Product Details

Aubagio

Teriflunomide
14 mg
Tablet


DIN/PIN/NPN

02416328

Manufacturer

Sanofi Genzyme, a Division of Sanofi-Aventis Canada Inc.

Formulary Listing Date

2022-07-29  

Unit Price

60.2464

Amount MOH Pays

14.9300

Coverage Status

Discontinued Drug Limited Use Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AA31

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02502933 Ach-Teriflunomide 14.9300 14.9300
02500639 Apo-Teriflunomide 14.9300 14.9300
02416328 Aubagio 60.2464 14.9300
02504170 Jamp Teriflunomide 14.9300 14.9300
02523833 M-Teriflunomide 14.9300 14.9300
02500469 Mar-Teriflunomide 14.9300 14.9300
02500310 Nat-Teriflunomide 14.9300 14.9300
02500434 PMS-Teriflunomide 14.9300 14.9300
02505843 Sandoz Teriflunomide 14.9300 14.9300
02501090 Teva-Teriflunomide 14.9300 14.9300
 

LU Clinical Criteria

LU Code Auth. Period Clinical Criteria
647 1 year

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.

 

EAP Criteria

Therapeutic Class Reimbursement Criteria
Renewals of Multiple Sclerosis Drugs – Telephone Request Service (TRS) Drugs

Teriflunomide

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

EAP will renew coverage of teriflunomide for patients who are stable and experienced no more than one disabling attack/relapse in the past year and have an EDSS score less than or equal to 5.

Prescriber must provide the following information:

  • Description of the patient’s clinical course in the last year, including details of all attacks; 

  • Date and details of the most recent neurological examination (within the last 90 days); AND 

  • EDSS score

Dosage: 14 mg daily 

Standard Approval Duration: 2 years for first renewal, 5 years for 2nd and subsequent renewals 

Renewal requests where patients have experienced more than 1 attack in the past year will be externally reviewed.

Product Monograph

View Monograph