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09-J0000-44

Original Effective Date: 12/15/04

Reviewed: 01/11/17

Revised: 02/15/17

Next Review: 01/10/18

Subject: Omalizumab (Xolair®)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Xolair® (Omalizumab) is a recombinant DNA-derived humanized IgG1k murine monoclonal antibody that selectively binds to human IgE. Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils, which limits the degree of release of mediators of the allergic response.

Omalizumab is a treatment option limited to patients with elevated serum levels of IgE.  Its current indication is for patients with severe allergic asthma who are uncontrolled on inhaled glucocorticosteroids (ICS), although the dose of concurrent treatment has varied in different studies. Improved asthma control is reflected by fewer symptoms, less need for reliever medications and fewer exacerbations.  Additionally, omalizumab is indicated for treatment of chronic idiopathic urticarial who remain symptomatic despite H1 antihistamine treatment.

A 2012 Global Initiative for Asthma (GINA) Global Strategy for Asthma Management and Prevention Report recommends consideration of a trial of omalizumab for allergic patients with an elevated IgE not controlled on high dose inhaled glucocorticosteroids and a long acting B2 -agonist and who continue to have exacerbations.

Recommendations included in a 2014 practice parameter from the Joint Task Force on Practice Parameters (JTFPP) for the diagnosis and management of acute and chronic urticaria provides a step-based approach to the treatment of chronic urticaria.  Omalizumab is included in the Step 4 care approach when chronic urticaria has been refractory to treatment with potent antihistamines and leukotriene receptor antagonists. 

POSITION STATEMENT:

 

Certificate of Medical Necessity

Submit a completed Certificate of Medical Necessity (CMN) along with your request to expedite the medical review process.

1. Click the link Omalizumab (Xolair®) - Certificate of Medical Necessity (MS Word) to open the form.

2. Complete all fields on the form thoroughly.

3. Print and submit a copy of the form with your request.

Note: Florida Blue regularly updates CMNs. Ensure you are using the most current copy of a CMN before submitting to Florida Blue. For a complete list of available CMNs, visit the Certificates of Medical Necessity page.

Initiation of omalizumab (Xolair) meets the definition of medical necessity for members diagnosed with either of the following conditions when ALL associated criteria are met:

1. Moderate to severe persistent asthma

a. Member has a positive skin test or in vitro reactivity to a perennial aeroallergen – laboratory documentation must be provided

b. Member’s baseline pretreatment serum total IgE is between 30 IU/mL and 700 IU/mL – laboratory documentation must be provided

c. Member’s symptoms remain uncontrolled or inadequately controlled despite three months of treatment with at least ONE of the following:

i. Combination moderate- or high-dose inhaled corticosteroids (Table 4 and 5) AND long-acting beta agonist (e.g., formoterol fumarate (Foradil), salmeterol xinafoate (Serevent))

ii. Combination moderate- or high-dose inhaled corticosteroids (Table 4 and 5) AND leukotriene modifier (e.g., montelukast, zafirlukast)

iii. Combination moderate- or high-dose inhaled corticosteroids (Table 4 and 5) AND theophylline

iv. Combination inhaled corticosteroid/long-acting beta 2 agonist (e.g., fluticasone propionate/salmeterol (Advair), mometasone/formoterol (Dulera), budesonide/formoterol (Symbicort))

d. Omalizumab is prescribed by a board certified allergist, immunologist, or pulmonologist

e. Omalizumab is not used in combination with mepolizumab (Nucala) or reslizumab (Cinqair)

f. Dose does not exceed 375 mg every 2-4 weeks; maximum 6 vials or 180 HCPCS units every 28 days

g. Member is 6 years of age or older

2. Chronic idiopathic urticaria

a. Member’s symptoms remained uncontrolled or inadequately controlled despite four weeks of treatment with a second-generation antihistamine (e.g., cetirizine, fexofenadine, desloratadine) used in combination with an H2-antihistamine (e.g., ranitidine, famotidine) and a leukotriene modifier (e.g., montelukast, zafirlukast)

b. Omalizumab is prescribed by a board certified allergist or immunologist

c. Omalizumab dose does not exceed 300 mg every 4 weeks; maximum 2 vials or 60 HCPCS units every 28 days

d. Member is 12 years of age or older

Duration of approval: 180 days

Continuation of omalizumab (Xolair) meets the definition of medical necessity for members diagnosed with either of the following conditions when ALL associated criteria are met:

1. Moderate to severe persistent asthma

a. Authorization/reauthorization has been previously approved by Florida Blue or another health plan in the past two years, OR the member has previously met all indication-specific initiation criteria

b. Member has a history of beneficial clinical response to omalizumab as evidenced by one or more of the following:

i. Decreased frequency of exacerbations (defined as worsening of asthma that requires an increase in inhaled corticosteroid dose or treatment with systemic corticosteroids)

ii. Increase in predicted FEV1 or peak flow from pretreatment baseline

iii. Reduction in reported asthma-related symptoms, such as, asthmatic symptoms upon awakening, coughing, fatigue, shortness of breath, sleep disturbance, or wheezing

c. Omalizumab is not used in combination with mepolizumab (Nucala) or reslizumab (Cinqair)

d. Dose does not exceed 375 mg every 2-4 weeks; maximum 6 vials or 180 HCPCS units every 28 days

