Pharmacy Prior Authorization Criteria

Lenmeldy (atidarsagene autotemcel)

Indications for Prior Authorization

Lenmeldy (atidarsagene autotemcel)

• For diagnosis of Metachromatic Leukodystrophy (MLD)
  Indicated for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ) metachromatic leukodystrophy (MLD).

Criteria

Lenmeldy

*Per prescribing information, Lenmeldy is for one-time, single dose intravenous use only.

Prior Authorization

Length of Approval: 1 Time Authorization in Lifetime*

• Diagnosis of metachromatic leukodystrophy (MLD)
AND
• Molecular genetic testing confirms mutation in the arylsulfatase A (ARSA) gene
AND
• Disease is one of the following:
• Pre-symptomatic late infantile (PSLI) as confirmed by both of the following:
• Disease onset at less than or equal to 30 months of age
AND
• One of the following:
• Absence of neurological signs and symptoms of MLD (e.g., peripheral neuropathy, gait difficulties, hypotonia)
• Abnormal reflexes or abnormalities on brain magnetic resonance imaging (MRI) and/or nerve conduction tests not associated with functional impairment (e.g., no tremor, no peripheral ataxia)
OR
• Pre-symptomatic early juvenile (PSEJ) as confirmed by both of the following:
• Disease onset at greater than 30 months and less than 7 years of age
AND
• One of the following:
• Absence of neurological signs and symptoms of MLD (e.g., peripheral neuropathy, gait difficulties, hypotonia)
• Abnormal reflexes or abnormalities on brain magnetic resonance imaging (MRI) and/or nerve conduction tests not associated with functional impairment (e.g., no tremor, no peripheral ataxia)
OR
• Early-symptomatic early juvenile (ESEJ) as confirmed by all of the following:
• Disease onset at greater than 30 months and less than 7 years of age
• Gross motor function classification (GMFC)-MLD score less than or equal to 1
• Intelligence quotient (IQ) of greater than or equal to 85
AND
• Prescribed by a specialist with expertise in MLD at an authorized treatment center
AND
• Both of the following:
• Patient has never received Lenmeldy treatment in their lifetime
• Patient has never received prior hematopoietic stem cell transplant (HSCT)

P & T Revisions

2024-05-16

References

1. Lenmeldy Prescribing Information. Orchard Therapeutics. Boston, MA. March 2024.

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Revision History

• 2024-05-16: New Program

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