CurrentHighmark Blueshield NenyPolicy N/A

Outpatient Medical Injectable Monoclonal Antibodies Request Form — Asthma and Eosinophilic Conditions

A clinician-completed request form used to request prior authorization or document clinical information for outpatient medical benefit administration of injectable monoclonal antibody products for asthma and eosinophilic conditions.

Policy Summary

PayerHighmark Blueshield Neny

PolicyOutpatient Medical Injectable Monoclonal Antibodies Request Form — Asthma and Eosinophilic Conditions

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed request form (fax 833-619-5745) with required clinical fields including diagnosis, prior therapy history, and relevant objective measures (ACT/ACQ, FEV1, blood eosinophil count).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6distinct clinical indication sections

>=7named biologics listed

833-619-5745submission fax

Coverage criteria for biologic therapies

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Asthma initial/continuation requirements: Provider documents member has SEVERE asthma and UNCONTROLLED asthma using clinician-entered measures (ACT or ACQ score), number of exacerbations in the past 12 months requiring oral or systemic corticosteroids, and pre-bronchodilator FEV1 with test date; documents prior and current asthma medications (name, dose, duration) including whether the requested product will be used as add-on maintenance and whether it will be combined with other biologics; documents eosinophilic phenotype when applicable with blood eosinophil count and date of drawsee form fields

Form requests list of prior biologics tried and any contraindications to listed biologics

inv-02: Asthma — Continuation of Therapy — clinical improvement documentation required

Continuation is covered when ALL of the following are documented:

Continuation criteria: Provider documents clinical improvement while on the requested product as evidenced by one or more of: decreased rescue medication use, decreased frequency of exacerbations, increased predicted FEV1 from pretreatment baseline (include baseline and current FEV1), reduction in reported asthma-related symptoms, or ACQ/ACT improvement meeting the specified thresholdsACQ decrease >=0.5 or ACT increase >=3

Form asks whether the product will continue as add-on maintenance and whether Nucala treatment resulted in improvement

inv-03: EGPA (Nucala only) — criteria specific to eosinophilic granulomatosis with polyangiitis

Nucala for EGPA is covered when ALL of the following are documented:

EGPA with Nucala: Provider documents history of relapsing disease, that the member is on a stable dosage of oral prednisolone or prednisone for at least 4 weeks, and that standard of care (glucocorticoid with or without immunosuppressive therapy) will be continued while on Nucalastable prednisone >=4 weeks

Nucala-specific requirement

inv-04: HES (Nucala only) — hypereosinophilic syndrome criteria

Nucala for HES is covered when ALL of the following are documented:

HES with Nucala: Provider documents diagnosis of hypereosinophilic syndrome for greater than or equal to 6 months, absence of an identifiable non-hematologic secondary cause, negative or documented status for FIP1L1-PDGFRα kinase–positive HES, at least 2 HES flares within the past 12 months, baseline blood eosinophil count prior to starting Nucala, and that the member has been stable on HES therapy (corticosteroids, immunosuppressive or cytotoxic therapy) for at least 4 weeks before starting Nucala>=6 months diagnosis; >=2 flares in past 12 months; stable therapy >=4 weeks

Nucala-specific requirement; presence of FIP1L1-PDGFRα kinase–positive HES is specifically queried

inv-05: CRSwNP (Nucala only) — chronic rhinosinusitis with nasal polyps criteria

Nucala for CRSwNP is covered when ALL of the following are documented:

CRSwNP with Nucala: Provider documents that Nucala will be used as add-on maintenance therapy, inadequate response to intranasal corticosteroids for at least 8 weeks (unless intolerant or contraindicated), presence of diagnostic symptoms (nasal drainage, nasal obstruction/congestion, facial pressure/pain, decrease or loss of smell lasting at least 12 weeks), confirmation of bilateral nasal polyps by endoscopy or CT, documented NPS (bilateral nasal polyp) score and VAS score, and the member's prior surgical history for nasal polyp removal>=8 weeks of intranasal corticosteroid use prior to biologic; symptom duration >=12 weeks

Nucala-specific requirement; asks whether Nucala resulted in improvement in VAS score and whether it will be used in combination with other biologics

The asthma section requires documentation of criteria establishing severe, uncontrolled asthma including clinician-entered ACT or ACQ scores, the number of exacerbations in the prior 12 months requiring systemic corticosteroids, and pre-bronchodilator FEV1. Absence of these documented features or the required prior therapy history on the form will render the request incomplete and insufficient for approval consideration.

