The resources you need to prescribe ZTALMY

ZTALMY OneTM Enrollment Form

A form for prescribing ZTALMY and enrolling patients in ZTALMY One

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Sample Letter of Medical Necessity (LMN)

A template letter that can be customized by your office

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Clinical Documentation Reference

This reference can help you provide relevant clinical information in the LMN

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Prescribing ZTALMY

ZTALMY 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.

Logo for the ZTALMY One comprehensive patient support program
ZTALMY One provides resources, support, and education to help your patients throughout treatment.

ZTALMY One helps facilitate access to treatment

After you prescribe ZTALMY, ZTALMY One will provide support throughout the entire access process

Benefits verification

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.

Prior authorization support

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.

Your patient's prescription delivery

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.

ZTALMY One helps make treatment more affordable

ZTALMY One Copay Savings Program

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).

Prescription Support Programs

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).

ZTALMY One provides ongoing support for your patients

Caregivers will receive monthly check-in calls from ZTALMY One to discuss:

  • Any weight changes that may affect their child's dosage
  • Upcoming refills
  • The next delivery of ZTALMY to the patient's home

Resources to support your patient's treatment

For Healthcare Providers

Getting Your Patients Started on ZTALMY

Instructions for prescribing ZTALMY and information on how ZTALMY One works

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Dosage & Titration Reference for ZTALMY

Information on dosing and titrating ZTALMY

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For Caregivers

How to Give ZTALMY

Detailed and illustrated instructions for how to prepare and administer ZTALMY

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Treatment Tracker

A convenient tracker for caregivers to record their child’s dosing and titration

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Getting Started Brochure

Resource to help caregivers learn more about starting ZTALMY and the support services available to them

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Calculate a dose for a
patient starting ZTALMY

DOSING
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Learn about the safety
data
for ZTALMY

SAFETY

IMPORTANT SAFETY INFORMATION AND INDICATION

WARNINGS AND PRECAUTIONS

  • 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.

IMPORTANT SAFETY INFORMATION AND INDICATION

INDICATION AND USAGE

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.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

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.

DRUG INTERACTIONS

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.

USE IN SPECIFIC POPULATIONS

DRUG ABUSE AND DEPENDENCE

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.