Pharmacy Prior Authorization Criteria

Lamzede (velmanase alfa-tycv)

For diagnosis of Alpha - Mannosidosis
Indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

AND

Deficiency in alpha-mannosidase enzyme activity as measured in fibroblasts or leukocytes
Molecular genetic testing confirms mutations in the MAN2B1 gene

AND

Treatment is only for non-central nervous system disease manifestations (e.g., large head, prominent forehead, protruding jaw, skeletal abnormalities)

Prior Authorization (Reauthorization)

Length of Approval: 24 Month(s)

Patient does not show evidence of progressive disease while on therapy as evidenced by one of the following:

Reduction in serum oligosaccharide concentration from baseline
Improvement in clinical signs and symptoms from baseline (e.g., 3-minute stair climbing test, 6-minute walking test, pulmonary function, quality of life)

2024-03-29, 2023-05-19

Lamzede Prescribing Information. Chiesi USA, Inc. Cary, NC. February 2023.
ClinicalTrials.gov. A Placebo-Controlled Phase 3 Trial of Repeated Lamazym Treatment of Subjects With Alpha-Mannosidosis. Available at: https://www.clinicaltrials.gov/ct2/show/NCT01681953?term=nct01681953&draw=2&rank=1. Accessed March 30, 2023.
ClinicalTrials.gov. Trial on Safety and Efficacy of Velmanase Alfa Treatment in Pediatric Patients With Alpha-Mannosidosis (rhLaman-08). Available at: https://www.clinicaltrials.gov/ct2/show/NCT02998879?term=NCT02998879&draw=2&rank=1. Accessed March 30, 2023.
Bordwardt, L., Guffon, N., et al. Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial. Avaiable at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6326984/. Accessed March 30, 2023.
Malm, D, Nilssen, O. Alpha-Mannosidosis. Available at: https://www.ncbi.nlm.nih.gov/books/NBK1396/. Accessed March 30, 2023.
Alpha Mannosidosis. Available at : https://rarediseases.org/rare-diseases/alpha-mannosidosis/. Accessed March 30, 2023.