Prior Auth Protocol

FDA Approved Indications:

Qudexy XR
- Partial Onset Seizure and Primary Generalized Tonic-Clonic Seizures - initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures and adjunctive therapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures
- Lennox-Gastaut Syndrome (LGS) - adjunctive therapy in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome

Trokendi XR
- Partial Onset Seizure and Primary Generalized Tonic-Clonic Seizures - initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures and adjunctive therapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures
- Lennox-Gastaut Syndrome (LGS) - adjunctive therapy in patients 6 years of age and older with seizures associated with Lennox-Gastaut syndrome

Health Net Approved Indications and Usage Guidelines:

Diagnosis of partial seizures, primary generalized, tonic-clonic seizures, or Lennox-Gastaut syndrome.

AND

Failure or clinically significant adverse effects to generic immediate release topiramate

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

Qudexy XR and Trokendi XR taken once a day provides steady state plasma levels comparable to immediate release topiramate taken every 12 hours, when administered at the same total 200 mg daily dose.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
topiramate, immediate-release (Topamax^R)	150 to 400 mg/day based on age and indication	150 to 400 mg/day based on age and indication

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Trokendi XR	200 to 400 mg PO QD Pediatric patients 6 years and older: 5 mg/kg to 9 mg/kg PO QD	Length of Benefit
Qudexy XR	200 to 400 mg PO QD Pediatric patients 2 years to less than 10 years monotherapy: 150 mg to 400 mg PO QD Pediatric patients 2 years and older adjunctive therapy: 5 mg/kg to 9 mg/kg PO QD	Length of Benefit

Product Availability:

Qudexy XR extended-release capsules: 25 mg, 50 mg, 100 mg, 150 mg and 200 mg

Trokendi XR extended-release capsules: 25 mg, 50 mg, 100 mg, and 200 mg

References:

Trokendi XR [Prescribing Information] Winchester, KY: Catalent Pharma Solutions; May 2015.
Qudexy XR [Prescribing Information] Maple Grove, MN; Upsher-Smith Laboratories, Inc. March 2015.
Micromedex^R Healthcare Series [Internet database]. Greenwood Village, CO: Thomson Healthcare. Updated periodically. Accessed July 9, 2015.
Clinical Pharmacology Website. Available at: http://clinicalpharmacology-ip.com/. Accessed July 9, 2015.