Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Tysabri is covered subject the Medical Policy Statement below and is subject to retrospective review to ensure compliance with this statement.

2)    Tysabri is a recombinant humanized monoclonal antibody that is used to treat relapsing remitting multiple sclerosis or moderate-to-severe Crohn’s disease.

3)    Because Tysabri increases the risk of progressive multifocal leukoencephalopathy (PML), a severe and often fatal degenerative neurological disease, it can only be prescribed through a risk minimization plan called Tysabri Outreach Unified Commitment to Health, which registers prescribers, infusion centers, and pharmacies.

1)    Tysabri is covered subject to this Medical Policy Statement and is subject to retrospective review to ensure compliance.

2)    QualChoice considers Natalizumab (Tysabri) medically necessary for the treatment of individuals with relapsing, remitting multiple sclerosis (but not for the treatment of chronic progressive multiple sclerosis) for persons with a contraindication, allergy, intolerance, or failure of a one-month trial of an alternate disease-modifying multiple sclerosis therapy, such as fingolimod, glatiramer, or interferon.

3)    QualChoice considers Natalizumab medically necessary for the treatment of adults with moderate-to-severely active Crohn`s disease with evidence of inflammation, and who have had an inadequate response to, or are unable to tolerate, conventional Crohn`s disease therapies including anti-inflammatory drugs (e.g., sulfasalazine), corticosteroids, immunosuppressive agents (e.g., 6-mercaptopurine or azathioprine), and inhibitors of tumor necrosis factor-alpha (e.g., adalimumab or infliximab). 

4)    Tysabri should not be used in combination with TNF-alpha inhibitors or immunosuppressants such as 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate.

5)    Patients being treated with natalizumab should be reevaluated every 6 months to determine if continued therapy is medically necessary. QualChoice considers Natalizumab experimental and investigational for all other indications.

6)    QualChoice considers testing for anti-natalizumab antibodies medically necessary for individuals with a suboptimal clinical response. Repeat testing at 3 months after the initial positive result is recommended in individuals in whom antibodies are detected to confirm that antibodies are persistent. Prescribers should consider the overall benefits and risks of natalizumab in persons with persistent antibodies.

7)    QualChoice considers diagnostic tests, including polymerase chain reaction (PCR) testing of cerebrospinal fluid for John Cunningham (JC) polyomavirus, for diagnosis of progressive multifocal leukoencephalopathy in persons before initiating natalizumab treatment not medically necessary.

Codes Used In This BI:

J2323   Natalizumab (Tysabri) Injection, 1 mg

Tysabri is available only through a risk minimization plan called Tysabri Outreach Unified Commitment to Health (the TOUCH™ Prescribing Program) which registers prescribers, infusion centers, and pharmacies associated with infusion centers.  Additionally, Tysabri can only be prescribed to patients who are enrolled in and meet all the requirements of the program.

Calabresi PA, Giovannoni G, Confavreux C, et al; AFFIRM and SENTINEL Investigators. The incidence and significance of anti-natalizumab antibodies: Results from AFFIRM and SENTINEL. Neurology. 2007; 69(14):1391-1403.

2. MacDonald JK, McDonald JWD.Natalizumab for induction of remission in Crohn’s disease. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD006097. DOI:10.1002/14651858.CD006097.pub2.

3. National Institute for Health and Clinical Excellence (NICE). Natalizumab for the treatment of adults with highly active relapsing-remitting multiple sclerosis. NICE Technology Appraisal Guidance 127. London, UK: NICE; August 2007.

4. Polman CH, O`Connor PW, Havrdova E, et al. A randomized, placebo-controlled trial of Natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2; 354(9):899-910.

5. Rudick RA, Stuart WH, Calabresi PA, et al. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2; 354(9):911-23.

6. U.S. Food and Drug Administration Drug Safety Communication: Risk of Progressive Multifocal Encephalopathy (PML) with the use of Tysabri (natalizumab). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm199872.htm. Accessed May 25, 2010.

7. U.S. Food and Drug Administration Drug Safety Communication: Safety Update on Progressive Multifocal Encephalopathy (PML) associated with Tysabri (Natalizumab).http://www.fda.gov/Drugs/DrugSafety/ucm252045.htm. Accessed April 26, 2011.

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.