XOLAIR (omalizumab) Prior Authorization

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1 MP9309 Covered Service: Prior Authorization Required: Additional Information: Yes when meets criteria below Yes as shown below May only be prescribed by Allergy, Pulmonary, Immunology or Dermatology specialists with prior authorization through Navitus Prevea360 Health Plan Approved Criteria: 1.0 Use of omalizumab requires prior authorization through Navitus, and is considered medically necessary for any one of the following diagnosis and criteria: 1.1 Chronic Idiopathic Urticaria all of the following are required: Twelve (12) years of age or older; and Prescribed by Allergist, Dermatologist, or Immunologist; and Clinically documented with a primary diagnosis of chronic idiopathic urticaria (provide documentation with authorization request); and Presence of urticaria (hives) on most days of the week for a duration longer than six weeks; and Other forms of urticaria have been ruled out (i.e., angioedema, urticarial vasculitis, and specific physical forms of chronic urticaria, such as delayed pressure urticaria, cholinergic urticaria, or cold urticaria); and Urticaria Control Test score < 12; and Avoidance of urticaria triggers that can aggravate the condition; and Tried/Failed or intolerant to ONE of the following: High dose H1 antihistamines for at least two weeks, either 1 st or 2 nd generation (twice daily dosing of at least ONE of the following): Cetirizine 10mg loratadine 10mg levocetirizine 5mg desloratadine 5mg fexofenadine 180mg; or High-dose H1 antihistamines with a high-dose H2 blocker and montelukast for at least two weeks; and 1 of 8

2 1.1.9 Dose is within the FDA labeled dose (i.e. 300 mg every 4 weeks). 1.2 Moderate to Severe Persistent Allergic Asthma Six (6) years of age or older; and Prescribed by Allergist, Pulmonologist or Immunologist; and One of the following: Ages 12 years and older: IgE level > 30 IU/mL and < 700 IU/mL Ages 6 to <12 years: IgE level > 30 IU/mL and < 1300 IU/mL Positive skin test or RAST for relevant specific allergy sensitivity; and Potential co-morbidities addressed such as GERD, allergic rhinitis, and drug-disease interactions from non-prescription and/or prescription medications have been considered and ruled out; and Patient is not a current smoker or has received smoking cessation counseling; and Diagnosis of moderate to severe persistent asthma, defined as: Diagnosed for least 3 months; and month trial of high-dose inhaled corticosteroids (see Table 1 below) in combination with a long-acting bronchodilator or leukotriene modifier; and Symptoms are not well-controlled or poorly controlled based on ONE of the following: One of the following: Patient must meet at least one of the measures in Table 2 (see below); OR Has experienced 2 exacerbations in the previous 12 months requiring additional medical treatment (oral corticosteroids, emergency department or urgent care visits, or hospitalizations); and Patient is adherent to standard therapy; OR Patient adherence to standard therapy is suboptimal but is being addressed through consultation or training by clinic staff, and is documented in the medical record and presented during the request; and Will not be used concomitantly with NUCALA (mepolizumab) or CINQAIR (reslizumab); and 2 of 8

3 Ruled out non-asthma diagnoses: hyperventilation, laryngeal dysfunction, panic disorder; and Dosing in accordance with the FDA approved labeling for the age, weight, and pretreatment IgE level (see table 3 or 4 below) and does not exceed 375mg every 2 weeks TABLE 1. High Dose Corticosteroids Drug Beclomethasone HFA 40 or 80 mcg/puff High Daily Dose (Adult) > 480 mcg Budesonide DPI 90, 180, or 200 mcg/inhalation Budesonide inhaled Inhalation for suspension Ciclesonide HFA 80 or 160 mcg Flunisolide HFA 80 mcg/puff Fluticasone HFA/MDI: 44, 110 mcg/puff DPI: 50, 100, 250 mcg/inhalation Mometasone DPI 200 mcg/inhalation > 1200 mcg N/A > 640 mcg > 640 mcg > 440 mcg > 500 mcg > 400 mcg TABLE 2. Outcome Measure values for uncontrolled asthma Measure Not well controlled Poorly controlled Baseline symptoms (outside of exacerbation) > 2 days/week Throughout the day Nighttime awakening 1-3 times/week 4 times/week Interference with normal activity Some limitation Extremely limited Short acting beta agonist use of symptom control FEV1 Asthma exacerbations requiring oral steroids 2 times in the past 12 months > 2 days/week Several times per day 60-80% predicted or personal best Yes < 60% predicted or personal best Yes Asthma Control Test (ACT) Comment(s): 3 of 8

4 1.0 Prevea360 Health Plan considers all other indications from those listed above as experimental and investigational and are not covered, and include (but not limited to): 1.1 Seasonal allergic rhinitis 1.2 Perennial allergic rhinitis 1.3 Atopic dermatitis 1.4 Peanut allergy 1.5 Acute bronchospasm or status asthmaticus 2.0 Dosage limitations per the current package insert 2.1 For Asthma: TABLE 3: FDA-approved dosing based on pre-treatment IgE level and body weight (12 years of age and older) Pre-treatment serum IgE (IU/mL) Body weight (kg) >60-70 >70-90 > mg q 4 wks 150 mg q 4 wks 150 mg q 4 wks 300 mg q 4 wks > mg q 4 wks 300 mg q 4 wks 300 mg q 4 wks 225 mg q 2 wks > mg q 4 wks 225 mg q 2 wks 225 mg q 2 wks 300 mg q 2 wks > mg q 2 wks 225 mg q 2 wks 300 mg q 2 wks > mg q 2 wks 300 mg q 2 wks 375 mg q 2 wks > mg q 2 wks 375 mg q 2 wks > mg q 2 wks TABLE 4: FDA-approved dosing based on pre-treatment IgE level and body weight (Ages 6 to <12 years) 4 of 8