Codes, score thresholds, and symptom duration

Named biologic HCPCS/J-codes listed on formHCPCS

J0517	FASENRA (listed on form)
J2182	NUCALA (listed on form)
J2786	CINQAIR (listed on form)
J2356	TEZSPIRE (listed on form)

ACQ/ACT response thresholds

ACQ/ACT response thresholdDecrease in ACQ-6 score by 0.5 or increase in ACT score by 3 from pretreatment baseline

Measured timepointChange measured from pretreatment baseline to current assessment as documented on continuation section

Supporting clinical improvementsCan be documented alongside decreased rescue medication use, decreased exacerbation frequency, or increased predicted FEV1

Nasal polyp symptom duration

Nasal polyp symptom duration requirementDecrease or loss in sense of smell lasting for at least 12 weeks

Other qualifying symptomsNasal drainage, nasal blockage/obstruction/congestion, facial pressure or pain (document presence as part of diagnosis)

Confirmation requirementDiagnosis confirmed by bilateral polyps on nasal endoscopy or CT scan (document imaging/endoscopy)

What providers must submit and watch for

Prior Authorization

Prior Authorization Submission

Use the form-based prior authorization submission process. Complete and fax the Outpatient Medical Injectable Monoclonal Antibodies request form to 833-619-5745 (Medical Benefit only). Verify member eligibility and benefits through the health plan before submitting.

Fax number: 833-619-5745
Form title: Outpatient Medical Injectable Monoclonal Antibodies for the Treatment of Asthma and Eosinophilic Conditions
Submitter: Requesting physician or facility; include office contact phone/fax

Denial Risk

Incomplete or Missing Documentation May Trigger Denial

The request form must include all required documentation fields. Incomplete or missing documentation may delay review or result in denial of the request. Attach all relevant clinical records (labs, pulmonary function tests, medication history, operative reports where applicable).

Attach baseline and current FEV1 if relevant (include dates)
Attach blood eosinophil count and date of lab draw when eosinophilic phenotype is claimed
Attach documentation of exacerbations requiring systemic corticosteroids in past 12 months

Documentation Required

Required Documentation on Form

Required documentation on the form: complete patient demographics, member UMI, date of birth, payer (Medicare or Commercial), ICD-10 diagnosis code(s), requested product and HCPCS/J-code, indication-specific clinical fields, and facility/requesting provider NPI and contact information. For asthma and eosinophilic conditions include ACT/ACQ scores, medication history with names/doses/duration, prior biologic trials (e.g., Fasenra J0517, Nucala J2182, Cinqair J2786, Tezspire J2356, Xolair, Dupixent), contraindications, and whether the request is new start or continuation. Check the form for condition-specific fields for EGPA, HES, and CRSwNP and provide the supporting items listed (e.g., nasal polyp scores, history of surgeries, prednisone stability, HES flare history).

Patient demographics: name, DOB, member UMI
Payer indication: Medicare or Commercial
Provider details: requesting physician name, NPI, facility name and NPI, addresses, contact phone and fax
Clinical: ICD-10 code(s) and date of service
Requested product: drug name and HCPCS/J-code (if applicable)
Asthma-specific: ACT/ACQ scores, number of exacerbations in past 12 months, pre-bronchodilator FEV1 with date, list of medications (name, dose, duration)
Prior biologic therapy: document trials and failures (Nucala, Xolair, Fasenra, Cinqair, Dupixent, Tezspire)
Eosinophilic phenotype: blood eosinophil count and date of draw
EGPA/HES/CRSwNP: condition-specific checkboxes and supporting documentation (prednisone stability, HES duration/flares, NPS/VAS scores, prior surgeries)

Background and context

The form collects the clinical measures used to define uncontrolled or severe asthma: clinician-entered ACT score and/or ACQ score, the number of exacerbations in the past 12 months requiring oral or systemic corticosteroids, and the pre-bronchodilator FEV1 with date of test. These fields are intended to document baseline disease status for initial therapy requests and to support assessment of clinical response for continuation requests.

Key definitions used on the form

Uncontrolled Asthma — definition

Definition — Uncontrolled AsthmaClinician documents uncontrolled asthma using ACT score, ACQ score, number of exacerbations in past 12 months requiring oral/systemic corticosteroids, and pre-bronchodilator FEV1 (with test date)

Exacerbation historyNumber of exacerbations requiring oral or systemic corticosteroid treatment in the prior 12 months (document count)

Objective lung functionPre-bronchodilator FEV1 with date of test documented on the form

Prior and current therapy documentationList of inhalers, oral medications, and injections used over past year including name, dose, and duration

HES duration and related criteria

HES duration criterionMember diagnosed with hypereosinophilic syndrome for greater than or equal to 6 months

Secondary cause checkForm asks whether there is an identifiable non-hematologic secondary cause of HES (document yes/no)

FIP1L1-PDGFRα kinase statusForm queries whether member has FIP1L1-PDGFRα kinase–positive HES (document yes/no)

Flare history and stabilityAt least 2 HES flares in past 12 months and stability on HES therapy for ≥4 weeks prior to Nucala (document both)