CurrentHealth NetPolicy CP.PMN.15

Clinical Policy: Asenapine (Saphris, Secuado)

Defines medical necessity, prior authorization, dosing limits, and step-therapy requirements for asenapine (Saphris sublingual and Secuado transdermal) for schizophrenia and bipolar I disorder across applicable Health Net lines of business.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Asenapine (Saphris, Secuado)

Policy CodePolicy CP.PMN.15

Change TypeNo material change

Effective DateDec 1, 2014

Next Review Date

Key ActionPrior authorization is required and providers must submit documentation showing the member has met approval criteria (including step therapy and dose limits).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved indications

20 mg/daySaphris max dose

7.6 mg/daySecuado max dose

12 moStandard approval duration

Fail 2 agentsStep therapy

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Coverage Criteria for Asenapine (Saphris, Secuado)

Initial — Bipolar

Initial Approval Criteria — Bipolar disorder (Saphris requests specific items):

Bipolar initial approval: Member has a diagnosis of bipolar disorder; member age meets policy (Saphris has pediatric dosing allowances); request is for Saphris; for Saphris requests, member must use generic asenapine tablets unless contraindicated or clinically significant adverse effects are experienced; member has failed two preferred atypical antipsychotics (aripiprazole, ziprasidone, quetiapine, risperidone, or olanzapine) each used for >= 4 weeks at up to maximally indicated doses, unless all are contraindicated or produce clinically significant adverse effects; dose does not exceed both 20 mg per day and 2 tablets per day.

Initial — Schizophrenia

Initial Approval Criteria — Schizophrenia:

Schizophrenia initial approval: Member has a diagnosis of schizophrenia; member is age >= 18 years; requests originating from or subject to states with limitations on step therapy (see Appendix D) must follow the applicable state provision; for Saphris requests, member must use generic asenapine tablets unless contraindicated or clinically significant adverse effects are experienced; member has failed two preferred atypical antipsychotics (aripiprazole, ziprasidone, quetiapine, risperidone, or olanzapine) each used for >= 4 weeks at up to maximally indicated doses, unless all are contraindicated or produce clinically significant adverse effects; dose does not exceed any of the following: Saphris <= 20 mg/day and <= 2 tablets per day OR Secuado <= 7.6 mg/day (1 patch per day).

Continuation

Continued Therapy Criteria (all indications):

Continued therapy: Member is currently receiving Saphris or Secuado via the plan benefit, or documentation supports current receipt of Saphris or Secuado for bipolar disorder or schizophrenia for at least 30 days; member is responding positively to therapy; if the request is for a dose increase, the new dose must not exceed policy maximums (Saphris 20 mg/day and 2 tablets per day; Secuado 7.6 mg/day and 1 patch per day).

Non–FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies or evidence of coverage. Refer to the plan’s off‑label use policies (e.g., CP.CPA.09 for commercial, HIM.PA.154 for Marketplace, CP.PMN.53 for Medicaid) when submitting requests for off‑label indications.

When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for specific coverage rules and document any state‑level requirements when submitting prior authorization requests for Medicaid members.

Use of asenapine (Saphris or Secuado) for elderly patients with dementia‑related psychosis is not approved and carries a boxed warning that such patients treated with antipsychotic drugs are at an increased risk of death. The policy also notes important contraindications, including severe hepatic impairment (Child‑Pugh C) and known hypersensitivity to Saphris, Secuado, or components of their formulations.

Coding and Product References

NDC / Product codesNDC

NDCs not listed

No explicit NDC codes provided in this document excerpt.

Referenced product labelingNDC

NDC (product PIs referenced)

Product prescribing information for Saphris and Secuado referenced; exact NDCs not listed in this section.

Maximum daily doses — Saphris and Secuado dosing limits

Saphris maximum daily dose20 mg per day (maximum)

Saphris tablet per-day limitMaximum 2 sublingual tablets per day

Secuado maximum daily dose7.6 mg per day (maximum; delivered via transdermal patch)

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required and Approval Duration

Prior authorization is required for Saphris and Secuado. Approval durations vary by line of business: Medicaid — 12 months; HIM — 12 months for Saphris (refer to HIM.PA.103 for Secuado); Commercial — 12 months or duration of request, whichever is less. For continuation requests, member must be currently receiving the medication via the plan or have documentation showing at least 30 days of therapy.

Medicaid: 12 months
HIM: 12 months for Saphris (see HIM.PA.103 for Secuado)
Commercial: 12 months or duration of request, whichever is less
Continuation requirement: ≥30 days of therapy or currently receiving via benefit

Step Therapy

State Step Therapy Limitations and Bypasses

Some states restrict or modify step therapy requirements for antipsychotic medications or for certain mental health settings. When a request is for treatment of a member in a state listed in Appendix D, follow the state-specific limitations and redirection/step-therapy bypass rules. Examples: Arkansas (AR): for HIM requests, step therapy is prohibited for treatment of psychosis and serious mental illness; Nevada (NV): for Medicaid requests, only one preferred atypical antipsychotic trial is required; Texas (TX): for HIM requests, only one preferred atypical antipsychotic trial is required. Illinois (IL): as of 1/1/2026 (per IL HB 5395) the step therapy requirements below do not apply for HIM requests.

