Limited coverage drugs – sodium phenylbutyrate and ursodoxicoltaurine

Initial coverage:

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

• Adult patient with a diagnosis of definite ALS
  AND
• Has had ALS symptoms for 18 months or less
  AND
• Has a Forced Vital Capacity (FVC) of at least 60% of predicted value
  AND
• Does not require permanent noninvasive ventilation 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 requires invasive or permanent noninvasive ventilation
  OR
• Patient becomes non-ambulatory and is unable to cut food and feed themselves without assistance, irrespective of whether a gastrostomy is in place. ​

6 months