Natalizumab (Tysabri®), Natalizumab-sztn (Tyruko®)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indications
A. Indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of tumor necrosis factor alpha (TNF-α). Tysabri and Tyruko should not be used in combination with immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-α.
B. Indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Tysabri and Tyruko increases the risk of progressive multifocal leukoencephalopathy (PML). When initiating and continuing treatment with Tysabri or Tyruko, physicians should consider whether the expected benefit of Tysabri or Tyruko is sufficient to offset this risk.
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
Crohn’s disease (CD):
A. Initial requests: Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to therapy.
B. Continuation requests: Chart notes or medical record documentation supporting positive clinical response to therapy or remission.
III. PRESCRIBER SPECIALTIES
The medication must be prescribed by or in consultation with one of the following:
A. Crohn’s disease: gastroenterologist
B. Multiple sclerosis: neurologist
IV. CRITERIA FOR INITIAL APPROVAL
A. Crohn’s disease (CD)
Authorization of 12 months may be granted to adult members who have received any other biologic indicated for the treatment of moderately to severely active Crohn’s disease and who have been tested for anti-JCV antibodies.
B. Relapsing forms of multiple sclerosis (MS)
Authorization of 12 months may be granted to members who have been diagnosed with a relapsing form of multiple sclerosis (including relapsing-remitting and secondary progressive disease for those who continue to experience relapse) and those who have been tested for anti-JCV antibodies.
C. Clinically isolated syndrome (CIS)
Authorization of 12 months may be granted to members for the treatment of clinically isolated syndrome of multiple sclerosis and those who have been tested for anti-JCV antibodies.
V. CONTINUATION OF THERAPY
A. Crohn’s disease (CD)
1. Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for moderately to severely active Crohn’s disease and who achieve or maintain remission.
2. Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for moderately to severely active Crohn’s disease and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline:
i. Abdominal pain or tenderness
ii. Diarrhea
iii. Body weight
iv. Abdominal mass
v. Hematocrit
vi. Appearance of the mucosa on endoscopy, computed tomography enterography (CTE), magnetic resonance enterography (MRE), or intestinal ultrasound
vii. Improvement on a disease activity scoring tool (e.g., Crohn’s Disease Activity Index [CDAI] score)
B. Relapsing forms of multiple sclerosis (MS) or clinically isolated syndrome (CIS)
Authorization of 12 months may be granted for all members (including new members) who achieve or maintain a positive clinical response with the requested drug as evidenced by experiencing disease stability or improvement.
VI. OTHER
For all indications: Members cannot use the requested drug concomitantly with any other disease modifying multiple sclerosis agents (Note: Ampyra and Nuedexta are not disease modifying), immunosuppressants, or TNF inhibitors (e.g., adalimumab, infliximab).
VII. DOSAGE AND ADMINISTRATION
Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.
MEDICATION QUANTITY LIMITS
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
Tysabri (Natalizumab;Tyruko (Natalizumab-sztn) |
Crohn's Disease, Multiple Sclerosis or Clinically Isolated Syndrome |
Route of Administration: Intravenous ≥18 Years 300mg every 4 weeks |
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. Tysabri [package insert]. Cambridge, MA: Biogen Inc; June 2022.
2. Talley NJ, Abreu MT, Achkar J, et al. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011;106(Suppl 1):S2-S25.
3. Lichtenstein GR, Loftus Jr EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol. 2018;113:481-517.
4. Feuerstein JD, Ho EY, Shmidt E, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn’s Disease. Gastroenterology 2021; 160: 2496- 2508.
ORIGINAL EFFECTIVE DATE: 1/13/2007
MOST RECENT REVIEW DATE: 5/1/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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