CurrentCapital District Physicians' Health Plan (CDPHP)Policy N/A

Xolair (omalizumab) Injection Coverage as a Medical Benefit

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Medicaid coverage and prior authorization for medically administered Xolair injection for qualifying asthma, chronic idiopathic urticaria, nasal polyps, and IgE-mediated food allergy indications in New York; pharmacy-dispensed prefilled syringes are covered under the NYRx pharmacy benefit.

Policy Summary

PayerCapital District Physicians' Health Plan (CDPHP)

PolicyXolair (omalizumab) Injection Coverage as a Medical Benefit

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for Xolair injection billed with HCPCS J2357.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4Covered clinical indications

J2357HCPCS code requiring prior authorization

30-700 IU/mLAsthma baseline IgE range

30-1500 IU/mLNasal polyps baseline IgE range

1 year

Policy Summary

PayerCapital District Physicians' Health Plan (CDPHP)

PolicyXolair (omalizumab) Injection Coverage as a Medical Benefit

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for Xolair injection billed with HCPCS J2357.

SourceLink

On This Page

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CurrentCapital District Physicians' Health Plan (CDPHP)Policy N/A

Xolair (omalizumab) Injection Coverage as a Medical Benefit

Customize your policy alerts

Sign up for all cdphp policy alerts

Know when cdphp releases new policies or updates existing guidance.

Monitor payer policy activity

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Policy Summary

PayerCapital District Physicians' Health Plan (CDPHP)

PolicyXolair (omalizumab) Injection Coverage as a Medical Benefit

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for Xolair injection billed with HCPCS J2357.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4Covered clinical indications

J2357HCPCS code requiring prior authorization

30-700 IU/mLAsthma baseline IgE range

30-1500 IU/mLNasal polyps baseline IgE range

1 year

Policy Summary

PayerCapital District Physicians' Health Plan (CDPHP)

PolicyXolair (omalizumab) Injection Coverage as a Medical Benefit

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for Xolair injection billed with HCPCS J2357.

SourceLink

On This Page

Minimum food allergy indication age

Covered Indications

Severe persistent allergic asthma

Covered for severe persistent allergic asthma when all of the following are met.

Severe persistent allergic asthma: Member is older than 6 years; baseline IgE is 30-700 IU/mL, or 700-1300 IU/mL subject to the dose limitation; member has at least one perennial aeroallergen; member experienced at least two asthma exacerbations in the preceding 12 months requiring medical management; symptoms are inadequately controlled while adherent to high-dose ICS with LABA for three months or require oral systemic steroids to maintain control; and treatment is prescribed by an allergist/immunologist or pulmonologist.Age >6 years; IgE 30-700 IU/mL, with consideration of 700-1300 IU/mL; dose not >750 mg/month; at least 2 exacerbations in 12 months; 3 months of high-dose ICS plus LABA

Examples of perennial aeroallergens include dust mites, pet dander, and cockroach.

Chronic idiopathic urticaria

Covered for chronic idiopathic urticaria when all of the following are met.

Chronic idiopathic urticaria: Member is 12 years of age or older; has at least a six-week history of urticaria characterized by wheals, angioedema, or both; has persistent wheals and itching despite an adequate trial of a second-generation H1 antihistamine at standard dosing and a trial at 2-4 times standard dosing; and treatment is prescribed by an allergist/immunologist or dermatologist.Age >=12 years; history >=6 weeks; H1 antihistamine trials at standard and 2-4 times standard dose

The criteria require persistent symptoms despite both standard-dose and 2-4-times-standard-dose second-generation H1 antihistamine trials.

Nasal polyps

Covered for nasal polyps when all of the following are met.

Prior intervention: Member has had prior nasal surgery or prior treatment with a course of systemic corticosteroids.One of the two interventions
At least one must be documented.

IgE-mediated food allergy

Covered for mitigation of IgE-mediated allergic food reactions, including anaphylaxis, that may occur with accidental exposure when all of the following are met.

