ModifiedmhnPolicy CP.PMN.64

Quetiapine Extended-Release (Seroquel XR) Coverage Criteria

Defines medical necessity criteria, prior authorization requirements, and coverage limits for Seroquel XR for commercial, HIM, and Medicaid lines of business for specified psychiatric indications.

Policy Summary

Payermhn

PolicyQuetiapine Extended-Release (Seroquel XR) Coverage Criteria

Policy CodePolicy CP.PMN.64

Change TypeMaterial revisions (generic requirement addedcontinued therapy revisedIR trial removed)

Effective DateSep 1, 2015

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, age, prior treatments/step-therapy where specified, dosing limits, and use of generic quetiapine ER unless contraindicated.

SourceLink

POLICY UPDATE CHANGES

Added requirement to use generic quetiapine XR unless contraindicated or clinically significant adverse effects are experienced.

Revised continued therapy criteria to allow continuity of care for all indications.

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

800 mg/daySchizophrenia max

300 mg/dayMDD max

12 monthsApproval duration

2Boxed warnings

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Generic requiredGeneric preference

Coverage Criteria for Quetiapine XR (Seroquel XR)

Initial Therapy — Covered when ALL of the following are met for each respective indication group

Covered when ALL of the following are met for each respective indication group

I.A Bipolar Disorder and Schizophrenia

1: Diagnosis of bipolar disorder or schizophrenia
2: Member meets one of the following age criteria: Schizophrenia: Age ≥ 13 years; Bipolar disorder: Age ≥ 10 years
3: Member meets one of the following: (a) request is for treatment of a member in a State with limitations on step therapy in certain mental health settings (see Appendix D); OR (b) for Seroquel XR requests, member must use generic quetiapine extended-release (ER) unless contraindicated or clinically significant adverse effects are experienced
4
- 4a: Schizophrenia: 800 mg per day
- 4b: Bipolar disorder: Adults: 800 mg per day; Children and adolescents: 600 mg per day
- 4c: Maximum of 2 tablets per day

I.B Major Depressive Disorder (adjunctive)

1-2: Diagnosis of MDD and Age ≥ 18 years
3: Member meets 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 at up to maximally indicated doses, each used for ≥ 4 weeks unless exceptions apply; AND (ii) failure of a ≥ 4-week trial of aripiprazole adjunctive with an antidepressant at up to maximally indicated doses unless contraindicated or adverse effects
4: Seroquel XR is prescribed concurrently with an antidepressant
5: Member meets one of the following: (a) request is for a member in a State with limitations on step therapy (see Appendix D); OR (b) for Seroquel XR requests, member must use generic quetiapine ER unless contraindicated or clinically significant adverse effects are experienced

I.C Other diagnoses/indications: If request is for an indication not covered in Sections I.A or I.B, refer to policy exclusions and off-label use policies; non-FDA approved indications not addressed in this policy are not authorized unless supported per off-label use policies

Continuation Therapy — Covered when ALL of the following are met for continued therapy

Covered when ALL of the following are met for continued therapy

II.A Continued Therapy

1: Member is currently receiving Seroquel XR via the Centene benefit, or documentation supports current receipt for a covered indication for ≥ 30 days
2: Member is responding positively to therapy
3: For Seroquel XR requests, member must use generic quetiapine ER unless contraindicated or clinically significant adverse effects are experienced
4: If request is for a dose increase, the new dose does not exceed the following limits: Schizophrenia 800 mg/day; Bipolar disorder — Adults 800 mg/day, Children and adolescents 600 mg/day; MDD 300 mg/day; and a maximum of 2 tablets per day

Dosing and maximum dose by indication

Dosing regimens and maximum doses by indication and age

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

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

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

Requests for Seroquel XR for dementia-related psychosis are not authorized. This indication is listed in the policy section "Diagnoses/Indications for which coverage is NOT authorized" and will be denied per the criteria.

Seroquel XR is contraindicated in individuals with a known hypersensitivity to Seroquel XR or any components of the formulation. Requests for members with documented hypersensitivity should not be approved.

Indications that are not FDA‑approved and are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (for example, CP.CPA.09, HIM.PA.154, or CP.PMN.53).

The policy highlights safety concerns for use of quetiapine in patients with dementia: the drug carries a boxed warning for increased mortality in elderly patients with dementia-related psychosis. Dementia-related psychosis is explicitly listed among diagnoses for which coverage is not authorized, reinforcing the boxed‑warning safety restriction.

Coding and Dosing Summary

Dosing thresholds by indication — Seroquel XR

Schizophrenia (adults)Target dose 400–800 mg/day; initial 300 mg PO QD; maximum 800 mg/day.

Schizophrenia (adolescents)Initial 50 mg PO QD; target 400–800 mg/day; maximum 800 mg/day.

Bipolar I — manic/mixed (adults)Initial 300 mg PO QD; target 400–800 mg/day; maximum 800 mg/day.

Bipolar I — manic/mixed (children/adolescents)Initial 50 mg PO QD; target 400–600 mg/day; maximum 600 mg/day.

Bipolar I — depressive episodes (adults)Initial 50 mg PO QD; target 300 mg/day; maximum 300 mg/day.

Major depressive disorder (MDD, adults)Initial 50 mg PO QD; target 150–300 mg/day; maximum 300 mg/day.

