ModifiedCentenePolicy CP.PMN.64

Clinical Policy: Quetiapine Extended-Release (Seroquel XR)

Defines medical necessity, prior authorization and dosing limits for Seroquel XR (quetiapine ER) for Centene lines of business (Commercial, HIM, Medicaid) including indications, age limits, step therapy expectations, and exclusions.

Policy Summary

PayerCentene

PolicyQuetiapine Extended-Release (Seroquel XR)

Policy CodePolicy CP.PMN.64

Change TypeCriteria revision and state-specific step therapy updates

Effective DateSep 1, 2015

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis, age eligibility, step therapy compliance or exception, dosing within policy limits, and use of generic quetiapine ER unless contraindicated.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for IL HIM per IL HB 5395.

Removed requirement for trial and failure of immediate release quetiapine for schizophrenia and bipolar disorder.

Must use generic quetiapine XR language added; for bipolar disorder, max 600 mg/day for children and adolescents.

Added redirection bypass for members in states with limitations on step therapy and Appendix D listing affected states (e.g., AR, NV, TX).

800maximum adult schizophrenia/bipolar dose

600maximum pediatric bipolar dose

300maximum MDD adjunctive dose

12 mo

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Coverage Criteria for Quetiapine XR (Seroquel XR)

Initial Therapy (Bipolar Disorder and Schizophrenia)

Covered when ALL of the following are met:

Initial Approval - Bipolar Disorder and Schizophrenia: 1) Diagnosis of bipolar disorder or schizophrenia; 2) Age criteria: schizophrenia: age ≥ 13 years OR bipolar disorder: age ≥ 10 years; 3) One of the following: a) Request is for a member in a State with limitations on step therapy in certain mental health settings (see Appendix D); OR b) member uses generic quetiapine extended-release (ER) unless contraindicated or clinically significant adverse effects are experienced; 4) Dose does not exceed all of the following: a) schizophrenia: 800 mg per day; b) bipolar disorder: adults 800 mg per day, children and adolescents 600 mg per day; c) tablet limit: 2 tablets per day.

Provider must submit documentation supporting criteria.

Initial Therapy (MDD adjunctive)

Covered when ALL of the following are met:

Initial Approval - Major Depressive Disorder (Adjunctive): 1) Diagnosis of major depressive disorder (MDD); 2) Age ≥ 18 years; 3) One of the following: a) Request is for a member in a State with limitations on step therapy in certain mental health settings (see Appendix D); OR b) for all other requests both of the following must be met: i) failure of three antidepressants from at least two different classes, each used ≥4 weeks at up to maximally indicated doses (unless age ≥65, contraindication, or clinically significant adverse effects); and ii) failure of a ≥4-week trial of aripiprazole adjunctive to an antidepressant at up to maximally indicated doses (unless contraindicated or clinically significant adverse effects); 4) Seroquel XR is prescribed concurrently with an antidepressant; 5) Member must use generic quetiapine ER unless contraindicated or clinically significant adverse effects are experienced (Illinois HIM exception per IL HB 5395 noted); 6) Dose does not exceed 300 mg per day and 2 tablets per day.

Step therapy exemptions apply for certain states and populations (see Appendix D and policy history).

Continued Therapy

Covered when ALL of the following are met:

Continued Therapy: 1) Member is currently receiving Seroquel XR via the Centene benefit, or documentation supports current receipt of Seroquel XR for a covered indication for at least 30 days; 2) Member is responding positively to therapy; 3) Member must use generic quetiapine ER unless contraindicated or clinically significant adverse effects are experienced; 4) If a dose increase is requested, the new dose must not exceed: schizophrenia 800 mg/day; bipolar disorder: adults 800 mg/day, children and adolescents 600 mg/day; MDD 300 mg/day; and 2 tablets per day.

Approval durations are typically 12 months; continued therapy criteria revised to allow continuity of care for all indications.

Other Indications / Off-label

For uses not covered by the listed indications:

Other Indications: 1) If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, refer to the appropriate no-coverage or non-formulary policy for the relevant line of business (e.g., CP.CPA.190, HIM.PA.33, CP.PMN.255, or HIM.PA.103, CP.PMN.16); OR 2) If the requested use (diagnosis, age, dosing) is not listed in Section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53).

Follow the referenced line-of-business policies for consideration of non-listed or off-label requests.

Dosing and maximums

Dosing regimens and maximum doses by indication and age

Schizophrenia dosing: Adults: Initial 300 mg PO QD; Target 400 to 800 mg/day; Adolescents: Initial 50 mg PO QD; Target 400 to 800 mg/day; Maximum dose 800 mg/day.

Source: Dosage and Administration.

Bipolar I disorder dosing (manic/mixed): Adults: Initial 300 mg PO QD; Target 400 to 800 mg/day. Children and adolescents: Initial 50 mg PO QD; Target 400 to 600 mg/day. Maximum doses: Adults 800 mg/day; Children and adolescents 600 mg/day.

Source: Dosage and Administration.

Bipolar I disorder dosing (depressive episodes): Adults: Initial 50 mg PO QD; Target 300 mg/day; Maximum 300 mg/day.