IgE-mediated food allergy: Request is obtained by an allergist or immunologist; member is at least one year of age; member has a confirmed IgE-mediated food allergy; positive skin testing or allergen-specific IgE blood testing is documented for each allergy within 12 months of the request; significant allergic symptoms, including moderate to severe skin, respiratory, or gastrointestinal symptoms, occurred with exposure to the applicable allergens; Xolair is used with a food-avoidant diet for the applicable allergens; and pretreatment serum IgE levels are provided for initial requests.Age >=1 year; allergy testing within 12 months of request

The indication includes mitigation of reactions, including anaphylaxis, after accidental exposure.

Pharmacy-filled prefilled syringes are not covered under this medical benefit. They are administered through the NYRx pharmacy benefit; this policy applies to medically administered Xolair single-dose vials.

Covered Codes and Clinical Thresholds

ICD-10 Diagnosis CodesICD-10Covered

J45	Asthma
L50	Urticaria
J33.9	Nasal polyp, unspecified
Z91	Personal history of allergy, including select subcodes for specific allergens

HCPCS CodeHCPCSCovered

J2357

Injection, omalizumab, 5 mg; administered as a medical benefit and requires prior authorization

NDCNDCCovered

50242-0040-62

Xolair 150 mg/5 mL single-dose vial, sterile powder without preservatives

Asthma baseline IgE

Standard IgE range30-700 IU/mL

Extended IgE range700-1300 IU/mL may be considered when all other criteria are met

Extended-range dose conditionThe dose based on IgE level and body weight must not exceed 750 mg per month

Asthma exacerbations

Required numberAt least 2 asthma exacerbations

Lookback periodWithin the preceding 12 months

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Xolair (omalizumab) injection billed under HCPCS J2357.

HCPCS J2357 requires prior authorization.

Step Therapy

Required Antihistamine Trials

For chronic idiopathic urticaria, document persistent symptoms despite required second-generation H1-antihistamine therapy at both standard dosing and 2–4 times the standard dose.

Document wheals (hives), itching, angioedema, or both despite an adequate trial at standard dosing.
Document a second-generation H1-antihistamine trial at 2–4 times the standard dose.

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Policy Context

Xolair (omalizumab) is covered as a medically administered injection for allergic and immunologic conditions when disease remains inadequately controlled despite appropriate standard therapy. Covered indications include severe persistent allergic asthma, chronic idiopathic urticaria, chronic rhinosinusitis with nasal polyps, and reduction of IgE-mediated allergic food reactions, including anaphylaxis that may occur after accidental exposure. Coverage is subject to the indication-specific clinical criteria and prior authorization requirements described in this policy.

Clinical Definitions

Chronic rhinosinusitis with nasal polyps

Required durationChronic rhinosinusitis with nasal polyps must have lasted at least 12 weeks

Current disease confirmationCurrent nasal polyposis must be documented

Accepted confirmation methodsDirect examination, nasal endoscopy, imaging studies such as a sinus CT scan, or similar evidence

Perennial aeroallergen

Sensitization requirementAllergic asthma associated with sensitization to at least one perennial aeroallergen

ExampleDust mites

Example

Initial Therapy Requirements

Asthma initial therapy

Initial therapy for severe persistent allergic asthma requires all listed clinical criteria.

Asthma initial authorization: Age older than 6 years; IgE 30-700 IU/mL or qualifying 700-1300 IU/mL level; perennial aeroallergen sensitization; at least two medically managed exacerbations in the prior 12 months; inadequate control despite adherence to high-dose ICS with LABA for three months or need for oral systemic steroid to maintain control; and specialist prescriber.Dose based on IgE and weight must not exceed 750 mg/month for the 700-1300 IU/mL exception

Prescriber must be an allergist/immunologist or pulmonologist.

Chronic idiopathic urticaria initial therapy

Initial therapy for chronic idiopathic urticaria requires all listed clinical criteria.

