Topiramate Extended-Release (Qudexy XR, Trokendi XR) Form

Topiramate extended-release (Qudexy® XR, Trokendi XR®) is a sulfamate-substituted monosaccharide.
FDA approved indication Qudexy XR is indicated: • As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. • As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic- clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older. • For the preventive treatment of migraine in patients 12 years of age and older. Trokendi XR is indicated: • As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older. • As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic- clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older. • For the preventive treatment of migraine in patients 12 years of age and older. Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria
It is the policy of health plans affiliated with Centene Corporation® that Qudexy XR and Trokendi XR are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Partial-Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox- Gastaut Syndrome (must meet all):

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

   2. Age is one of the following (a or b): a. Qudexy XR: ≥ 2 years; b. Trokendi XR: ≥ 6 years; Page 1 of 8

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   3. Member meets one of the following (a or b): a. Request is for the treatment of a member in a State with limitations on step therapy in certain settings (see Appendix D); b. Both of the following (i and ii): i. Failure of a trial of generic immediate-release topiramate (at up to maximally indicated doses), unless contraindicated or clinically significant adverse effects are experienced; ii. For Qudexy XR and Trokendi XR, member must use generic extended-release topiramate (generic Qudexy) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
   4. Dose does not exceed: a. Monotherapy for adults and pediatric members ≥ 10 years of age: 400 mg per day; b. Monotherapy for members 2 years to ˂ 10 years of age: Weight (kg) Up to 11 12 to 22 23 to 31 32 to 38 Greater than 38 Maximum Daily Dose 250 mg 300 mg 350 mg 350 mg 400 mg c. Adjunctive therapy for members ≥ 17 years of age: 400 mg per day; d. Adjunctive therapy for members ≤ 16 years of age: 9 mg/kg per day up to 400 mg per day. Approval duration:
      HIM/Medicaid – 12 months Commercial – 12 months or duration of request, whichever is less B. Migraine Prophylaxis (must meet all):
   5. Diagnosis of migraine headaches that require prophylaxis;
2. Age ≥ 12 years;

3. Failure of a trial of generic immediate-release topiramate (at up to maximally indicated doses), unless contraindicated or clinically significant adverse effects are experienced;

   4. For Qudexy XR and Trokendi XR, member must use generic extended-release topiramate (generic Qudexy) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
   5. Dose does not exceed 100 mg per day. Approval duration:
      HIM/Medicaid – 12 months Commercial – 12 months or duration of request, whichever is less C. Other diagnoses/indications (must meet 1 or 2):
   6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: Page 2 of 8

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   CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. II. Continued Therapy A. Partial-Onset Seizures, Primary Generalized Seizures, Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome (must meet all):
4. 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;
5. If request is for a dose increase, new dose does not exceed: a. Monotherapy for adults and pediatric members ≥ 10 years of age: 400 mg per day; b. Monotherapy for members 2 years to ˂ 10 years of age: Weight (kg) Up to 11 12 to 22 23 to 31 32 to 38 Greater than 38 Maximum Daily Dose 250 mg 300 mg 350 mg 350 mg 400 mg c. Adjunctive therapy for members ≥ 17 years of age: 400 mg per day; d. Adjunctive therapy for members ≤ 16 years of age: 9 mg/kg per day up to 400 mg per day. Approval duration:
   HIM/Medicaid – 12 months Commercial – 12 months or duration of request, whichever is less B. Migraine Prophylaxis (must meet all):
   1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
6. Member is responding positively to therapy;

7. Failure of a trial of generic immediate-release topiramate (at up to maximally indicated doses), unless contraindicated or clinically significant adverse effects are experienced; Page 3 of 8

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   4. For Qudexy XR and Trokendi XR, member must use generic extended-release topiramate (generic Qudexy) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;

8. If request is for a dose increase, new dose does not exceed 100 mg per day. Approval duration:
   HIM/Medicaid – 12 months Commercial – 12 months or duration of request, whichever is less C. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
      Drug Dosing Regimen topiramate, immediate- release (generic for Topamax®) 150 to 400 mg per day based on age and indication Page 4 of 8 Dose Limit/
      Maximum Dose 150 to 400 mg/day based on age and indication

   CLINICAL POLICY
   Topiramate Extended-Release
   Drug Dosing Regimen topiramate, extended- release (generic for Qudexy XR) Seizures Monotherapy Adults and pediatric patients ≥ 10 years of age: 400 mg PO QD Pediatric patients 2 – 9 years of age: 150 mg to 400 mg PO QD Adjunctive therapy Adults (≥ 17 years old): 200 mg to 400 mg PO QD Pediatric patients 2 – 16 years old: 5 mg/kg to 9 mg/kg PO QD Migraine Prophylaxis 100 mg PO QD Dose Limit/
   Maximum Dose Seizures 150 to 400 mg/day based on age and indication Migraine Prophylaxis 100 mg/day Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s):
   o Qudexy XR: none reported o Trokendi XR: recent alcohol use (i.e., within 6 hours prior to and 6 hours after Trokendi XR use) • Boxed warning(s): none reported Appendix D: States with Limitations against Redirections in Certain Settings State Step Therapy Notes Prohibited? No NV Applies to Medicaid requests only Failure of ONE of the following, at up to maximally indicated doses, unless clinically significant adverse effects are experienced or both are contraindicated: generic immediate-release topiramate or generic extended-release topiramate (generic Qudexy). V. Dosage and Administration Drug Name
   Topiramate extended release (Qudexy XR) Indication Dosing Regimen Seizures Monotherapy Adults and pediatric patients ≥ 10 years of age: 400 mg PO QD Maximum Dose Adults and monotherapy for pediatric patients ≥ 2 years old: 400 mg/day Page 5 of 8

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   Drug Name
   Indication Dosing Regimen Pediatric patients 2 – 9 years of age: 150 mg to 400 mg PO QD Adjunctive therapy Adults (≥ 17 years old): 200 mg to 400 mg PO QD Pediatric patients 2 – 16 years old: 5 mg/kg to 9 mg/kg PO QD 25 to 100 mg PO QD Adults: 200 to 400 mg PO QD Pediatric patients 6 years to ˂ 10 years of age monotherapy: 150 mg to 400 mg PO QD Pediatric patients 6 to 16 years of age adjunctive therapy: 5 mg/kg to 9 mg/kg PO QD 25 to 100 mg PO QD Maximum Dose Pediatric patients ≥ 2 years old as adjunctive therapy: 9 mg/kg/day up to 400 mg/day 100 mg/day Adults and monotherapy for pediatric patients ≥ 6 years: 400 mg/day Adjunctive therapy for pediatric patients 6 – 16 years old: 9 mg/kg/day up to 400 mg/day 100 mg/day Availability
   Capsules: 25 mg, 50 mg, 100 mg, 150 mg, 200 mg Capsules: 25 mg, 50 mg, 100 mg, 200 mg Migraine prophylaxis Seizures Topiramate extended release (Trokendi XR) Migraine prophylaxis VI. Product Availability Drug Topiramate extended release (Qudexy XR) Topiramate extended release (Trokendi XR) VII.