CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

Kebilidi (eladocagene exuparvovec-tneq) Coverage Criteria

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This policy governs prior authorization coverage for Kebilidi under the New Hampshire Medicaid Fee-for-Service Program for adult and pediatric patients with aromatic L-amino acid decarboxylase deficiency, subject to specified clinical and treatment criteria.

Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicyKebilidi (eladocagene exuparvovec-tneq) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization to establish that all approval criteria are met; treatment is limited to one dose per lifetime.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10Approval criteria requirements

16 months–10 yearsEligible patient age range

≥3 monthsStable standard therapy

1 dose/lifetimeTreatment limitation

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CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

Kebilidi (eladocagene exuparvovec-tneq) Coverage Criteria

Customize your policy alerts

Sign up for all New Hampshire Department of Health and Human Services policy alerts

Know when New Hampshire Department of Health and Human Services releases new policies or updates existing guidance.

Monitor payer policy activity

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Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicyKebilidi (eladocagene exuparvovec-tneq) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization to establish that all approval criteria are met; treatment is limited to one dose per lifetime.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10Approval criteria requirements

16 months–10 yearsEligible patient age range

≥3 monthsStable standard therapy

1 dose/lifetimeTreatment limitation

Kebilidi Coverage Criteria

Initial Kebilidi Therapy

Initial Kebilidi therapy is covered only when <strong>all</strong> applicable criteria are met.

ALL of the following

Patient is at least 16 months of age through 10 years of age.
Diagnosis of severe aromatic L-amino acid decarboxylase (AADC) deficiency established by all of the following
- ONE of the following
  - Patient has biallelic pathogenic variants in the DOPA decarboxylase (DDC) gene identified by molecular genetic testing.
  - Patient's cerebrospinal fluid (CSF) or plasma neurotransmitter profile is consistent with AADC deficiency.
- Patient has significantly reduced AADC enzyme activity in plasma.
- Prescriber is an optometrist or ophthalmologist, or an optometrist or ophthalmologist has been consulted.
Patient is experiencing persistent neurological defects (e.g., autonomic dysfunction, hypotonia, dystonia, and other movement disorders) secondary to AADC deficiency despite standard medical therapy (e.g., dopamine agonists, monoamine oxidase inhibitor, pyridoxine, or other forms of vitamin B6).
Patient should be on stable dosages for at least 3 months prior to treatment with Kebilidi.
Patient is unable to ambulate independently.
Patient has achieved skull maturity as assessed by neuroimaging.
Patient does not have any contraindications that would preclude surgical intraputaminal administration.
For females of reproductive potential, a negative pregnancy test is required prior to administration.

Kebilidi is not covered when the patient has pyridoxine 5'-phosphate oxidase deficiency or tetrahydrobiopterin (BH4) deficiency. Kebilidi is also not covered when the patient has received prior gene therapy or has a baseline anti-adeno-associated virus, serotype 2 (anti-AAV2) antibody titer above the established threshold for a positive result.

Repeat Kebilidi treatment is not covered. Kebilidi is limited to a single dose per lifetime.

Coverage is denied when the stated approval criteria are not met.

Clinical Parameters

Age

Minimum age16 months

Maximum age10 years

Eligible age rangeAt least 16 months through 10 years of age

Stable standard medical therapy

Required durationAt least 3 months

Therapy statusStandard medical therapy dosages must be stable

TimingStable dosages are required before treatment with Kebilidi

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization and Lifetime Dose Limit

Prior authorization is required before Kebilidi™ (eladocagene exuparvovec-tneq) administration. Coverage is limited to a single dose per lifetime; repeat dosing is not covered.

Submit the prior authorization request before treatment.
Lifetime limitation: one dose per patient.

Documentation Required

Persistent Symptoms Despite Standard Therapy

The patient must have persistent neurological defects secondary to severe AADC deficiency despite standard medical therapy. Examples include autonomic dysfunction, hypotonia, dystonia, and other movement disorders.

Document standard therapy, such as dopamine agonists, a monoamine oxidase inhibitor, pyridoxine, or other forms of vitamin B6.
The patient should be receiving stable dosages of standard therapy for at least 3 months before Kebilidi treatment.

Medication and Indication Overview

Kebilidi (eladocagene exuparvovec-tneq) is indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. Coverage focuses on severe AADC deficiency supported by required genetic or biochemical findings, with persistent neurological defects despite standard medical therapy.

AADC Deficiency

Aromatic L-amino acid decarboxylase (AADC) deficiency

DisorderSevere aromatic L-amino acid decarboxylase (AADC) deficiency

Genetic evidenceBiallelic pathogenic variants in the DDC gene identified by molecular genetic testing

Neurotransmitter evidenceCerebrospinal fluid or plasma neurotransmitter profile consistent with AADC deficiency

Enzyme activitySignificantly reduced AADC enzyme activity in plasma

Initial Treatment Requirements

Initial Therapy

Initial treatment is covered when all approval criteria are met.

Initial Kebilidi treatment

Age: Patient is ≥16 months of age through 10 years of age≥16 months through 10 years
Severe AADC deficiency
- ONE of the following diagnostic findings
  - Molecular genetic testing: Biallelic pathogenic variants in the DOPA decarboxylase (DDC) gene are identified

Prior Standard Medical Therapy

Step	Required prior standard medical therapy	Response requirement	Duration before Kebilidi treatment
1	Dopamine agonists, a monoamine oxidase inhibitor, pyridoxine, or other forms of vitamin B6	Persistent neurological defects secondary to AADC deficiency, including autonomic dysfunction, hypotonia, dystonia, or other movement disorders	Stable dosages for ≥3 months

Lifetime Treatment Limit

Quantity limit

MedicationKebilidi

Quantity limit1 dose

Lifetime limitSingle dose per lifetime

Administration Setting

Billing Rule

Confirm surgical intraputaminal feasibility

Arrange administration in a hospital outpatient setting only when it is feasible through surgical intraputaminal administration. Confirm that the patient has no contraindications that would preclude this surgical administration.

Documentation Required

Clinical Documentation Supporting Approval

Clinical documentation accompanying the request must support each applicable approval criterion for Kebilidi.

Patient: Document age of at least 16 months through 10 years, inability to ambulate independently, skull maturity by neuroimaging, and—when applicable for a female of reproductive potential—a negative pregnancy test before administration.
Diagnosis: Document severe AADC deficiency and either biallelic pathogenic DDC gene variants identified by molecular genetic testing or a CSF/plasma neurotransmitter profile consistent with AADC deficiency.
Laboratory: Document significantly reduced plasma AADC enzyme activity; absence of pyridoxine 5'-phosphate oxidase or BH4 deficiency; and a baseline anti-AAV2 antibody titer that is not above the established positive threshold.
Neurologic and specialist evaluation: Document persistent neurological defects despite standard therapy, assessment of skull maturity, and that the prescriber is an optometrist or ophthalmologist or has consulted one.
Treatment and safety: Document standard-therapy history and stable dosing for at least 3 months, no prior gene therapy, and absence of contraindications to surgical intraputaminal administration.