CurrentmeridianPolicy CP.PMN.53

Clozapine Orally Disintegrating Tablet (ODT)

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Defines medical necessity and coverage criteria for clozapine ODT for members under the Medicaid line of business, including initial and continued therapy requirements and dosing limits.

Policy Summary

Payermeridian

PolicyClozapine Orally Disintegrating Tablet (ODT)

Policy CodePolicy CP.PMN.53

Change TypeNo material changes

Effective DateSep 1, 2023

Last ReviewJul 21, 2023

Next Review DateJul 21, 2024

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) showing the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18Minimum age for covered indication

900 mg/dayMaximum allowable dose

12 monthsApproval duration

30 daysContinuation minimum use

2015

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CurrentmeridianPolicy CP.PMN.53

Clozapine Orally Disintegrating Tablet (ODT)

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Defines medical necessity and coverage criteria for clozapine ODT for members under the Medicaid line of business, including initial and continued therapy requirements and dosing limits.

Policy Summary

Payermeridian

PolicyClozapine Orally Disintegrating Tablet (ODT)

Policy CodePolicy CP.PMN.53

Change TypeNo material changes

Effective DateSep 1, 2023

Last ReviewJul 21, 2023

Next Review DateJul 21, 2024

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) showing the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18Minimum age for covered indication

900 mg/dayMaximum allowable dose

12 monthsApproval duration

30 daysContinuation minimum use

2015

Coverage Criteria for Clozapine ODT

Initial Therapy

Covered when ALL of the following are met for initial approval (Schizophrenia or Schizoaffective Disorder):

Initial Approval - Schizophrenia or Schizoaffective Disorder: 1. Diagnosis of schizophrenia or schizoaffective disorder; 2. Age ≥ 18 years; 3. Failure of a ≥ 4 week trial of olanzapine orally disintegrating tablet at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; 4. Medical justification supports member’s inability to use regular (non-orally disintegrating) clozapine tablets; 5. Dose does not exceed 900 mg per day.

Approval duration: 12 months

Continuation Therapy

Continued therapy covered when ALL of the following are met:

Continued Therapy: 1. Currently receiving medication via Centene benefit or documentation supports that member is currently receiving clozapine ODT for schizophrenia or schizoaffective disorder and has received this medication for at least 30 days; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed 900 mg per day.

Approval duration: 12 months

Other/Off-label

Other/Off-label uses:

Other Indications: 1. If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow applicable PDL/no coverage or non-formulary policy (CP.PMN.255 for Medicaid or CP.PMN.16 for Medicaid) as appropriate; OR 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III and initial/continuation criteria do not apply, refer to the off-label use policy CP.PMN.53 for Medicaid.

Approval duration: 12 months

General scope and applicability

Policy is a guide to medical necessity and assists in coverage decisions; providers must exercise clinical judgment and follow coverage documents.

Policy application: Coverage decisions are subject to the terms, conditions, exclusions and limitations of the member's coverage documents, applicable state and federal requirements, and Health Plan-level administrative policies; this clinical policy is a guide and does not guarantee payment.

Providers must consult state Medicaid manual when state Medicaid provisions conflict with this clinical policy.

Non‑FDA approved indications are not authorized under this policy unless the request includes sufficient documentation of efficacy and safety consistent with the Health Plan's off‑label use policy (CP.PMN.53) or other applicable evidence of coverage documents.

The policy text does not list specific itemized exclusions beyond the general statement that coverage decisions are subject to the terms, conditions, exclusions and limitations of the member's coverage documents and applicable law; providers should consult the member's evidence of coverage for plan‑level exclusions.

Known serious hypersensitivity to clozapine or to any component of clozapine ODT is a contraindication to therapy and is listed as a specific contraindication in Appendix B.

The provided clinical policy text does not state additional explicit not medically necessary conditions beyond its coverage criteria and contraindications; coverage determinations remain subject to the Health Plan's terms and applicable legal/regulatory requirements.

Coding

No codes listed in this sectionmixed

No codes listed

Coding — miscellaneous

Coding listedNo procedure, diagnosis, or billing codes are listed in this policy section.

Threshold entriesNo coding thresholds or numeric code-related limits provided.

Code group statusCoding section explicitly indicates 'No codes listed in this section' (neutral).

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization: document member meets initial or continued therapy criteria

Submit prior authorization demonstrating the member meets all initial or continued therapy criteria: diagnosis of schizophrenia or schizoaffective disorder, age ≥ 18 years, prior trial or other requirements (e.g., prior olanzapine ODT trial unless contraindicated, inability to use regular clozapine tablets), and dose limits (≤ 900 mg/day) or documentation of current use for continuation.

Initial criteria: diagnosis, age ≥18, failure of ≥4 week olanzapine ODT trial (unless contraindicated), inability to use regular clozapine tablets, dose ≤900 mg/day [[see cited chunks]].
Continuation: documentation of current use for ≥30 days and positive response; dose increases must not exceed 900 mg/day.

