Trokendi XR – Qudexy XR - NC Standard

Restricted Product(s)

Restriction applies to brand and generic products

• Qudexy XR® (topiramate er)
• Trokendi XR® (topiramate er)

FDA Approved Use

• Trokendi XR 
  • For initial monotherapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures or adjunctive therapy in patients 6 years of age and older with partial onset, primary generalized tonic-clonic seizures. 
  • For adjunctive therapy in patients 6 years of age or older with seizures associated with Lennox-Gastaut syndrome (LGS). 
  • For prophylaxis of migraine in patients 12 years of age and older. 
• Qudexy XR 
  • For initial monotherapy in patients 2 years and older with partial onset or primary generalized tonic-clonic seizures and adjunctive therapy in patients 2 years and older with partial onset or primary generalized tonic-clonic seizures 
  • For adjunctive therapy in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome 
  • For prophylaxis of migraine headache in adults and adolescents 12 years of age and older.

Criteria for Approval of Restricted Product(s)

1. The patient is/will be using the requested medication for seizure control; OR 
2. The patient is/will be using the requested medication for migraine prophylaxis; AND 
   1. Patients utilizing the Essential Formulary: 
      1. have tried and failed or have a contraindication to immediate release topiramate; AND 
      2. have tried and failed or have a clinical contraindication to ONE of the following: 
         1. Beta-blocker therapy 
         2. Amitriptyline 
         3. Divalproex sodium/ sodium valproate; AND 
3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Ailani J, Burch RC, Robbins MS, Board of Directors of the American Headache Society. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. 2021;61(7):1021-39.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

May 2024: Criteria update: Annual criteria review. Updated references.

Jan 2023: Criteria update: Added generic Trokendi XR (Topiramate ER) to the policy. Decreased duration of approval to one year.

Feb 2021: Criteria update: Added generic Qudexy XR (Topiramate ER) to the policy. Authorized generic has switched to a true generic.

Nov 2020: Criteria update: Annual criteria review. No changes to policy

Oct 2018: Original utilization management criteria issued.