CurrentAvMedPolicy N/A

Prior authorization form and criteria for ganaxolone (Ztalmy)

This document is a pharmacy prior authorization/step-edit request form and clinical criteria for coverage of Ztalmy (ganaxolone) for members; it governs prescriber submission requirements and medical necessity criteria for initial and reauthorization of therapy.

Policy Summary

PayerAvMed

PolicyPrior authorization form and criteria for ganaxolone (Ztalmy)

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionFax a completed, signed prior authorization request with required clinical documentation to the payer to request approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization duration

12 monthsReauthorization duration

10 bottles/30 daysQuantity limit

>=2 yrsMinimum age

Coverage Criteria for Ztalmy (ganaxolone)

Initial Therapy

Covered when ALL of the following are met for initial authorization (6 months):

Initial authorization criteria: Medication prescribed by or in consultation with a neurologist.

Initial authorization criteria: Member is 2 years of age or older.

Initial authorization criteria: Diagnosis of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) confirmed with genetic testing (documentation must be submitted).

Initial authorization criteria: Member is refractory to at least TWO antiepileptic drugs (e.g., clobazam, levetiracetam, topiramate, valproate) verified by chart notes or pharmacy paid claims.

Policy Summary

PayerAvMed

PolicyPrior authorization form and criteria for ganaxolone (Ztalmy)

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionFax a completed, signed prior authorization request with required clinical documentation to the payer to request approval.

SourceLink

On This Page

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Continuation / Reauthorization

Reauthorization criteria (12 months):

Reauthorization criteria: Member continues to meet the initial authorization criteria.

Reauthorization criteria: Member has demonstrated a positive response to Ztalmy therapy, defined as a decrease from baseline and stabilization of seizure frequency (submit chart notes).

Reauthorization criteria: Member is absent of unacceptable toxicity from therapy (e.g., somnolence, pyrexia, suicidal thoughts or behavior).

Reauthorization criteria: Reauthorization duration: 12 months.Reauthorization duration: 12 months

All applicable documentation (lab results, diagnostics, and chart notes) must be provided for approval.

Initial Dosing and Coverage

Initial dosing and coverage

Dosing guidance and initial coverage criteria:

Weight-based dosing: For members weighing 28 kg or less: titrate per days 1–7, 8–14, 15–21, and 22 and ongoing with maximum total daily doses of 18 mg/kg/day (days 1–7), 33 mg/kg/day (days 8–14), 48 mg/kg/day (days 15–21), and 63 mg/kg/day (day 22 and ongoing); dosing schedules use mg/kg three times daily as specified on the form.

Exact dosing tables are on the form.

Weight-based dosing: For members weighing more than 28 kg: titrate with fixed dosing as specified on the form: 150 mg three times daily (450 mg/day) days 1–7; 300 mg three times daily (900 mg/day) days 8–14; 450 mg three times daily (1350 mg/day) days 15–21; 600 mg three times daily (1800 mg/day) day 22 and ongoing.

Quantity limit: 10 bottles per 30 days.

Initial coverage note: Authorization may be delayed if dosing schedule, length of therapy, diagnosis, weight, or other required fields are incomplete; supporting documentation must be provided.

Reauthorization Requirements

Reauthorization

Reauthorization requires demonstration of benefit and absence of unacceptable toxicity.

Reauthorization: Member has decreased and stabilized seizure frequency compared to baseline (submit chart notes demonstrating response).

Reauthorization: Member has no unacceptable toxicity from therapy (examples include somnolence, pyrexia, suicidal thoughts or behavior).

Reauthorization: Member continues to meet the initial authorization criteria (see Initial Therapy).

