VIMPAT, Lacosamide Form

Lacosamide (Motpoly XR, Vimpat®) is an anticonvulsant. FDA Approved Indication(s) Motpoly XR is indicated for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg. Vimpat is indicated: • For the treatment of partial-onset seizures in patients 1 month of age and older. • As adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Motpoly XR and Vimpat are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Partial-Onset Seizures (must meet all):

1. Diagnosis of partial-onset seizures;
2. For Vimpat: Age ≥ 1 month;
3. For Motpoly XR: Weight ≥ 50 kg;

4. 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. All the following (i, ii, and iii) i. Failure of two preferred alternatives (see Appendix B for examples), unless clinically significant adverse effects are experienced or all are contraindicated; ii. If request is for brand Vimpat, member must use generic lacosamide, unless contraindicated or clinically significant adverse effects are experienced; iii. If request is for Motpoly XR, member must use generic immediate-release lacosamide (generic Vimpat), at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; Page 1 of 8

   CLINICAL POLICY Lacosamide

   5. If request is for intravenous (IV) Vimpat, oral Vimpat administration is temporarily not feasible (e.g., status epilepticus, reliance on gastrostomy tube, recent oral or neck surgery, esophageal condition or intraoral infection, myasthenia gravis or other neuromuscular condition);
   6. Dose does not exceed any of the following (a or b): a. Age ≥ 17 years (i and ii):
      i. 400 mg per day; ii. One of the following (1 or 2): 1) 2 tablets or capsules per day; 2) 40 mL per day; b. Age 1 month to < 17 years (i, ii, iii, or iv):
      i. Weight ≥ 50 kg: 400 mg per day; ii. Weight 30 kg to < 50 kg: 8 mg/kg per day; iii. Weight 6 kg to < 30 kg: 12 mg/kg per day; iv. Weight < 6 kg: 15 mg/kg per day. Approval duration: 12 months (oral formulation); 1 month (IV formulation)
      B. Primary Generalized Tonic-Clonic Seizures (must meet all):
5. Diagnosis of primary generalized tonic-clonic seizures;
6. Request is for Vimpat;
7. Age ≥ 4 years;
8. 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 two preferred alternatives (see Appendix B for examples), unless clinically significant adverse effects are experienced or all are contraindicated;
   ii. If request is for brand Vimpat, member must use generic lacosamide, unless contraindicated or clinically significant adverse effects are experienced;
   5. If request is for intravenous (IV) Vimpat, oral Vimpat administration is temporarily not feasible (e.g., status epilepticus, reliance on gastrostomy tube, recent oral or neck surgery, esophageal condition or intraoral infection, myasthenia gravis or other neuromuscular condition);
   6. Vimpat will be used as adjunctive therapy;

9. Dose does not exceed any of the following (a or b): a. Age ≥ 17 years (i and ii):
   i. 400 mg per day; ii. One of the following (1 or 2): 1) 2 tablets per day; 2) 40 mL per day; b. Age 4 to < 17 years (i, ii, or iii):
   i. Weight ≥ 50 kg: 400 mg per day; ii. Weight 30 kg to < 50 kg: 8 mg/kg per day; iii. Weight 11 kg to < 30 kg: 12 mg/kg per day. Approval duration: 12 months (oral formulation); 1 month (IV formulation) Page 2 of 8

   CLINICAL POLICY Lacosamide 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.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.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.PMN.53 for Medicaid.
      II. Continued Therapy A. All Indications in Section I (must meet all):
   3. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Motpoly XR or Vimpat for seizures and has received this medication for at least 30 days;
   4. Member is responding positively to therapy;

10. If request is for brand Vimpat, member must use generic lacosamide, unless contraindicated or clinically significant adverse effects are experienced;

