CurrentColorado Rocky Mountain Health PlansPolicy N/A

Cobenfy (xanomeline and trospium chloride) prior authorization

Defines prior authorization and medical necessity criteria for coverage of Cobenfy for members, including initial and reauthorization requirements, for Colorado Rocky Mountain Health Plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyCobenfy (xanomeline and trospium chloride) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 1, 2026

Next Review DateMar 1, 2026

Key ActionObtain prior authorization and document diagnosis plus trials of three specified atypical antipsychotics (drug name, date, duration) unless inpatient-initiation or new-to-plan exceptions apply.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3required atypical antipsychotics trials

12 moauthorization period

3 moinpatient discharge window

≤120 dnew-to-plan window

Definitions

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Coverage criteria overview

Continuation Therapy / Reauthorization

Reauthorization will be approved for continuation of therapy when the following is met:

Reauthorization: Documentation of a positive clinical response to therapy.

Authorization will be issued for 12 months.

Coverage of Cobenfy is subject to state mandates and the member’s specific benefit plan. Any applicable federal regulatory requirements and the member’s benefit design may modify or limit coverage determinations. Additionally, other plan policies and utilization management programs (for example, prior authorization rules, step therapy requirements, or quantity limits) may apply and should be considered when submitting a request for coverage.

Continuation / Reauthorization Criteria

Reauthorization

Reauthorization requirements and approval period:

Reauthorization requirement: Documentation of a positive clinical response to Cobenfy therapy.

When met, authorization will be issued for 12 months.

Step Therapy Requirements

Required prior trials (document drug, date, duration)	Coverage requirement
{"text":"aripiprazole (Abilify)","status":""}\|{"text":"Member must have documented failure, contraindication, or intolerance to this atypical antipsychotic as one of three required trials before Cobenfy will be approved (document drug, date and duration).","status":""}
{"text":"olanzapine (Zyprexa)","status":""}\|{"text":"Member must have documented failure, contraindication, or intolerance to this atypical antipsychotic as one of three required trials before Cobenfy will be approved (document drug, date and duration).","status":""}
{"text":"quetiapine IR or ER (Seroquel or Seroquel XR)","status":""}\|{"text":"Member must have documented failure, contraindication, or intolerance to this atypical antipsychotic as one of three required trials before Cobenfy will be approved (document drug, date and duration).","status":""}
{"text":"risperidone (Risperdal)","status":""}\|{"text":"Member must have documented failure, contraindication, or intolerance to this atypical antipsychotic as one of three required trials before Cobenfy will be approved (document drug, date and duration).","status":""}
{"text":"ziprasidone (Geodon)","status":""}\|{"text":"Member must have documented failure, contraindication, or intolerance to this atypical antipsychotic as one of three required trials before Cobenfy will be approved (document drug, date and duration).","status":""}
{"text":"Exception: inpatient initiation or new-to-plan stabilized","status":""}\|{"text":"If treatment was initiated during a recent behavioral inpatient admission (discharge within past 3 months) or the member is new to the plan and currently stabilized on Cobenfy, the three‑trial requirement may be waived; document discharge date or plan effective date as applicable.","status":""}

Provider actions and documentation requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial Cobenfy (cariprazine) therapy. Requests must meet the documented diagnosis and prior-trial requirements OR meet one of the allowed exceptions for inpatient initiation or new-to-plan stabilization. Authorization (when approved) will be issued for 12 months.

Prior authorization required before coverage.
Authorization length: 12 months when approved.

Documentation Required

Initial prior authorization criteria

For initial approval, document that the member has a diagnosis of schizophrenia and has a history of failure, contraindication, or intolerance to three listed atypical antipsychotics. Each prior trial must include the drug name, start/end dates (or duration), and reason for failure/intolerance/contraindication.

Required diagnosis: schizophrenia.
Required prior trials: three atypical antipsychotics from the specified list.
For each prior agent, document: drug name, dates or duration of trial, and reason for failure/contraindication/intolerance.