Duration: 12 months

Diagnosis, Dosing, and Code Fields

Diagnosis codes (form field)ICD-10

ICD code if applicable

Documented diagnosis ICD code field on form

inv-05: Weight-based dosing thresholds

ThresholdsMembers weighing 28 kg or less vs more than 28 kg (weight determines dosing schedule and maximum total daily doses)

<= 28 kg dosing summaryTitration by weight with specified mg/kg 3x daily: Days 1–7: 6 mg/kg 3x daily (18 mg/kg/day); Days 8–14: 11 mg/kg 3x daily (33 mg/kg/day); Days 15–21: 16 mg/kg 3x daily (48 mg/kg/day); Day 22 and ongoing: 21 mg/kg 3x daily (63 mg/kg/day)

> 28 kg dosing summaryFixed-dose titration: Days 1–7: 150 mg 3x daily (450 mg/day); Days 8–14: 300 mg 3x daily (900 mg/day); Days 15–21: 450 mg 3x daily (1350 mg/day); Day 22 and ongoing: 600 mg 3x daily (1800 mg/day)

Provider Submission Requirements & Actions

Prior Authorization

Prior Authorization Required

Prior authorization required for Ztalmy (ganaxolone). A completed, signed prior authorization/step-edit request form must be faxed to the payer at 1-305-671-0200 with all required clinical information. The prescribing physician must sign and clearly print name (preprinted stamps not valid). All other information may be filled in by office staff. If the information provided is not complete, correct, or legible, the authorization process can be delayed or denied.

Fax: 1-305-671-0200
Prescriber signature required (no preprinted stamps)

Step Therapy

Step Therapy / Prior Treatment Requirement

Step therapy / prior treatment requirement: Member must be refractory to at least two antiepileptic drugs. Refractoriness should be verified by chart notes or pharmacy paid claims (examples include clobazam, levetiracetam, topiramate, valproate).

Must be refractory to ≥ 2 antiepileptic drugs — document via chart notes or pharmacy paid claims
Examples: clobazam, levetiracetam, topiramate, valproate

Documentation Required

Required Submission Information & Supporting Documentation

Required submission information and supporting documentation: Prescriber must sign and print name. Submit member and prescriber details, drug form/strength, dosing schedule, length of therapy, diagnosis and ICD code if applicable, weight and date, planned quantity/days of therapy, and expected length of therapy. For initial authorization submit documentation of genetic testing confirming CDKL5 deficiency disorder, and supporting chart notes, labs, and diagnostics. For reauthorization submit chart notes demonstrating clinical response (reduction and stabilization of seizure frequency) and absence of unacceptable toxicity. Use of samples to initiate therapy does not meet criteria.

Member details: name, AvMed #, DOB
Prescriber details: name, signature, date, office contact, phone, fax, DEA or NPI
Drug details: form/strength, dosing schedule, length of therapy, quantity limit (10 bottles/30 days)
Clinical docs: genetic testing for CDKL5, chart notes, labs/diagnostics, prior therapy verification, seizure frequency baseline and follow-up
Reauthorization: evidence of positive response and tolerability

Denial Risk

Incomplete Information or Missing Documentation

Incomplete, incorrect, or illegible information can delay the authorization process or result in denial. Lack of required supporting documentation (e.g., genetic testing, chart notes, lab results, or evidence of prior therapies) may cause denial. Ensure all applicable criteria are checked and supported on the request — missing items will jeopardize approval.

Incomplete/illegible forms may delay or cause denial
Missing supporting documentation (genetic test, chart notes, prior therapy evidence) may result in denial
All applicable checklist criteria must be checked and supported

Requirement	Details
Prior antiepileptic drug trials	Member must be refractory to at least TWO antiepileptic drugs (e.g., clobazam, levetiracetam, topiramate, valproate) verified by chart notes or pharmacy paid claims
Step therapy requirement summary	Prior trials of at least two antiepileptic drugs required before approval

Background and Indication

Ztalmy (ganaxolone) is indicated for treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) when diagnosis is confirmed by genetic testing. The medication is covered under this policy with specific requirements: it must be prescribed by or in consultation with a neurologist, the member must be 2 years of age or older, and genetic documentation of CDD must be provided. Initial authorization is for 6 months, and reauthorization for responders is for 12 months provided the member demonstrates reduced and stabilized seizure frequency and absence of unacceptable toxicity.

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