CurrentUnitedHealthcarePolicy CSLA2025D00136A

Kebilidi (Eladocagene Exuparvovec-Tneq) (for Louisiana Only)

Policy governs medical benefit drug coverage for Kebilidi to treat aromatic L‑amino acid decarboxylase (AADC) deficiency for members in Louisiana and applies to providers seeking authorization for the therapy.

Policy Summary

PayerUnitedHealthcare

PolicyKebilidi (Eladocagene Exuparvovec-Tneq) (for Louisiana Only)

Policy CodePolicy CSLA2025D00136A

Change TypeNew Medical Benefit Drug Policy

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization (limited to one lifetime treatment and up to 60 days from approval) and submit required supporting medical records.

SourceLink

POLICY UPDATE CHANGES

New Medical Benefit Drug Policy

1treatment per lifetime authorized

60 daysmaximum authorization length

E70.81diagnosis code

C9399, J3590procedure/HCPCS codes

Louisianastate applicability

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Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Diagnosis and diagnostic confirmation: Submission of medical records documenting a diagnosis of AADC deficiency; diagnosis confirmed by presence of biallelic mutations in the DDC (dopa decarboxylase) gene AND decreased AADC enzyme activity in plasma per current laboratory standards AND one or more typical clinical characteristics (e.g., hypotonia, oculogyric crises, dystonia, hypokinesia, autonomic dysfunction, developmental delay)

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Anatomic/surgical readiness: Patient has achieved skull maturity, as confirmed by neuroimaging, necessary for stereotactic neurosurgical administration of Kebilidi

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Refractory to standard therapy: Patient has persistent symptoms of AADC deficiency despite use of standard medical therapy (e.g., dopamine agonists, monoamine oxidase inhibitors, pyridoxine, other forms of vitamin B6)

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Functional status: Patient is unable to ambulate independently

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Anti‑AAV2 antibody: Patient does not have an anti‑AAV2 (serotype 2) antibody titer higher than 1:1200 or greater than 1 optical density by ELISA<=1:1200 or <=1 OD

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Prescribing clinician: Therapy is prescribed by a neurologist or neurosurgeon

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No prior gene therapy: Patient has not previously received Kebilidi or other gene therapy for treatment of AADC deficiency in their lifetime

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Dosing is in accordance with the United States Food and Drug Administration approved labeling

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Authorization limits: Authorization limited to no more than one treatment per lifetime and for no longer than 60 days from approval1 treatment; <=60 days

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Patients with anti‑AAV2 antibody titers greater than 1:1200 or with an ELISA optical density value greater than 1 OD are excluded from coverage for Kebilidi (eladocagene exuparvovec‑tneq). This threshold is used to determine eligibility for stereotactic intraputaminal gene therapy because elevated anti‑AAV2 antibodies may affect treatment safety and efficacy.

Kebilidi is considered not medically necessary for individuals who have previously received Kebilidi or any other gene therapy for AADC deficiency at any time in their lifetime. Prior receipt of gene therapy for this indication disqualifies the patient from coverage for additional gene‑replacement treatment.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required before Kebilidi (for AADC deficiency) will be covered. Authorization is limited to a single lifetime treatment and will be issued for no more than 60 days from the approval date.

One lifetime treatment only
Authorization duration limit: ≤ 60 days from approval
Prescribed by a neurologist or neurosurgeon
Dosing must follow FDA‑approved labeling

Denial Risk

Triggers for Potential Denial

Coverage may be denied if the submitted records do not clearly document a confirmed diagnosis of AADC deficiency. Examples of documentation triggers that increase denial risk include absence of: confirmed biallelic DDC pathogenic variants, decreased AADC enzyme activity per laboratory standards, or typical clinical phenotype features consistent with AADC deficiency.

No documentation of biallelic DDC (DDC) gene mutations
No laboratory evidence of decreased AADC enzyme activity
Lack of clinical history describing typical AADC features (e.g., hypotonia, oculogyric crises, dystonia, hypokinesia, autonomic dysfunction, developmental delay)
Prior receipt of Kebilidi or other gene therapy for AADC deficiency (eligibility is lifetime-limited)

Step Therapy

Step Therapy / Prior Treatment Requirement

Prior to authorization, documentation must demonstrate that the patient had persistent symptoms despite standard medical therapy and that stepwise/conservative medical management was attempted. Per clinical guidance, first‑line medical therapy typically includes selective dopamine agonists, monoamine oxidase (MAO) inhibitors, and pyridoxine; additional symptomatic agents (e.g., anticholinergics, benzodiazepines, melatonin, alpha‑adrenoceptor blockers) and a stepwise, multi‑drug approach are commonly used.

Documentation of persistent symptoms despite standard medical therapy (e.g., dopamine agonists, MAO inhibitors, pyridoxine/other vitamin B6)
Documentation of prior medical treatments tried, doses, duration, and response
Confirmation that patient is unable to ambulate independently (where applicable)

Background

Aromatic L‑amino acid decarboxylase (AADC) deficiency is a rare, autosomal recessive neurological disorder caused by biallelic pathogenic variants in the DDC gene that lead to deficient AADC enzyme activity and impaired synthesis of dopamine and serotonin. Clinically, patients typically present with early‑onset movement and autonomic abnormalities — for example, hypotonia, oculogyric crises, dystonia, hypokinesia — along with developmental delay and other features. Kebilidi is a one‑time AAV2 vector gene replacement therapy delivered via stereotactic intraputaminal administration intended to restore AADC expression and improve dopamine production; patient selection for this procedure requires documentation of diagnosis, skull maturity for neurosurgical administration, failure of standard medical therapies, and functional impairment such as inability to ambulate independently.

Definitions

AADC deficiency — definition

DefinitionAromatic L‑amino acid decarboxylase (AADC) deficiency: a rare genetic neurological disorder caused by biallelic pathogenic variants in the DDC gene leading to deficient AADC enzyme activity and impaired synthesis of dopamine and serotonin.

Key biochemical defectLow AADC enzyme activity resulting in inability to convert L‑DOPA and 5‑HTP to dopamine and serotonin

Typical clinical featuresMovement disorders (hypokinesia, dystonia, oculogyric crises), autonomic dysfunction, developmental delay, and motor dysfunction

GeneticsAutosomal recessive; caused by biallelic pathological variants in the DDC gene

Kebilidi — product description

Generic nameeladocagene exuparvovec-tneq

Brand nameKebilidi

Product typeOne-time gene replacement therapy delivering DDC via a recombinant adeno-associated virus serotype 2 (AAV2) vector

IndicationTreatment of aromatic L‑amino acid decarboxylase (AADC) deficiency (FDA accelerated approval)

OpenPayer

Kebilidi (Eladocagene Exuparvovec-Tneq) (for Louisiana Only)

Coverage Criteria for Kebilidi (eladocagene exuparvovec-tneq)

Diagnosis and Procedure Codes

Provider Requirements, Prior Authorization, and Documentation

Background

Definitions

C9399	Unclassified drugs or biologicals.
J3590	Unclassified biologics