CurrentEmblemHealthPolicy MG.MM.PH.228

Cinqair (reslizumab) intravenous infusion - Coverage Criteria

Clinical coverage policy for Cinqair (reslizumab) intravenous infusion as add-on maintenance treatment of severe eosinophilic asthma in adults, governing preauthorization, dosing, and approval criteria for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyCinqair (reslizumab) intravenous infusion - Coverage Criteria

Policy CodePolicy MG.MM.PH.228

Change TypeRevised (material update to HCPCS max unitsminor wording clarifications)

Effective Date

Next Review DateMar 11, 2025

Key ActionObtain prior authorization and submit clinical evidence verifying age ≥18, qualifying eosinophil counts or steroid dependence, prior controller therapy, and prescriber specialty.

SourceLink

POLICY UPDATE CHANGES

Max units updated from 345 billable units to 400 billable units.

Removed leukotriene receptor antagonists as an example of additional asthma controller or asthma maintenance medications.

3 mg/kg IV q4wapproved dosing

400HCPCS max units /4w

6 moinitial approval

12 morenewal approval

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Coverage Criteria for Cinqair (reslizumab)

Asthma: Initial and Continuation Therapy

Approve Cinqair for asthma when ONE of the following conditions (A or B) is met:

Overall: Either A. Initial Therapy OR B. Currently Receiving Cinqair

A. Initial Therapy

A.i: Patient is ≥ 18 years of age
See policy age requirement
A.ii: Either: blood eosinophil count ≥ 400 cells/µL within the previous 4 weeks (or within 4 weeks prior to treatment with Cinqair or another monoclonal antibody that may lower eosinophil levels) OR patient is dependent on systemic corticosteroids>= 400 cells/µL or steroid dependence
Examples of monoclonal antibodies that may lower eosinophils are listed in policy
A.iii: Patient has received ≥ 3 consecutive months of combination therapy with BOTH: (a) an inhaled corticosteroid AND (b) at least one additional asthma controller or asthma maintenance medication>= 3 months
Combination inhaler containing both components meets this requirement
A.iv: Patient has uncontrolled asthma at baseline as defined by ONE of: (a) ≥2 exacerbations requiring systemic corticosteroids in the previous year; OR (b) ≥1 exacerbation requiring hospitalization, ED, or urgent care in the previous year; OR (c) FEV1 < 80% predicted; OR (d) FEV1/FVC < 0.80; OR (e) asthma worsens upon tapering oral corticosteroids
'Baseline' defined as prior to receiving Cinqair or another monoclonal antibody therapy
A.v: Medication prescribed by or in consultation with an allergist, immunologist, or pulmonologist

B. Currently Receiving Cinqair

B.i: Patient has received at least 6 months of therapy with Cinqair>= 6 months
Patients with <6 months or restarting should be considered under Initial Therapy
B.ii: Patient continues to receive therapy with one inhaled corticosteroid or one inhaled corticosteroid-containing combination
B.iii: Patient has responded to therapy as determined by the prescriber (examples: decreased exacerbations, symptoms, health care visits, or oral corticosteroid requirement)
Examples of response provided in policy

Concurrent use of Cinqair with another monoclonal antibody therapy is not recommended. Examples of monoclonal antibody therapies listed in the policy include Fasenra, Nucala, Dupixent, Tezspire, Xolair, and Adbry. Requests for coverage that propose treating a member with Cinqair at the same time as any of these agents may be denied under the conditions listed in the policy.

Cinqair (reslizumab) is indicated only as add-on maintenance treatment for severe eosinophilic asthma in adults ≥18 years and is not indicated for other eosinophilic conditions. Specifically, use of Cinqair for indications such as eosinophilic esophagitis, eosinophilic gastroenteritis, hypereosinophilic syndrome, or nasal polyps is not recommended. Concurrent administration with another monoclonal antibody therapy (for example, Fasenra, Nucala, Dupixent, Tezspire, Xolair, or Adbry) is also not recommended and may be considered not medically necessary.

Coding: Procedure, Drug, and Diagnosis Codes

Applicable Procedure CodesHCPCS

J2786

Injection, reslizumab, 1 mg

Applicable NDCsNDC

59310-0610-31	Cinqair 10mg/mL Solution
59310-0610-33	Cinqair 10mg/mL Solution

ICD-10 DiagnosesICD-10

J45.50	Severe persistent asthma, uncomplicated
J45.909	Unspecified asthma, uncomplicated
J45.998	Other asthma

inv-07: Blood eosinophil count — key clinical threshold (used in approval criteria)

Blood eosinophil threshold≥ 400 cells/µL within the previous 4 weeks (or within 4 weeks prior to treatment with Cinqair or another monoclonal antibody that may lower blood eosinophil levels)

Alternate eligibilityOr systemic corticosteroid dependence (as an alternative to the eosinophil threshold)

Timing for laboratory testCount must be from within the previous 4 weeks or within 4 weeks prior to starting Cinqair or another monoclonal antibody therapy

Monoclonal antibodies that may lower eosinophils (examples)Cinqair, Adbry, Dupixent, Fasenra, Nucala, Tezspire, Xolair

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cinqair. The treating physician or primary care provider must submit clinical evidence that the member meets the criteria for treatment. Without clinical documentation (medical records, labs, prior therapies, and any relevant consultations), EmblemHealth will not be able to properly review the preauthorization request or perform post-payment review.

Prior authorization required before initiation of therapy.
Submit documentation showing blood eosinophil count and prior controller therapy.
Prescriber must be an allergist, immunologist, or pulmonologist or treatment must be in consultation with one.

Documentation Required

Required Clinical Documentation

Treating physician must submit clinical documentation to support the prior authorization request, including but not limited to: medical records showing age, blood eosinophil count (within 4 weeks), documentation of asthma control/uncontrolled status (exacerbations, hospitalizations, ED/urgent care visits), spirometry results (FEV1, FEV1/FVC), prior and current medication lists, dates and duration of prior therapies, and notes demonstrating response to therapy for continuation requests.

Definitions and Baseline

inv-13: Baseline — Defined as status prior to receiving Cinqair or another monoclonal antibody therapy for asthma.

DefinitionBaseline is defined as status prior to receiving Cinqair or another monoclonal antibody therapy for asthma.

Purpose in criteriaUsed to determine whether asthma was uncontrolled at baseline (e.g., exacerbation history, spirometry) prior to monoclonal antibody exposure.

Examples of monoclonal antibodies referencedCinqair, Dupixent, Fasenra, Nucala, Tezspire, Xolair

Cinqair (reslizumab) is an interleukin-5 (IL-5) antagonist monoclonal antibody indicated as add‑on maintenance therapy for patients ≥18 years with severe eosinophilic asthma. The agent is intended for chronic management of eosinophilic asthma and has limitations of use: it is not indicated for treatment of other eosinophilic conditions or for relief of acute bronchospasm or status asthmaticus.