Pharmacy Prior Authorization Criteria

Cobenfy (xanomeline and trospium chloride)

Indications for Prior Authorization

Cobenfy (xanomeline and trospium chloride)

• For diagnosis of Schizophrenia
  Indicated for the treatment of adults with schizophrenia.

Criteria

Cobenfy

Step Therapy

Length of Approval: 12 Months [A,2]

• Both of the following:
• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30 day supply), contraindication, or intolerance to two of the following [B,C,1-3]:
• aripiprazole
• asenapine
• clozapine
• olanzapine
• paliperidone
• quetiapine IR/ER
• risperidone
• ziprasidone
OR
• For continuation of prior therapy [A,D,2]

P & T Revisions

2024-11-06, 2024-09-18, 2024-06-05, 2023-12-15, 2023-02-01, 2022-10-21, 2022-08-05, 2022-02-14, 2022-01-31, 2021-11-22, 2021-11-16, 2021-01-19, 2021-01-19, 2020-09-03, 2020-03-18, 2020-01-08

References

1. Cobenfy Prescribing Information. Bristol-Myers Squibb. Princeton, NJ. September 2024.
2. Department of Veterans Affairs (VA)/Department of Defense (DoD) Clinical Practice Guideline for Management of First-Episode Psychosis and Schizophrenia. Version 1.0 – 2023. Available at: https://www.healthquality.va.gov/guidelines/MH/scz/VADoDCPGSchizophreniaCPG_Final_508.pdf. Accessed October 10, 2024.
3. Kaul I, Sawchak S, Walling DP, et al. Efficacy and safety of xanomeline-trospium chloride in schizophrenia. JAMA Psychiatry. 2024;81(8):749-56.

---

End Notes

1. There is insufficient evidence to recommend for or against any specific duration for treatment with an antipsychotic after response or remission of psychosis [2].
2. Antipsychotics are recommended in acute episodes of schizophrenia or first-episode psychosis who have previously responded to antipsychotics. Medication choice is individualized to patient characteristics and medication side effect profiles [2].
3. Patients experiencing an acute exacerbation or relapse of psychotic symptoms with diagnosed schizophrenia could be eligible for inclusion in the pivotal EMERGENT-3 phase 3 trial if they had previously tried other agents, including oral antipsychotics and lithium therapy [1,3].
4. The continued use of an antipsychotic medication for maintenance treatment of schizophrenia to prevent relapse and hospitalization is recommended in patients who have responded to treatment [2].

---

Revision History

• 2024-11-06: New program
• 2024-09-18: Updated indication section, to include Fanapt's indication in bipolar I disorder. No change to criteria.
• 2024-06-05: Annual Review - No criteria changes
• 2023-12-15: Added Optum RX EHB formulary to guideline.
• 2023-02-01: Annual Review - no criteria changes
• 2022-10-21: update guideline
• 2022-08-05: Update Guideline
• 2022-02-14: Annual Review - Separation of Caplyta to address new indication of Bipolar Depression. Addition of diagnosis check within ST criteria.
• 2022-01-31: Annual Review - Separation of Caplyta to address new indication of Bipolar Depression. Addition of diagnosis check within ST criteria.
• 2021-11-22: Removal of Vraylar - ST retired
• 2021-11-16: Addition of Invega Hafyera and Lybalvi
• 2021-01-19: Program Update: Brand Saphris added as target to step therapy
• 2021-01-19: Program Update: added generic Saphris (asenapine) to list of prerequisite drugs
• 2020-09-03: Program Update: update prerequisite drug list to add clozapine, ziprasidone, paliperidone
• 2020-03-18: Annual Review, also added Caplyta as target to guideline
• 2020-01-08: Added Secuado as target to guideline

---