Xenpozyme (olipudase alfa-rpcp) — Medica

Initial criteria

• Diagnosis of ASMD has been established by acid sphingomyelinase (ASM) enzymatic assay testing
• Diagnosis of ASMD has been confirmed by genetic testing demonstrating biallelic pathogenic variants in the sphingomyelin phosphodiesterase-1 (SMPD1) gene
• Diagnosis of Gaucher disease has been excluded
• Patient has ASMD type B OR patient has ASMD type A/B
• Prescriber confirms patient has two or more non-central nervous system signs of ASMD type B or A/B (examples include hepatosplenomegaly, interstitial lung disease, decreased diffusing capacity of the lungs, progressive liver disease with cirrhosis or fibrosis, dyslipidemia, osteopenia, thrombocytopenia, anemia, leukopenia)
• Medication is prescribed by or in consultation with a geneticist, endocrinologist, metabolic disorder sub-specialist, or a physician who specializes in lysosomal storage disorders

Approval duration

1 year