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Coverage criteria policies

Omalizumab (Xolair®) – Minnesota Health Care Programs

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Omalizumab (Xolair) requires prior authorization from HealthPartners Pharmacy Administration.

Coverage

Initial authorization criteria:

Severe Asthma

  1. Patients must be 6 years of age or older; and,
  2. IgE level must be >30 IU/mL; and,
  3. Patient must have severe persistent asthma with evidence of reversibility; and,
  4. Evidence must be provided showing that the patient has been compliant with adequate trials of high-dose inhaled corticosteroids (ICS) combined with long-acting inhaled beta-agonists (LABA) – unless the patient demonstrates a contraindication to one of those drugs. If patient has tried high dose ICS/LABA combo, there is no need for a concomitant trial with Serevent or Foradil; and,
  5. At time of request, provide baseline FEV1 and frequency of asthma exacerbation per month.

Chronic Idiopathic Urticaria

  1. Patients must be 12 years of age or older; and,
  2. Patient has been diagnosed with chronic idiopathic urticaria; and,
  3. Patient has tried and failed loratadine, cetirizine, diphenhydramine and montelukast.

Initial approval will be for 6 months in duration.

Severe persistent asthma is defined as:

  1. Asthma symptoms that have required urgent care or unscheduled services or hospitalization at least two times in the past 12 months; or,
  2. Asthma that requires high dose inhaled corticosteroid with concomitant use of a long-acting inhaled beta-agonist.

Adequate trial of inhaled corticosteroid is defined as 8 weeks of therapy with good compliance of daily administration of medications.

Reauthorization criteria:

  1. Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following:
    1. Parasitic (helminth) infection
    2. Malignancy
    3. Headache
    4. Injection site reaction
    5. Upper respiratory infection
    6. Fatigue
  2. Treatment has resulted in clinical improvement as documented by at least ONE of the following:
    1. Decreased frequency of exacerbations (defined as  improvement of asthma  as demonstrated by decreased use of oral/systemic corticosteroids and/or less frequent hospitalizations and/or reduced frequency of ER visits); or,
    2. Improvement in lung function, measured in FEV1.

Renewal approval will be for 12 months in duration.

Quantity limit:

  1. Asthma: 750 mg per 28 days
  2. Chronic Idiopathic Urticaria: 300 mg per 28 days

Indications that are not covered

Concurrent use with an IL-5 inhibitor such as Cinqair, Nucala, or Fasenra.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The services associated with these codes require prior authorization:
HCPCS Codes

Codes

Description

J2357

Injection, omalizumab, 5 mg

NDC Codes

Codes

Description

50242004062

Xolair 150 MG SOLR

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. https://mn.gov/dhs/partners-and-providers/policies-procedures/minnesota-health-care-programs/provider/types/rx/pa-criteria/xolair.jsp

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Policy activity

  • 05/07/2018 - Date of origin
  • 10/01/2018 - Effective date

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