Velmanase Alfa-tycv (Lamzede)
Defines medical necessity criteria, initial and continued therapy requirements, dosing limits, exclusions, documentation and coding implications for Velmanase alfa-tycv (Lamzede) across commercial, HIM, and Medicaid lines of business.
Policy updated per FDA labeling; added ambulatory requirement, exclusion for prior HSCT or bone marrow transplant, additional specialist prescribers, and dosing/max dose language.
Added requirement that member does not have central nervous system manifestations of AM.
Specified required laboratory threshold: Reduced AM activity defined as 10% of normal activity.
Added/updated HCPCS code J0217 for velmanase alfa-tycv.