Cobenfy – NC Standard Criteria

Restricted Product(s):

• Cobenfy (xanomeline and trospium chloride)

FDA Approved Use:

• Treatment of schizophrenia in adults

Criteria for Approval of Restricted Product(s):

1. The patient is 18 years of age or older; AND
2. The patient has a diagnosis of schizophrenia; AND
3. The patient has tried TWO unrestricted atypical antipsychotics, one of which must be aripiprazole, lurasidone, or ziprasidone, and had an inadequate response or intolerance; OR
   1. The patient has an FDA labeled contraindication to all atypical antipsychotics; OR
   2. The patient is at risk for metabolic syndrome (i.e., pre-existing obesity, diabetes, hyperlipidemia, etc.); AND
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval:

365 days

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria:

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval:

365 days

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

October 2024: Original utilization management policy issued.