Notification of Medical Policy Reviews March 2023

March 21, 2023

Medical Drug Policy Name	Revised Criteria
Enzyme Replacement Therapy (ERT) for Lysosomal Storage Disorders (PDF)	For Fabrazyme: Added diagnostic requirements for Fabry disease; required baseline laboratory values for plasma globotriaosylceramide (GL-3) and/or GL-3 inclusions, plasma or urinary globotriaosylceramide (Gb3/GL-3), or plasma globotriaosylsphingosine (lyso-Gb3); and specialist requirement. Policy notification given 8/2/2023 for effective date 10/1/2023.
Esketamine (Spravato) Nasal Spray (PDF)	Added requirement for no use in combination with ketamine of any formulation or route of administration used for the same indication within initial and continuation criteria sections. Added requirement within maximum units criteria that the requested dose is within FDA labeled dosing for the requested indication. Updated maximum units for clarity. Minor adjustments made to formatting throughout policy for clarity. Policy notification given 8/2/2023 for effective date 10/1/2023.

Medical Drug Policy Name

Revised Criteria

Enzyme Replacement Therapy (ERT) for Lysosomal Storage Disorders (PDF)

For Fabrazyme: Added diagnostic requirements for Fabry disease; required baseline laboratory values for plasma globotriaosylceramide (GL-3) and/or GL-3 inclusions, plasma or urinary globotriaosylceramide (Gb3/GL-3), or plasma globotriaosylsphingosine (lyso-Gb3); and specialist requirement. Policy notification given 8/2/2023 for effective date 10/1/2023.

Esketamine (Spravato) Nasal Spray (PDF)

Added requirement for no use in combination with ketamine of any formulation or route of administration used for the same indication within initial and continuation criteria sections. Added requirement within maximum units criteria that the requested dose is within FDA labeled dosing for the requested indication. Updated maximum units for clarity. Minor adjustments made to formatting throughout policy for clarity. Policy notification given 8/2/2023 for effective date 10/1/2023.

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