More topics

Limited coverage criteria – interferon beta-1b

Last updated on March 18, 2025

 

Return to Special Authority drug list 

Generic name

interferon beta-1b

Strength & form

0.3 mg single-use vial (Extavia®/Betaseron®)

Special Authority criteria

Approval period

Initial

As first-line monotherapy for the treatment of relapsing-remitting multiple sclerosis (MS) or secondary progressive MS, diagnosed according to the current clinical criteria and magnetic resonance imaging (MRI) evidence, when a Special Authority request is submitted by a neurologist from a designated MS clinic, for patients who meet ALL of the following criteria:

  • Patient is ambulatory with or without aid (EDSS of 6.5 or less)
  • Patient is 18 years of age or older

15 months

Renewal

As monotherapy, when a Special Authority request is submitted by a neurologist from a designated MS clinic for the treatment of patients with relapsing-remitting MS or secondary progressive MS, AND who have demonstrated that the therapeutic benefits outweigh any potential risks, as shown by relapse rate, EDSS, MRI scan, or overall clinical impression

24 months

Change of therapy

As monotherapy, when a Special Authority request is submitted by a neurologist from a designated MS clinic, for the treatment of patients with relapsing-remitting MS or secondary progressive MS, AND who have experienced failure or intolerance to a previous disease modifying therapy

15 months

Practitioner exemptions

  • A Collaborative Prescribing Agreement (CPA) (PDF, 400KB) is available to neurologists specializing in MS whose primary place of practice is in a designated MS clinic. Neurologists who have signed a CPA are not required to submit a Special Authority request form for coverage
  • PharmaCare covers interferon beta-1b for patients who meet the limited coverage criteria and whose prescription has been written by a neurologist who has entered into a CPA
  • PharmaCare coverage and actual reimbursement is subject to the rules of a patient’s PharmaCare plan, including any annual deductible requirement and any other applicable PharmaCare pricing policy
  • Each CPA must be signed by the neurologist who is requesting coverage and not a delegate
  • Practitioners who have not signed a CPA may submit a Special Authority request if the patient meets the criteria above. These prescriptions will not be covered automatically

Special notes

  • Discontinuation of therapy should be discussed with patients with stable or inactive disease who are 60 years of age or older

Special Authority request form(s)