CurrentmhnPolicy CP.PMN.281

Topiramate Extended-Release (Qudexy XR, Trokendi XR)

Criteria and coverage policy for extended-release topiramate formulations (Qudexy XR, Trokendi XR) for seizure disorders and migraine prophylaxis across commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyTopiramate Extended-Release (Qudexy XR, Trokendi XR)

Policy CodePolicy CP.PMN.281

Change TypeGeneric redirection extendedwording clarified

Effective Date09.01.22

Next Review Date

Key ActionSubmit prior authorization with documentation showing member met all listed approval criteria and trials of generic immediate‑release and generic extended‑release topiramate unless contraindicated or intolerant.

SourceLink

POLICY UPDATE CHANGES

Extended the generic redirection requirement to the Continued Therapy section for seizures.

Clarified redirection language from 'failure of' to 'member must use' for generic extended-release topiramate redirection.

Revised 'Failure of a trial' language to template 'Member must use' language.

12 monthsstandard approval duration (HIM/Medicaid)

400 mg/daymax monotherapy/adj adult dose

100 mg/daymigraine dose limit

3lines of business

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Initial Therapy - Seizures

Covered when ALL of the following are met

Initial Approval for Partial-Onset, Primary Generalized Tonic-Clonic, or Lennox-Gastaut: 1. Diagnosis of partial-onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut syndrome; 2. Age meets product-specific criteria: Qudexy XR ≥ 2 years OR Trokendi XR ≥ 6 years; 3. Member meets ONE of the following: (a) Request is for a member in a state with limitations on step therapy in certain settings (see Appendix D); OR (b) BOTH of the following: (i) Member must use generic immediate-release topiramate (at up to maximally indicated doses) unless contraindicated or clinically significant adverse effects are experienced; AND (ii) Member must use generic extended-release topiramate (generic Qudexy XR) at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced; 4. Dose does not exceed product- and age-specific maximums (see thresholds for monotherapy and adjunctive therapy).see thresholds

Approval duration: HIM/Medicaid 12 months; Commercial 12 months or duration of request, whichever is less.

Initial Therapy - Migraine

Covered when ALL of the following are met

Initial Approval for Migraine Prophylaxis: 1. Diagnosis of migraine headaches that require prophylaxis; 2. Age ≥ 12 years; 3. Member must use generic immediate-release topiramate (at up to maximally indicated doses) unless contraindicated or clinically significant adverse effects are experienced; 4. Member must use generic extended-release topiramate (generic Qudexy XR) at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed 100 mg per day.100 mg/day

Approval duration: HIM/Medicaid 12 months; Commercial 12 months or duration of request, whichever is less.

Continuation Therapy - Seizures

Covered when ALL of the following are met

Continued Therapy for Seizures: 1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Qudexy XR or Trokendi XR for a covered indication and has received this medication for at least 30 days; 2. Member is responding positively to therapy; 3. Member must use generic immediate-release topiramate (at up to maximally indicated doses), unless contraindicated or clinically significant adverse effects are experienced; 4. Member must use generic extended-release topiramate (generic Qudexy XR) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced (generic redirection requirement extended to continued therapy for seizures); 5. If request is for a dose increase, the new dose does not exceed product- and age-specific maximums.see thresholds

Approval duration: HIM/Medicaid 12 months; Commercial 12 months or duration of request, whichever is less.

Continuation Therapy - Migraine

Covered when ALL of the following are met

Continued Therapy for Migraine Prophylaxis: 1. Member meets ONE of the following: (a) Currently receiving medication via Centene benefit or member has previously met initial approval criteria; OR (b) Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. Member must use generic immediate-release topiramate (at up to maximally indicated doses), unless contraindicated or clinically significant adverse effects are experienced; 4. Member must use generic extended-release topiramate (generic Qudexy XR) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; 5. If request is for a dose increase, new dose does not exceed 100 mg per day.100 mg/day

Approval duration: HIM/Medicaid 12 months; Commercial 12 months or duration of request, whichever is less.

Coverage conditional on formulary alignment, generic redirection, and state step therapy limitations

Covered when administrative and formulary requirements are met, and when dosing/indication match labeling or approved policy exceptions.

Formulary/Label Alignment: If the drug has undergone a recent FDA label change (within the last 6 months) not yet reflected in this policy, provider must refer to the applicable no coverage criteria or non-formulary policy for the relevant line of business, or to the off-label use policy as specified for coverage determination.

See policies: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53.

Generic redirection for seizures: Members must use generic immediate-release topiramate or generic extended-release topiramate (generic Qudexy XR) prior to approval of brand extended-release products; generic redirection requirement is extended to continued therapy for seizures.

