CurrentAvMedPolicy N/A

Nucala (mepolizumab) — Coverage Criteria for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Defines prior authorization and clinical criteria for coverage of Nucala (mepolizumab) as add-on therapy for adults with CRSwNP for AvMed members; applies to prescribers and specialty pharmacy processing requests.

Policy Summary

PayerAvMed

PolicyNucala (mepolizumab) — Coverage Criteria (CRSwNP)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a prescriber-signed prior authorization form with documentation (labs, diagnostics, chart notes and pharmacy paid claims) to support each clinical criterion.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

100 mgquantity limit

12 monthsauth duration

>=18min age

specialty Rxsite of care

Coverage Criteria for Nucala (mepolizumab)

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Initial Authorization Criteria: Member has a diagnosis of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP); prescribed by or in consultation with an allergist, immunologist, or otolaryngologist; member is 18 years of age or older; diagnosis of CRSwNP confirmed by AAO-HNSF/AAAAI with ONE diagnostic procedure (anterior rhinoscopy OR nasal endoscopy OR CT); chronic rhinosinusitis defined by at least 12 weeks of mucosal inflammation AND at least TWO of the following symptoms: decreased sense of smell, facial pressure/pain/fullness, mucopurulent drainage, nasal obstruction; member has tried and failed intranasal corticosteroids for at least 30 consecutive days within the past year (verified by pharmacy paid claims); member is requesting Nucala (mepolizumab) as add-on therapy to maintenance intranasal corticosteroids (verified by pharmacy paid claims).

All documentation (lab results, diagnostics, chart notes) must be provided to support each checked item.

inv-02: Continuation Therapy / Reauthorization — Reauthorization covered when ALL of the following are met

Reauthorization covered when ALL of the following are met

Reauthorization Criteria: Member has experienced a positive clinical response to Nucala (examples: reduced nasal polyp size, improved nasal congestion, reduced sinus opacification, decreased sino-nasal symptoms, improved sense of smell, reduction in use of oral corticosteroids); member has been compliant on Nucala therapy and continues intranasal corticosteroid therapy (verified by pharmacy paid claims).

Reauthorization period is 12 months; all supporting documentation must be provided.

The Health Plan considers concomitant use of multiple biologic therapies to be experimental and investigational and therefore not permitted. Specifically, combination therapy involving Cinqair, Dupixent, Fasenra, Nucala, and Xolair has not had safety and efficacy established and will not be approved. If a member has an active authorization for any of these agents (Cinqair, Dupixent, Fasenra, or Xolair), subsequent requests for Nucala (mepolizumab) will be denied.

Initial Therapy

inv-16: Initial Therapy — Initial coverage criteria for Nucala (mepolizumab)

Initial coverage criteria for Nucala (mepolizumab)

Initial Nucala (CRSwNP): Member is >=18 years; prescribed by or in consultation with an allergist, immunologist, or otolaryngologist; diagnosis of CRSwNP confirmed by AAO-HNSF/AAAAI with ONE diagnostic procedure (anterior rhinoscopy OR nasal endoscopy OR CT); chronic rhinosinusitis present for at least 12 weeks with mucosal inflammation AND at least TWO symptoms (decreased sense of smell, facial pressure/pain/fullness, mucopurulent drainage, nasal obstruction); member has tried and failed intranasal corticosteroids for at least 30 consecutive days within the past year (verified by pharmacy paid claims); request is for Nucala as add-on to maintenance intranasal corticosteroids (verified by pharmacy paid claims).Quantity limit: 100 mg per 28 days; initial authorization duration: 12 months.

All documentation (lab results, diagnostics, chart notes) must be provided to support each checked item.

Continuation / Reauthorization Criteria

inv-17: Reauthorization — Reauthorization requirements

Reauthorization requirements

Reauthorization: Member demonstrates a positive clinical response to Nucala therapy (e.g., reduced nasal polyp size, improved nasal congestion, reduced sinus opacification, decreased sino-nasal symptoms, improved sense of smell, decreased oral corticosteroid use); member is compliant on Nucala therapy and continues intranasal corticosteroid therapy (verified by pharmacy paid claims); documentation provided to support clinical response and compliance.Reauthorization duration: 12 months.

All documentation (lab results, diagnostics, chart notes) must be provided to support each checked item.