5 3.0 Initial coverage for 6 months 4.0 For asthma, renewal (additional 12 months) requires the following: 4.1 Provide clinical documentation from an office visit in the preceding 6 months showing response to omalizumab therapy such as ONE of the following: Decreased frequency of use of unscheduled emergency department/urgent care visits for exacerbations Decreased oral steroid bursts for exacerbations Reduction in reported symptoms such as chest tightness, coughing, shortness of breath, or nocturnal awakenings Sustained (at least six months) improvement in Asthma Control Test (ACT) scores 4.2 ONE of the following: Patient is currently treated and is compliant with standard therapy (e.g. inhaled corticosteroid, long acting beta-2 agonist, leukotriene receptor antagonist, long-acting muscarinic antagonist, theophylline); or Patient has documented intolerance, FDA labeled contraindication or hypersensitivity to ALL standard therapies; or Patient no longer requires use of standard therapies 5 of 8

6 4.3 The dose is within dosing based on pre-treatment serum IgE level and patient s body weight defined in FDA approved labeling (see table 3 and 4) AND does not exceed 375 mg every 2 weeks 5.0 For urticaria, renewal (additional 12 months) requires the following: 5.1 Provide clinical documentation from an office visit in the preceding 6 months showing response to omalizumab therapy such as: Decreased urticaria activity and/or improvement in disease on the Urticaria Control Test (at least 12) The dose is within the FDA labeled dose (i.e. 300 mg every 4 weeks) 6.0 Documentation is expected to be maintained in the patient s medical record and to be available to Prevea360 Health Plan. Every page of the record is expected to be legible and include both the appropriate patient identification information (e.g., complete name dates of service(s)), and information identifying the physician or nonphysician practitioner responsible for and providing the care of the patient. The patient's medical record must contain documentation that fully supports the medical necessity for services. This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. 6.1 The medical record must include the following information: A physician's order The name of the drug or biological administered The route of administration The dosage (e.g., mgs, mcgs, cc's or IU's) When a portion of the drug or biological is discarded, the medical record must clearly document the amount administered and the amount wasted or discarded. 7.0 The following are key points to remember when billing for (J2357): 7.1 J2357 is defined in the HCPCS manual as: Injection, omalizumab, 5 mg Coverage only when an FDA approved indication accompanies J Unit limits are as follows: units in four (4) weeks units per date of service when the diagnosis is adjunct to subcutaneous immunotherapy 6 of 8

7 units per date of service when the diagnosis is seasonal allergic rhinitis and a diagnosis of moderate to severe persistent asthma is not present on the claim units per date of service when the diagnosis is persistent asthma 7.2 Coverage denied when: Billed and the patient's age is less than 6 years Billed by any provider more than once every two (2) weeks Billed by any provider more than once every four (4) weeks and the diagnosis is chronic idiopathic urticaria or latex allergy Billed by any provider more than once every three (3) weeks and the diagnosis is seasonal allergic rhinitis, and a diagnosis of moderate to severe persistent asthma is not present 8.0 Coding specifications* *Codes and descriptors listed below are provided for informational purposes only and may not be all inclusive or current. Listing of a code in this drug policy does not imply that the service described by the code is a covered or non-covered service. Benefit coverage for any service is determined by the member s policy of health coverage with Prevea360 Health Plan, Inc. Inclusion of a code in the table below does not imply any right to reimbursement or guarantee claim payment. Other drug or medical policies may also apply. 8.1 NDC and HCPCS codes Medication Name How Supplied National Drug Brand Generic Code (NDC) HCPCS code XOLAIR omalizumab 150mg/vial single dose vial J NOTE: The use of physician samples or manufacturer discounts does not guarantee later coverage under the provisions of the medical certificate and/or pharmacy benefit. All criteria must be met in order to obtain coverage of the listed drug product. 7 of 8

8 Originated: Revised: Reviewed: Committee/Source Utilization Management Committee/ Medical Affairs/ P&T Committee Medical Director Committee/Quality and Care Management Division Management/Pharmacy Services UM Committee (UMC)/Director UM/ UMC Chair UM Committee (UMC)/Director UM/UMC Chair UM Committee (UMC)/Director UM/ UMC Chair Reformatted UM Committee (UMC)/Director UM/UMC Chair UM Committee (UMC)/Director UM/UMC Chair UM Committee (UMC)/Director UM/UMC Chair Medical Director Committee/Quality and Care Management Division Management/Pharmacy Services Management Division Date(s) December 10, 2003 March 24, 2011 April 16, 2014 January 20, 2016 December 21, 2016 June 21, 2017 January 10, 2018 March 21, 2018 March 10, 2004 March 9, 2005 March 8, 2006 May 2006 March 14, 2007 March 12, 2008 April 8, 2009 March 24, 2011 March 21, 2012 August 15, 2012 January 16, 2013 January 15, 2014 April 16, 2014 January 21, 2015 January 20, 2016 December 21, 2016 June 21, 2017 January 10, 2018 March 21, 2018 Effective: 04/01/2018 Published: 04/01/ of 8

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