2. Chronic idiopathic urticaria

a. Authorization/reauthorization has been previously approved by Florida Blue or another health plan in the past two years, OR the member has previously met all indication-specific initiation criteria

b. Dose does not exceed 300 mg every 4 weeks; maximum 2 vials or 60 HCPCS units every 28 days

Duration of approval: 1 year

The safety and efficacy of Xolair® in other allergic conditions and non-allergic asthma has not been established and therefore is considered experimental or investigational when administered for all other indications as there is insufficient clinical evidence to support its use, and specifically for the following:

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

Allergic Asthma:

Chronic Idiopathic Urticaria:

Table 1

ADMINISTRATION EVERY 4 WEEKS
Xolair® Doses (milligrams) Administered by Subcutaneous Injection Every 4 Weeks for Adults and Adolescents (12 Years of Age and Older) with Asthma

Pre-treatment Serum IgE (IU/mL)

Body Weight (kg)

30-60

> 60-70

> 70-90

> 90-150

>30-100

150

150

150

300

> 100-200

300

300

300

 

> 200-300

300

 

 

 

> 300-400

 

SEE TABLE 2

 

> 400-500

 

 

> 500-600

 

 

 

 

Table 2

ADMINISTRATION EVERY 2 WEEKS
Xolair® Doses (milligrams) Administered by Subcutaneous Injection Every 2 Weeks for Adults and Adolescents (12 Years of Age and Older) with Asthma

Pre-treatment Serum IgE (IU/mL)

Body Weight (kg)

30-60

> 60-70

> 70-90

> 90-150

>30-100

SEE TABLE 1

 

 

> 100-200

 

225

> 200-300

 

225

225

300

> 300-400

225

225

300

 

> 400-500

300

300

375

 

> 500-600

300

375

DO NOT DOSE

> 600-700

375

 

 

 

Table 3

Subcutaneous Xolair Doses Every 2 or 4 Weeks for Pediatric Patients
with Asthma Who Begin Xolair Between the Ages of 6 to <12 Years

   

Body Weight

Pre-treatment

Serum IgE

(IU/mL)

Dosing

Freq.

20-25

kg

>25-30

kg

>30-40

kg

>40-50

kg

>50-60

kg

>60-70

kg

>70-80

kg

>80-90

kg

>90-125

kg

>125-150

kg

   

Dose (mg)

30-100

Every

4

weeks

75

75

75

150

150

150

150

150

300

300

>100-200

150

150

150

300

300

300

300

300

225

300

>200-300

150

150

225

300

300

225

225

225

300

375

>300-400

225

225

300

225

225

225

300

300

 

>400-500

225

300

225

225

300

300

375

375

>500-600

300

300

225

300

300

375

DO NOT DOSE

>600-700

300

225

225

300

375

 

>700-800

Every

2

weeks

225

225

300

375

 

>800-900

225

225

300

375

>900-1000

225

300

375

 

>1000-1100

225

300

375

>1100-1200

300

300

 

>1200-1300

300

375

Dosing Adjustments

NOTE: Dosing in CIU is not dependent on IgE levels or body weight; the following information only applies to dosing in allergic asthma.

Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment. Therefore, re-testing of IgE levels during Xolair® treatment cannot be used as a guide for dose determination. Dose determination after treatment interruptions lasting less than 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 treatment with Xolair® has been interrupted for one year or more.

Doses should be adjusted for significant changes in body weight.

Drug Availability

150 mg single-use 5 mL vial

PRECAUTIONS:

Boxed Warning

• Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration

• Anaphylaxis has occurred after the first dose but also has occurred beyond 1 year after beginning treatment.

Contraindications

• Severe hypersensitivity reaction

Precautions/Warnings

• Anaphylaxis: Administer only in a healthcare setting prepared to manage anaphylaxis that can be life-threatening and observe patients for an appropriate period of time after administration

• Malignancy: Malignancies have been observed in clinical studies

• Acute Asthma Symptoms: Do not use for the treatment of acute bronchospasm or status asthmaticus

• Corticosteroid Reductions: Do not abruptly discontinue corticosteroids upon initiation

• Fever, Arthralgia, and Rash: Stop if patients develop signs and symptoms similar to serum sickness

• Eosinophilic Conditions: Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids

BILLING/CODING INFORMATION:

HCPCS Coding:

J2357

injection, omalizumab, 5 mg

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

J45.40

Moderate persistent asthma, uncomplicated

J45.41

Moderate persistent asthma with (acute) exacerbation

J45.42

Moderate persistent asthma with status asthmaticus

J45.50

Severe persistent asthma, uncomplicated

J45.51

Severe persistent asthma with (acute) exacerbation

J45.52

Severe persistent asthma with status asthmaticus

L50.1

Idiopathic urticaria

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage Products:

No National Coverage Determination (NCD) WAS found at the time of the last guideline revised date. The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: Omalizumab (Xolair), (L33924) located at fcso.com

DEFINITIONS:

FEV1:

FVC:

PEF:

Mild Intermittent Asthma:

Mild Persistent Asthma:

Moderate Persistent Asthma:

Severe Persistent Asthma:

RELATED GUIDELINES:

None.

