Xcopri®

Drug - Xcopri® (cenobamate) [SK Life Science]

September 2020

Therapeutic Area - Anticonvulsants

Approval criteria

Patient must be ≥ 18 years of age AND
Patient has a confirmed diagnosis of partial-onset seizures AND
Patient does NOT have familial short QT syndrome AND
Patient does NOT have severe hepatic impairment (Child-Pugh Class C) AND
Prescriber to provide attestation that the recommended dose titration be followed.
Patient has tried and failed THREE or more anti-epileptic drugs which include: gabapentin, lamotrigine, levetiracetam, divalproex sodium, oxcarbazepine, topiramate, valproic acid or carbamazepine OR
Prescriber is a neurologist and patient has tried and failed at least TWO anti-epileptic drugs which include: gabapentin, lamotrigine, levetiracetam, divalproex sodium, oxcarbazepine, topiramate, valproic acid or carbamazepine
Initial approval is for 6 months

Patient continues to meet above criteria AND
Patient has no treatment-limiting adverse effects (e.g., drug reaction with eosinophilia and systemic symptoms (DRESS), suicidal behavior, somnolence, fatigue) AND
Prescriber provides attestation of cenobamate effectiveness (e.g., reduced seizure frequency).
Renewal approval is for 6 months

400 mg/day
Titration Blister Packs: 1 pack/28 days
Maintenance Blister Packs: 1 pack/28 days
When a combination of the two or more Xcopri strengths must be prescribed, the prescriber must provide:
- Attestation that separate prescriptions for two various strengths will be issued AND
- The requested quantity, number of refill(s), and directions for use for each Xcopri strength on the prior authorization request form AND
- Attestation that when patient becomes stabilized on one Xcopri strength, reasonable efforts will be taken to ensure that all other Xcopri strengths will be used up to minimize waste

MHCP Provider Call Center (651) 431-2700 or 1-800-366-5411