CurrentAnthemPolicy N/A

CINQAIR (reslizumab) prior authorization for severe eosinophilic asthma

Prior authorization form and criteria for coverage of Cinqair (reslizumab) for Medicaid members in Anthem HealthKeepers Plus Virginia products; intended for prescribers requesting PA for initiation or renewal for severe eosinophilic asthma.

Policy Summary

PayerAnthem

PolicyCINQAIR (reslizumab) prior authorization for severe eosinophilic asthma

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with documentation of age, eosinophil count (≥400 cells/µL), prior exacerbations, controller therapy, and prior trials of Fasenra and Xolair.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial approval

12 monthsrenewal approval

≥400eosinophil threshold

2+required exacerbations

Fasenra, Xolairrequired prior trials

Coverage Criteria for CINQAIR (reslizumab)

Initial Therapy

Covered when ALL of the following are met for initial approval (6 months):

Initial approval: Member is 18 years of age or older.

Initial approval: Member has a diagnosis of severe asthma.

Initial approval: Asthma has an eosinophilic phenotype defined as blood eosinophils ≥400 cells/µL.≥400 cells/µL

Initial approval: Coadministration with another monoclonal antibody (for example, omalizumab, mepolizumab, benralizumab, dupilumab, tezepelumab-ekko) will be avoided.

Policy Summary

PayerAnthem

PolicyCINQAIR (reslizumab) prior authorization for severe eosinophilic asthma

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with documentation of age, eosinophil count (≥400 cells/µL), prior exacerbations, controller therapy, and prior trials of Fasenra and Xolair.

SourceLink

On This Page

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Initial approval: Cinqair will be used as add-on maintenance treatment in members regularly receiving both medium- to high-dose inhaled corticosteroids and an additional controller medication (for example, long-acting beta agonist or leukotriene modifiers), unless otherwise contraindicated.

Initial approval: Member has had two or more exacerbations in the previous year requiring oral or injectable corticosteroid treatment (in addition to regular maintenance therapy) or one exacerbation resulting in hospitalization.

Initial approval: There is at least one objective measure available for assessment of clinical status (use of systemic corticosteroids, use of inhaled corticosteroids, number of hospitalizations/ER/unscheduled visits for the condition, or FEV1).

Initial approval: Member has tried and failed adequate trials of the two different preferred products (Fasenra® and Xolair®).

Initial approvals are for 6 months.

Continuation Therapy / Renewal

Covered when ALL of the following are met for renewal (12 months):

Renewal approval: Member has been assessed for toxicity.

Renewal approval: Member has shown improvement in asthma symptoms or exacerbations as evidenced by a decrease in one or more of the following: use of systemic corticosteroids, hospitalizations, ER visits, or unscheduled visits to a healthcare provider; or improvement from baseline in FEV1.

Renewals are for 12 months.

The policy does not allow coadministration of Cinqair (reslizumab) with other monoclonal antibody therapies. The Virginia DMAS considers concomitant use of Cinqair with Dupixent, Fasenra, Nucala, Tezspire, or Xolair to be experimental and investigational; the safety and efficacy of these combinations have not been established and such combinations will not be permitted under this policy.

Initial Therapy (6-month approval)

Initial therapy

Initial therapy (6-month approval) criteria:

Initial: Age ≥18 years.

Initial: Diagnosis of severe asthma.

Initial: Eosinophilic phenotype with blood eosinophils ≥400 cells/µL.≥400 cells/µL

Initial: Avoidance of concomitant monoclonal antibody therapy.

Initial: Member is on medium- to high-dose inhaled corticosteroids plus another controller medication.

Initial: Member has had ≥2 exacerbations in the prior year requiring oral or injectable corticosteroids (or ≥1 hospitalization).

Initial: Objective measures are available for assessment (systemic or inhaled corticosteroid use, hospitalizations/ER/unscheduled visits, or FEV1).

Initial: Failure of two preferred products (Fasenra® and Xolair®).

6-month approval.

Continuation / Renewal (12-month approval)

Renewal requirements

Renewal (12-month approval) requires assessment for toxicity and clinical improvement.

