ZTALMY (ganaxolone suspension)

ZTALMY (ganaxolone suspension)

Self-Administration – oral

Diagnosis considered for coverage:

• 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

Coverage Criteria:

For diagnosis of CDD:

• Dose does not exceed the maximum FDA recommended dose:
  • For patients weighing 28 kg or less: 63 mg/kg/day
  • For patients weighing more than 28 kg: 1,800 mg per day; AND
• Patient is 2 years of age or older; AND
• Patient has a documented diagnosis of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD); AND
• Documented mutation in the CDKL5 gene; AND
• Prescribed by or in consultation with a neurologist; AND
• Patient is experiencing motor seizures (e.g., bilateral tonic, generalized tonic-clonic, bilateral clonic, atonic, focal, or bilateral tonic-clonic); AND
• Trial and failure, contraindication, or intolerance to two formulary anticonvulsants (e.g., valproic acid, levetiracetam, lamotrigine)

Reauthorization Criteria:

For diagnosis of CDD:

• Dose does not exceed the maximum FDA recommended dose:
  • For patients weighing 28 kg or less: 63 mg/kg/day
  • For patients weighing more than 28 kg: 1,800 mg per day; AND
• Documentation of positive clinical response to therapy as evidenced by a reduction in the frequency of seizures from baseline

Coverage Duration: 

• Initial: 6 months
• Reauthorization: 12 months

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Ztalmy contains ganaxolone, a Schedule V controlled substance (CV)

Policy Updates:

• 12/1/2022 – New policy approved by P&T

References:

• Ztalmy Prescribing Information. Marinus Pharmaceuticals, Inc. Radnor, PA. June 2022.