Product Details

Tysabri

Natalizumab
300 mg/15 mL
Concentrate for solution for infusion
Single-Use 15-mL Vial (Preservative-Free)

DIN/PIN/NPN

02286386

Manufacturer

Biogen Idec Canada Inc.

Formulary Listing Date

2021-04-30  

Unit Price

3,596.1729

Amount MOH Pays

3,596.1729

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AA23

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Multiple Sclerosis Drugs

Natalizumab

  • Brand(s): Tysabri
  • Dosage Form/Strength: 300 mg/15 mL concentrate for solution for intravenous infusion

Initiation Criteria: 

As monotherapy for the treatment of Rapidly Evolving Severe Relapsing-Remitting Multiple Sclerosis (RES-RRMS) for the patient who meets all the following: 

  1. The patient’s physician provides documentation setting out the details of the patient’s most recent neurological examination within ninety (90) days of the submitted request. This must include a description of any recent attacks, including the corresponding dates, and the neurological findings; AND 

  1. Has been diagnosed with MS; AND 

  1. Is 18 to 65 years of age; AND 

  1. Has a current EDSS of less than or equal to 5.0; AND 

  1. Has had ONE of the following types of relapses in the past year:
    •     The occurrence of one relapse with partial recovery during the past year AND has at least ONE gadolinium-enhancing lesion on brain MRI, OR significant increase in T2 lesion load compared to a previous MRI (i.e., 3 or more new lesions);
    OR
    •     The occurrence of two or more relapses with partial recovery during the past year;
    OR
    •     The occurrence of two or more relapses with complete recovery during the past year AND has at least ONE gadolinium-enhancing lesion on brain MRI, OR significant increase in T2 lesion load compared to a previous MRI; 

  1. has failed to respond to full and adequate courses1 of at least one of interferon OR glatiramer acetate OR dimethyl fumarate; OR teriflunomide OR documented intolerance or contraindication to 2 of the 3 therapies. (Note that needle phobia is not acceptable.)

  1. is being followed by a neurologist experienced in the management of RRMS 

  1. details of past treatment, including dates and Patient response; 

1Failure to respond to a full and adequate course: defined as a trial of at least 6 months of interferon or glatiramer therapy or dimethyl fumarate AND experienced at least one disabling relapse (attack) while on interferon or glatiramer or dimethyl fumarate. 

MRI reports do NOT need to be submitted with the initial request. 

Duration of Approval: 1 year 

Renewals will be considered for requests meeting the following:

  • Documentation providing the date and details of the patient’s most recent neurological examination and EDSS scores (exam must have occurred within the last ninety (90) days); AND 

  • Evidence that the Patient is stable and has experienced no more than one (1) disabling attack/relapse in the past year (Note: if the Patient has had more than one attack/relapse, the request will be sent for external review); AND 

  • A recent Expanded Disability Status Scale (EDSS) that is less than or equal to 5.0 (Note that the request will be rejected if the EDSS is greater than 5.0). 

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

Natalizumab

  • Brand(s): Tysabri
  • Dosage Form/Strength: 300 mg/15 mL

EAP will renew coverage of Natalizumab for patients with RRMS who have benefited from therapy and have an EDSS score less than or equal to 5. 

The physician 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 

Standard Approval Duration: 2 years 

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.

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