Subject: Tysabri 1846-A SGM P2022a
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. Tysabri is 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
should not be used in combination with immunosuppressants
(e.g., 6-mercaptopurine, azathioprine, cyclosporine, or
methotrexate) or inhibitors of TNF-α.
B. 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 (if
applicable), including response to therapy. If therapy is not
advisable, documentation of clinical reason to avoid 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. 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.
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.
Place of Service:
Outpatient
The above policy is based on the following references:
- Tysabri [package insert]. Cambridge, MA: Biogen Inc; June 2022.
- 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.
- 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.
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.
March 28, 2023
