Sandoz Teriflunomide

For the treatment of Relapsing Remitting Multiple Sclerosis (RRMS) in adult patients with active disease meeting ALL the following criteria:

1. 18 years of age or older; AND

2. Diagnosis of RRMS is in accordance with the McDonald 2017 criteria demonstrating dissemination of lesions in the central nervous system in space and time meeting the following:

- 2 or more attacks (Note 1) and clinical evidence of 2 or more lesions (Note 2); OR

- 2 or more attacks and clinical evidence of 1 lesion with clear historical evidence of a prior attack involving a lesion in a different location;

Note 1: If the patient has experienced only one attack, the patient must meet ONE of the additional criteria of dissemination in time in the list below:

- Additional clinical attack
- Simultaneous presence of both enhancing and non-enhancing, symptomatic or asymptomatic MS-typical MRI lesions; OR a new T2 or enhancing MRI lesion compared to a baseline scan (without regard to timing of baseline scan)
- Presence of cerebrospinal fluid (CSF)-specific oligoclonal bands

Note 2: If the patient has evidence of only one lesion the patient must meet ONE of the additional criteria of dissemination in space in the list below:

- additional clinical attack implicating different CNS site
- 1 or more MS-typical T2 lesions in 2 or more areas of the Central Nervous System (CNS): periventricular, cortical, juxtacortical, infratentorial or spinal cord

AND

3. Patient has experienced a clinical relapse and/or new MS lesions in the last 2 years; AND

4. Patient has an Expanded Disability Status Scale (EDSS) score less than 6.0 before start of therapy; AND

5. Teriflunomide is used as monotherapy; AND

6. The drug request is from a neurologist experienced in the management of RRMS.

Exclusion Criteria:

1. Combination therapy with another disease modifying therapy for RRMS will not be reimbursed.
2. Patients with an EDSS score equal to or greater than 7.0.

Renewal Criteria:

Teriflunomide may be continued for the treatment of RRMS for patients who have not experienced a suboptimal response with teriflunomide monotherapy and who have an EDSS score less than 7.0.

Patients who continue to experience clinical attacks or increased lesions or worsening EDSS should be evaluated for appropriateness of therapy and consideration of other treatment options available on the ODB formulary or through the Exceptional Access Program.

Renewal duration: 1 year

Recommended Dose: 14mg once daily

Refer to the product monograph for prescribing information.

Teriflunomide

• Brand(s): Aubagio
• Dosage Form/Strength: 14mg tablet