Source: Dosage and Administration.

Major depressive disorder dosing:

Policy coverage rules

Coverage conditions and policy-level rules

Generic first: For Seroquel XR requests, member must use generic quetiapine extended-release (ER) unless contraindicated or clinically significant adverse effects are experienced.

Added as a policy requirement in 1Q 2023; noted in Appendix D.

Step therapy for MDD (state-dependent): For MDD, some states require failure of an alternative agent (e.g., generic quetiapine ER, aripiprazole, or an antidepressant) at up to maximally indicated doses used for ≥4 weeks prior to Seroquel XR, unless exempt (age ≥65, contraindication, or clinically significant adverse effects). Appendix D lists state-specific provisions and redirection/limitations.

Appendix D entries and policy history document state-specific additions (AR, NV, TX) and IL HIM exception effective 1/1/2026.

Continuity of care/continued therapy: Continued therapy criteria were revised to allow continuity of care for all indications; prior requirement to trial immediate-release quetiapine for schizophrenia and bipolar disorder was removed in 1Q 2025.

Policy change documented in 1Q 2024 and 1Q 2025 revisions.

Coverage is NOT authorized for dementia-related psychosis. This indication is explicitly excluded from policy coverage and requests for Seroquel XR for treatment of psychosis related to dementia should be denied per the policy exclusion.

Non–FDA approved (off‑label) indications for Seroquel XR are not addressed by this policy unless the provider supplies sufficient documentation demonstrating efficacy and safety in accordance with applicable off‑label use policies: CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, or CP.PMN.53 for Medicaid. Absent that documentation, coverage for off‑label uses is not authorized under this policy.

Seroquel XR is contraindicated in individuals with a known hypersensitivity to Seroquel XR or any components of the formulation. Providers should document any hypersensitivity history; requests for members with documented allergy to the product or ingredients must be denied.

The product carries a boxed warning noting increased mortality in elderly patients with dementia‑related psychosis. This safety concern underlies the policy exclusion of dementia‑related psychosis from coverage. Additionally, the boxed warnings include risks of suicidal thoughts and behaviors in children, adolescents, and young adults receiving antidepressants; providers should consider these warnings when treating younger patients and ensure appropriate monitoring and documentation.

Coding and Quantity Limits

Tablet limit — 2 tablets per day

Tablet limitMaximum 2 tablets per day for all indications (schizophrenia, bipolar disorder, and MDD continued/initial therapy).

Schizophrenia max dose800 mg per day; must also not exceed 2 tablets per day.

Bipolar disorder max dose (adults)800 mg per day; must also not exceed 2 tablets per day.

Bipolar disorder max dose (children/adolescents)600 mg per day; must also not exceed 2 tablets per day.

MDD adjunctive max dose300 mg per day; must also not exceed 2 tablets per day.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, medication trials, and laboratory results) supporting the diagnosis, age, treatment history, reason for branded product or bypass, dose, and that the member meets step therapy or exception criteria. Failure to provide required documentation may result in denial.

Prior authorization mandatory with supporting clinical documentation (office notes, labs, medication trial records).
Include documentation of diagnosis, age, current therapy, treatment response, and dosing.
When requesting branded Seroquel XR or a bypass of generic quetiapine ER, include documentation of trial(s) with generic quetiapine ER or documentation of contraindication or clinically significant adverse effects.

Documentation Required

Required Documentation

Documentation must demonstrate that the member currently meets initial or continued therapy criteria: diagnosis, age eligibility, prior medication trials (including number, class, dose, and duration), reason for failure (lack of efficacy, intolerance, or contraindication), and positive response for continued use. For branded-product exceptions or to bypass step therapy, submit records of prior trials of generic quetiapine ER (dates, doses, outcomes) or clinical justification for why generic therapy is contraindicated or not tolerated. Incomplete documentation may delay or prevent approval.

Background

Quetiapine extended‑release (Seroquel XR) is an atypical antipsychotic indicated for schizophrenia, bipolar I disorder (manic/mixed and depressive episodes), and as adjunctive treatment for major depressive disorder in adults. The policy defines age‑based indication limits and dose maxima: for schizophrenia and adult bipolar indications the recommended target is 400–800 mg/day with a maximum of 800 mg/day; for bipolar children and adolescents the maximum is 600 mg/day; and for adjunctive treatment of major depressive disorder the target is 150–300 mg/day with a maximum of 300 mg/day. The policy also notes safety boxed warnings relevant to dementia‑related mortality and suicidality that affect coverage and prescribing considerations.

Definitions and References

Abbreviations

ERextended-release

IRimmediate-release

MDDmajor depressive disorder

FDAFood and Drug Administration

Seroquel XR Prescribing Information and guideline references

Primary prescribing informationSeroquel XR Prescribing Information. AstraZeneca Pharmaceuticals LP; January 2022. Available at www.seroquelxr.com.

Practice guideline — bipolar disorderHirschfeld RMA et al. Practice guideline for the treatment of patients with bipolar disorder, 2nd ed.; American Psychiatric Association; April 2002.