Product Details

Sandoz Dimethyl Fumarate DR Capsules

Dimethyl Fumarate
120 mg
DR Capsule


DIN/PIN/NPN

02513781

Manufacturer

Sandoz Canada Inc.

Formulary Listing Date

2021-11-30  

Unit Price

9.1933

Amount MOH Pays

9.1933

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AX07

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02495341 Ach-Dimethyl Fumarate 9.1933 9.1933
02505762 Apo-Dimethyl Fumarate 9.1933 9.1933
02494809 GLN-Dimethyl Fumarate 9.1933 9.1933
02516047 Jamp Dimethyl Fumarate 9.1933 9.1933
02502690 Mar-Dimethyl Fumarate 9.1933 9.1933
02497026 PMS-Dimethyl Fumarate 9.1933 9.1933
02513781 Sandoz Dimethyl Fumarate DR Capsules 9.1933 9.1933
02404508 Tecfidera 18.3866 9.1933
02540746 Auro-Dimethyl Fumarate 4.4266 4.4266
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Multiple Sclerosis Drugs

Dimethyl fumarate

  • Brand(s): Tecfidera and generics
  • Dosage Form/Strength: 120 mg delayed-release capsule

For the treatment of Relapsing–Remitting Multiple Sclerosis (RRMS) in patients who meet all of the following criteria: 

  1. The patient’s physician provides documentation setting out the details of the patient’s most recent neurological examination (which must have been conducted within ninety [90] days of the request, including a description of any recent attacks, the dates of attacks, and neurological findings).

  2. Patient has had one (1) or more clinical relapses in the previous year.

  3. The drug is requested by and followed by a neurologist experienced in the management of RRMS.

  4. The patient has a recent Expanded Disability Status Scale (EDSS) score ≤ 5.

Dosage:
- Initial: 120 mg twice daily
- Maintenance: 240 mg twice daily 

Renewal requests will be considered. Renewals for Tecfidera can be submitted through the Telephone Request Service. 

The date and details of the most recent neurological examination and EDSS scores must be provided (exam must have occurred within the last ninety [90] days); AND 

  • The patient must be stable or experienced no more than one clinical relapse* in the past year; AND 

  • The patient has a recent EDSS score ≤ 5.

Dosage: 120 mg twice daily.
Maintenance: 240 mg twice daily

Duration of Approval: 1 year

*Renewal requests where patients have experienced more than one (1) clinical relapse in the past year are to be externally reviewed. 

As applicable, please also include information regarding the requesting physician’s specialty (e.g., is the physician a neurologist or a physician with specialized experience with multiple sclerosis (MS), the name of the MS clinic where the patient was examined, or an MS consult note as this information may reduce the turnaround times for assessment.

Duration of Approval:
- First Renewal: 2 years
- Second and subsequent renewals: 5 years

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Renewals of Multiple Sclerosis Drugs – Telephone Request Service (TRS) Drugs

Dimethyl Fumarate

  • Brand(s): Tecfidera
  • Dosage Form/Strength: 120mg and 240 mg capsule

EAP will renew coverage of dimethyl fumarate 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: 120 mg twice daily
- Maintenance: 240 mg twice daily

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

Product Monograph

View Monograph