CurrentEmblemHealthPolicy N/A

Adasuve (loxapine) inhalation — coverage criteria

Policy governs medical necessity, coverage criteria, dosing, limits, and exclusions for Adasuve (loxapine inhalation) for acute agitation associated with schizophrenia or bipolar disorder for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyAdasuve (loxapine) inhalation — coverage criteria

Policy CodePolicy N/A

Change TypeNo material clinical changes in most recent revision

Effective DateN/A

Next Review DateN/A

Key ActionSubmit clinical evidence confirming diagnosis, age, and REMS enrollment documentation when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Removed: F25.0 Schizoaffective disorder, bipolar type.

Annual Review: removed PI link, no criteria changes (4/29/2024).

Annual Review: removed NDC 10885-0003-XX, added NDC 51097-0001-XX, Added ICD-10 R45.1, F25.0 (8/11/2023).

Medical Policy created per FDA Label (4/6/2020).

280billable units per 28 days (max)

12 moauthorization length

10 mgrecommended single dose

18+minimum patient age

Coverage and Medical Necessity Criteria

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inv-01: Initial Approval

Covered when ALL of the following are met

Initial Approval Criteria: A. Member is 18 years of age or older; AND B. Member has a confirmed diagnosis of schizophrenia or bipolar disorder made by or in consultation with a psychiatrist; AND C. Member suffers from psychomotor agitation as defined in DSM-IV (excessive motor activity associated with inner tension) with behaviors that interfere with care; AND D. Adasuve administration will occur in an enrolled healthcare facility as required by the REMS program.

Dose: single-use inhaler 10 mg administered by a healthcare professional via oral inhalation.

inv-02: Renewal

Renewal Criteria

Renewal: Patient continues to meet initial approval criteria.

Authorization duration is 12 months and may be renewed contingent on documentation that criteria remain met.

Adasuve is not considered medically necessary when any of the following exclusion conditions are present: member is under 18 years of age; disease progression while on Adasuve (loxapine); current diagnosis or history of asthma, COPD, or other disease associated with bronchospasm; acute respiratory symptoms or signs (e.g., wheezing); current use of medications to treat airways disease such as asthma or COPD therapies; history of bronchospasm following Adasuve treatment; known hypersensitivity to loxapine or amoxapine (serious skin reactions have been reported with oral loxapine and amoxapine); or when the requested indication is not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature.

Because Adasuve can cause bronchospasm, administration is restricted under a REMS program and must be given only in an enrolled healthcare facility where appropriate monitoring and treatment of respiratory events are available. Presence of any exclusion criteria above may result in denial of coverage or make the drug not medically necessary; providers should document the absence of these exclusion conditions when submitting authorization requests.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Adasuve (loxapine inhalation) requires prior authorization. Coverage is granted only when the member meets the clinical criteria described in the policy (adult ≥18, diagnosis of schizophrenia or bipolar disorder with psychomotor agitation confirmed by or in consultation with a psychiatrist, administration in a REMS-enrolled healthcare facility, and other medical necessity criteria).

Applicable procedure code: J2062

Step Therapy

Step therapy: There is no step therapy requirement for Adasuve in this policy.

Documentation Required

Required Clinical Documentation and Submission

Documentation Required: The treating provider must submit clinical evidence to support medical necessity. Required documentation includes: diagnosis, documentation of psychomotor agitation, confirmation the diagnosis and treatment plan were made by or in consultation with a psychiatrist, member age, documentation that Adasuve will be administered in a REMS-enrolled facility, and any relevant prior treatments or contraindications. Failure to submit required documentation may prevent preauthorization approval and may subject claims to post-payment review and potential denial.

Required clinical information: diagnosis, psychiatrist involvement/consult note, description of agitation behaviors, member age (≥18), REMS enrollment site documentation, medication and respiratory history.

Denial Risk

Exclusion-Triggered Denial

Exclusion-triggered Denial: Requests will be denied if any exclusion criteria are present, including age <18, current or historical diagnosis of asthma, COPD, or other conditions associated with bronchospasm, acute respiratory symptoms (e.g., wheezing), current use of medications to treat airway disease, history of bronchospasm with Adasuve, known hypersensitivity to loxapine or amoxapine, or indications not supported by accepted compendia/peer-reviewed literature. Adasuve must be given only in a REMS-enrolled facility; absence of appropriate REMS administration may result in denial.

Exclusion examples: age <18; asthma/COPD/bronchospasm history; acute respiratory signs (wheezing); concurrent inhaled or other airway medications; prior bronchospasm with Adasuve; known hypersensitivity to loxapine/amoxapine.

Background and Clinical Context

Adasuve (loxapine inhalation) is a drug‑device combination delivered as an inhalation powder in a single‑use, disposable 10 mg inhaler intended for the acute treatment of agitation associated with schizophrenia or bipolar disorder. The product is administered by oral inhalation only by a healthcare professional, with a recommended single dose of 10 mg. Due to the risk of bronchospasm, use is limited to administration in facilities enrolled in the REMS program where monitoring and management of respiratory adverse events are available.

Definitions

Adasuve

ProductAdasuve (loxapine) inhalation powder, single-use disposable inhaler, 10 mg

FormulationInhalation powder (drug-device combination)

Intended useAcute treatment of agitation associated with schizophrenia or bipolar disorder

Psychomotor agitation

Definition (DSM-IV)Psychomotor agitation: excessive motor activity associated with a feeling of inner tension

Clinical manifestationsBehaviors that interfere with care (e.g., threatening, escalating, urgently distressing, or self-exhausting behaviors)

Relevance to treatmentMay prompt use of rapidly absorbed antipsychotic medications for immediate control of agitation

Setting and Administration Level Criteria

inv-17: Outpatient/Facility administration

Criteria determining appropriate level of care for administration (facility versus outpatient)

Outpatient/Facility administration: Adasuve must be administered only in an enrolled healthcare facility per the REMS program due to risk of bronchospasm; administration must be performed by a healthcare professional.

Use of Adasuve outside an enrolled facility is not permitted by REMS and is not covered.

Medication and Administration Details

inv-18: Medication (Inhaled loxapine)

Adasuve (inhaled loxapine) dosing and administration: Adasuve is an inhalation powder of loxapine supplied as a single-use, disposable 10 mg inhaler; it must be administered by a healthcare professional via oral inhalation. The recommended single dose for acute agitation is 10 mg using the single-use inhaler.

Administration must occur in an enrolled healthcare facility per REMS because of bronchospasm risk.

Policy Revision History

2025-02-14annual_reviewLatest

Annual review — no criteria changes; removed ICD-10 code F25.0 (Schizoaffective disorder, bipolar type).

2024-04-29annual_review

Annual review — removed PI link; no clinical criteria changes.

2023-08-11annual_review

Annual review — removed NDC 10885-0003-XX, added NDC 51097-0001-XX, and added ICD-10 code R45.1 and F25.0.

2022-03-17administrative_update

Transferred policy to new template.

2020-04-06creation

Medical policy created per FDA label.