Cobenfy (xanomeline/trospium) — Coverage and Authorization Criteria for Schizophrenia
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Defines coverage and authorization criteria for Cobenfy (xanomeline/trospium) for treatment of schizophrenia in adult members when contract benefits permit.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Initial Therapy (Schizophrenia)
Covered when ALL of the following are met:
Authorization of 12 months may be granted.
Authorization of 12 months may be granted.
Continuation Therapy
Continuation / maintenance coverage:
Authorization of 12 months may be granted.
Authorization of 12 months may be granted.
Cobenfy (xanomeline/trospium) is not medically necessary for members who do not meet the criteria specified elsewhere in this policy.
Use of Cobenfy is not medically necessary when the patient does not meet the policy's authorization criteria.
Procedures, Codes and Quantity Limits
| No codes listed |
Prior Authorization, Step Therapy, and Provider Requirements
Prior authorization required — schizophrenia (12‑month authorization possible)
Authorization of up to 12 months may be granted for adults (≥18 years) with a diagnosis of schizophrenia who meet the policy criteria; continuation/maintenance authorization may be granted for adult patients who achieve or maintain a positive clinical response, and continuation is allowed if medication was initiated in the inpatient setting.
- Authorization duration: 12 months for eligible adults (≥18 years).
- Continuation allowed when medication initiated inpatient or when patient maintains a positive clinical response.
Step therapy — no explicit steps required in this policy
The policy states coverage intent is consistent with FDA labeling and evidence‑based guidelines; the document does not impose additional explicit step therapy sequencing requirements for Cobenfy.
- Follow FDA‑approved prescribing and evidence‑based guidelines when selecting therapy.
- No specific prerequisite medications or step edits are specified in this policy.
Benefit verification required prior to authorization
Verify individual member benefits and applicable contract language before requesting authorization; benefits may vary by contract and exclusions, limitations, or exceptions may apply.
- Confirm the member has pharmacy/medical benefits that cover Cobenfy and that no contract exclusions apply.
- Wellmark will determine medical necessity only if the benefit exists for the member; this policy may not apply to FEP.
Not medically necessary if authorization criteria are not met
Use of Cobenfy is considered not medically necessary when the patient does not meet the policy's authorization criteria (e.g., age <18 years or no diagnosis of schizophrenia); requests not meeting criteria may be denied.
- Do not submit authorization requests for patients younger than 18 for schizophrenia treatment under this policy.
- Requests lacking a schizophrenia diagnosis or other required criteria risk denial as not medically necessary.
Background and Context
Cobenfy (xanomeline/trospium) is a muscarinic agonist indicated for the treatment of schizophrenia in adults. This policy aligns coverage with the FDA‑approved indication and specifies authorization criteria for adults (≥18 years) diagnosed with schizophrenia; when those criteria are not met, coverage is considered not medically necessary.
Drug and Term Definitions
Site-of-Care and Continuity Considerations
Pharmacotherapy
Pharmacotherapy (Cobenfy)
Quantity limits apply: standard limit = 60 capsules per 30 days per listed strength; starter pack limit = 1 pack (56 capsules) per 28 days.
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