CurrentCignaPolicy N/A

Antiseizure Medications - Zonisamide Step Therapy Policy

Defines step therapy requirements for coverage of zonisamide products (generic capsules, Zonegran brand capsules, and Zonisade oral suspension) for Cigna-administered health benefit plans. Affects prescribers and pharmacy prior authorization reviewers.

Policy Summary

PayerCigna

PolicyAntiseizure Medications - Zonisamide Step Therapy Policy

Policy CodePolicy N/A

Change TypeAdministrative name change

Effective DateN/A

Next Review DateOct 15, 2025

Key ActionRequire trial of one generic zonisamide capsule (Step 1) before approving a Step 2 product (Zonegran or Zonisade) unless patient cannot swallow solids.

SourceLink

POLICY UPDATE CHANGES

Policy name changed from 'Antiepileptics - Zonisamide Step Therapy' to 'Antiseizure Medications - Zonisamide Step Therapy Policy.'

2step levels

1 yearapproval duration

≥16min patient age

2brand products

Coverage Criteria

Step Therapy Criteria (Initial and Ongoing)

Covered when ALL of the following are met

Step therapy conditions

Step 2 approval pathways
- Pathway A: Prior trial of Step 1: The patient has tried one Step 1 product (generic zonisamide capsules).
- Pathway B: Swallowing impairment exception: The patient cannot swallow or has difficulty swallowing solid oral dosage forms; in this case, Zonisade (oral suspension) is approved.

Ongoing therapy: Coverage continuation follows the same step therapy logic; approvals are issued for up to 1 year and require meeting the Step 2 approval pathway used at initiation (prior trial of Step 1 or documented swallowing impairment).

Policy Summary

PayerCigna

PolicyAntiseizure Medications - Zonisamide Step Therapy Policy

Policy CodePolicy N/A

Change TypeAdministrative name change

Effective DateN/A

Next Review DateOct 15, 2025

Key ActionRequire trial of one generic zonisamide capsule (Step 1) before approving a Step 2 product (Zonegran or Zonisade) unless patient cannot swallow solids.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

This policy requires Step Therapy for zonisamide products. Coverage for Step 2 products (Zonegran and Zonisade) is available only when the Step Therapy criteria are met. If the Step Therapy rule is not met for a Step 2 product at the point of service, coverage will be determined by the Step Therapy criteria. All approvals are provided for 1 year in duration.

Any exception other than the specific Step Therapy criteria described in this policy is considered not medically necessary. The policy states that exceptions are limited to the pathways within the Step Therapy requirements and that other requests that do not meet those criteria will not be approved.

Initial Therapy / Step Requirement

Initial coverage is allowed when the applicable Step requirement below is satisfied.

Initial therapy pathways

Step 1 prerequisite: The patient has tried one Step 1 product: generic zonisamide capsules. Approval of a Step 2 product (Zonegran or Zonisade) requires documentation of that trial.
Swallowing impairment exception: If the patient cannot swallow or has difficulty swallowing solid oral dosage forms, approve Zonisade (zonisamide oral suspension) without requirement for a prior Step 1 trial.

Approval duration: All approvals are provided for 1 year in duration.

Step Therapy Table and Rules

Step	Required action	Swallowing exception / notes	Approval duration
Step 1
Patient must try a generic zonisamide capsule (Step 1) prior to use of Step 2 products.
If patient cannot swallow or has difficulty swallowing solid oral dosage forms, the swallowing exception allows use of Zonisade (oral suspension) instead of meeting Step 1.
Approvals are provided for 1 year.

Provider Action and Documentation Requirements

Step Therapy

Step therapy requirement for zonisamide products

This program requires that patients try Step 1 zonisamide products before coverage of Step 2 products is allowed. If the Step Therapy rule is not met at the point of service for a Step 2 product, coverage will be determined by the step therapy criteria below. All approvals are provided for 1 year in duration.

Step 1: generic zonisamide capsules
Step 2: Zonisade (oral suspension) and Zonegran (brand capsules)
If patient has tried one Step 1 product, approve a Step 2 product
If patient cannot swallow or has difficulty swallowing solid oral dosage forms, approve Zonisade

Documentation Required

Coding and documentation expectations

Requests should include the applicable diagnosis and/or procedure codes and supporting clinical documentation as required by the member's benefit plan. Documentation should demonstrate prior trials of Step 1 products (when applicable), reasons for step therapy failure or intolerance, or clinical justification for immediate use of a Step 2 product (for example, inability to swallow solid oral dosage forms). Coverage determinations will be made in accordance with the terms of the applicable benefit plan and supporting materials.

Include relevant ICD-10 diagnosis code(s) and procedure code(s) where applicable
Provide clinical notes documenting trial(s) of Step 1 product, dates, doses, and reason for discontinuation (e.g., adverse effect, lack of efficacy)
If requesting Zonisade due to swallowing difficulty, include documentation of dysphagia or other swallowing impairment

Denial Risk

Step therapy noncompliance may lead to denial

Failure to meet the Step Therapy rule for a Step 2 product at the point of service may result in denial of coverage.

Denials may occur when there is no documentation of trial and failure/intolerance of a Step 1 product when required
Prior authorization requests lacking required codes or supporting documentation per the benefit plan may be denied

Drug Definitions

Zonisade — product description

ProductZonisade (zonisamide oral suspension)

Strength / Concentration100 mg per 5 mL

Formulation / RouteOral suspension

FlavorStrawberry flavored

Zonegran — product description

ProductZonegran (zonisamide capsules, brand)

Available strengths25 mg and 100 mg capsules

Formulation / RouteOral capsule — swallow whole

Background

Zonisamide products are indicated as adjunctive therapy for the treatment of partial‑onset seizures in adults and pediatric patients aged ≥16 years. Available formulations include generic zonisamide capsules (Step 1), Zonegran brand capsules, and Zonisade oral suspension (Step 2). Zonisade is a 100 mg/5 mL oral suspension and Zonegran capsules are available in 25 mg and 100 mg strengths.