CurrentAvMedPolicy N/A

Nucala - Chronic Rhinosinusitis with Nasal Polyps (CRSWNP) (Pharmacy)

Pharmacy prior authorization/step-edit form and policy for coverage of Nucala (mepolizumab) as add-on therapy for adults with CRSwNP, specifying initial and reauthorization criteria, quantity limit, specialty pharmacy, and prohibited concomitant biologic combinations.

Policy Summary

PayerAvMed

PolicyNucala - Chronic Rhinosinusitis with Nasal Polyps (CRSWNP) (Pharmacy)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit a completed pharmacy prior authorization/step-edit request with prescriber signature and all supporting documentation (labs, diagnostics, chart notes) or the request may be denied.

SourceLink

POLICY UPDATE CHANGES

No material change to policy — brief indicates has_material_change=false.

18+Age requirement (years)

100 mg/28dDosage limit

12 moAuthorization duration

>=30dRequired intranasal steroid trial

Coverage Summary

Pharmacy prior authorization/step-edit form and policy for coverage of Nucala (mepolizumab) as add-on therapy for adults with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). Coverage is covered with criteria and requires that all initial and reauthorization criteria be met (including prescriber specialty, age ≥18, diagnostic confirmation, chronicity and symptom criteria, verification of a ≥30-day intranasal corticosteroid trial, and ongoing intranasal corticosteroid use); quantity limit is 100 mg per 28 days and authorization duration is 12 months.

Key threshold facts

Age requirement>= 18 years

Prior intranasal corticosteroid trial>= 30 consecutive days within 1 year of request

Chronicity requirement>= 12 weeks of mucosal inflammation

Quantity limit100 mg per 28 days

Authorization duration12 months

Initial Authorization (12 months)

Covered when ALL of the following are met:

ALL of the following

Prescribed by or in consultation with an allergist, immunologist or otolaryngologist
Member is 18 years of age or older>= 18 years
Diagnosis: Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Diagnostic confirmation
- ONE of: Anterior rhinoscopy
- ONE of: Nasal endoscopy
- ONE of: Computed tomography (CT)
Chronicity and symptom criteria
- At least TWO of: Decreased sense of smell
- At least TWO of: Facial pressure, pain, fullness
- At least TWO of: Mucopurulent drainage
- At least TWO of: Nasal obstruction
Prior intranasal corticosteroid trial: Member has tried and failed intranasal corticosteroids for at least 30 consecutive days within a year of request (verified by pharmacy paid claims)>= 30 consecutive days within 1 year of request
verified by pharmacy paid claims
Concomitant maintenance intranasal corticosteroid: Member is requesting Nucala (mepolizumab) as add-on therapy to maintenance intranasal corticosteroids (verified by pharmacy paid claims)
verified by pharmacy paid claims

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Prior Authorization

Prior Authorization Required

A completed pharmacy prior authorization/step-edit request must be submitted (prescriber signature required); all documentation (lab results, diagnostics, chart notes) must be provided or request may be denied.

Reauthorization / Continuation Therapy (12 months)

Reauthorization (12 months)

Covered when ALL of the following are met:

ALL of the following

Member has experienced 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, reduction in use of oral corticosteroids)
examples provided
Member has been compliant on Nucala therapy and continues to receive therapy with an intranasal corticosteroid (verified by pharmacy paid claims)
verified by pharmacy paid claims

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Concomitant Biologic Exclusions

Requests will NOT be approved if the member has an active authorization on file for Cinqair (reslizumab), Dupixent (dupilumab), Fasenra (benralizumab), and/or Xolair (omalizumab) because concomitant use with Nucala is considered experimental and investigational and safety and efficacy of these combinations have not been established.

Prohibited Concomitant Biologic TherapiesmixedNot Covered

Cinqair	Reslizumab - concomitant use considered experimental/investigational and will NOT be permitted
Dupixent	dupilumab - concomitant use considered experimental/investigational and will NOT be permitted
Fasenra	benralizumab - concomitant use considered experimental/investigational and will NOT be permitted
Xolair	omalizumab - concomitant use considered experimental/investigational and will NOT be permitted

Denial Risk

Concomitant Biologic Exclusion

Requests for Nucala will NOT be approved if the member has an active authorization on file for Cinqair, Dupixent, Fasenra, and/or Xolair due to experimental/investigational status of combinations.

Provider Requirements & Documentation

Documentation Required

Diagnostic Documentation

Provide clinical procedure evidence (anterior rhinoscopy, nasal endoscopy, or CT) confirming CRSwNP and documentation of at least 12 weeks of mucosal inflammation with at least two specified symptoms.

Documentation Required

Prior Therapy Verification

Verification of trial and failure of intranasal corticosteroids for at least 30 consecutive days and ongoing use of intranasal corticosteroids must be confirmed by pharmacy paid claims.

Documentation Required

Prescriber Requirement

Prescribing physician must sign and clearly print name on the request (preprinted stamps not valid).

Prior Authorization

Prior Authorization Required

OpenPayer

Nucala - Chronic Rhinosinusitis with Nasal Polyps (CRSWNP) (Pharmacy)

Coverage Summary

Initial Authorization (12 months)

Reauthorization / Continuation Therapy (12 months)

Concomitant Biologic Exclusions

Applicable Codes & Limits

Provider Requirements & Documentation

Clinical Evidence & Definitions

Revision History