Urticaria initial authorization: Age at least 12 years; urticaria for at least six weeks with wheals, angioedema, or both; persistent symptoms despite second-generation H1 antihistamine trials at standard and 2-4 times standard dosing; and specialist prescriber.

Required Prior Treatment Trials

Step	Required therapy	Duration	Inadequate response requirement
1	High-dose inhaled corticosteroid (ICS) with LABA	3 months	Asthma symptoms remain inadequately controlled despite adherence, or oral systemic steroids are required to maintain control.

Step	Required therapy	Dosing requirement	Inadequate response requirement
1	Second-generation H1 antihistamine	Trial at standard dosing and a trial at 2–4 times the standard dose	Persistent wheals and itching, angioedema, or other urticaria symptoms despite treatment.

Step	Required therapy	Regimen and duration	Response requirement
1	Mometasone nasal spray and Xhance nasal spray	Each for at least 3 months, at 2 sprays in each nostril twice daily	Inadequate response despite compliant use.

Dose and Quantity Restrictions

Xolair (omalizumab)

Maximum dose750 mg

Dose determinationBased on the member's IgE level and body weight

Limitation periodPer month

Administration and Benefit Channel

Billing Rule

Administer the covered single-dose vial in the office

The coverage described in this policy applies to the Xolair single-dose vial administered as a medical benefit. Prefilled syringes filled at a pharmacy are administered under the NYRx pharmacy benefit rather than the medical benefit.

Medical benefit product: Xolair 150 mg/5 mL single-dose vial, sterile powder without preservatives.
NDC: 50242-0040-62.
Pharmacy-filled prefilled syringes are not covered under this medical benefit.

Each exacerbation must have required medical management

Chronic idiopathic urticaria duration

Minimum durationAt least 6 weeks

Clinical featuresUrticaria characterized by wheals, angioedema, or both

Persistent symptomsWheals and itching must persist despite adequate second-generation H1-antihistamine trials

Nasal polyps chronicity

Minimum chronicityAt least 12 weeks

Current conditionThe member must currently have nasal polyposis

ConfirmationNasal polyposis must be confirmed by direct examination, nasal endoscopy, imaging studies such as a sinus CT scan, or similar evidence

Nasal polyps baseline IgE

Qualifying baseline IgE30-1500 IU/mL

Applicable conditionChronic rhinosinusitis with nasal polyps

Use requirementXolair must be used in combination with an intranasal corticosteroid

Nasal corticosteroid treatment

Mometasone duration and adherenceAt least 3 months of compliant use

Mometasone dose2 sprays in each nostril twice daily

Xhance duration and adherenceAt least 3 months of compliant use

Xhance dose2 sprays in each nostril twice daily

Treatment responseThe member must have an inadequate response despite both nasal corticosteroid treatments

Documentation Required

Asthma Clinical Documentation

For allergic asthma, submit clinical documentation supporting the diagnosis, severity, allergic sensitization, exacerbation history, inadequate control, and required treatment.

Member is at least 6 years of age and has moderate to severe persistent or severe persistent allergic asthma.
Baseline IgE is 30–700 IU/mL; levels of 700–1,300 IU/mL may be considered if all other criteria are met and the required dose does not exceed 750 mg per month.
Positive skin testing or in vitro reactivity to at least one perennial aeroallergen, such as dust mites, pet dander, or cockroach.
At least two asthma exacerbations in the preceding 12 months requiring medical management.
Symptoms inadequately controlled despite adherence to high-dose inhaled corticosteroid plus LABA therapy for 3 months, or oral systemic steroids are required to maintain control.
Prescriber must be an allergist/immunologist or pulmonologist.

Documentation Required

Chronic Idiopathic Urticaria Documentation

For chronic idiopathic urticaria, document the duration and clinical features of disease, prior antihistamine treatment, and inadequate response.

Member is older than 12 years of age.
At least 6 weeks of urticaria with wheals (hives), angioedema, or both; document persistent wheals and itching.
Document adequate trials of a second-generation H1-antihistamine at standard dosing and at 2–4 times standard dosing, with continued symptoms.
Prescriber must be an allergist/immunologist or dermatologist.

