CurrentCentenePolicy CP.PMN.15

Clinical Policy: Asenapine (Saphris, Secuado)

Centene medical policy governing prior authorization and coverage criteria for asenapine (Saphris sublingual and Secuado transdermal) for treatment of schizophrenia and bipolar I disorder across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyClinical Policy: Asenapine (Saphris, Secuado)

Policy CodePolicy CP.PMN.15

Change TypeNo material changes

Effective DateDec 1, 2014

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, age criteria, required step therapy trials (two preferred atypical antipsychotics each ≥ 4 weeks) or state-specific exceptions, and dosing within policy limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

20 mg/daySaphris max daily dose

7.6 mg/daySecuado max daily dose

≥4 wksStep trial minimum

≥10Min age (bipolar)

12 moTypical approval duration

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Coverage Criteria

Initial Therapy — Bipolar Disorder

Covered when ALL of the following criteria are met:

Bipolar Initial: 1. Diagnosis of bipolar disorder; 2. Age >= 10 years; 3. Request is for Saphris; 4. Member meets ONE of: (a) request is for treatment of a member in a state with limitations on step therapy (see Appendix D) OR (b) failure of two preferred atypical antipsychotics (e.g., aripiprazole, ziprasidone, quetiapine, risperidone, or olanzapine) at up to maximally indicated doses, each used for >= 4 weeks, unless all are contraindicated or clinically significant adverse effects are experienced; 5. For Saphris requests, member must use generic asenapine tablets unless contraindicated or clinically significant adverse effects are experienced; 6. Dose does not exceed BOTH: (a) 20 mg per day AND (b) 2 tablets per day.

Initial Therapy — Schizophrenia

Covered when ALL of the following criteria are met:

Schizophrenia Initial: 1. Diagnosis of schizophrenia; 2. Age >= 18 years; 3. Member meets ONE of: (a) request is for treatment of a member in a state with limitations on step therapy (see Appendix D) OR (b) failure of two preferred atypical antipsychotics (e.g., aripiprazole, ziprasidone, quetiapine, risperidone, or olanzapine) at up to maximally indicated doses, each used for >= 4 weeks, unless all are contraindicated or clinically significant adverse effects are experienced; 4. For Saphris requests, member must use generic asenapine tablets unless contraindicated or clinically significant adverse effects are experienced; 5. Dose limits must not exceed any of the following: (a) Saphris — 20 mg per day AND 2 tablets per day; OR (b) Secuado — 7.6 mg per day AND 1 patch per day.

Continuation Therapy — Continuation/Renewal

Covered when ALL of the following criteria are met:

Continuation: 1. Member is currently receiving Saphris or Secuado via the Centene benefit, or documentation supports the member has received Saphris or Secuado for at least 30 days; 2. Member is responding positively to therapy; 3. If a dose increase is requested, the new dose does not exceed policy maximums: Saphris — 20 mg per day and 2 tablets per day; Secuado — 7.6 mg per day and 1 patch per day.>=30 days therapy for continuation

Not Authorized / Other Indications

Not Authorized: Non-FDA approved indications that are not addressed in this policy are NOT authorized unless sufficient documentation of efficacy and safety is provided per the applicable off-label use policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents.

Refer to listed off-label policies per line of business.

Contraindications for asenapine include severe hepatic impairment (Child-Pugh C) and known hypersensitivity to Saphris, Secuado, or any components of the sublingual formulation or transdermal system. These conditions are absolute exclusions and requests for therapy in members with these contraindications should be denied.

For members enrolled in Medicaid, state Medicaid coverage provisions take precedence when they conflict with the coverage provisions in this clinical policy. Providers should consult the applicable state Medicaid manual for any state‑specific coverage rules or exceptions that override this policy.

Non‑FDA approved (off‑label) indications that are not addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety per the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Marketplace, and CP.PMN.53 for Medicaid) or unless coverage is supported by the member's evidence of coverage documents.

Coding and Dosing

Available product formulations/dosagesmixed

Saphris: 2.5 mg, 5 mg, 10 mg	Asenapine sublingual tablets strengths
Secuado: 3.8 mg/day, 5.7 mg/day, 7.6 mg/day	Asenapine transdermal system dosage rates

Maximum daily doses

Saphris (sublingual) — maximum daily dose20 mg per day

Saphris — tablet/day limitMaximum 2 tablets per day (per policy)

Secuado (transdermal) — maximum daily dose7.6 mg per day

Step therapy trial duration

Minimum trial duration per preferred atypical antipsychotic>= 4 weeks per agent (each preferred antipsychotic trial)

Number of preferred agents required (standard)Failure of two preferred atypical antipsychotics unless contraindicated or state limitations apply

State exceptions noteSome states (see Appendix D) limit or prohibit step therapy; follow state‑specific rules (e.g., AR prohibits step therapy)

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit a prior authorization request and supporting clinical documentation (e.g., office/clinic notes, labs, symptom history, prior medication trials and dates, and rationale for therapy) demonstrating the member meets all policy criteria.

Applies to requests for Saphris (asenapine) and Secuado (asenapine transdermal).
For Saphris, generic asenapine tablets must be used first unless contraindicated or intolerant.
Dose limits apply (see policy criteria for specific age/agent limits).

Step Therapy

Step Therapy Requirements

Step therapy requirements generally require failure of two preferred atypical antipsychotics at up to maximally indicated doses, each used for ≥ 4 weeks, unless all are contraindicated or clinically significant adverse effects occurred. Some states and lines of business have modified step requirements or redirection rules — see Appendix D and policy notes for state‑specific exceptions.

Preferred agents examples: aripiprazole, ziprasidone, quetiapine, risperidone, olanzapine.
For schizophrenia and bipolar disorder, member must meet step therapy criteria unless a state/setting exception applies.

Denial Risk

Documentation & Indication Denial Risk

Requests that lack required documentation or that seek coverage for non‑FDA (off‑label) indications without sufficient evidence risk denial. Providers should supply clear clinical justification and relevant records showing prior therapy failures or contraindications.

Non‑FDA indications require additional evidence per applicable off‑label policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53) and may be denied if unsupported.
Clinical documentation should include dates/durations of prior antipsychotic trials and description of adverse effects or contraindications when claiming exemptions from step therapy.

Note

State Step‑Therapy Limitations & Redirection

State and program‑level limits on step therapy and redirection supersede default policy requirements where applicable. Appendix D lists states with limitations or special redirection rules for certain mental health settings; providers must follow those state‑specific provisions.

Examples from Appendix D: Arkansas — step therapy prohibited for certain mental health settings; Nevada and Texas — single‑drug redirection requirements in specified programs (see Appendix D for details).
Illinois HIM: as of 1/1/2026 per IL HB 5395, step therapy requirements do not apply for HIM requests.

Step Therapy

Step‑Therapy and Redirection Bypass

When a state or program permits redirection bypass (single‑drug redirection) or prohibits step therapy in the applicable mental health setting, prior authorization review will apply those exceptions. Providers should indicate the member’s state, line of business, and setting on the request and include any supporting legal or program documentation to expedite review.

Appendix D contains the current list of states and the specific redirection or prohibition language; this has been updated over time (e.g., TX, NV, AR, IL entries).
If a state exception applies, providers should document the basis (statute/house bill or program type) on the PA form to avoid unnecessary step requirements.

OpenPayer

Clinical Policy: Asenapine (Saphris, Secuado)

Coverage Criteria

Coding and Dosing

Provider Actions and Requirements

Background

Definitions

Treatment Modalities