ModifiedHealth NetPolicy CP.PHAR.223

Reslizumab (Cinqair)

Policy governing medical necessity and prior authorization criteria for reslizumab (Cinqair) as add-on maintenance therapy for patients with severe eosinophilic asthma aged 18 and older across specified Health Net lines of business.

Policy Summary

PayerHealth Net

PolicyReslizumab (Cinqair)

Policy CodePolicy CP.PHAR.223

Change TypeMaterial clinical updates

Effective DateJun 1, 2016

Next Review Date

Key ActionPrior authorization is required and providers must submit office notes, lab results (including absolute blood eosinophil count), and documentation of controller therapy adherence (PDC ≥ 0.8 for continuation).

SourceLink

POLICY UPDATE CHANGES

For initial approval criteria, added allowance for ER visit; removed intubation option for alignment.

For continuation criteria, adherence was defined as proportion of days covered (PDC) >= 0.8.

Tezspire (tezepelumab) was added as another agent with which Cinqair should not be used concurrently.

≥18minimum age

≥400eosinophil threshold

≤3 mg/kgmax dosing

PDC≥0.8continuation adherence

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authorization period

Coverage Criteria for Reslizumab (Cinqair)

Initial Therapy

Covered when ALL of the following are met:

Initial criteria: 1) Diagnosis of asthma;

Severe asthma (must meet all subcriteria): 2) Severe asthma (must meet all): member has an absolute blood eosinophil count ≥ 400 cells/mcL within the past 3 months;

Age requirement: 3) Age ≥ 18 years;

Specialist involvement: 4) Prescribed by or in consultation with an allergist, immunologist, or pulmonologist;

Exacerbation history: 5) History of ≥ 2 exacerbations within the prior 12 months, defined as either (a) systemic/oral corticosteroid treatment (or increase in dose if already on oral corticosteroid) OR (b) urgent care/ER visit or hospital admission, despite adherent controller therapy (medium‑ to high‑dose ICS plus either a LABA or an LTRA if LABA contraindicated);

Controller therapy concurrent: 6) Cinqair is prescribed concurrently with an inhaled corticosteroid (ICS) plus either a long‑acting beta‑2 agonist (LABA) or a leukotriene receptor antagonist (LTRA);

No concurrent specified biologics: 7) Cinqair is not prescribed concurrently with Fasenra, Nucala, Dupixent, Xolair, or Tezspire;

Dose limit: 8) Dose does not exceed 3 mg/kg once every 4 weeks.

Continuation Therapy

Covered for continued therapy when ONE of the following applies:

Continuation pathways: a) Member is currently receiving medication via the Centene benefit or has previously met initial approval criteria;

Additionally, member must demonstrate adherence (PDC ≥ 0.8 over the last 6 months) and positive clinical response; dose increases must not exceed 3 mg/kg q4w; Cinqair must not be prescribed concurrently with Fasenra, Nucala, Dupixent, Xolair, or Tezspire.

Continuation pathways: b) Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (see state‑specific addendums).

Reslizumab (Cinqair) is not covered for treatment of acute bronchospasm or status asthmaticus. Requests for indications that are not FDA‑approved and are not supported by the plan's off‑label use policies (see CP.CPA.09, HIM.PA.154, CP PMN.53) will be denied unless sufficient documentation is provided demonstrating safety and efficacy per those off‑label criteria. Coverage is limited to the add‑on maintenance indication for severe eosinophilic asthma meeting the policy's specified criteria (including age, eosinophil threshold, exacerbation history, concurrent controller therapy, and dosing limits).

Concurrent use of Cinqair with other biologic agents specified in the policy is not recommended and may lead to denial of coverage. The policy specifically lists Fasenra, Nucala, Dupixent, Xolair, and, per recent updates, Tezspire (tezepelumab) as agents with which reslizumab should not be prescribed concurrently; clinicians must account for prior or current biologic therapy when requesting authorization.

Requests that do not meet the policy's stated medical necessity criteria will be considered not medically necessary. Examples include but are not limited to: an absolute blood eosinophil count below 400 cells/mcL within the prior 3 months, failure to document the required exacerbation history (e.g., fewer than two exacerbations in the prior 12 months requiring systemic corticosteroids, urgent/ER visit, or hospitalization despite adherent controller therapy), lack of documentation that the member is on concurrent inhaled corticosteroid plus LABA (or LTRA when LABA is contraindicated), exceeding the dosing limit of 3 mg/kg every 4 weeks, or concurrent prescribing with excluded biologic agents. Providers must submit office chart notes, relevant lab results, and other supporting documentation to demonstrate that all approval criteria are met.

Product Availability, Dosing, and Coding

Product availability/dose formmixed

100 mg/10 mL

Single-use vial concentration

HCPCS Codes referencedHCPCS

J2786

Injection, reslizumab; 1 mg

inv-08: Absolute blood eosinophil count — AEC ≥ 400 cells/mcL within the past 3 months.

Absolute blood eosinophil countAEC ≥ 400 cells/mcL within the past 3 months

Measurement timeframeWithin the past 3 months prior to request

PurposeMeets initial-therapy threshold for severe eosinophilic asthma eligibility

inv-09: Dose limit — Maximum 3 mg/kg every 4 weeks.

Maximum dose3 mg/kg every 4 weeks (does not exceed 3 mg/kg q4w)

Dosing frequencyOnce every 4 weeks (q4w)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Prior authorization is required for Cinqair (reslizumab). Initial approvals vary by line of business: Medicaid/HIM — 12 months; Commercial — 6 months or the member's renewal period, whichever is longer.

