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DrugTysabri (natalizumab) [procedure code J2323]

November 2013

Therapeutic area - Multiple Sclerosis

Approval criteria

Tysabri is being used as monotherapy for relapsing forms of multiple sclerosis in patients who, after documented compliance, have had an inadequate response to, are unable to tolerate, or have a contraindication to Copaxone and at least 1 of the following [Avonex, Betaseron, Rebif] administered during separate trials.

Inadequate response is defined as meeting two of the following three criteria during treatment with another Disease Modifying Drug:

  • Unchanged or increased relapse rate or ongoing severe relapses compared with the previous year despite treatment
  • The patient continues to have CNS lesion progression as measured by MRI
  • The patient continues to have worsening disability. Examples of worsening disability include, but are not limited to, decreased mobility or decreased ability to perform activities of daily living due to disease progression.

The initial PA will allow for 6 infusions.  
Patient must undergo antibody testing at 6 months and if positive, repeated at 9 months.
If patient has 2 positive antibody tests, no further infusions of Tysabri will be authorized.

Criteria for continuation of Therapy
Continued response: defined as no relapses or a decrease in the relapse rate. 

For Medicaid coverage of Tysabri, patient cannot be on other immune modulating drugs including but not limited to:

  • Avonex
  • Betaseron
  • Copaxone
  • Enbrel
  • Humira
  • Kineret
  • Novantrone
  • Rebif
  • Remicaid
  • Rituxan


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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