Exceptions allowed for contraindication or clinically significant adverse effects.

State-specific limitation: For Nevada Medicaid, step therapy redirection requires trial/failure of one of the following at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced: generic immediate-release topiramate OR generic extended-release topiramate (generic Qudexy XR).

Requests for uses that are not FDA‑approved and are not addressed in this policy will not be authorized unless the provider supplies sufficient documentation per the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or relevant evidence of coverage documents.

When pursuing coverage for an off‑label indication, the provider must submit clinical evidence demonstrating efficacy and safety consistent with the referenced off‑label use policies. Supporting materials may include office chart notes, diagnostic test results, specialty consultation notes, and peer‑reviewed literature as required by the off‑label policy referenced for the member’s line of business.

Uses for non‑FDA‑approved indications that lack sufficient documentation in accordance with the off‑label use policies may be considered not medically necessary and can be denied.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit supporting documentation (e.g., office chart notes, test results, lab data) that the member meets the initial approval criteria. Requests lacking sufficient documentation to demonstrate the criteria are met may be denied.

Prior authorization request must include clinical documentation supporting diagnosis, age, prior trials, and dosing.
Documentation may include office notes, diagnostic testing, medication history, and laboratory results.

Step Therapy

Step Therapy / Generic Redirection Requirement

Member must use generic immediate-release topiramate (at up to maximally indicated doses) unless contraindicated or there are clinically significant adverse effects. For Qudexy XR and Trokendi XR, member must also use generic extended‑release topiramate (generic Qudexy XR) at up to maximally indicated doses unless contraindicated or intolerant. Some states (see Appendix D) have limitations on redirection or step therapy; follow state-specific rules.

Generic immediate‑release topiramate required prior to brand XR products unless contraindicated/intolerant.
Generic extended‑release topiramate (generic Qudexy XR) required for Qudexy XR/Trokendi XR unless contraindicated/intolerant.
See Appendix D for state-specific redirection/step therapy limitations.

Documentation Required

Off‑Label Indications — Documentation Required

Off‑label or non‑FDA indications that are not addressed in this policy may be denied unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy for the line of business.

Off‑label requests must follow off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid).
If the use is not listed in Section III and no recent label change applies, refer to the off‑label policies above for documentation requirements.

Note

Label Changes / Refer to Formulary or Off‑Label Policies

If the drug has undergone a recent label change (within the last 6 months) that is not yet reflected in this policy, refer to the applicable formulary or non‑formulary policies or the off‑label use policy for the relevant line of business to determine coverage and documentation requirements.

Formulary/no coverage policies: CP.CPA.190 (commercial), HIM.PA.33 (marketplace), CP.PMN.255 (Medicaid).
Non‑formulary policies: CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP.PMN.16 (Medicaid).
Off‑label policies: CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid).

Drug Indications and Product Definitions

Qudexy XR indications

Indications (seizures)Initial monotherapy and adjunctive therapy for partial‑onset seizures, primary generalized tonic‑clonic seizures, and seizures associated with Lennox‑Gastaut syndrome in patients 2 years and older

Indication (migraine)Preventive treatment of migraine in patients 12 years of age and older

Age-specific monotherapyQudexy XR monotherapy indicated in patients ≥2 years

Trokendi XR indications

Indication (migraine)Preventive treatment of migraine in patients 12 years of age and older

Age-specific monotherapyTrokendi XR monotherapy indicated in patients ≥6 years

Named extended‑release topiramate products with dosing/regimen and availability

Named productsQudexy XR (extended‑release) — available capsules: 25, 50, 100, 150, 200 mg; Trokendi XR (extended‑release) — available capsules: 25, 50, 100, 200 mg

Qudexy XR dosing/regimen (seizures)Monotherapy adults & pediatrics ≥10 years: 400 mg PO QD; Pediatrics 2–9 years: 150–400 mg PO QD; Adjunctive adults ≥17 years: 200–400 mg PO QD; Pediatrics 2–16 years adjunctive: 5–9 mg/kg PO QD

Trokendi XR dosing/regimen (seizures)Monotherapy adults & pediatrics ≥10 years: 400 mg PO QD; Pediatrics 6–<10 years monotherapy: 150–400 mg PO QD; Adjunctive adults ≥17 years: 200–400 mg PO QD; Pediatrics 6–16 years adjunctive: 5–9 mg/kg PO QD

Migraine dosing (both products)25 to 100 mg PO QD; maximum 100 mg/day

OpenPayer

Topiramate Extended-Release (Qudexy XR, Trokendi XR)

Coverage Criteria

Dosing and Coding Limits

Provider Actions & Requirements

Drug Indications and Product Definitions

Background