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
Renewal criteria
- 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
Quantity limits
- 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
Questions?
MHCP Provider Call Center (651) 431-2700 or 1-800-366-5411