CurrentHighmark DelawarePolicy N/A

Outpatient Medical Injectable Xolair

This document is an outpatient medical benefit request form for Omalizumab (XOLAIR, HCPCS J2357) used by providers to request authorization for initiation or continuation of therapy across indications (asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, IgE-mediated food allergy). It collects patient, provider, dosing, diagnosis, and clinical attestation information required for review.

Policy Summary

PayerHighmark Delaware

PolicyOutpatient Medical Injectable Xolair

Policy CodePolicy N/A

Change TypeInformational form

Effective Date

Next Review Date

Key ActionProviders must complete and fax the Outpatient Medical Injectable XOLAIR request form to 833-581-1861 including member, provider, HCPCS code (J2357), diagnosis code(s), dose, frequency, number of visits, indication-specific attestation, and attach pertinent clinical information.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

1HCPCS drug code listed

4Indications captured on form

Document summary

This outpatient medical benefit request form is for Omalizumab (XOLAIR, HCPCS J2357) used by providers to request authorization for initiation or continuation of therapy across indications including moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU), and IgE-mediated food allergy.

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The form collects patient and provider identifiers, diagnosis code(s), requested dose/frequency/number of visits, and administrative details including whether the drug will be Buy & Bill or supplied by a specialty pharmacy (with pharmacy name and NPI). It also requests indication-specific confirmations and clinical data such as prior therapy history, allergen testing results, baseline IgE (including baseline IgE titer >= 30 IU/mL where applicable), and documentation of response for continuation requests.

Clinical criteria captured by the form

Asthma (moderate to severe persistent)

Form questions to document eligibility/clinical criteria for Xolair use in moderate to severe persistent asthma:

Moderate to severe persistent asthma: Member has MODERATE TO SEVERE persistent Asthma (YES/NO)
Allergen reactivity: Positive skin test or in vitro reactivity to a perennial aeroallergen (YES/NO)
Prior asthma medications: List of prior asthma medications used over past year (free-text)
Inadequate control: Asthma symptoms inadequately controlled (YES/NO)
Adherence: Member is compliant with current therapeutic regimen (YES/NO)
Baseline IgE titer greater than or equal to 30 IU/mL (YES/NO)>= 30 IU/mL
If YES provide IgE value and date of lab draw
Start or continuation: New Start or Continuation of Therapy (checkbox)
Clinical improvement documented by decreased rescue medication use, decreased exacerbations, or reduction in reported asthma-related symptoms (checkboxes)
Concomitant biologics: Concomitant use with other biologics (Fasenra, Nucala, Cinqair or Dupixent) (YES/NO)
Response for continuation: For continuation: Has treatment with Xolair resulted in a clinically meaningful response from baseline? (YES/NO)

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What providers must do

Prior Authorization

Submit Xolair outpatient injectable request

Providers must complete and fax the Outpatient Medical Injectable XOLAIR request form to 833-581-1861. The form must include patient and provider information, the HCPCS drug code J2357, ICD-10 diagnosis code(s), requested dose, frequency, number of visits, requested date(s) of service, indication-specific attestation (asthma, CRSwNP, CSU, IgE-mediated food allergy), and attach pertinent clinical information.

Affected code: J2357
ICD-10 diagnosis code(s)
Dose
Frequency
Number of visits requested
Indication attestations (Asthma, CRSwNP, CSU, IgE-mediated food allergy)
Attachments: pertinent clinical information

Documentation Required

Clinical attestation and supporting data

For each indication providers must document prior therapies and treatment history, include response to Xolair for continuation requests, provide baseline IgE value and date when applicable, report allergen testing results for asthma and food allergy, and note any concomitant use of other biologics.

Prior therapies / medications used over the past year (by indication)
For continuation: documentation of clinical response to Xolair
Baseline IgE value and date of lab draw (if applicable; threshold captured on form)
Allergen testing results: positive skin test or in vitro reactivity for asthma; SPT or food-specific IgE for food allergy
Concomitant biologic use (Fasenra, Nucala, Cinqair, Dupixent)

Billing Rule

Buy & Bill or Specialty Pharmacy selection

The form requires the provider to indicate whether the medication will be billed as Buy & Bill or supplied by a specialty pharmacy. If supplied by a specialty pharmacy, the form captures the dispensing pharmacy name and NPI.

Affected code: J2357
Indicate Buy & Bill vs Drug supplied by Specialty Pharmacy (include Pharmacy Name and NPI when applicable)

Definitions

XOLAIRBrand name for omalizumab, immunoglobulin E (IgE) targeted monoclonal antibody; HCPCS code J2357 is requested on form.

Baseline IgE titer>= 30 IU/mL

IgE noteIf baseline IgE >= 30 IU/mL, provide IgE value and date of lab draw when applicable.

This is a standardized request form used by Highmark Delaware to collect clinical and administrative information for outpatient administration of Xolair under the medical benefit, requesting indication-specific confirmations, prior therapy history, and laboratory and testing results to support prior authorization decisions.