CurrentCapital BluecrossPolicy N/A

XOLAIR (OMALIZUMAB) PREAUTHORIZATION REQUEST

A payer preauthorization request form and checklist used by providers to request prior authorization for omalizumab (Xolair) for multiple labeled and off-label indications, capturing patient, provider, dosing, indication-specific clinical criteria, and site-of-care information. It documents required clinical elements for initial and continuing therapy but is a form rather than a standalone coverage policy.

Policy Summary

PayerCapital Bluecross

PolicyXOLAIR (OMALIZUMAB) PREAUTHORIZATION REQUEST

Policy CodePolicy N/A

Change TypeAdministrative form (no material coverage change)

Effective Date

Next Review Date

Key ActionProviders must complete and fax the Xolair preauthorization request form to 866.805.4150 with all required clinical documentation for initial and reauthorization requests.

SourceLink

6Indications listed on form

20+Required clinical/data fields on form

Document purpose and scope

This is an administrative prior authorization request form for Xolair (omalizumab) used by Capital BlueCross to request coverage consideration. The form functions as a checklist capturing general administrative data (request date, member and provider information, site of service) and requires submission by fax to 866.805.4150 for initial and reauthorization requests.

The form enumerates the indications accepted for consideration: moderate-to-severe persistent allergic asthma, chronic idiopathic/spontaneous urticaria (CIU/CSU), chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergic reactions, immune checkpoint inhibitor–related pruritus, and systemic mastocytosis, and it identifies indication-specific initial and continuation clinical criteria to support an authorization decision.

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Indication-specific initial and continuation criteria

Moderate-to-severe persistent allergic asthma (initial approval criteria)

Covered when ALL of the following are met:

Age & indication exclusions: Patient is at least 6 years of age>= 6 years
Not for acute bronchospasm, status asthmaticus, or other allergic conditions not indicated
Allergen sensitivity: Positive skin test or in vitro reactivity to a perennial aeroallergen
Measured before therapy
Weight: Patient weight within allowed range20 kg to 150 kg
Total serum IgE level ranges (age-dependent)
- IgE (age >=12): >= 30 IU/mL and < 700 IU/mL for patients age >= 12 years>= 30 IU/mL and < 700 IU/mL
- IgE (age 6 to <12): >= 30 IU/mL and < 1300 IU/mL for patients aged 6 to < 12 years>= 30 IU/mL and < 1300 IU/mL
Prior therapy and disease activity
- Baseline clinical status assessment (at least one required)
  - Systemic corticosteroid use: Use of systemic corticosteroids
  - Inhaled corticosteroid use: Use of inhaled corticosteroids
  - Healthcare utilization: Number of hospitalizations, ER visits, or unscheduled visits due to condition
  - Pulmonary function: Forced expiratory volume in 1 second (FEV1)

Required submissions, documentation, and billing notes

Prior Authorization

Submit preauthorization request form

Providers must complete and fax the Xolair preauthorization request form to 866.805.4150 with all required clinical documentation for initial and reauthorization requests.

Diagnosis (ICD-10 code(s))
HCPCS code(s)
Prior therapies tried and reason for discontinuation
Baseline test results (labs, imaging) as applicable

Documentation Required

Document baseline and response measures

Include baseline objective measures and provide documentation of clinical response when requesting continuation/re-authorization.

UAS7 (urticaria activity score)
FEV1 (forced expiratory volume in 1 second)
CT scans
Nasal Polyposis Score (NPS)
Total IgE and blood eosinophil counts
History of hospitalizations or ER visits

Billing Rule

Site-of-service justification

Indicate the site of service on the form and include documentation if a less intensive site of care is contraindicated or inappropriate; see MP 3.016 for site-of-service requirements.

Documentation Required

Specialty prescriber requirement

Indicate whether the prescriber is a specialist in the patient's diagnosis or has consulted a specialist; the prescriber specialty or consultation must be documented on the form.

Age, lab, and measure thresholds; definitions referenced

Key thresholds

Age for allergic asthma>= 6 years

Weight range for allergic asthma20 kg to 150 kg (44 lbs to 330 lbs)

Serum total IgE (age >=12)>= 30 IU/mL and < 700 IU/mL

Serum total IgE (age 6 to <12)>= 30 IU/mL and < 1300 IU/mL

CRSwNP symptom duration>= 8 weeks

Second-generation H1-antihistamine trial for CIU/CSU>= 1 month of scheduled dosing

UAS7: The form references the Urticaria Activity Score over 7 days (UAS7) as an objective clinical evaluation tool to document baseline disease activity and to assess response for chronic idiopathic/spontaneous urticaria (CIU/CSU).

FEV1: The form defines and uses Forced Expiratory Volume in 1 second (FEV1) as a pulmonary function measurement for baseline assessment and for documenting improvement from baseline in moderate-to-severe persistent allergic asthma.