Limited coverage drugs – sodium phenylbutyrate and ursodoxicoltaurine

Last updated on July 19, 2023
Generic name sodium phenylbutyrate and ursodoxicoltaurine
Strength / Form Powder for oral suspension
3 g sodium phenylbutyrate, 1 g ursodoxicoltaurine per sachet
Special Authority criteria Approval period

Initial coverage:

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

  • Adult patient with a diagnosis of definite ALS
  • Has had ALS symptoms for 18 months or less
  • Has a Forced Vital Capacity (FVC) of at least 60% of predicted value
  • Does not require permanent noninvasive ventilation or invasive ventilation.
  • 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
  • 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

Practitioner exemptions

  • None

Special notes

  • None

Special Authority requests