Prior Authorization, Step Therapy, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and continuation of Seroquel XR (quetiapine extended-release). Providers must submit documentation demonstrating that all approval criteria are met for the member's indication, age, prior medication trials, dosing limits, and clinical response.

Applies to initial and continued therapy requests.
Documentation must show diagnosis, age, prior trials (including durations and outcomes), contraindications, or clinically significant adverse effects when disputing redirection to generic quetiapine ER.

Denial Risk

Denial Risk for Unmet Step Therapy/Redirection

Requests may be denied if step therapy or redirection requirements are not met where applicable. For many Seroquel XR requests, the member must use generic quetiapine ER unless a contraindication or clinically significant adverse effect is documented. Failure to meet required prior trials for Major Depressive Disorder (MDD) or other specified conditions may result in denial.

Drug Background and Context

Quetiapine extended‑release (Seroquel XR) is an atypical antipsychotic with FDA approvals for schizophrenia (age ≥ 13 years), bipolar I disorder (manic/mixed episodes and depressive episodes per age indications), and as adjunctive therapy for major depressive disorder (MDD) in adults. dosing guidance and maximum doses vary by indication and age (see dosing tables).

Definitions and Safety Warnings

ER — extended‑release definition

ER (abbreviation)Defined as extended-release (ER) formulation as listed in Appendix A.

Tablet strengths (appendix info)Extended‑release formulation available in multiple strengths (see dosing/administration table).

Usage noteER denotes a formulation designed for once‑daily dosing (PO QD) per dosing regimens in the policy.

MDD — major depressive disorder definition

MDD (abbreviation)Major depressive disorder (MDD) as listed in Appendix A.

Indication contextIn this policy MDD refers to adults for adjunctive Seroquel XR use; see dosing and prior‑trial requirements in Section I.B.

Policy Summary

Payermhn

PolicyQuetiapine Extended-Release (Seroquel XR) Coverage Criteria

Policy CodePolicy CP.PMN.64

Change TypeMaterial revisions (generic requirement addedcontinued therapy revisedIR trial removed)

Effective DateSep 1, 2015

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, age, prior treatments/step-therapy where specified, dosing limits, and use of generic quetiapine ER unless contraindicated.

SourceLink

On This Page

6: Dose does not exceed both: 300 mg per day and 2 tablets per day

II.B Other continued therapy considerations: Continued therapy requests for indications not in Section I should follow applicable coverage, exclusion, and off-label policies

Major depressive disorder (MDD): Adults: Initial 50 mg PO QD; Target 150–300 mg/day.Maximum 300 mg/day

Denial risk includes unmet step therapy (e.g., failure to trial required antidepressants or aripiprazole for adjunctive MDD) and lack of documented contraindication to generic quetiapine ER.
Dose and tablet limits must be met; exceeding maximums without justification may lead to denial.

Documentation Required

Supporting Documentation Required

Provider must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, medication administration records, lab results, and other clinical information sufficient to verify prior trials, adverse effects, contraindications, and current treatment response.

Documentation should confirm medication names, doses, dates of therapy, durations (e.g., ≥ 4 weeks where required), and reason for discontinuation if applicable (lack of efficacy or clinically significant adverse effects).
For continuation requests, documentation should show member has been receiving Seroquel XR via the Centene benefit or elsewhere for at least 30 days and is responding positively to therapy.

Documentation Required

Documentation Should Support Prior Trials/Contraindications

When contesting redirection to generic quetiapine ER, documentation must specifically support prior trials and failures or document contraindications/clinically significant adverse effects to alternative agents.

For MDD adjunctive use, document failure of three antidepressants from at least two classes (each ≥ 4 weeks at up to maximally indicated doses) and a ≥ 4-week trial of aripiprazole with an antidepressant, unless exceptions apply.
If generic quetiapine ER is deemed contraindicated or not tolerated, provide clinical details of the adverse effects or contraindication.

Step Therapy

State-Specific Step Therapy/Redirection Rules

State-specific limitations on step therapy/redirection apply. Certain states prohibit or restrict redirection in defined mental health settings; Appendix D lists states and any applicable notes. If the member resides in or is being treated in a state with limitations, redirection requirements may be bypassed.

Arkansas (AR): Step therapy prohibited for treatment of psychosis and serious mental illness — redirection bypass applies.
Nevada (NV): Applies to Medicaid requests only; specific single-drug redirection rules for MDD as noted in Appendix D.
Texas (TX): Applies to HIM requests only; single-drug redirection requirements for MDD apply as noted in Appendix D.
Illinois (IL): As of 1/1/2026, certain step therapy requirements for HIM requests do not apply per IL HB 5395.

Concomitant therapy requirementFor adjunctive MDD use, Seroquel XR must be prescribed concurrently with an antidepressant per coverage criteria.

Boxed warnings and serious safety communications

Dementia‑related psychosis mortality warningBoxed warning: increased mortality in elderly patients with dementia‑related psychosis.

Suicidality in youthBoxed warning: suicidal thoughts and behaviors in children, adolescents, and young adults taking antidepressants.

Contraindication related to hypersensitivityKnown hypersensitivity to Seroquel XR or any components in the formulation is listed as a contraindication in Appendix C.