Subject: Tysabri 1846-A SGM P2021a
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
1. Tysabri is indicated for inducing and maintaining clinical response and remission in adult patients 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-α. Tysabri should
not be used in combination with immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine,
or methotrexate) or inhibitors of TNF-α.
2. Tysabri is 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 increases the risk of progressive multifocal leukoencephalopathy (PML). When initiating
and continuing treatment with Tysabri, physicians should consider whether the expected benefit of Tysabri
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.
B. Continuation requests: Chart notes or medical record documentation supporting positive clinical
response to therapy or remission.
III. CRITERIA FOR INITIAL APPROVAL
A. Moderately to severely active Crohn’s disease (CD)
Authorization of 12 months may be granted to 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 and those who have been tested for anti-JCV antibodies.
IV. CONTINUATION OF THERAPY
A. Moderately to severely active Crohn’s disease (CD)
1. Authorization of 12 months may be granted for all 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 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. Endoscopic appearance of the mucosa
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.
V. 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).
VI. DOSAGE AND ADMINISTRATION
Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.
Place of Service:
Outpatient
The above policy is based on the following references:
- Tysabri [package insert]. Cambridge, MA: Biogen Idec, Inc; June 2020.
- 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.
- 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.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
January 20, 2022