Coding and Age / Quantity Limits

Diagnosis codes (form field)ICD-10

ICD code — field present on form; specific ICD-10 code to be supplied by prescriber

inv-05: Age — 18 years or older

Minimum age18 years or older

Applies toMembers with a diagnosis of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

VerificationAge must be documented on the prior authorization form

inv-06: Quantity limit — 100 mg per 28 days

Quantity limit100 mg per 28 days

UnitDose (mepolizumab 100 mg)

NotesQuantity limit appears on the drug information section of the PA form

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization required. Initial and reauthorization requests may be delayed or denied if information is incomplete, incorrect, or illegible. Initial authorization is granted for 12 months when all clinical criteria are met.

Prior authorization fax: 1-305-671-0200
Initial Authorization Duration: 12 months
Reauthorization Duration: 12 months

Step Therapy

Samples and Verification

Samples may NOT be used to meet step-edit or prior authorization criteria. Prior therapies and concomitant maintenance intranasal corticosteroid use will be verified via pharmacy paid claims or submitted chart notes; include records to support prior-treatment history.

Use of samples to initiate therapy does not meet step edit/preauthorization criteria
Previous therapies will be verified through pharmacy paid claims or submitted chart notes
Maintenance intranasal corticosteroid use must be verifiable (pharmacy paid claims)

Documentation Required

Required Documentation

A prescriber-signed prior authorization form is required. To support each checked clinical criterion, provide documentation such as lab results, diagnostic reports (e.g., anterior rhinoscopy, nasal endoscopy, or CT), and chart notes confirming diagnosis, prior therapies, and clinical response. Requests may be denied if supporting documentation is not provided for every checked criterion.

Prescriber signature required (preprinted stamps not valid)
Provide documentation for each checked clinical criterion: lab results, diagnostics, chart notes
Documentation must confirm CRSwNP diagnosis and prior therapy attempts

Denial Risk

Concomitant Biologic Therapy Exclusion

Concomitant use of biologic therapies is NOT permitted. Requests will NOT be approved if the member has an active authorization for Cinqair®, Dupixent®, Fasenra®, and/or Xolair®. The Health Plan considers combination use of these biologics to be experimental and investigational.

Denied if active authorization exists for Cinqair®, Dupixent®, Fasenra®, or Xolair® on file
Safety and efficacy of concomitant biologic combinations have not been established

Step	Requirement
1	Documentation of prior intranasal corticosteroid use verified by pharmacy paid claims (samples cannot be used to meet step-edit or prior authorization criteria).

Background

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a chronic inflammatory condition of the sinonasal mucosa characterized by mucosal inflammation, nasal obstruction, and loss of smell. Management centers on maintenance intranasal corticosteroids and, for patients with refractory disease and type 2 inflammation, add-on biologic therapy to reduce polyp size, improve sinonasal symptoms, and decrease the need for systemic corticosteroids.

For coverage under this policy, CRSwNP must be documented as the diagnosis on the prior authorization form and supported by the required diagnostic confirmation and clinical documentation. The prior authorization form requires that all criteria be met and that supporting documentation (lab results, diagnostics, and chart notes) be provided to substantiate the diagnosis and prior therapies.

Definitions and Diagnostic Criteria

inv-14: Chronic rhinosinusitis (per policy) — Definition and symptom criteria

Definition (duration)Chronic rhinosinusitis defined by at least 12 weeks of mucosal inflammation

Required symptom countAt least TWO of: decreased sense of smell, facial pressure/pain/fullness, mucopurulent drainage, nasal obstruction

DiagnosisChronic Rhinosinusitis with Nasal Polyps (CRSwNP)

inv-15: Diagnostic confirmation — One of: anterior rhinoscopy, nasal endoscopy, or CT

Acceptable diagnostic proceduresOne of: anterior rhinoscopy, nasal endoscopy, or computed tomography (CT)

Guideline referenceDiagnosis confirmed per AAO-HNSF/AAAAI clinical practice guidance as listed on the PA form

Documentation requirementConfirmatory procedure must be documented and provided with the prior authorization request

Policy Summary

PayerAvMed

PolicyNucala (mepolizumab) — Coverage Criteria (CRSwNP)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a prescriber-signed prior authorization form with documentation (labs, diagnostics, chart notes and pharmacy paid claims) to support each clinical criterion.

SourceLink

On This Page

OpenPayer

Nucala (mepolizumab) — Coverage Criteria for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Coverage Criteria for Nucala (mepolizumab)

Initial Therapy

Continuation / Reauthorization Criteria

Coding and Age / Quantity Limits

Quantity Limit Details

Provider Actions and Requirements

Step Therapy / Prior Treatment Verification

Site of Care / Dispensing

Background

Definitions and Diagnostic Criteria