ZTALMY OneTM Enrollment Form
A form for prescribing ZTALMY and enrolling patients in ZTALMY One
Download PDF



Lina has CDD. She was not taking
ZTALMY at the time of this photo.
Lina has CDD. She was not taking
ZTALMY at the time of this photo.
A form for prescribing ZTALMY and enrolling patients in ZTALMY One
Download PDFA template letter that can be customized by your office
Download PDFThis reference can help you provide relevant clinical information in the LMN
Download PDFZTALMY is supplied through Orsini Specialty Pharmacy by ZTALMY One, a comprehensive support program for you and your patients. Follow these steps to prescribe ZTALMY and enroll your patients in ZTALMY One.
Fill out the ZTALMY One Enrollment Form.
Have your patient's caregiver sign the enrollment form to receive additional resources from ZTALMY One throughout treatment. Your patient's caregiver can sign the form electronically.
Include an LMN with the enrollment form. The Clinical Documentation Reference can help you capture relevant clinical information for the LMN. The LMN can help with prior authorization.
Fax the ZTALMY One Enrollment Form and LMN to 1‑844‑ZTALMY‑F (1‑844‑982‑5693). Download the ZTALMY One fax cover sheet.
What's next? After you submit the enrollment form and LMN, ZTALMY One will send an email to your office confirming that we have everything we need to begin prior authorization.
ZTALMY One will investigate your patient’s benefits, including specific coverage and payer requirements. If there are any issues, such as patient eligibility, a Patient Care Coordinator* will reach out to you within 2 business days to explain what is needed.
ZTALMY One provides prior authorization and appeals support. To help with prior authorization, a Patient Care Coordinator will:
Create a patient key in CoverMyMeds® for each patient and upload all relevant documentation.
Contact you to fill in any outstanding information for the CoverMyMeds® patients key.
Be sure to sign and submit the prior authorization in CoverMyMeds® so that it can be processed.
If a prior authorization does not get approved, ZTALMY One will investigate the reasons for denial or rejection, and provide support for an appeal, including an appeals template if needed.
Download the appeal letter template.
Once your patient's coverage has been determined, ZTALMY One will contact the caregiver to coordinate delivery and discuss any out-of-pocket costs. Please remind caregivers that they must answer or return this call to receive their prescription.
*ZTALMY One Patient Care Coordinators do not provide medical advice or individual patient care.
The ZTALMY One Copay Savings Program helps commercially insured eligible patients pay as low as zero dollars per fill for a ZTALMY prescription*
*Eligible patients may pay as low as $0 per fill for a ZTALMY prescription for a maximum 30-day supply per fill and assistance may be up to a maximum of $25,000 per calendar year. State and federal health care program beneficiaries not eligible even if they elect to be processed as an uninsured (cash-paying) patient. The savings program is not health insurance. Marinus reserves the right to rescind, revoke or amend this offer without notice. Click here for full terms and conditions. For questions, please call ZTALMY One (1‑844‑982‑5691).
If your patient has no insurance, limited insurance, or a gap or delay in coverage, Prescription Support Programs may be able to help with the cost of your patient's prescription.
*Eligible patients may pay as low as $0 per fill for a ZTALMY prescription for a maximum 30-day supply per fill and assistance may be up to a maximum of $25,000 per calendar year. State and federal health care program beneficiaries not eligible even if they elect to be processed as an uninsured (cash-paying) patient. The savings program is not health insurance. Marinus reserves the right to rescind, revoke or amend this offer without notice. Click here for full terms and conditions. For questions, please call ZTALMY One (1‑844‑982‑5691).
Caregivers will receive monthly check-in calls from ZTALMY One to discuss:
Instructions for prescribing ZTALMY and information on how ZTALMY One works
Download PDFDetailed and illustrated instructions for how to prepare and administer ZTALMY
Download PDFA convenient tracker for caregivers to record their child’s dosing and titration
Download PDFResource to help caregivers learn more about starting ZTALMY and the support services available to them
Download PDFSomnolence and Sedation: ZTALMY can cause somnolence and sedation. In a clinical study somnolence and sedation appeared early during treatment and were generally dose related. Other CNS depressants, including opioids, antidepressants, and alcohol, could potentiate these effects. Monitor patients for these effects and advise them not to drive or operate machinery until they have gained sufficient experience on ZTALMY to gauge whether it adversely affects their ability to drive or operate machinery.
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.
Somnolence and Sedation: ZTALMY can cause somnolence and sedation. In a clinical study somnolence and sedation appeared early during treatment and were generally dose related. Other CNS depressants, including opioids, antidepressants, and alcohol, could potentiate these effects. Monitor patients for these effects and advise them not to drive or operate machinery until they have gained sufficient experience on ZTALMY to gauge whether it adversely affects their ability to drive or operate machinery.
Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including ZTALMY, increase the risk of suicidal thoughts or behavior. Monitor patients taking ZTALMY for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior. Advise patients, caregivers, and their families to be alert for these behavioral changes and report behaviors of concern immediately to healthcare providers. When considering ZTALMY, or any other AED, balance the risk of suicidal thoughts or behaviors with the risk of untreated illness. If these symptoms emerge during treatment, consider whether it may be related to the AED or the underlying illness.
Withdrawal of Antiepileptic Drugs: As with most AEDs, withdraw ZTALMY gradually to minimize the risk of increased seizure frequency and status epilepticus. If withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered.
The most common adverse reactions (incidence of at least 5% and at least twice the rate of placebo) were somnolence, pyrexia, salivary hypersecretion, and seasonal allergy.
Cytochrome P450 inducers will decrease ganaxolone exposure. Avoid concomitant use with strong or moderate CYP3A4 inducers; if unavoidable, consider a dosage increase of ZTALMY, but do not exceed the maximum recommended dosage.
Pregnancy: Use caution when ZTALMY is administered to pregnant women as there are no adequate data on the developmental risk associated with use in pregnant women. In animal studies, developmental adverse effects were observed following exposure during organogenesis or throughout gestation and lactation.
Lactation: ZTALMY is excreted in human milk at concentrations resulting in a dose to the breastfed infant of less than 1% maternal dose. The effects of ZTALMY on milk production and the breastfed infant are unknown.
Hepatic Impairment: Monitor patients with hepatic impairment for the incidence of adverse reactions. Patients with hepatic impairment may require a reduced dosage of ZTALMY.
ZTALMY contains ganaxolone, a Schedule V controlled substance (CV). Advise patients of the potential for abuse and dependence. It is recommended that ZTALMY be tapered according to the dosage recommendations unless symptoms warrant immediate discontinuation.
Please see full Prescribing Information.