Step Therapy

Step therapy requirement and denial risk

Step therapy requires that the three prior agents be selected from the following atypical antipsychotics. If documentation of trials is incomplete or missing, the request may be denied.

Acceptable agents to document trials: aripiprazole, olanzapine, quetiapine (IR or ER), risperidone, ziprasidone.
Failure to document diagnosis and detailed prior-trial information may result in denial.

Documentation Required

Inpatient initiation documentation

If Cobenfy was initiated during a recent behavioral health inpatient admission, document the inpatient discharge date. The discharge must be within the past 3 months for this inpatient-initiation exception to apply.

Document date of discharge from the behavioral inpatient admission (≤ 3 months).
Member must be currently stable on Cobenfy following discharge.

Documentation Required

New-to-plan stabilization documentation

If the member is new to the plan and already stabilized on Cobenfy, provide proof of plan coverage effective date to demonstrate continuity. The effective date must be within the past 120 days to qualify for the new-to-plan stabilization exception.

Document plan coverage effective date (≤ 120 days) to support new-to-plan stabilization.
Provide any available evidence the member is clinically stable on therapy.

Background

Cobenfy is the brand formulation combining xanomeline and trospium chloride and is FDA‑approved for the treatment of schizophrenia. This policy requires prior authorization for Cobenfy.

Initial coverage is granted when one of three pathways is met: (a) the member has a diagnosis of schizophrenia and a documented history of failure, contraindication, or intolerance to three specified atypical antipsychotics (document drug name, date, and duration of each trial); (b) Cobenfy was started during a recent behavioral inpatient admission with discharge within the past 3 months and the member is currently stable (document discharge date); or (c) the member is new to the plan and is already stabilized on Cobenfy with the plan coverage effective date within ≤120 days.

Reauthorization requires documentation of a positive clinical response and, when approved, authorization is issued for 12 months.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyCobenfy (xanomeline and trospium chloride) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 1, 2026

Next Review DateMar 1, 2026

SourceLink

On This Page

Required prior trials (document drug, date, duration)	Coverage requirement
{"text":"aripiprazole (Abilify)","status":""}\|{"text":"Member must have documented failure, contraindication, or intolerance to this atypical antipsychotic as one of three required trials before Cobenfy will be approved (document drug, date and duration).","status":""}
{"text":"olanzapine (Zyprexa)","status":""}\|{"text":"Member must have documented failure, contraindication, or intolerance to this atypical antipsychotic as one of three required trials before Cobenfy will be approved (document drug, date and duration).","status":""}
{"text":"quetiapine IR or ER (Seroquel or Seroquel XR)","status":""}\|{"text":"Member must have documented failure, contraindication, or intolerance to this atypical antipsychotic as one of three required trials before Cobenfy will be approved (document drug, date and duration).","status":""}
{"text":"risperidone (Risperdal)","status":""}\|{"text":"Member must have documented failure, contraindication, or intolerance to this atypical antipsychotic as one of three required trials before Cobenfy will be approved (document drug, date and duration).","status":""}
{"text":"ziprasidone (Geodon)","status":""}\|{"text":"Member must have documented failure, contraindication, or intolerance to this atypical antipsychotic as one of three required trials before Cobenfy will be approved (document drug, date and duration).","status":""}
{"text":"Exception: inpatient initiation or new-to-plan stabilized","status":""}\|{"text":"If treatment was initiated during a recent behavioral inpatient admission (discharge within past 3 months) or the member is new to the plan and currently stabilized on Cobenfy, the three‑trial requirement may be waived; document discharge date or plan effective date as applicable.","status":""}

OpenPayer

Cobenfy (xanomeline and trospium chloride) prior authorization

Definitions

Coverage criteria overview

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Step Therapy Requirements

Provider actions and documentation requirements

Background