CurrentHighmark DelawarePolicy N/A

Outpatient Medical Injectable Monoclonal Antibodies for the Treatment of Asthma and Eosinophilic Conditions Request Form

This request form governs prior-authorization data collection for outpatient medical benefit injectable monoclonal antibody therapies (e.g., Nucala, Fasenra, Cinqair, Tezspire, Xolair, Dupixent) for members with asthma and eosinophilic conditions submitted to Highmark Delaware.

Policy Summary

PayerHighmark Delaware

PolicyOutpatient Medical Injectable Monoclonal Antibodies Request Form

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionFax the completed prior-authorization form with required clinical data to Highmark at 1-833-619-5745.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6clinical indication sections

5named biologics

1fax number

Coverage Criteria for Indications

Asthma (initial)

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Asthma initial authorization data: Member has severe or uncontrolled asthma; documentation includes ACT/ACQ score, number of exacerbations in past 12 months requiring oral or systemic corticosteroids, pre-bronchodilator FEV1 with date, prior-year asthma medication history, and blood eosinophil count/date when eosinophilic phenotype is indicated.see form fields

Form captures presence of eosinophilic phenotype and prior biologic exposure; use as basis for medical necessity review.

Asthma (continuation)

Continuation of therapy requires documentation of clinical improvement on the requested product

Continuation response criteria: One or more of: decreased utilization of rescue medications; decreased frequency of exacerbations; increased predicted FEV1 from pretreatment baseline (baseline and current FEV1 provided); reduction in reported asthma-related symptoms; decrease in ACQ-6 by 0.5 or increase in ACT by 3 from pretreatment baseline.see individual item thresholds on form

Form asks whether product will continue as add-on maintenance therapy and if used in combination with other biologics.

HES (Nucala)

Nucala for Hypereosinophilic Syndrome (HES) authorization data

HES prerequisites: Diagnosis of HES for greater than or equal to 6 months; absence of an identifiable non-hematologic secondary cause of HES; documentation of baseline blood eosinophil count (prior to starting Nucala) and stability on HES therapy for at least 4 weeks prior to starting Nucala; history of at least 2 HES flares within the past 12 months when applicable.>=6 months, >=2 flares, stable on therapy >=4 weeks

Form includes specific questions about FIP1L1-PDGFRα kinase–positive HES and flares, and requests baseline eosinophil count and stability on HES therapy.

EGPA (Nucala)

Nucala for Eosinophilic Granulomatosis with Polyangiitis (EGPA) authorization data

EGPA prerequisites: History of relapsing disease; member on a stable dosage of oral prednisolone or prednisone for at least 4 weeks when applicable; plan to receive standard of care (glucocorticoid with or without immunosuppressive therapy) while on Nucala.>=4 weeks stable steroid dose

Form asks these items for authorization review.

CRSwNP (Nucala)

Nucala for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) authorization data

CRSwNP prerequisites: Inadequate response to nasal corticosteroids for at least 8 weeks (unless not tolerated/contraindicated); symptoms consistent with CRSwNP for at least 12 weeks (nasal drainage, obstruction/congestion, facial pressure/pain, or decreased/loss of smell); bilateral nasal polyps confirmed by endoscopy or CT; provide NPS and VAS scores and surgical history for prior 10 years.>=8 weeks topical steroid trial, symptoms >=12 weeks

Form requests NPS and VAS scores, prior surgeries, and whether Nucala will be used as add-on maintenance therapy or in combination with other biologics.

The form explicitly queries for FIP1L1-PDGFRα kinase–positive HES as part of the HES section. If present, this finding is identified on the form as a distinct diagnostic consideration and would suggest an alternate diagnosis and treatment pathway rather than routine Nucala use; the form captures this to inform exclusionary or alternate-therapy decisions during prior authorization review.

The form asks whether the requested product will be prescribed in combination with other biologics (Fasenra, Cinqair, Nucala, Tezspire, Xolair, Dupixent) and repeats this query on the continuation section. Concurrent or combination use must be documented on the form and will require justification; such combination therapy is specifically captured because it may be considered not medically necessary unless clinically justified and will be evaluated during the authorization review.

