Relyvrio (sodium phenylbutyrate-taurursodiol) — Blue Cross Blue Shield of Alabama

Initial criteria

• Diagnosis of amyotrophic lateral sclerosis (ALS) [also known as Lou Gehrig’s disease]
• The requested agent will be or was started within 18 months of symptom onset
• Baseline percent predicted forced vital capacity (FVC) or slow vital capacity (SVC) greater than 60%
• If the patient has an FDA labeled indication, then ONE of the following: • The patient’s age is within FDA labeling for the requested indication for the requested agent OR • There is support for using the requested agent for the patient’s age for the requested indication
• Patient is able to perform most activities of daily living, defined as scores of 2 points or better on each individual item of the ALS Functional Rating Scale-Revised (ALSFRS-R)
• ONE of the following: • BOTH of the following: – The patient is currently treated with riluzole AND will continue riluzole in combination with the requested agent OR • The patient has an intolerance, hypersensitivity, or FDA labeled contraindication to riluzole
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist) or has consulted with a specialist in the area of the patient’s diagnosis