Antipsychotics — Second‑generation antipsychotic pharmacy coverage
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Pharmacy policy defining medical necessity criteria, prior authorization requirements, age and quantity limits, and documentation expectations for oral second‑generation antipsychotic products managed under the pharmacy benefit.
Added coverage criteria for Bysanti (milsaperidone).
Updated criteria for Cobenfy (xanomeline and trospium chloride) to add a quantity limit of 60 capsules per 30 days.
Removed brand clozapine and brand clozapine ODT from the policy as they are no longer on the market.
Coverage Criteria
Brand SGA and product‑specific medical necessity
Brand second‑generation antipsychotics are considered medically necessary when product‑specific trial and other criteria are met.
See individual drug entries for exceptions requiring more trials
Product‑specific requirement
Product‑specific requirement
Product‑specific alternative pathway
Product‑specific requirement and boxed warning regarding dementia‑related psychosis
Product‑specific requirement
Product‑specific requirement
Product restricted to PD psychosis
Use of drugs for conditions not listed in this policy is considered investigational. This policy applies the product‑specific medical necessity criteria and FDA‑approved indications for the antipsychotic agents included; therapies or indications not described here are not covered under these criteria.
Use of medications that do not meet the product‑specific criteria in this policy or that are prescribed for indications not listed in this policy are considered investigational and not medically necessary. Coverage decisions require documentation that the request meets the listed drug‑specific requirements (for example, required prior trials, age limits, dose and quantity limits) or evidence of clinical justification as specified in the individual drug entries.
Provider Actions and Requirements
Obtain prior authorization; approvals up to 12 months
Prior authorization is required for brand second‑generation antipsychotics. When criteria are met, approvals may be issued for up to 12 months.
Document required trials of generic SGAs (1–3 trials depending on product)
Most brand SGAs require documented prior trials of generic second‑generation antipsychotics; the number of required trials varies by product (typically 1, and for some products 2 or 3).
- General requirement: 1 generic SGA trial with inadequate response or intolerance for individuals not previously treated with the requested therapy ([[see citations]]).
- Bysanti (milsaperidone): requires trial of 2 generic SGAs and age ≥18; dose limit 24 mg/day.
- Cobenfy (xanomeline and trospium chloride): requires trial of 3 generic SGAs and age ≥18; additional product‑specific requirements apply.
Provide complete medical record documentation with request
Submit office visit notes that document the diagnosis, relevant history, physical evaluation, and medication history to demonstrate that medical necessity criteria are met.
- Include documentation of inadequate response or intolerance to required generic SGA trials as applicable per product‑specific criteria.
- For product‑specific approvals, include supporting documentation required by the drug entry (e.g., DSM diagnosis for Cobenfy; clinical necessity for Opipza formulation).
Denial risk if required prior trials are not documented
Requests may be denied if records do not document the required number of prior generic SGA trials and inadequate response or intolerance as specified in the product‑specific criteria.
- Failure to document the required trials (e.g., 1 general trial, 2 for Bysanti, 3 for Cobenfy) and associated outcomes risks denial of the request.
Initial Therapy
Initial therapy — product-specific initial approval rules
Initial approval rules vary by product.
Reauthorization / Continuation Criteria
Reauthorization
Reauthorization
Step Therapy Requirements
| Product | Required number of prior generic SGA trials |
|---|---|
| {"text":"Abilify (aripiprazole)","status":""}|{"text":"1 generic SGA trial (documentation of inadequate response or intolerance)","status":""} | |
| {"text":"Brand quetiapine / Seroquel / Seroquel XR","status":""}|{"text":"1 generic SGA trial (documentation of inadequate response or intolerance)","status":""} | |
| {"text":"Caplyta (lumateperone)","status":""}|{"text":"1 generic SGA trial (documentation of inadequate response or intolerance)","status":""} | |
| {"text":"Fanapt (iloperidone)","status":""}|{"text":"1 generic SGA trial (documentation of inadequate response or intolerance)","status":""} | |
| {"text":"Geodon (ziprasidone) oral","status":""}|{"text":"1 generic SGA trial (documentation of inadequate response or intolerance)","status":""} | |
| {"text":"Invega (paliperidone)","status":""}|{"text":"1 generic SGA trial (documentation of inadequate response or intolerance)","status":""} | |
| {"text":"Latuda (lurasidone) [brand]","status":""}|{"text":"Requires trial of generic lurasidone (i.e., 1 generic SGA trial of lurasidone) prior to brand coverage","status":""} | |
| {"text":"Lybalvi (olanzapine and samidorphan)","status":""}|{"text":"1 generic SGA trial (documentation of inadequate response or intolerance)","status":""} | |
| {"text":"Risperdal (risperidone)","status":""}|{"text":"1 generic SGA trial (documentation of inadequate response or intolerance)","status":""} | |
| {"text":"Saphris / Secuado (asenapine formulations)","status":""}|{"text":"1 generic SGA trial (documentation of inadequate response or intolerance)","status":""} | |
| {"text":"Vraylar (cariprazine)","status":""}|{"text":"1 generic SGA trial (documentation of inadequate response or intolerance); product-specific requirements for bipolar depression require trials of quetiapine, lurasidone, or olanzapine‑fluoxetine combination","status":""} | |
| {"text":"Zyprexa / Zyprexa Zydis (olanzapine)","status":""}|{"text":"1 generic SGA trial (documentation of inadequate response or intolerance)","status":""} | |
| {"text":"Bysanti (milsaperidone)","status":""}|{"text":"2 generic SGA trials (documentation of inadequate response or intolerance); individual must be aged ≥18 and dose limited to 24 mg/day","status":""} | |
| {"text":"Cobenfy (xanomeline and trospium chloride)","status":""}|{"text":"3 generic SGA trials (documentation of inadequate response or intolerance); individual must be aged ≥18 and meet schizophrenia diagnosis and psychiatrist involvement","status":""} | |
| {"text":"Nuplazid (pimavanserin)","status":""}|{"text":"Not subject to the other brand SGA trial requirements; restricted to Parkinson's disease psychosis indication","status":""} | |
| {"text":"Opipza (aripiprazole oral film)","status":""}|{"text":"Either 1 generic SGA trial OR documentation that oral film formulation is clinically necessary (e.g., trouble swallowing)","status":""} | |
| {"text":"Rexulti (brexpiprazole)","status":""}|{"text":"Requires trial of aripiprazole (specified generic SGA) with inadequate response or intolerance","status":""} | |
| {"text":"Symbyax (fluoxetine‑olanzapine)","status":""}|{"text":"Requires trial of generic fluoxetine‑olanzapine with inadequate response or intolerance","status":""} |
Product-Specific Quantity and Dose Limits
Coding Information
Site of Care
Manage oral SGAs through the pharmacy benefit
These oral antipsychotic drugs are managed through the pharmacy benefit; submit requests and prescriptions via pharmacy channels per benefit rules.
Definitions
Background
Antipsychotic medications are used to treat acute psychosis and chronic psychotic disorders such as schizophrenia, and are also used for acute agitation and bipolar mania. First‑generation antipsychotics are associated with a higher risk of extrapyramidal symptoms and tardive dyskinesia, whereas second‑generation (atypical) antipsychotics generally have a lower risk of these movement‑related adverse effects. This policy establishes when brand second‑generation antipsychotics are considered medically necessary based on product‑specific criteria, including required prior trials of generic SGAs, age and dose/quantity limits, and indication‑specific restrictions.
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