Lamzede (velmanase alfa) for alpha-mannosidosis — Coverage Criteria
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Covers use of Lamzede for treatment of non‑central nervous system manifestations of alpha‑mannosidosis for Blue Cross Blue Shield of Tennessee members when authorization criteria are met; applies to providers seeking prior authorization and continued therapy.
No material clinical or coverage changes in this revision.
Coverage Criteria for Lamzede (velmanase alfa)
Initial therapy (Alpha‑Mannosidosis)
Covered when ALL of the following are met:
Authorization of 12 months may be granted
Continuation of therapy
Covered for continued treatment when ALL of the following are met:
Authorization of 12 months may be granted for continued treatment
All indications other than treatment of non‑central nervous system manifestations of alpha‑mannosidosis are considered experimental/investigational and not medically necessary.
Use of Lamzede (velmanase alfa) for indications beyond the FDA‑approved treatment of non‑CNS manifestations of alpha‑mannosidosis is not medically necessary.
Functional and Biochemical Measures
Prior Authorization, Documentation, and Non‑covered Indications
Prior Authorization Required
Prior authorization is required for initiation and reauthorization of Lamzede (velmanase alfa) for treatment of non‑CNS manifestations of alpha‑mannosidosis. Approval, when granted, is for up to 12 months. Requests for indications other than treatment of non‑CNS manifestations of alpha‑mannosidosis are considered experimental/investigational and will be denied as not medically necessary.
- Prior authorization required for initial and continuation therapy
- Approval period: up to 12 months
Required Documentation for Prior Authorization and Reauthorization
Initial prior authorization requests must include documentation demonstrating diagnosis and baseline functional and biochemical measures. Reauthorization requests must document clinical response to therapy compared with baseline.
- Initial request must include: alpha‑mannosidase enzyme assay or genetic testing results confirming diagnosis; baseline serum or urine oligosaccharide concentration; baseline value for at least ONE functional test: 3‑minute stair climbing test (3MSCT), 6‑minute walk test (6MWT), or forced vital capacity (FVC, % predicted).
- Continuation/reauthorization requests must include: medical records documenting response to therapy (e.g., improvement in 3MSCT, 6MWT, or FVC % predicted from baseline, or reduction in serum or urine oligosaccharide concentration from baseline).
Non‑covered Indications
Requests for Lamzede for any indication other than treatment of non‑central nervous system manifestations of alpha‑mannosidosis are considered experimental/investigational and are not covered.
Background
Alpha‑mannosidosis is a hereditary lysosomal storage disorder caused by deficiency of the enzyme alpha‑mannosidase, leading to accumulation of oligosaccharides and multisystem disease. Clinical consequences include progressive somatic manifestations outside the central nervous system that are the target of enzyme replacement therapy with Lamzede.
Definitions and Diagnostic Confirmation
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