Background on Asenapine

Asenapine is an atypical antipsychotic available in two formulations: sublingual tablets (Saphris) and a transdermal system (Secuado). Both agents are indicated for treatment of schizophrenia and bipolar I disorder in adults (Saphris also has select pediatric and adjunctive indications per product labeling). The formulations differ in route and dosing: Saphris is administered sublingually, typically twice daily, while Secuado is a once‑daily transdermal patch available in multiple daily dose strengths. Asenapine products carry a boxed warning that they are not approved for treatment of dementia‑related psychosis due to increased mortality risk in this population.

Product Definitions and Formulations

Secuado — transdermal system strengths and availability

Available transdermal strengths3.8 mg/day, 5.7 mg/day, and 7.6 mg/day transdermal systems are available

Indication notedAsenapine transdermal system (Secuado) indicated for schizophrenia

Dosing frequencyApplied once daily (QD) as transdermal system

Saphris — sublingual tablet formulation and dosing frequency

FormulationAsenapine sublingual tablets (Saphris)

Typical dosing for schizophrenia (adults)5 to 10 mg sublingual twice daily (BID)

Outpatient (Medication Management) Criteria

Pharmacotherapy

Pharmacotherapy — criteria for pharmacologic treatment

Pharmacotherapy:

Therapeutic alternatives: Preferred alternative atypical antipsychotics include aripiprazole, olanzapine, quetiapine, risperidone, and ziprasidone with dosing guidance provided in Appendix B.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Asenapine (Saphris, Secuado)

Policy CodePolicy CP.PMN.15

Change TypeNo material change

Effective DateDec 1, 2014

Next Review Date

Key ActionPrior authorization is required and providers must submit documentation showing the member has met approval criteria (including step therapy and dose limits).

SourceLink

On This Page

Appendix D contains state-specific rules and which lines of business they apply to
AR (HIM): step therapy prohibited for antipsychotic treatment of serious mental illness
NV (Medicaid): failure of ONE preferred atypical antipsychotic required (≥4 weeks)
TX (HIM): failure of ONE preferred atypical antipsychotic required (≥4 weeks)
IL (HIM): step therapy requirements do not apply as of 1/1/2026 per IL HB 5395

Documentation Required

Required Clinical Documentation

Provider must submit clinical documentation to support that the member meets ALL approval criteria. Insufficient documentation may result in denial. Acceptable supporting documentation includes office chart notes, medication history, prior authorization forms, and relevant lab or diagnostic results.

Required: office chart notes documenting diagnosis and treatment history
Medication history showing prior trials, doses, and duration
Documentation of contraindications or adverse effects when bypassing step therapy
Prior authorization forms and any behavioral health setting details (if applicable)

Documentation Required

Supportive Documentation to Establish Medical Necessity

Provide supportive documentation (e.g., prescribing information, clinical guidelines, and peer-reviewed literature) to justify medical necessity when applicable — especially for dose exceptions, use of brand when generic available, or when deviating from step therapy. Include PI excerpts or guideline statements when referencing recommended dosing or contraindications.

Prescribing Information (Saphris, Secuado) when citing approved doses and boxed warnings
Evidence or guideline excerpts supporting use in specific indications or age groups
Documentation of adverse reactions or contraindications to preferred agents

Step Therapy

Step Therapy Failure Required

Step therapy failure is generally required prior to approval except where state rules or clinical contraindications apply. Standard requirement: failure of two preferred atypical antipsychotics (examples: aripiprazole, ziprasidone, quetiapine, risperidone, or olanzapine) each used at up to maximally indicated doses for ≥4 weeks, unless contraindicated or clinically significant adverse effects occur. For schizophrenia, the member must be ≥18 years; for bipolar disorder age criteria apply as specified in the clinical criteria.

Typical requirement: failure of TWO preferred atypical antipsychotics, each ≥4 weeks at adequate dose
If contraindications or significant adverse effects to preferred agents are documented, step therapy may be bypassed
For states with limitations (see Appendix D), the number of required failures may be reduced or eliminated

Step Therapy

Step Therapy and State-Specific Bypasses

State-specific step therapy and redirection bypasses must be applied. If the member is treated in a state listed in Appendix D where redirection or step therapy is limited or prohibited for the applicable line of business, do not enforce the standard step requirements and document the state exception on the PA request. Examples include single-drug redirect allowances (NV, TX) or complete prohibition of step therapy (AR for HIM). Illinois HIM requests are exempt from the step requirements as of 1/1/2026 per IL HB 5395.

When Appendix D lists a limitation for the member’s state and line of business, apply that state rule instead of standard step therapy
Document the state and statutory basis (e.g., IL HB 5395) on the PA request to support bypass
If relying on a state bypass, still submit clinical documentation supporting the medical need and any prior agent intolerance or contraindication

Pediatric bipolar dosing

2.5 to 10 mg sublingual twice daily (BID) for pediatric bipolar indication

Transdermal system strengths list (3.8, 5.7, 7.6 mg/day)

Strengths list3.8 mg/day

Strengths list5.7 mg/day

Strengths list7.6 mg/day