Limited coverage criteria – edaravone

edaravone

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

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 a Special Authority request is submitted 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

A Special Authority request must be submitted for renewal, by a specialist with experience in the diagnosis and management of ALS.

6 months