CurrentUnitedHealthcarePolicy N/A

Cobenfy (xanomeline and trospium chloride) prior authorization

Defines UnitedHealthcare prior authorization and medical necessity requirements for coverage of Cobenfy for treatment of schizophrenia, affecting providers requesting initial or continuation coverage for members in North Carolina.

Policy Summary

PayerUnitedHealthcare

PolicyCobenfy prior authorization for schizophrenia

Policy CodePolicy N/A

Change TypeNew policy

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis plus three prior atypical antipsychotic trials or meet specified exceptions.

SourceLink

POLICY UPDATE CHANGES

New program established for Cobenfy requiring prior authorization.

3required prior antipsychotic trials

12 monthsauthorization duration (initial/reauthorization)

120 daysnew-to-plan stabilization window

3 monthsinpatient-initiation window

Schizophreniaindication covered

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Coverage Criteria for Cobenfy

inv-01: Initial Authorization

Covered when ONE of the following is met:

Initial Authorization Option A: Diagnosis of schizophrenia AND history of failure, contraindication, or intolerance to three of the following antipsychotics: aripiprazole; olanzapine; quetiapine IR or ER; risperidone; ziprasidone (please document drug, date and duration of each trial)3 drugs

Document drug, date and duration of trial

Initial Authorization Option B: Treatment with Cobenfy was initiated during a behavioral inpatient admission with discharge within the past 3 months and the member is currently stable on therapy (please document date of discharge)<= 3 months since discharge

Inpatient-initiation exception

Initial Authorization Option C: Member is new to the plan and currently stabilized on Cobenfy as evidenced by coverage effective date less than or equal to 120 days (please document coverage effective date)<= 120 days since coverage effective date

New-to-plan stability exception

inv-02: Reauthorization / Continuation

Covered when ALL of the following are met:

Reauthorization: Documentation of a positive clinical response to therapypositive response

Authorization will be issued for 12 months

Coverage criteria may be influenced by state mandates, applicable federal regulatory requirements, and the member’s specific benefit plan terms. Additionally, other UnitedHealthcare policies and utilization management programs may apply and affect coverage decisions for Cobenfy.

Initial Therapy

inv-10: Initial Therapy

Initial approval conditions

Primary initial approval: Diagnosis of schizophrenia AND documented history of failure, contraindication, or intolerance to three of the following atypical antipsychotics: aripiprazole; olanzapine; quetiapine IR or ER; risperidone; ziprasidone (please document drug, date and duration of each trial)3 prior antipsychotic trials

Document drug, date and duration of each trial

Inpatient-initiation exception: Treatment with Cobenfy was initiated during a behavioral inpatient admission with discharge within the past 3 months and the member is currently stable on therapy (please document date of discharge)<= 3 months since discharge

Inpatient-initiation exception

Continuation of Therapy

inv-11: Continuation of Therapy

Reauthorization criteria

Continuation of Therapy: Documentation of a positive clinical response to Cobenfypositive response

Reauthorization/continuation approvals issued for 12 months

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cobenfy (xanomeline and trospium chloride). Initial approvals are granted for up to 12 months when criteria are met.

Step Therapy

Step Therapy Requirement

Member must have a documented history of failure, contraindication, or intolerance to three listed atypical antipsychotics prior to initial approval. Acceptable agents include aripiprazole, olanzapine, quetiapine IR or ER, risperidone, and ziprasidone.

aripiprazole (generic Abilify)
olanzapine (generic Zyprexa)
quetiapine IR or ER (generic Seroquel or Seroquel XR)
risperidone (generic Risperdal)
ziprasidone (generic Geodon)

Step Therapy Requirements

Prior trial requirement	Drugs (examples)	Notes
Required prior trials before initial coverage (step therapy)	Aripiprazole; Olanzapine; Quetiapine IR or ER; Risperidone; Ziprasidone	Member must have history of failure, contraindication, or intolerance to three of the listed atypical antipsychotics; document drug name, dates, and duration of each trial.

Background

Cobenfy (xanomeline and trospium chloride) is FDA-approved for the treatment of schizophrenia. This policy requires demonstration of prior antipsychotic therapy before initial approval: unless an exception applies, the member must have a documented history of failure, contraindication, or intolerance to three atypical antipsychotics (document drug name, dates and duration of each trial).

Prior authorization is required for Cobenfy; when criteria are met, initial and reauthorization approvals are issued for up to 12 months. The policy includes exceptions to the step-therapy requirement for members who were initiated on Cobenfy during a recent behavioral inpatient admission (discharge within the past 3 months) or members new to the plan who are stabilized on therapy within 120 days of coverage effective date.

Definitions

Cobenfy definition

DefinitionCobenfy: the FDA‑approved medication for treatment of schizophrenia (xanomeline and trospium chloride).

Active ingredient(s)Xanomeline and trospium chloride

IndicationTreatment of schizophrenia (FDA‑approved)

Prior therapy expectationPolicy requires trial of three atypical antipsychotics before coverage unless exception applies