Omalizumab (Xolair)

OFFICE ADMININSTRATION

Indications for Prior Authorizations: 

  • 1) Moderate to severe asthma
  • 2) Chronic idiopathic urticaria

1)

All of the following must be met for Moderate to Severe Asthma:

  • Must have documented diagnosis of moderate to severe persistent asthma that is uncontrolled on standard asthma therapies and must meet one of the three following conditions within the past year:
    • at least one acute asthma related ED visit
    • at least one acute inpatient discharge visit with asthma as the principal diagnosis
    • at least four unscheduled outpatient visits for asthma
  • Must be prescribed AND followed by a pulmonologist or allergist
  • Must be at least 12 years of age
  • Must have a baseline total serum IgE level of greater than or equal 30 IU/ml and less than 700 IU/ml
  • Must have FEV1 reversibility of greater than or equal to 12% within 30 minutes after administration of albuterol or any short acting beta agonist
  • Must have a baseline FEV1 < 80% of predicted value OR if baseline FEV1 > 80% of predicted value, then patient must be on continuous oral steroid therapy (equivalent of prednisone dose of 5mg/day or more)
  • Must have documented use and failure to respond to maximum tolerated inhaled steroid dose in combination with long acting beta agonist AND leukotriene for three months before requesting omalizumab (omalizumab is for patients who suffer from chronic and uncontrolled asthma)
  • Must have been compliant with the conventional therapy. (Verify the compliance with the continuous refills of the prescribed medications)
  • Must not be a current smoker

Administration:

  • Administer 150 to 375 mg SC every 2 or 4 weeks. Since the solution is slightly viscous, the injection may take 5 – 10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg)
  • Limit injections to not more than 150 mg per site

Maximum approved dose is 375 mg for every injection

kg

>20-25

>25-30

>30-40

>40-50

>50-60

>60-70

>70-80

>80-90

>90-125

>125-150

lbs

>44-55

>55-66

>66-88

>88-110

>110-132

>132-154

>154-176

>176-198

>198-275

>275-331

Baseline Serum

Dose in milligrams

               

IgE Level (IU/ml)

                   

>30-100

75

75

150

150

150

150

150

150

300

300

>100-200

150

150

300

300

300

300

300

300

225

225

>200-300

150

150

300

300

300

225

225

225

300

300

>300-400

225

225

225

225

225

225

300

300

375

375

>400-500

225

300

300

300

300

300

375

375

375

375

>500-600

300

300

300

300

300

375

375

375

375

 

>600-700

300

225

375

375

375

375

375

375

 

 

Every 4 Week Dosing

                 

Every 2 Week Dosing

                   

Dosing Adjustment:

  • Total IgE levels are elevated during treatment and remain elevated for up to one year after d/c of treatment. Therefore, re-testing of IgE levels during Omalizumab therapy cannot be used as a guide for dose determination. Dose determination after therapy interruptions lasting < 1 year should be based on serum IgE levels obtained at the initial dose determination. Total serum IgE levels may be re-tested for dose determination if therapy with omalizumab has been interrupted for one year or more. In addition, dose should be adjusted for significant changes in body weight

Approval: 

  • Initially for 24 weeks or 6 months
  • Approve for subsequent 24 weeks (6 months) if patient has:
    • Reduction in asthma symptoms by showing a reduction in dose and frequency of inhaled steroids compared to baseline, AND
    • Patient is continually compliant with all asthma medications, AND
    • Patient has improved FEV1 from baseline
  • Approve for additional 24 weeks (6 months) if patient continues to be stable. (e.g., no oral prednisone, no increase in inhaled steroid dose)

Patients for whom therapy with omalizumab is not indicated include:

  • Patients who do not have moderate to severe asthma
  • Patients who have not received inhaled steroids or the dose of inhaled steroids have not been maximized in their therapy
  • IgE level less than 30 or greater than 700
  • Patients who suffer from an acute exacerbation of asthma symptoms
  • To prevent peanut allergies in patients who have a history of peanut allergies
  • Prevention of asthma in patients who have a family history of asthma
  • Allergic rhinitis

2)

All of the following must be met for treatment of chronic idiopathic urticaria:

  • Prescribed by an allergist or immunologist
  • History of at least 6 months of moderate to severe chronic idiopathic urticaria
  • Presence of hives associated with itching
  • Complete diagnostic work-up to rule out underlying cause, including ANA titer, ESR, CBC, complement assay, skin biopsy, and allergen provocation or elimination trials
  • Patient has a history of:
    • Inadequate response to 2 or more H1-antihistamines (e.g. cetirizine, desloratadine, fexofenadine, levocertizine or loartadine) at maximum doses
    • Inadequate response to  montelukast
  • Patient is 12 years old or older

Dosing:

  • Up to 300 mg subcutaneous injection every 4 weeks

Approval:

  • Initial coverage: up to 3 months
  • May be renewed for 6 months based on continued response and continued need for treatment

 

Last review date: September 1, 2014

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