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Coverage criteria policies

Natalizumab (Tysabri®) - Minnesota Health Care Programs

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

Natalizumab (Tysabri) requires prior authorization from HealthPartners Pharmacy Administration.

Authorization criteria

Initial authorizations

  1. 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 glatiramer or Glatopa and at least 1 of the following [Avonex, Betaseron, Rebif] administered during separate trials.
    1. Inadequate response is defined as meeting at least two of the following three criteria during treatment with another Disease Modifying Drug:
      1. Unchanged or increased relapse rate or ongoing severe relapses compared with the previous year despite treatment
      2. The patient continues to have CNS lesion progression as measured by MRI
      3. 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.

Reauthorizations

  1. Patient must have a continued response to Tysabri (defined as no relapses or a decrease in the relapse rate).
Important Limitations:

Patient cannot be on other immune modulating drugs including but not limited to:

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

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.

Definitions:

TYSABRI is an integrin receptor antagonist indicated for treatment of: Multiple Sclerosis (MS) relapsing forms of multiple sclerosis.

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 Codes

Codes

Description

J2323

Injection, natalizumab, 1 mg

NDC Codes

Codes

Description

64406000801

Tysabri 300 mg/15 mL single-use vials

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. https://mn.gov/dhs/partners-and-providers/policies-procedures/minnesota-health-care-programs/provider/types/rx/pa-criteria/tysabri.jsp

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Policy activity

  • 01/01/2017 - Date of origin
  • 10/01/2018 - Effective date
Review date
  • 08/2018
Revision date
  • 05/07/2018

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