Limited coverage drugs – edaravone

Last updated on August 26, 2024

Generic name

edaravone

Strength / Form

Oral suspension 105mg/5mL
Solution for intravenous infusion 30 mg/100 mL (0.3mg/mL) 

Special Authority criteria

Approval period

Initial coverage

For the treatment of amyotrophic lateral sclerosis (ALS), if all the following conditions are met:

  • Adult patient with a diagnosis of probable or definite ALS

AND

  • Has scores of at least two points on each item of the ALS Functional Rating Scale – Revised (ALSFRS-R)

AND

  • Has a forced vital capacity greater than or equal to 80% of predicted

AND

  • Has had ALS symptoms for two years or less

AND

  • Patient is not currently requiring permanent non-invasive or invasive ventilation

AND

  • When prescribed by a specialist with experience in the diagnosis and management of ALS.

6 months

Renewal coverage

Approval for renewals will not be granted and coverage will be discontinued in patients who meet any of the following criteria:

  • Patient becomes non-ambulatory (ALSFRS-R score ≤ 1 for item 8)

AND

  • Is unable to cut food and feed themselves without assistance, irrespective of whether a gastrostomy is in place (ALSFRS-R score < 1 for item 5a or 5b);

OR

  • Patient requires permanent non-invasive or invasive ventilation

6 months

Practitioner exemptions

  • None

Special notes

  • None

Special Authority request form(s)