CurrentMass General Brigham Health PlanPolicy N/A

Cobenfy (xanomeline/trospium) prior authorization for schizophrenia

Defines prior authorization requirements for coverage of Cobenfy (xanomeline/trospium chloride) for adults with schizophrenia under the Commercial/Exchange pharmacy benefit.

Policy Summary

PayerMass General Brigham Health Plan

PolicyCobenfy (xanomeline/trospium) prior authorization for schizophrenia

Policy CodePolicy N/A

Change TypeAdministrative — no material clinical changes

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis of schizophrenia plus required trial history or stabilization on Cobenfy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization duration

2 caps/dayquantity limit

2 agentsrequired trials

Commercial/Exchangeapplicable plan

Coverage Criteria for Cobenfy (xanomeline/trospium)

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Initial authorization

Pathway a
- Diagnosis of schizophrenia
- Prior antipsychotic trials: Trial and failure, contraindication, or intolerance to two of the following oral formulations: aripiprazole, asenapine, olanzapine, paliperidone, quetiapine IR/ER, risperidone, ziprasidone2 agents
Pathway b: Member has been started and stabilized on the requested medication
Samples are not considered adequate justification

Members who are new to the plan within the past 90 days may be eligible for authorization only if they are currently receiving treatment with the requested medication. Coverage does not consider medication obtained as samples or supplied through a manufacturer patient assistance program to qualify as current treatment.

Provider Actions, Documentation, and Authorization Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cobenfy under the pharmacy benefit for Commercial/Exchange members.

Prior Authorization required for Commercial/Exchange pharmacy benefit
Contact Pharmacy Benefit: Phone 800-711-4555, Fax 844-403-1029

Step Therapy

No Step Therapy Program

No step therapy program applies to this policy. The policy uses specific trial requirements for new starts instead (see clinical criteria).

Step therapy: none — specific trial requirements used for new starts

Documentation Required

Required Clinical Documentation

Documentation must include a diagnosis of schizophrenia and evidence of trials, failures, contraindications, or intolerance to required agents for new starts. For continuation requests, documentation of positive response to therapy is required. Samples and manufacturer's patient assistance program supplies do not count as evidence of current therapy for new-to-plan members.

Required documentation: diagnosis of schizophrenia
Required documentation: evidence of trial and failure, contraindication, or intolerance to two specified oral antipsychotics for new starts
Continuation documentation: positive response to therapy
Samples/manufacturer assistance do not qualify as 'currently receiving' for new-to-plan rule

Denial Risk

Denial-risk Conditions

Requests for new starts that do not document a diagnosis of schizophrenia or do not document trials, contraindications, or intolerance to the required oral antipsychotics (per initial criteria) are at risk for denial.

Denial risk if request lacks required diagnosis of schizophrenia
Denial risk if request lacks documented trials/failures/contraindications/intolerance for new starts

Note

New-to-Plan Member Rule

Members new to the plan within the past 90 days who are not currently receiving the requested medication (excluding samples or manufacturer assistance) may not be eligible for coverage under the new-to-plan rule.

New-to-plan rule: applies to members enrolled ≤ 90 days
Exclusion: samples and manufacturer patient assistance do not count as current therapy

Definitions and Key Terms

Cobenfy (xanomeline/trospium) — description and indication

Drug compositionFixed combination of a muscarinic agonist (xanomeline) and a muscarinic antagonist (trospium)

IndicationTreatment of schizophrenia in adults

Formulation noteMarketed as Cobenfy (xanomeline/trospium chloride)

Positive response to therapy — definition and references

Definition in policyPositive response to therapy is not explicitly defined in the policy

Assessment tools referencedPolicy references clinical scales such as the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impressions (CGI) for assessing response

Supporting literatureReferences include validation and linking studies for PANSS and CGI and clinical trial publications assessing xanomeline–trospium

Background

Cobenfy (xanomeline/trospium) is a fixed combination therapy composed of a muscarinic receptor agonist (xanomeline) with a peripheral muscarinic antagonist (trospium). It is indicated for the treatment of schizophrenia in adults, and the policy’s initial authorization pathway requires either a documented diagnosis of schizophrenia with trials of two specified oral antipsychotics or documentation that the member was started and stabilized on Cobenfy (with samples explicitly not considered adequate justification).