CurrentUnitedHealthcarePolicy N/A

Aqneursa (levacetylleucine) prior authorization

Defines prior authorization and medical necessity criteria for Aqneursa (levacetylleucine) for treatment of neurological manifestations of Niemann-Pick disease type C (NPC); applies to providers seeking coverage through UnitedHealthcare.

Policy Summary

PayerUnitedHealthcare

PolicyAqneursa (levacetylleucine) prior authorization

Policy CodePolicy N/A

Change TypeNew prior authorization programcriteria additions

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization and submit genetic confirmation of NPC (NPC1/NPC2 mutation analysis) plus documentation of neurological indication and miglustat use or failure.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program for Aqneursa (levacetylleucine) was established.

Criteria added that Aqneursa must not be taken in combination with Miplyffa (arimoclomol).

Criteria added that Aqneursa should be used with miglustat or after failure/contraindication/intolerance to miglustat.

Annual review in 1/2026 noted without changes to coverage criteria.

12 monthsauthorization duration

≥15 kgminimum patient weight

genetic confirmationNPC diagnosis requirement

neurological onlyindication limitation

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