ZTALMY

Indicated For

CDKL5 deficiency disorder, seizures associated with CDKL5 deficiency disorder

About This Medication

# ZTALMY One Patient Guide: How to Get ZTALMY at Low or No Cost ZTALMY One is a comprehensive patient support program from Marinus Pharmaceuticals, Inc. that helps eligible patients access **ZTALMY (ganaxolone) oral suspension, CV**—a prescription medicine approved to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in people 2 years of age and older[1][4][5]. This guide explains eligibility, application steps, and support options in simple terms to help you or your loved one start treatment affordably. ## About ZTALMY **ZTALMY** is a neuroactive steroid that works as a GABAA receptor modulator to help reduce seizures in patients with CDD, a rare genetic disorder caused by mutations in the CDKL5 gene[4][5][10]. It's taken as an oral suspension, with dosing based on weight: up to 63 mg/kg/day for patients ≤28 kg, or 1,800 mg/day for those >28 kg[10]. As a Schedule V controlled substance, it requires careful handling due to potential for abuse or dependence[4]. Always follow your healthcare provider's instructions and consult them for medical advice—ZTALMY One coordinators provide support, not medical care[1]. ## Who Qualifies for ZTALMY One? ZTALMY One offers **two main types of financial help**: the Copay Savings Program for commercially insured patients and Prescription Support Programs for those uninsured, underinsured, or with coverage gaps[1][2][4]. Unlike traditional patient assistance programs (PAPs), there are **no strict income limits**—eligibility focuses on insurance status[program details][8]. - **Copay Savings Program**: Commercially insured patients (private insurance) may pay **as low as $0 per fill** for up to a 30-day supply, with a maximum annual benefit of $25,000 per calendar year[1][2][4]. - **Prescription Support**: Help for no insurance, limited coverage, or delays—covers costs for eligible patients[2][4][8]. **Key exclusions**: - Beneficiaries of state/federal programs (e.g., Medicare, Medicaid) are **ineligible** for savings, even if paying cash[1][2][4]. - Must reside in the U.S. or U.S. territories[4]. - Offer not valid for cash-paying patients without qualifying support[4]. ## Income Eligibility Breakdown ZTALMY One does **not** use Federal Poverty Level (FPL) thresholds or household size limits like many PAPs. Instead: | Eligibility Type | Requirements | Annual Benefit Limit | Notes | |------------------|--------------|----------------------|-------| | **Commercial Insurance (Copay Savings)** | Valid private prescription; U.S. resident | Up to $25,000/calendar year; $0 copay max 30-day fills | Medicare/Medicaid excluded[1][2][4] | | **Uninsured/Underinsured** | No/few coverage; prescription support applies | Varies; Terms & Conditions | Gap/delay coverage[2][8] | | **Government Insurance** | N/A | Ineligible | Full exclusion[1][4] | Contact ZTALMY One for personalized eligibility (1-844-982-5691)[1]. ## Insurance Requirements - **Commercial only** for copay card: Reduces out-of-pocket to $0 (limits apply)[1][2]. - **Uninsured/limited**: Prescription Support bridges gaps[2][4]. - **Government programs**: No savings; explore other state/federal aid[1][4]. ZTALMY One verifies benefits quickly[1][2]. ## Step-by-Step Application Process ZTALMY One offers **multiple application methods** for ease[program details]. Your doctor starts it: 1. **Get Prescribed**: Neurologist confirms CDD diagnosis, CDKL5 mutation, seizures (e.g., tonic-clonic), and trials of ≥2 other anticonvulsants[10]. Fill ZTALMY One Enrollment Form[2]. 2. **Submit Documents**: Prescription, proof of insurance, enrollment form[program details]. Doctor/HCP handles much of this[2]. 3. **Benefits Check**: ZTALMY One reviews coverage **within 2 business days**; Patient Care Coordinator calls if issues (answer 1-844-982-5691)[1][2]. 4. **Approval & Schedule**: Confirm costs, delivery via **Orsini Specialty Pharmacy**[1][2][3]. 5. **Receive Medication**: Shipped directly; start treatment[1]. Call 1-844-982-5691 for help anytime[1]. ## Timeline and Delivery - **Processing**: **2 business days** for coverage confirmation[1][2][program details]. - **Delivery**: Orsini ships to your door; coordinator schedules[1][3]. Answer calls to avoid delays[1]. - **Refills**: **Reauthorization required**—doctor resubmits proof of benefit (e.g., seizure reduction) every 12 months[10][program details]. ## Alternatives if Denied or Ineligible - **Appeal**: Ask coordinator for reasons; resubmit docs or appeal insurance[1]. - **Other Options**: Check state programs, generic anticonvulsants (e.g., valproic acid), or clinical trials. **No biosimilars** available[program details][10]. Global Access Program for non-U.S. (physician request via Durbin, not free)[7]. RxAssist lists similar aid[8]. Consult HCP for switches. ## Reauthorization and Ongoing Support **Reauthorization** needed: Document clinical response (seizure reduction) annually; dose within limits[10]. ZTALMY One provides education/resources throughout[1][3]. ## Important Disclaimer This guide is for informational purposes only and not a substitute for professional medical/financial advice. Eligibility/programs can change; Marinus/Immedica reserves rights to amend/revoke without notice[1][2][4]. Terms & Conditions apply—call 1-844-982-5691 for full details. Report savings to IRS if required. ZTALMY has risks; discuss with provider[4][5]. Word count: 942.

Program information last verified: March 30, 2026