Ztalmy GANAXOLONE CDKL5 Deficiency Disorder User Guide
- June 3, 2024
- Ztalmy
Table of Contents
STANDARD COMMERCIAL DRUG FORMULARY
PRIOR AUTHORIZATION GUIDELINES
GANAXOLONE
| Generic | Brand | HICL | GCN | Medi-Span | Exception/Other |
|---|---|---|---|---|---|
| GANAXOLONE | ZTALMY | 47912 | GPI-10 (7260003300) |
GUIDELINES FOR USE
1. Does the patient have a diagnosis of seizures and meet ALL of the following criteria?
- The patient is 2 years of age or older
- The patient’s seizures are associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD)
If yes, approve for 12 months by HICL or GPI-10 with a quantity limit of #36
mL per day.
If no, do not approve.
DENIAL TEXT: *Some terms are already pre-defined in parenthesis. Please
use these definitions if the particular text you need to use does not already
have a definition(s) in it.
Our guideline named GANAXOLONE (Ztalmy) requires the following rule(s) to be
met for approval:
A. You have seizures
B. You are 2 years of age or older
C. Your seizures are associated with cyclin-dependent kinase-like 5 (CDKL5)
deficiency disorder (CDD: a type of genetic disorder)
Your doctor told us [INSERT PT SPECIFIC INFO PROVIDED]. We do not have
information showing you [INSERT UNMET CRITERIA]. This is why your request is
denied. Please work with your doctor to use a different medication or get us
more information if it will allow us to approve this request.
RATIONALE
For further information, please refer to the Prescribing Information and/or
Drug Monograph for Italy.
REFERENCES
Italy [Prescribing Information]. Radnor, PA: Marinus Pharmaceuticals, Inc.;
June 2022.
| Library | Commercial | NSA |
|---|---|---|
| Yes | Yes | No |
Part D Effective: N/A
Commercial Effective: 10/01/22
Created: 08/22
Client Approval: 09/22
P&T Approval: 07/22
Copyright © 2022 MedImpact Healthcare Systems, Inc. All rights reserved. This
document is proprietary to MedImpact.
MedImpact maintains the sole and exclusive ownership, right, title, and
interest in and to this document.