Limited Coverage Drugs – edaravone

Generic Name

edaravone

Strength

30 mg/100 mL (0.3 mg/mL)

Form

solution for intravenous infusion

Special Authority Criteria

Approval Period

Initial

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

  • Adult patient with a diagnosis of probable ALS or definite ALS1;

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

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

  • 1Probable or definite diagnosis of ALS is determined using the El Escorial and revised Airlie House diagnostic criteria.

Special Authority Request Form(s)