Documentation Required

Nasal Polyps Documentation

For chronic rhinosinusitis with nasal polyps, submit diagnostic confirmation, disease duration, treatment response, and required prior-treatment documentation.

Member is at least 18 years of age and the request is submitted by an allergist or otolaryngologist.
Chronic disease must have lasted at least 12 weeks.
Current nasal polyposis must be confirmed by direct examination, nasal endoscopy, imaging, or sinus CT.
Document inadequate response after at least 3 months of compliant mometasone and/or Xhance nasal spray at 2 sprays in each nostril twice daily.
Document either prior nasal surgery or a prior course of systemic corticosteroids.
Document concurrent intranasal corticosteroid use and baseline IgE of 30–1,500 IU/mL.

Documentation Required

Food Allergy Documentation

For mitigation of IgE-mediated allergic food reactions, including anaphylaxis, submit allergy testing and clinical food-allergy documentation.

Request must be submitted by an allergist or immunologist for a member at least 1 year of age.
Document confirmed IgE-mediated food allergy, including a positive skin test or allergen-specific IgE blood test for each allergy within 12 months of the request.
Document significant allergic symptoms—moderate to severe skin, respiratory, or gastrointestinal symptoms—when exposed to the applicable allergens.
Document use with a food-avoidance diet and provide pretreatment serum IgE levels with initial requests.

Denial Risk

Failure to Meet Indication-Specific Criteria

Requests may be denied when indication-specific requirements are not met, including age, laboratory, diagnostic, treatment-response, prescriber, or treatment-history requirements.

Asthma: member younger than 6, no qualifying perennial aeroallergen sensitization, IgE outside the allowable range, fewer than two qualifying exacerbations, inadequate documentation of high-dose ICS/LABA response or systemic-steroid dependence, or required dose over 750 mg per month when IgE is 700–1,300 IU/mL.
Chronic idiopathic urticaria: member 12 or younger, fewer than 6 weeks of qualifying symptoms, or no documented inadequate response to second-generation H1-antihistamines at standard and 2–4 times standard dosing.
Nasal polyps: member younger than 18, disease lasting less than 12 weeks, no confirmed current polyposis, inadequate or undocumented nasal corticosteroid treatment history, no prior nasal surgery or systemic corticosteroid course, IgE outside 30–1,500 IU/mL, or missing intranasal corticosteroid use.
Food allergy: member younger than 1, absent qualifying testing or significant exposure-related symptoms, no food-avoidance diet, or missing pretreatment serum IgE on the initial request.

Billing Rule

Prefilled Syringes Use the Pharmacy Benefit

Pharmacy-filled Xolair prefilled syringes are not covered under this medical benefit. Coverage for those products is provided through the pharmacy benefit administered by NYRx.

Medical-benefit billing applies to the covered Xolair injection product, including HCPCS J2357.
Route pharmacy-filled prefilled syringe claims through the NYRx pharmacy benefit rather than this medical benefit.

At least 6 weeks; antihistamine trials at standard and 2-4 times standard dose

Prescriber must be an allergist/immunologist or dermatologist.

Nasal polyps initial therapy

Initial therapy for nasal polyps requires all listed clinical criteria.

Nasal polyps initial authorization

Prior intervention: Member has had prior nasal surgery or prior treatment with a course of systemic corticosteroids.One of the two interventions
At least one must be documented.

IgE-mediated food allergy initial therapy

Initial therapy for IgE-mediated food allergy requires all listed clinical criteria.

Food allergy initial authorization: Age at least one year; request by an allergist or immunologist; confirmed IgE-mediated food allergy; positive skin or allergen-specific IgE blood testing for each allergy within 12 months; documented significant symptoms upon exposure; use with a food-avoidant diet; and pretreatment serum IgE provided.Testing within 12 months of request; age >=1 year

Significant symptoms include moderate to severe skin, respiratory, or gastrointestinal symptoms.