Olpruva (sodium phenylbutyrate) — Highmark

Preferred products

• Generic sodium phenylbutyrate

Initial criteria

• The member is using Olpruva for chronic management of urea cycle disorders (ICD-10: E72.20)
• The member is using Olpruva for urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), argininosuccinic acid synthetase (ASS), or ornithine transcarbamylase (OTC)
• The member is using Olpruva as adjunctive therapy to dietary management
• If the member is less than 18 years of age, the member weighs 20 kg or greater and has a body surface area (BSA) of 1.2 m2 or greater
• The member has experienced therapeutic failure, intolerance, or contraindication to plan-preferred generic sodium phenylbutyrate

Reauthorization criteria

• The prescriber attests that the member has experienced positive clinical response to therapy (e.g., reduction in blood ammonia levels)
• The member is continuing use of requested drug with standard of care (e.g., dietary protein restriction and/or amino acid supplementation)

Approval duration

12 months