Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Eladocagene exuparvovec-tneq (Kebilidi) may be considered medically necessary when
ALL
the following criteria are met:
-
Individual is age 16 months or older;
and
-
Individual has genetically confirmed AADC deficiency due to biallelic mutations in the DDC gene;
and
-
Individual has a severe phenotype (i.e., individuals who cannot sit, stand, or ambulate independently);
and
-
Individual has one (1) or more of the following clinical characteristics associated with AADC deficiency:
-
Infantile hypotonia;
or
-
Ptosis;
or
-
Oculogyric crises;
or
-
Dystonia and other hyperkinetic movement disorders;
or
-
Hypokinesia and other features of parkinsonism;
or
-
Excessive sweating;
or
-
Stridor and nasal congestion;
or
-
Sleep disorder (hypersomnolence or insomnia);
or
-
Autonomic dysfunction;
or
-
Developmental delay / intellectual disability;
and
-
Individual has decreased AADC enzyme activity in plasma;
and
-
Individual's skull has reached maturity, as confirmed by neuroimaging, to allow placement of ClearPoint® system for stereotactic surgery;
and
-
Eladocagene exuparvovec-tneq (Kebilidi) is being administered in a medical center which specializes in stereotactic neurosurgery;
and
-
Individual has persistent neurological defects secondary to AADC deficiency, despite standard medical therapy (dopamine agonists, monoamine oxidase inhibitor, pyridoxine, or other forms of vitamin B6);
and
-
The individual does not have the presence of other significant medical or neurological conditions that would create an unacceptable operative or anesthetic risk;
and
-
Individual does not have pyridoxine 5'-phosphate oxidase or tetrahydrobiopterin (BH4) deficiency;
and
- Individual does not have contraindication for imaging studies (CT [computed tomography] scan, PET [positron emission tomography] or magnetic resonance imaging [MRI]), including sedation limitations or metal that would interfere with a brain MRI; and
-
Individual does not have an anti-adeno-associated virus, serotype 2 (anti-AAV2) antibody titer higher than 1:1200 or >1 optical density value by enzyme-linked immunosorbent assay;
and
-
Individual does not have a clinically active infection;
and
- Individual has not received treatment with other experimental therapies within the last 24 weeks prior to planned gene therapy administration, or any other gene therapy in their lifetime.
Note:
The safety and effectiveness of repeat administration of eladocagene exuparvovec-tneq (Kebilidi) has not been evaluated. Therefore, coverage will be limited to once per lifetime.
The use of eladocagene exuparvovec-tneq (Kebilidi) for any other indication than listed above is considered experimental/investigational and therefore, not covered. The safety and/or efficacy cannot be established by review of the available published peer-reviewed literature.
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