Lamzede (velmanase alfa-tycv) — Medica

Initial criteria

• Patient has a confirmed diagnosis of alpha-mannosidosis, defined as alpha-mannosidase activity less than 10% of normal activity in blood leukocytes
• Patient has biallelic pathogenic variants in Mannosidase Alpha Class 2B Member 1 (MAN2B1) as confirmed by genetic testing
• Patient has non-central nervous system manifestations (e.g., progressive motor function disturbances, physical disability, hearing and speech impairment, skeletal abnormalities, immune deficiency)
• Medication is prescribed by or in consultation with a geneticist, endocrinologist, metabolic disorder sub-specialist, or a physician who specializes in the treatment of lysosomal storage disorders

Approval duration

1 year