without aid or rest some 500 meters
4.5  Walking without aid, up and about much of the day, able to work a full day, may have some limitation of full activity or require some help, relatively severe disability but able to walk without aid or rest some 300 meters  
5.0  Walking without aid or rest for some 200 meters, disability severe enough to impair full daily activities, can work a full day without special provisions 
5.5  Ambulatory without aid or rest for about 100 meters; disability severe enough to prevent full daily activities 
6.0  Intermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting 
6.5  Needs canes, crutches, braces to walk for 20 meters without resting 
7.0  Unable to walk beyond five meters even with aid; mostly confined to a wheelchair; wheels self in standard wheelchair and transfers alone; up and about in wheelchair some 12 hours a day
7.5  Unable to take more than a few steps; restricted to wheelchair; may need aid in transfer; wheels self but cannot carry on in standard wheelchair a full day; may require motorized wheelchair 
8.0  Essentially restricted to bed, chair, or wheelchair, but may be out of bed itself much of the day; retains many self-care functions; generally has effective use of arms 
8.5  Essentially restricted to bed much of day; has some effective use of arms; retains some self-care functions 
9.0  Helpless bed patient; can communicate and eat 
9.5  Totally helpless bed patient; unable to communicate effectively or eat/swallow 
10.0  Death due to MS 

Procedure Code Attachment


Glossary




This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.

Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Mountain State Blue Cross Blue Shield plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.

Mountain State Blue Cross Blue Shield (MSBCBS) retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of MSBCBS. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.