Ganaxolone (Ztalmy) Form

Ganaxolone (Ztalmy®) is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator.
FDA Approved Indication(s) Ztalmy 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/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Ztalmy is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Seizures Associated with CDKL5 Deficiency Disorder (must meet all):

1. Diagnosis of CDD
   2. Prescribed by or in consultation with a neurologist;
   3. Age ≥ 2 years;
   4. Member is experiencing baseline monthly seizure frequency;
   5. Dose does not exceed any of the following (a or b):
      a. Weight < 28 kg: 63 mg/kg/day;
      b. Weight > 28 kg: 1,800 mg/day. Approval duration: 6 months B. Other diagnoses/indications (must meet 1 or 2):

2. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: Page 1 of 5

   CLINICAL POLICY Ganaxolone CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

3. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. II. Continued Therapy A. Seizures Associated with CKDL5 Deficiency Disorder (must meet all):
4. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Ztalmy for a covered indication and has received this medication for at least 30 days;
5. Member is responding positively to therapy;
   
   3. If request is for a dose increase, new dose does not exceed any of the following (a or b):
      a. Weight < 28 kg: 63 mg/kg/day;
      b. Weight > 28 kg: 1,800 mg/day. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

7. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.
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   CLINICAL POLICY Ganaxolone IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CDD: cyclin-dependent kinase-like 5 deficiency disorder
   CDKL5: cyclin-dependent kinase-like 5 Appendix B: Therapeutic Alternatives
   Not applicable. Appendix C: Contraindications/Boxed Warnings None reported.
   FDA: Food and Drug Administration GABA: gamma-aminobutyric acid V. Dosage and Administration
   Indication Seizure treatment associated with CDD Dosing Regimen Weight ≤ 28 kg: 6 mg/kg PO TID (18 mg/kg/day) Maximum Dose Weight ≤ 28 kg: 21 mg/kg TID (63 mg/kg/day) Weight > 28 kg: 150 mg PO TID (450 mg/day) Weight > 28 kg: 600 mg TID daily (1,800 mg/day) VI. Product Availability
   Oral suspension: 50 mg/mL VII.