Note

Prior authorization guidance: policy guides medical necessity; follow plan rules

Follow the Health Plan's prior authorization procedures; this clinical policy is a guide to medical necessity to assist coverage decisions but does not guarantee payment. Providers should follow applicable plan rules and prior authorization submission processes.

Background

Clozapine orally disintegrating tablet (ODT) is an atypical antipsychotic indicated for treatment‑resistant schizophrenia and for reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder. Use of clozapine requires enrollment in the Clozapine REMS program and baseline and ongoing monitoring of absolute neutrophil count due to the risk of severe neutropenia; this safety monitoring is required for initiation and continuation of therapy. Approval under this policy is intended to guide medical necessity determinations and is subject to plan coverage rules and applicable laws.

Definitions

ODT — definition

TermODT (orally disintegrating tablet)

Abbreviation sourceListed in Appendix A: Abbreviation/Acronym Key.

Formulation noteODT refers to the orally disintegrating tablet formulation of clozapine used in this policy.

Clozapine REMS — definition

Program requirementClozapine ODT is available only through the restricted Clozapine REMS program.

PurposeREMS required due to risk of severe neutropenia and need for baseline and regular absolute neutrophil count monitoring.

Dispensing condition

Pharmacotherapy

Pharmacotherapy (clozapine ODT)

Indications: FDA indications include treatment-resistant schizophrenia and reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder.

Safety Monitoring: Requires baseline and regular absolute neutrophil count (ANC) monitoring and enrollment in the Clozapine REMS program; observe for orthostatic hypotension, bradycardia, syncope, seizure risk, myocarditis/cardiomyopathy, and increased mortality in elderly patients with dementia-related psychosis.

Policy Summary

Payermeridian

PolicyClozapine Orally Disintegrating Tablet (ODT)

Policy CodePolicy CP.PMN.53

Change TypeNo material changes

Effective DateSep 1, 2023

Last ReviewJul 21, 2023

Next Review DateJul 21, 2024

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) showing the member meets all approval criteria.

SourceLink

On This Page

Policy provides a guide to medical necessity and assists coverage decisions and administering benefits.
Coverage and payment remain subject to the member's coverage documents and Health Plan administrative policies.

Step Therapy

Step therapy — trial of olanzapine ODT required

Step therapy requires documented failure of a ≥4 week trial of olanzapine ODT at up to maximally indicated doses before approving clozapine ODT, unless olanzapine is contraindicated or clinically significant adverse effects prevent its use.

Trial length: ≥ 4 weeks on olanzapine ODT at up to maximally indicated doses.
Exception: contraindication or clinically significant adverse effects that prevent use.

Note

Follow Health Plan terms, conditions, exclusions and limitations

Providers must comply with all applicable Health Plan terms, conditions, exclusions and limitations when submitting claims; this policy is advisory and does not override coverage documents.

Coverage decisions and administration of benefits remain subject to the member's coverage documents and applicable law.
The Health Plan may change, amend, or withdraw this clinical policy at any time.

Documentation Required

Required documentation: submit chart notes, labs, and clinical information

Include supporting clinical documentation with all prior authorization requests: office chart notes, laboratory results (e.g., monitoring required for clozapine), and other clinical information showing the member meets approval criteria.

Required: office chart notes, lab results, or other clinical information demonstrating criteria are met.
Documentation should support diagnosis, prior treatment trials, duration of current therapy (if applicable), and safety monitoring.

Note

Adhere to Health Plan coverage terms and administrative policies

When submitting claims or prior authorization requests, adhere to the Health Plan's terms, conditions, exclusions and limitations; this clinical policy does not guarantee payment and is intended to guide medical necessity determinations.

Policy is a guide to medical necessity and assists coverage decisions but is not a contract or guarantee of payment.
Providers must follow coverage documents (e.g., evidence of coverage, certificate of coverage) and Health Plan administrative procedures.

Denial Risk

Denial risk: insufficient documentation or unsupported off‑label requests

Requests may be denied if documentation does not demonstrate that the member meets all approval criteria, or if a non‑FDA (off‑label) indication is requested without sufficient off‑label justification per the off‑label use policy.

Denial risk: lack of documentation that approval criteria are met.
Denial risk: requests for non‑FDA indications without sufficient documentation per off‑label use policy CP.PMN.53.

Note

Coverage decisions subject to coverage documents and Health Plan policies

Coverage determinations and benefit administration are governed by the member's coverage documents and applicable Health Plan policies and procedures; follow those documents when seeking coverage or benefits.

Coverage decisions are subject to terms, conditions, exclusions and limitations of coverage documents and applicable law.
This clinical policy does not replace or supersede contractual coverage documents.

Patients initiating and continuing clozapine ODT must have baseline and ongoing ANC monitoring per REMS requirements.

Health Plan — definition

Definition'Health Plan' means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or affiliates.

RoleThis clinical policy provides a guide to medical necessity to assist in coverage decisions and administering benefits for the Health Plan.

LimitationsPolicy does not constitute a contract or guarantee of payment; coverage decisions remain subject to coverage documents and applicable law.