CurrentCignaPolicy N/A

Antiseizure Medications - Topiramate Step Therapy Policy

Defines step therapy requirements for coverage of branded and extended-release topiramate products for Cigna-administered health benefit plans; affects prescribers and pharmacists requesting coverage for listed topiramate products.

Policy Summary

PayerCigna

PolicyAntiseizure Medications - Topiramate Step Therapy Policy

Policy CodePolicy N/A

Change TypeAdded Step 2 product

Effective DateN/A

Next Review DateDec 4, 2024

Key ActionDocument evidence that the patient has tried one Step 1 product (generic topiramate tablets or generic sprinkle) before seeking coverage for a Step 2 product.

SourceLink

POLICY UPDATE CHANGES

Topiramate Sprinkle Capsule (branded product) was added to the policy as a Step 2 Product.

Step 1required initial product tier

Step 2products requiring prior Step 1 trial

1 yearapproval duration

NCapplicable state

Coverage Criteria

Policy Summary

PayerCigna

PolicyAntiseizure Medications - Topiramate Step Therapy Policy

Policy CodePolicy N/A

Change TypeAdded Step 2 product

Effective DateN/A

Next Review DateDec 4, 2024

Key ActionDocument evidence that the patient has tried one Step 1 product (generic topiramate tablets or generic sprinkle) before seeking coverage for a Step 2 product.

SourceLink

On This Page

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Provider Actions & Operational Notes

Step Therapy

Step therapy prerequisite for Step 2 products

Step therapy prerequisite for Step 2 products: Step 2 products require documentation of a trial of one Step 1 product prior to approval. If the patient has tried one Step 1 product, a Step 2 product may be approved. All approvals are provided for a 1‑year duration.

Step 1 products: generic topiramate tablets; generic topiramate sprinkle capsules.
Step 2 products: Eprontia; Qudexy XR (brand and generic); Topamax tablets; Topamax Sprinkle Capsules; Topiramate Sprinkle Capsule (branded product); Trokendi XR (brand and generic); Topiramate ER capsules (branded product).

Step Therapy

Step therapy structure

Step therapy structure: Step 1 consists of generic topiramate formulations (tablets and sprinkle capsules). Step 2 includes branded and generic extended‑release and other topiramate formulations listed above. The expected workflow is: confirm trial of one Step 1 product in the medical record or prior-therapy history; if met, process approval for the requested Step 2 product per criteria; if not met, apply Step Therapy criteria for coverage determination at point of service.

Note

Decision context

Decision context: Coverage determinations must consider the terms of the applicable benefit plan document in effect on the date of service, any applicable laws/regulations, relevant collateral materials (including this coverage policy), and the specific facts of the individual case. Medical directors retain clinical judgment and discretion in individual coverage decisions.

Denial Risk

Coverage contingent on step therapy

Coverage contingent on step therapy: If the Step Therapy rule is not met at the point of service for a requested Step 2 product, process the request against the Step Therapy criteria. Requests that do not meet the Step Therapy criteria are considered not medically necessary.

Indications and Limits

Indications and age limits for topiramate formulations

Indication — partial onset & primary generalized tonic-clonic seizuresTopiramate (standard and XR formulations) indicated for initial monotherapy in patients ≥ 2 years of age; Trokendi XR indicated for initial monotherapy in patients ≥ 6 years of age.

Indication — adjunctive therapy for seizuresTopiramate (standard and XR) indicated as adjunctive therapy for partial onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients ≥ 2 years (≥ 6 years for Trokendi XR).

Indication — migraine prophylaxisTopiramate and Trokendi XR indicated for preventive treatment of migraine in patients > 12 years of age.

Product-specific note — Trokendi XR age limitsTrokendi XR (brand and generic) carries higher pediatric age thresholds: monotherapy and adjunctive seizure indications apply from age ≥ 6 years (versus ≥ 2 years for other formulations).

Product-specific note — sprinkle capsulesTopiramate sprinkle capsules (including Topamax sprinkle) may be swallowed whole or administered by sprinkling capsule contents on a small amount of soft food.

Step therapy implicationStep 1 trial (generic topiramate tablets or generic sprinkle capsules) required before coverage of Step 2 topiramate products; approvals provided for 1 year when criteria met.

Background

Topiramate and topiramate extended-release formulations are antiepileptic medications used for seizure disorders and migraine prophylaxis per product labeling. Specific formulations referenced in this policy include immediate-release topiramate (tablets and sprinkle capsules) and extended-release/topiramate XR products.

This policy distinguishes between Step 1 products (generic topiramate tablets and generic topiramate sprinkle capsules) and Step 2 products, which include branded and certain extended-release or other topiramate formulations such as Eprontia, Qudexy XR (brand and generic), Topamax (tablets and sprinkle), branded Topiramate Sprinkle Capsule, Trokendi XR (brand and generic), and branded Topiramate ER capsules.

Step Therapy Details

Requirement	Operational details
Patient must have tried one Step 1 product (generic topiramate tablets or generic topiramate sprinkle capsules)	Evidence of trial of 1 Step 1 product is required before coverage of any Step 2 topiramate product; approvals are provided for 1 year in duration.
If the Step Therapy rule is not met at point of service for a Step 2 product, coverage will be determined by the Step Therapy criteria and use not meeting the criteria is considered not medically necessary.	Step 1 products defined as: generic topiramate tablets or generic topiramate sprinkle capsules. Document the prior trial in the authorization request.

Step 2 product	Rule / notes
Eprontia (topiramate oral solution)	Step 2 product; requires prior trial of one Step 1 product for approval; approvals provided for 1 year.
Qudexy XR (topiramate extended-release capsules) — brand and generic	Included as Step 2; prior Step 1 trial required. Generic versions including authorized generic are listed.
Topamax (topiramate tablets) and Topamax Sprinkle Capsules	Included as Step 2; prior Step 1 trial required before coverage of these branded or generic formulations.
Topiramate Sprinkle Capsule (branded product)	Added to policy as a Step 2 product (selected revision); requires prior trial of one Step 1 product before coverage.
Trokendi XR (topiramate extended-release capsules) — brand and generic	Included as Step 2; prior Step 1 trial required for coverage; approvals provided for 1 year.
Topiramate ER capsules (branded product)	Listed as a Step 2 product; requires documentation of prior trial of one Step 1 product for approval.

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