Medical Policy |
Revision |
Anifrolumab-fnia (Saphnelo™) |
Original medical policy criteria issued. |
Botulinum Toxin Injection |
Added hemifacial spasm as a covered indication; updated criteria for blepharospasm to include blepharospasm associated with dystonia or facial nerve (VII) disorders (including benign essential blepharospasm and hemifacial spasm) separately without step therapy requirement. |
Enzyme Replacement Therapy (ERT) for Lysosomal Storage Disorders |
Added newly approved Nexviazyme to policy for treatment of late-onset Pompe disease in patients 1 year or older, added drug to SOC criteria and associated dosing and maximum units to FDA label reference table; updated Pompe disease criteria to include genetic testing as option for diagnosis confirmation. |
Lumasiran (Oxlumo™) |
Removed baseline diagnostic metabolic testing requirements, and no secondary causes of hyperoxaluria; added use to lower urinary oxalate levels and no FDA labeled contraindications to therapy for clarity according to FDA labeling; reformatted continuation criteria to require a positive clinical response while using the medication as demonstrated by improvement, stabilization, or slowed worsening of disease. |