    4. If request is for intravenous (IV) Vimpat, oral Vimpat administration is temporarily not feasible (e.g., status epilepticus, reliance on gastrostomy tube, recent oral or neck surgery, esophageal condition or intraoral infection, myasthenia gravis or other neuromuscular condition);
    5. If request is for a dose increase, new dose does not exceed any of the following (a or b): a. Age ≥ 17 years (i and ii):
       i. 400 mg per day; ii. One of the following (1 or 2): 1) 2 tablets or capsules per day; 2) 40 mL per day; b. Age 1 month to < 17 years (i, ii, iii, or iv):
       i. Weight ≥ 50 kg: 400 mg per day; ii. Weight 30 kg to < 50 kg: 8 mg/kg per day; iii. Weight 6 kg to < 30 kg: 12 mg/kg per day; iv. Weight < 6 kg: 15 mg/kg per day. Approval duration: 12 months (oral formulation); 1 month (IV formulation) B. 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): Page 3 of 8

    CLINICAL POLICY Lacosamide 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.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.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.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.PMN.53 for Medicaid or evidence of coverage documents.
       IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration IV: intravenous 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 Class Examples 45 to 400 mg per day based on age and indication Dose Limit/ Maximum Dose 45 to 400 mg/day based on age and indication lacosamide, immediate- release (generic for Vimpat®) Anticonvulsants for partial seizures Anticonvulsants for tonic-clonic seizures carbamazepine (Tegretol®), felbamate (Felbatol®), gabapentin (Neurontin®), lamotrigine (Lamictal®), levetiracetam (Keppra®), oxcarbazepine (Trileptal®), phenytoin (Dilantin®), tiagabine (Gabitril®), topiramate (Topamax®), valproic acid (Depakene®), divalproex sodium (Depakote®), zonisamide (Zonegran®) carbamazepine (Tegretol®), lamotrigine (Lamictal®), levetiracetam (Keppra®), phenytoin (Dilantin®), primidone (Mysoline®), topiramate (Topamax®), valproic acid (Depakene®), divalproex sodium (Depakote®) Varies according to the agent used Varies according to the agent used 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. Page 4 of 8

    CLINICAL POLICY Lacosamide Appendix C: Contraindications / Boxed Warnings 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, unless all are contraindicated or clinically significant adverse effects are experienced: generic lacosamide or preferred alternative (see Appendix B for examples). V. Dosage and Administration
    Drug Name Immediate-release lacosamide (Vimpat) Indication Partial-onset seizures, primary generalized tonic- clonic seizures Extended-release lacosamide (Motpoly XR) Partial-onset seizures Maximum Dose Adults (17 years and older): 400 mg/day
    Pediatric patients 4 Years to less than 17 years: ≥ 50 kg: 400 mg/day 30 kg to < 50 kg: 8 mg/kg/day 6 kg to < 30 kg: 12 mg/kg/day < 6 kg: 15 mg/kg/day Adults (17 years and older): 400 mg/day
    Pediatric patients weighing ≥ 50 kg: 400 mg/day Dosing Regimen Adults (17 years and older): Initial dosage for monotherapy is 100 mg PO or IV BID; Initial dosage for adjunctive therapy is 50 mg PO or IV BID.
    Pediatric patients 1 month old to < 17 years old: The recommended dosage is based on body weight and is administered PO BID or IV TID. Adults (17 years and older): Initial dosage for monotherapy is 200 mg PO or IV QD; Initial dosage for adjunctive therapy is 100 mg PO or IV QD.
    Pediatric patients weighing ≥ 50 kg: Initial dosage is 100 mg PO or IV QD. Page 5 of 8

    CLINICAL POLICY Lacosamide VI. Product Availability
    Drug Name Immediate-release lacosamide (Vimpat) Extended-release lacosamide (Motpoly XR) Availability • Tablets: 50 mg, 100 mg, 150 mg, 200 mg
    • Oral solution: 10 mg/mL (200 mL) • Single-dose vial for intravenous use: 200 mg/20 mL
    Capsules: 100 mg, 150 mg, 200 mg
    VII.