CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cinqair (reslizumab) (Intravenous) - Coverage Criteria

Clinical coverage and prior authorization criteria for Cinqair (reslizumab) IV for adults with severe eosinophilic asthma across Medicaid, Commercial, and Medicare lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCinqair (reslizumab) (Intravenous) - Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and document age, specialist involvement, eosinophil ≥400 cells/µL (or steroid dependence), optimized controllers, exacerbation history, and prior failure/intolerance to Nucala or Fasenra.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 mg/kg q4wdose

≥400 cells/µLeosinophil threshold

6 monthsinitial duration

12 monthsrenewal duration

J2786HCPCS

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Initial Therapy

Covered when ALL of the following are met:

Initial criteria: Member is 18 years of age or older; AND Cinqair is prescribed by, or in consultation with, a pulmonologist or allergist/immunologist; AND documentation of severe asthma; AND asthma with an eosinophilic phenotype with blood eosinophil count >= 400 cells per microliter within 4 weeks of starting therapy OR systemic corticosteroid dependence; AND adherent to optimized inhaled corticosteroid therapy for at least 3 months; AND adherent to an additional controller medication (long-acting beta2-agonist, long-acting muscarinic antagonist, or leukotriene modifier) for at least 3 months unless contraindicated or not tolerated; AND inadequate asthma control with >= 2 exacerbations in the previous 12 months requiring additional medical treatment (e.g., oral corticosteroids, ED/urgent care visits, or hospitalizations); AND will be used as add-on maintenance therapy; AND prior failure, intolerance, or contraindication to Nucala (mepolizumab) or Fasenra (benralizumab); AND will not be used concomitantly with other anti-IgE, anti-IL4, anti-IL5, or IgG2 lambda monoclonal antibody agents (e.g., Dupixent, Fasenra, Nucala, Xolair, Tezspire); AND baseline measurement of at least one clinical status parameter (use of systemic corticosteroids, use of inhaled corticosteroids, number of hospitalizations/ER/unscheduled visits for asthma, or FEV1); AND not for treatment of other eosinophilic conditions (e.g., allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome) or for relief of acute bronchospasm or status asthmaticus.

Continuation of Therapy

Covered when ALL of the following are met:

Continuation criteria: Member is 18 years of age or older; AND Cinqair is prescribed by, or in consultation with, a pulmonologist or allergist/immunologist; AND member is tolerating treatment with absence of unacceptable toxicity (examples include malignancy, parasitic/helminth infection, anaphylaxis); AND treatment has resulted in clinical benefit as demonstrated by decreased use of systemic corticosteroids, a two-fold or greater decrease in inhaled corticosteroid use for at least 3 days, reductions in hospitalizations/ER visits/unscheduled visits OR improvement in FEV1 from baseline; AND will be used as add-on maintenance therapy; AND will not be used concomitantly with other anti-IgE, anti-IL4, anti-IL5, or IgG2 lambda monoclonal antibody agents (e.g., Dupixent, Fasenra, Nucala, Xolair, Tezspire).

This policy excludes use of Cinqair (reslizumab) for non-asthma eosinophilic disorders and for acute symptom relief. Specifically, Cinqair will not be used for treatment of other eosinophilic conditions (for example, allergic bronchopulmonary aspergillosis/mycosis, Churg–Strauss syndrome, hypereosinophilic syndrome) or for relief of acute bronchospasm or status asthmaticus. These exclusions apply regardless of eosinophil counts or prior biologic therapy and are consistent with the stated initial-therapy criteria and baseline assessment requirements.

Therapies used at a dose or for a condition that is not a recognized medically accepted indication are considered investigational and are not covered. Investigational use is defined as use at a dose or for a condition not listed in standard reference compendia (e.g., AHFS‑DI, DrugDex, Clinical Pharmacology, Lexi‑Drugs) or not supported by peer‑reviewed published medical literature demonstrating sufficient evidence of benefit.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — Cinqair (reslizumab) is reviewed prospectively via the prior authorization process. Coverage is under the Medical Benefit when used within policy guidelines. Use outside these stated guidelines or without meeting prior authorization criteria may result in non-payment unless approved under an exception process.

Prior authorization required prior to initiation of therapy
Coverage may be denied or not paid if used outside guidelines without an approved exception

Note

Medicare Step Therapy Exception

Medicare members who have received Cinqair within the past 365 days are exempt from the step therapy requirement.

Medicare exemption applies only if medication was received within prior 365 days

Step Therapy

Step Therapy Requirement

Step therapy requirement — members must have had failure, intolerance, or contraindication to Nucala (mepolizumab) or Fasenra (benralizumab) prior to initiation of Cinqair, unless the Medicare exception above applies.

Documented failure, intolerance, or contraindication to Nucala or Fasenra is required prior to Cinqair
Medicare members with prior Cinqair use within 365 days are exempt from this step therapy requirement

Documentation Required

Documentation Requirements

Documentation requirements — prior authorization requests must include member age, prescribing clinician specialty or documentation of consultation with a pulmonologist or allergist/immunologist, and supporting clinical documentation as specified in initial and continuation criteria.

Member age (>= 18 years) must be documented
Prescriber is a pulmonologist or allergist/immunologist or documentation of consultation with such a specialist
Baseline clinical measures (systemic or inhaled corticosteroid use, hospitalizations/ER visits/unscheduled visits, or FEV1) must be provided
Documentation of failure/intolerance/contraindication to Nucala or Fasenra when applicable

Denial Risk

Billing/Coverage Risk

Billing/coverage risk — use outside the stated guidelines or without meeting prior authorization and documentation requirements may result in non-payment.

Claims submitted for Cinqair that do not meet prior authorization criteria or lack required documentation may be denied or result in non-payment

Definitions and Background

inv-14: Components of severe asthma — severity features

Frequent daily symptomsSymptoms throughout the day

Nighttime awakeningsNighttime awakenings, often nightly (up to 7x/week)

SABA overuseShort-acting beta agonist use for symptom control several times per day

Marked activity limitationExtremely limited normal activities

Reduced lung functionPercent predicted FEV1 < 60%

Frequent/intense exacerbationsExacerbations requiring oral systemic corticosteroids that are more frequent/intense relative to moderate asthma

Cinqair (reslizumab) is an anti‑IL‑5 monoclonal antibody indicated as add‑on maintenance therapy for adults with severe eosinophilic asthma. Clinical development demonstrated reductions in exacerbation rates and improvements in lung function and patient outcomes among patients with elevated blood eosinophils. Per the coverage criteria, Cinqair is intended for adults (age ≥18) with a documented severe asthma phenotype (components may include frequent daily symptoms, nighttime awakenings, frequent SABA use, markedly limited activity, or percent predicted FEV1 <60%) and an eosinophilic phenotype or systemic corticosteroid dependence; it is administered intravenously per dosing guidance and used as add‑on maintenance therapy after optimization of inhaled controller regimens.

OpenPayer

Cinqair (reslizumab) (Intravenous) - Coverage Criteria

Coverage Criteria for Cinqair (reslizumab) IV

Coding, Dose, and Laboratory Thresholds

Provider Actions, Prior Authorization, and Documentation

Definitions and Background