Product and Scoring Details

Named HCPCS codes listed on formHCPCS

J0517	FASENRA
J2182	NUCALA
J2786	CINQAIR
J2356	TEZSPIRE

Clinical improvement thresholds (as captured on form)

ACQ-6 changeDecrease in ACQ-6 score by 0.5 from pretreatment baseline

ACT changeIncrease in ACT score by 3 from pretreatment baseline

Continuation requirementContinuation of therapy requires one or more clinical improvements (e.g., decreased rescue med use, fewer exacerbations, increased predicted FEV1, symptom reduction) documented on the form

Submission, Documentation, and Prior Biologic History

Prior Authorization

Form submission and product coding

Fax the completed Outpatient Medical Injectable Monoclonal Antibodies request form to Highmark at 1-833-619-5745. When listed, include the HCPCS code for the requested product on the submission (for example: J0517 FASENRA, J2182 NUCALA, J2786 CINQAIR, J2356 TEZSPIRE).

Fax number: 1-833-619-5745
Include HCPCS code for requested product when available (e.g., J0517, J2182, J2786, J2356)

Denial Risk

Incomplete submission — denial/delay risk

Incomplete or missing information on the faxed form may delay review or result in denial. Ensure the form is fully completed before faxing.

Incomplete or missing form elements (demographics, diagnosis, signatures, dates, or missing product/coding) can trigger denial or delay
Verify member eligibility and benefits prior to submission

Documentation Required

Required documentation

Submit the completed request form with all required documentation: patient demographics, member UMI, date of birth, ICD-10 diagnosis code(s), date of service, requesting physician and facility information (including NPI), office contact and fax/phone, supply source (specialty pharmacy vs buy-and-bill), and whether request is new start or continuation.

Required: Member name, DOB, UMI, ICD-10 code(s), date of service
Required: Requesting physician name, NPI, address; facility name, NPI, address; office contact phone and fax
Indicate product supply source: Specialty pharmacy (Alliance Rx Walgreens) or Buy & Bill or Other
Attach all pertinent clinical information and lab results (e.g., blood eosinophil count with date)

Documentation Required

Prior biologic trial documentation

Document prior biologic use and reason for discontinuation or failure. For asthma and eosinophilic conditions, list prior biologics tried, dates, outcomes, contraindications, and whether the member had inadequate response. If applicable, provide objective measures (exacerbation history, ACT/ACQ scores, FEV1, eosinophil counts).

Document prior use/failure of listed biologics (e.g., Nucala, Xolair, Fasenra, Cinqair, Dupixent, Tezspire)
Provide dates of prior biologic therapy, reason for discontinuation (inefficacy, adverse event, contraindication), and clinical response
Include objective measures supporting uncontrolled disease: ACT/ACQ scores, number of exacerbations requiring systemic steroids in past 12 months, pre-bronchodilator FEV1 with test date, blood eosinophil count with draw date

Definitions and Indication-Specific Prerequisites

Uncontrolled asthma — clinician-provided measures

Uncontrolled asthma definitionDocumented by clinician-provided measures: ACT score, ACQ score, number of exacerbations in past 12 months requiring systemic corticosteroids, and pre-bronchodilator FEV1 with date

Exacerbation historyNumber of exacerbations in past 12 months requiring oral or systemic corticosteroid treatment (document count and dates when possible)

Medication historyList of asthma medications over past year (inhalers, oral meds, injections) including name, dose, and duration

Eosinophilic phenotypeIndicate whether asthma has an eosinophilic phenotype and provide blood eosinophil count and date of lab draw when yes

Indication-specific criteria — definitions and prerequisites

HES duration prerequisiteDiagnosis of HES for greater than or equal to 6 months

HES stability and flaresDocument baseline blood eosinophil count prior to starting Nucala; member stable on HES therapy for at least 4 weeks and history of >=2 HES flares in past 12 months when applicable

EGPA relapse and steroid statusEGPA requires history of relapsing disease and member on stable oral prednisolone/prednisone dose for at least 4 weeks

EGPA standard of carePlan to receive standard of care while on Nucala (glucocorticoid with or without immunosuppressive therapy) must be documented

Background

This request form supports prior authorization for outpatient injectable monoclonal antibody therapies used as add-on maintenance or new-start biologic treatment for members with severe or uncontrolled asthma and for selected eosinophilic conditions (HES, EGPA, CRSwNP). It collects objective measures of disease control (e.g., ACT/ACQ scores, pre-bronchodilator FEV1, exacerbation history), biomarker data (blood eosinophil count with date), prior medication and biologic exposure, and indication-specific prerequisites to allow clinical review of medical necessity. Providers must fax the completed form to Highmark at 1-833-619-5745 with the requested product and associated HCPCS code when applicable.