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HealthPartners

Coverage criteria policies

Natalizumab (Tysabri®)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Tysabri requires prior authorization from HealthPartners Pharmacy Administration. The setting of drug administration will be reviewed as part of the prior authorization.

Note:

For all inquiries, transfer to the Medical Injectable Line (ext 26135).

Coverage

Tysabri is generally approved for use in members diagnosed with multiple sclerosis and moderate to severe Crohn’s disease when all of the following criteria are met:

Initial authorizations

  1. Prescribed and followed by Neurology or Gastroenterology.
  2. The member has had a trial and failure of an appropriate regimen of first-line therapy based on the indication for treatment:
    1. Multiple Sclerosis - Use of one of the following preferred agents: Tecfidera, Gilenya, Aubagio, Avonex, Plegridy, Rebif, Extavia, Copaxone 40 mg, Glatopa.
      This requirement will be waived for members presenting with a particularly aggressive initial disease course.
    2. Moderate to Severe Crohn’s Disease – Use of one of the following first-line therapies (i, ii, or iii) and two preferred biologic therapies (iv):
      1. Treatment with any of the following corticosteroid regimens for two weeks has been ineffective or is contraindicated:
        1. Prednisone 40-60 mg daily
        2. Oral budesonide 9 mg daily
        3. Budesonide rectal; or
      2. Inability to taper off one of the corticosteroid regimens above; or
      3. Breakthrough disease while stabilized for at least 3 months on one of the following therapies:
        1. Azathioprine 2-3 mg/kg daily
        2. 6-mercaptopurine 1-1.5 mg/kg daily
        3. Methotrexate 20mg weekly (GI intolerance requires trial of SC/IM methotrexate at 20mg weekly); and
      4. The member has had a trial and failure to two preferred biologic therapies (e.g., Enbrel, Humira, or Remicade) for at least 3 months or intolerance or a contraindication to use.
  3. For commercial products only (does not apply to Medicare or Minnesota Health Care Programs products), medication administration must occur at a clinic office or home-infusion setting unless medical necessity is met based on the criteria below, supported by medical documentation:
    1. The patient has experienced a severe or life-threatening reaction with previous infusions of the same or similar products; or,
    2. The patient has a medical condition that renders him or her unstable, exceptionally complex, immunocompromised or otherwise high-risk such that continued oversight in the current facility is required; or,
    3. There are no alternative settings available to the patient as a result of both of the following:
      1. The patient is unable to use home-infusion services as documented by the physician, social worker, or infusion provider; and,
      2. The patient is unable to access alternative settings due to unreasonable distance [>30 miles] or other extenuating circumstances.

Additional approval criteria for all indications

  1. The prescribed regimen is within the FDA-approved dosing regimen of 300 mg once every 4 weeks.
  2. No other biologic agent will be used concurrently to treat Crohn’s and no other disease-modifying agent will be used concurrently to treat Multiple Sclerosis.

Authorizations will be provided for one year with the following limitations:

  • A maximum of 13 infusions will be approved each calendar year. No more than one vial should be billed per infusion.

Definitions

Tysabri is an integrin receptor antagonist indicated:

  1. As monotherapy for the treatment of members with relapsing forms of multiple sclerosis. Tysabri increases the risk of PML. When initiating and continuing treatment with Tysabri, physicians should consider whether the expected benefit of Tysabri is sufficient to offset this risk.
  2. Inducing and maintaining clinical response and remission in adult members 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 CD therapies and inhibitors of TNF-alpha.

Setting: The type of physical site where the drug is provided. Settings include inpatient hospital, outpatient hospital, clinic office, or home-infusion.

  • Outpatient Hospital sites have physicians and practitioners on-site and are the appropriate site to manage unstable patients and patients experiencing certain moderate to severe adverse events. Hospital settings are typically the highest-cost, most-intensive, and are the highest level settings.
  • Clinic offices are lower level settings which are not outpatient hospital settings that can manage some unstable patients and patients experiencing adverse events. Physicians may or may not be readily available.
  • Home-infusion is a lower level setting, and is performed by a licensed nurse supported by a licensed pharmacy who have expertise in administering complex medications in a patient’s home. Home infusion providers regularly manage mild to moderate adverse events, and are prepared to manage severe adverse events if needed.
Important Limitations:

In CD, Tysabri should not be used in combination with immunosuppressants or inhibitors of TNF-alpha.

Progressive Multifocal Leukoencephalopathy (PML) - Tysabri increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability.

Tysabri is available only through a special restricted distribution program called the TOUCH™ Prescribing Program and must be administered only to members enrolled in this program.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

HCPCS Code

Codes

Description

J2323

Injection, natalizumab, 1 mg

NDC Code

Codes

Description

64406000801

Tysabri 300 MG/15ML CONC

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. Tysabri prescribing information. Biogen Idec Inc. Cambridge, MA. April 2018.
  2. DS Goodin, BA Cohen, P O’Connor, et al., The use of natalizumab (Tysabri) for the treatment of multiple sclerosis (an evidence-based review). Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2008; 71(10):766-773.
  3. Lichtenstein GR, Hanauer SB, Sandborn WJ, et al., Management of crohn’s disease in adults. Am J Gastroenterol 2009; 104:465-483.

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Policy activity

  • 10/22/2009 - Date of origin
  • 04/01/2018 - Effective date
Review date
  • 08/2018
Revision date
  • 02/05/2018

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