Prior authorization required for J2786 (Injection, reslizumab) — see coding guidance.
Inclusion or exclusion of codes does not guarantee coverage; verify with current professional coding guidance before claim submission.

Billing Rule

Billing Code and Coding-Related Denial Risk

Billing code information and coding-related denial risk. HCPCS code J2786 is referenced for reslizumab. Codes shown are informational only; inclusion or exclusion of codes in this policy does not guarantee coverage.

Background on Reslizumab (Cinqair)

Reslizumab (Cinqair) is a humanized interleukin‑5 antagonist monoclonal antibody indicated as add‑on maintenance therapy for adults with severe eosinophilic asthma. It is intended to reduce exacerbations in patients meeting the policy's clinical criteria and must be administered in a healthcare setting by personnel prepared to manage hypersensitivity reactions; dosing and product availability information (single‑use vial: 100 mg/10 mL) and administration guidance are provided in the prescribing information.

Definitions and Reference Information

inv-23: Reslizumab (Cinqair) — drug identity entry (humanized IL-5 antagonist monoclonal antibody).

Drug identityReslizumab (Cinqair) — humanized interleukin‑5 (IL‑5) antagonist monoclonal antibody (IgG4 kappa)

Indication summaryAdd‑on maintenance treatment for severe eosinophilic asthma in adults

Administration noteAdministered in a healthcare setting by a healthcare professional prepared to manage anaphylaxis

inv-24: PDC (Proportion of Days Covered) — definition and numeric equivalence (PDC ≥ 0.8 ~144/180 days).

DefinitionProportion of Days Covered (PDC) = days covered ÷ days in time frame

Numeric equivalencePDC ≥ 0.8 ≈ 144/180 days covered (about 5 of last 6 months)

Policy Summary

PayerHealth Net

PolicyReslizumab (Cinqair)

Policy CodePolicy CP.PHAR.223

Change TypeMaterial clinical updates

Effective DateJun 1, 2016

Next Review Date

SourceLink

On This Page

Administration settingAdministered in a healthcare setting by a healthcare professional prepared to manage anaphylaxis

inv-10: Adherence (PDC) — PDC ≥ 0.8 over the last 6 months (continuation requirement as defined previously).

Adherence thresholdPDC ≥ 0.8 over the last 6 months

Equivalent days coveredAt least 144 of the last 180 days (≈5 of 6 months)

ContextRequired for continuation requests to demonstrate adherence to controller therapy

inv-11: Adherence (PDC) restated — >= 0.8 (alternate reference to continuity criteria).

>= Adherence threshold (alternate)>= 0.8 (PDC) for the continuation/continuity criteria

Defined in reviewAdherence defined as PDC ≥ 0.8 during 1Q 2022 annual review

Documentation expectationDocumentation of controller therapy fills covering the measured period should be provided

HCPCS J2786 — Injection, reslizumab; providers should bill using current HCPCS guidance.
Providers should reference up-to-date professional coding resources; incorrect or outdated coding may result in claim denial.

Documentation Required

Required Documentation to Support Medical Necessity

Required documentation to support medical necessity. Submit clinical documentation demonstrating the member meets all approval criteria.

Office/consultation notes including specialty (allergist, immunologist, or pulmonologist) and treatment history.
Recent laboratory results showing absolute blood eosinophil count (AEC) — must document value and collection date.
Evidence of exacerbations (e.g., ER visit, hospitalization, systemic corticosteroid prescriptions) and documentation of adherence to controller therapy.
If prior authorization is for continuation or dose increase, include prior authorization history and dosing records.

Denial Risk

Noncovered Indications / Denial Conditions

Noncovered indications and denial conditions. Requests for acute bronchospasm/status asthmaticus or non‑FDA approved indications not supported by appropriate evidence will be denied.

Acute bronchospasm or status asthmaticus — not authorized.
Off‑label uses not addressed in this policy require sufficient documentation per applicable off‑label policies (CP.CPA.09, HIM.PA.154, CP PMN.53).

Prior Authorization

Controller Therapy & Concurrent Biologic Therapy

Controller therapy and concurrent biologic therapy requirements. Cinqair is an add‑on maintenance therapy and must be prescribed concurrently with an inhaled corticosteroid (ICS) plus either a LABA or an LTRA when LABA is contraindicated/intolerant. Cinqair should not be prescribed concurrently with other biologic agents listed.

Must document concurrent controller regimen (ICS + LABA or LTRA) and adherence.
Do not prescribe concurrently with other biologics: Fasenra, Nucala, Dupixent, Xolair, or Tezspire; concurrent biologic therapy requests will be denied (planner inv-15, inv-20).
If member cannot use LABA, document contraindication/intolerance and use of LTRA as alternative.

Documentation Required

Continuation Documentation and Renewal Requirements

Continuation criteria and renewal documentation. For continuation, document adherence to controller therapy and clinical response to Cinqair.

Adherence: Proportion of days covered (PDC) ≥ 0.8 for asthma controller therapy in the last 6 months (≈144 of 180 days).
Clinical response examples: reduction in exacerbations or systemic corticosteroid use, improved FEV1 from baseline, decreased rescue medication use.
If requesting dose increase, new dose must not exceed 3 mg/kg every 4 weeks; include justification and prior dosing records.

Use caseUsed to document adherence to controller therapy for continuation requests

inv-25: Cinqair Prescribing Information — reference to manufacturer-provided prescribing information.

Manufacturer referenceCinqair Prescribing Information — Teva Pharmaceutical Industries Ltd.; February 2020

PurposeSource for clinical and dosing details referenced in policy

Access noteAvailable at http://www.cinqair.com (accessed Oct 24, 2024) as cited in policy references