Renewal: Assessment for toxicity AND documented improvement in symptoms or exacerbations (reduced systemic steroid use, fewer hospitalizations/ER visits/unscheduled visits, or improved FEV1 compared with baseline).N/A

12-month approval upon meeting criteria.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and renewal of Cinqair (reslizumab). Initial approvals for severe eosinophilic asthma are issued for 6 months; renewals are issued for 12 months.

Initial approval duration: 6 months
Renewal approval duration: 12 months

Step Therapy

Step Therapy Requirement

Member must have tried and failed adequate trials of two different preferred products prior to approval.

Required prior trials: failed trials of Fasenra® and Xolair®

Documentation Required

Required PA Form Documentation

A completed PA form must be submitted. The form must include member demographics (name, Medicaid ID, date of birth, weight in kg), prescriber information (name, NPI, phone, fax, prescriber signature and date), and detailed drug information (drug name, form, strength, dosing frequency, quantity, length of therapy). Incomplete or illegible forms may delay processing. Fax completed forms to 844-512-7020. Email signup instructions are available at http://anthem.ly/signup-abcbs-va.

Member information: last name, first name, Medicaid ID number, date of birth, weight (kg)
Prescriber information: last name, first name, NPI number, phone number, fax number, prescriber signature and date
Drug information: drug name, drug form, drug strength, dosing frequency, quantity per day, length of therapy
Fax completed form to 844-512-7020

Denial Risk

Coadministration Prohibited

Coadministration of Cinqair with other monoclonal antibodies is prohibited. The following agents must not be used concomitantly with Cinqair: omalizumab (Xolair), mepolizumab (Nucala), benralizumab (Fasenra), dupilumab (Dupixent), tezepelumab-ekko (Tezspire).

Forbidden coadministration examples: omalizumab, mepolizumab, benralizumab, dupilumab, tezepelumab-ekko

Clinical Thresholds and Key Values

Hematologic threshold — eosinophilic phenotype

ThresholdBlood eosinophils ≥400 cells/µL

Measurement contextDefined as part of initial approval criteria for severe eosinophilic asthma (adult members)

PurposeIdentifies eosinophilic phenotype required for coverage of Cinqair (reslizumab)

Age applicabilityApplied for members 18 years of age or older per initial approval criteria

Severe asthma — definition & clinical context

DefinitionSevere asthma: asthma that remains uncontrolled despite optimized treatment with high‑dose ICS‑LABA, or requires high‑dose ICS‑LABA to prevent it from being uncontrolled; may include frequent symptoms, nighttime awakenings, high SABA use, limited activities, FEV1 <60% predicted, and frequent/exacerbating exacerbations.

Clinical context (initial approval)Member must have a diagnosis of severe asthma and be ≥18 years of age to qualify for initial Cinqair approval.

Required background therapyMust be receiving medium‑ to high‑dose inhaled corticosteroids plus an additional controller medication (e.g., LABA, leukotriene modifier) when used as add‑on maintenance treatment.

Assessment measuresObjective measures for assessment may include systemic or inhaled corticosteroid use, number of hospitalizations/ER/unscheduled visits, or FEV1.

Renewal contextRenewal requires assessment for toxicity and documented clinical improvement in symptoms or exacerbations (reduced systemic steroid use, fewer hospitalizations/ER visits/unscheduled visits, or improved FEV1).

Step Therapy Requirements

Step	Required prior trial(s)	Notes
1
Trial and failure of Fasenra (benralizumab)
Member must have tried and failed an adequate trial of the preferred product Fasenra before Cinqair approval

Background

Cinqair (reslizumab) is an anti–IL‑5 monoclonal antibody indicated as an add‑on maintenance treatment for adults with severe eosinophilic asthma. The policy defines the eosinophilic phenotype as blood eosinophils of ≥400 cells/µL and requires that patients be receiving regular controller therapy (medium‑ to high‑dose inhaled corticosteroid plus an additional controller) while using Cinqair as add‑on maintenance.

For initial authorization, Cinqair is intended for adults (≥18 years) with severe asthma who have had clinical evidence of exacerbations (typically ≥2 exacerbations in the prior year or ≥1 hospitalization) despite optimized controller therapy; initial approvals are for 6 months. Renewal (continuation) requires documented assessment for toxicity and evidence of clinical improvement (for example, decreased systemic corticosteroid use, fewer hospitalizations/ED visits/unscheduled visits, or improved FEV1) and, when met, renewals are issued for 12 months.