CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ztalmy (ganaxolone) for CDKL5 deficiency disorder seizures

Defines coverage and medical necessity criteria for Ztalmy (ganaxolone) for treatment of seizures associated with CDKL5 deficiency disorder (CDD) for Medicaid members. Includes initial and continuation approval criteria, dosing limits, quantity limits, and required documentation.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZtalmy (ganaxolone) for CDKL5 deficiency disorder seizures

Policy CodePolicy N/A

Change Typeclarified

Effective DateMar 1, 2023

Next Review Date

Key ActionInitial authorization may be granted for 6 months when prescriber is a neurologist (or in consultation), patient >=2 years old, dosing limits met, and required clinical documentation (genetic confirmation and baseline monthly seizure frequency) provided.

SourceLink

POLICY UPDATE CHANGES

Policy lists FDA-approved indication for Ztalmy for seizures associated with CDKL5 deficiency disorder and requires meeting specified initial and continuation criteria.

1Covered Indications

6 moAuth Duration (initial/renewal)

3 moStable dosing before renewal

10 bottles/30dQuantity limit

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Coverage Summary

Background/scope: This policy defines coverage and medical necessity criteria for Ztalmy (ganaxolone) for the treatment of seizures associated with CDKL5 deficiency disorder (CDD) for Medicaid members. Coverage stance: covered_with_criteria for the FDA-approved indication. Authorization: initial and renewal authorizations may be granted for 6 months. Age threshold: patient must be 2 years of age or older. At a high level, dosing and quantity limits apply: dosing must not exceed 63 mg/kg per day for patients 28 kg1,800 mg per day for patients ≥28 kg, and a product-specific quantity limit is applied to the oral suspension formulation.

Surface thresholds

Age>= 2 years

Dose (weight < 28 kg)63 mg/kg per day

Dose (weight >= 28 kg)1,800 mg per day

Required stable dosing period for continuationAt least 3 months of stable maintenance dose

Authorization durationUp to 6 months (initial and renewal)

Medical-Necessity Criteria

Indications / Covered Uses

Covered when ALL of the following are met:

ALL of the following

Indication is treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD)
FDA-approved indication
Member has no exclusions to the prescribed therapy

Criteria for Initial Approval

An authorization may be granted for 6 months when ALL of the following criteria are met:

ALL of the following

Ztalmy (ganaxolone) is prescribed by, or in consultation with, a neurologist

Coding

NDC / ProductNDCCovered

Ztalmy (ganaxolone) oral suspension 50 mg/mL

Ztalmy (ganaxolone) oral suspension 50 mg/mL — product and concentration as specified in policy; quantity limits apply: 10 (110 mL) bottles per 30 days (equates to 36.667 mL/day).

Provider Actions

Prior Authorization

Prior authorization required for initiation

Initial authorization may be granted for up to 6 months when all of the following are met: Ztalmy is prescribed by, or in consultation with, a neurologist; the patient is 2 years of age or older; dosing does not exceed 63 mg/kg/day for weight < 28 kg or 1,800 mg/day for weight ≥ 28 kg; and required clinical documentation (genetic confirmation and baseline monthly seizure frequency) is provided.

Documentation Required

Genetic confirmation documentation required

Provide enzyme assay or genetic testing chart notes or medical record documentation demonstrating a pathogenic or likely pathogenic mutation in the CDKL5 gene.

Documentation Required

Baseline seizure frequency required

Background & Evidence

FDA-approved indication: Ztalmy (ganaxolone) is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older. Policy limits use to this FDA-approved indication and requires documentation of genetic confirmation of a pathogenic or likely pathogenic CDKL5 mutation and baseline monthly seizure frequency. The policy also applies dosing limits (weight-based thresholds of 63 mg/kg/day for patients 28 kg and 1,800 mg/day for patients ≥28 kg) and a quantity limit for Ztalmy oral suspension 50 mg/mL (10 × 110 mL bottles per 30 days; equates to 36.667 mL/day).

Evidence

Definitions

Revision History

2023-03-01changes

Document includes dosing thresholds, prescriber specialty requirement, and required genetic documentation. Policy lists FDA-approved indication for Ztalmy for seizures associated with CDKL5 deficiency disorder and requires meeting specified initial and continuation criteria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZtalmy (ganaxolone) for CDKL5 deficiency disorder seizures

Policy CodePolicy N/A

Change Typeclarified

Effective DateMar 1, 2023

Next Review Date

SourceLink

On This Page

Patient is 2 years of age or older>= 2 years

Dosing must not exceed (A OR B)

Weight < 28 kg: 63 mg/kg per day63 mg/kg/day
Weight >= 28 kg: 1,800 mg per day1800 mg/day

Clinical documentation provided includes:

Enzyme assay or genetic testing in the form of chart notes or medical record documentation demonstrating pathogenic or likely pathogenic mutation in the CDKL5 gene
Genetic confirmation of CDKL5 mutation required
Baseline monthly seizure frequency

Continuation of Therapy

An authorization may be granted for 6 months when ALL of the following criteria are met:

ALL of the following

Patient has been receiving a stable maintenance dose of the requested drug for at least 3 months>= 3 months
Clinical demonstration of benefit (one of):
- Patient has demonstrated a positive clinical response to therapy (e.g., decrease in seizures)
- Improvement in quality of life using a validated scale for the disease state

Include baseline monthly seizure frequency in the submitted clinical documentation (e.g., chart notes or medical record).

Prior Authorization

Continuation authorization requirements

Renewal authorizations may be granted for 6 months when the patient has been on a stable maintenance dose of the requested drug for at least 3 months and clinical documentation shows a positive clinical response (for example, decreased seizures) or improvement in quality of life on a validated disease-specific scale.

Billing Rule

Quantity limits for dispensing

Quantity limit: Ztalmy (ganaxolone) oral suspension 50 mg/mL — 10 bottles (110 mL each) per 30 days (equivalent to 36.667 mL/day).