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Miplyffa (arimoclomol)United Healthcare

Niemann-Pick disease type C (NPC)

Initial criteria

  • Diagnosis of Niemann-Pick disease type C (NPC)
  • Diagnosis has been genetically confirmed by mutation analysis of NPC1 and NPC2 genes
  • Miplyffa is being used to treat neurological manifestations of NPC
  • Miplyffa is prescribed in combination with miglustat
  • Patient is not receiving Miplyffa in combination with Aqneursa (levacetylleucine)
  • Miplyffa is prescribed by or in consultation with a provider with expertise in the treatment of NPC

Reauthorization criteria

  • Documentation of positive clinical response to Miplyffa therapy (e.g., slowed disease progression from baseline based on assessment with NPC–specific scales)
  • Miplyffa continues to be prescribed in combination with miglustat
  • Patient is not receiving Miplyffa in combination with Aqneursa (levacetylleucine)
  • Miplyffa is prescribed by or in consultation with a provider with expertise in the treatment of NPC

Approval duration

12 months