OTHER:

Table 4

ESTIMATED COMPARATIVE DAILY DOSAGES FOR INHALED CORTICOSTEROIDS IN CHILDREN

Drug

Low Daily Dose

Child 0 – 4
Child 5 – 11

Medium Daily Dose

Child 0 – 4
Child 5 – 11

High Daily Dose

Child 0 – 4
Child 5 – 11

Beclomethasone HFA

40 or 80 mcg/puff

NA
80 – 16 mcg

NA
>160-120mcg

NA
>320mcg

Budesonide DPI

90, 180 or 200 mcg/inhalation

NA
180 – 400mcg

NA
>400 – 800mcg

NA
>800mcg

Budesonide Inhaled

Inhalation suspension for nebulization (child dose)

0.25 – 0.5mg
0.5mg

>0.5 – 1.0mg
1.0mg

>1.0mg
2.0mg

Flunisolide

250mcg/puff

NA
500 – 750mcg

NA
1000 – 1250mcg

NA
>1250mcg

Flunisolide HFA

80mcg/puff

NA
160mcg

NA
320mcg

NA
>
640mcg

Fluticasone HFA/MDI

44, 110 or 220mcg/puff

176mcg
88 – 176mcg

>176 – 352
>176 – 352

Mcg
mcg

>352mcg
>352mcg

Fluticasone DPI

250mcg/inhalation

NA
100 – 200mcg

NA
>200 – 400mcg

NA
>400mcg

Mometasone DPI

200mcg/inhalation

NA
NA

NA
NA

NA
NA

Triamcinoline acetonide

75mcg/puff

NA
300 – 600mcg

NA
>600 – 900mcg

NA
>900mcg

Table 5

ESTIMATED COMPARATIVE DAILY DOSAGES FOR INHALED CORTICOSTEROIDS FOR YOUTHS >12 YEARS OF AGE AND ADULTS

Drug

Low Daily Dose

Adult

Medium Daily Dose

Adult

High Daily Dose

Adult

Beclomethasone HFA

40 or 80mcg/puff

80 – 240mcg

>240 – 480mcg

>480mcg

Budesonide DPI

90, 180 or 200mcg/inhalation

180 – 600mcg

>600 – 1200mcg

>1200mcg

Flunisolide

250mcg/puff

500 – 1000mcg

>1000 – 2000mcg

>2000mcg

Flunisolide HFA

80mcg/puff

320mcg

>320 – 640mcg

>640mcg

Fluticasone HFA/MDI

44, 110 or 220mcg/inhalation

88 – 264mcg

>264 – 440mcg

>440mcg

Fluticasone DPI

50, 100 or 250mcg/inhalation

100 – 300mcg

>300 – 500mcg

>500mcg

Mometasone DPI

200mcg/inhalation

200mcg

400mcg

>400mcg

Triamcinolone acetanide

75mcg/puff

300 – 750mcg

>750 – 1500mcg

>1500mcg

REFERENCES:

  1. American College of Allergy, Asthma & Immunology. Editorial background. Anti-IgE. Accessed 10/31/07.
  2. American College of Allergy, Asthma & Immunology. Overview of Expert Care for Asthma. Accessed 11/06/07.
  3. American College of Allergy, Asthma & Immunology. Position Statement on the Administration of Immunotherapy Outside of the Prescribing Allergist Facility. Accessed 11/06/07.
  4. American Medical Association CPT Coding, 2009professional edition.
  5. Asthma. In: Pulmonary (acute & chronic). San Diego (CA): Work Loss Data Institute; 2009. p. 2-18.Accessed January 2012.
  6. Bernstein JA, Lang DM, Khan DA, et al. Joint Task Force on Practice Parameters (JTFPP), representing the American Academy of Allergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma & Immunology. Practice parameter:  The diagnosis and management of acute and chronic urticaria: 2014 update. J Allerg Clin Immunol. 2014; 133(5):1270-1277.
  7. Burch J, Griffin S, McKenna C, et al.  Omalizumab for the treatment of severe persistent allergic asthma in children aged 6-11 years: a NICE single technology appraisal.  Pharmacoeconomics. 2012; 30(11):991-1004.
  8. Burch J, Griffin S, McKenna C, Walker S, Paton J, Wright K, Woolacott N. Omalizumab for the treatment of severe persistent allergic asthma in children aged 6-11 years: a NICE single technology appraisal. Pharmacoeconomics. 2012 Nov 1;30(11):991-1004.
  9. Canadian Agency for Drugs and Technologies in Health (CADTH), formerly the Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Omalizumab as Add-on Therapy to Inhaled Steroids for Asthma. Issues in Emerging Health Technologies Bulletin, Issue 58. June 2004. Ottawa, ON. Available at:  http://www.cadth.ca/media/pdf/282_omalizumab_cetap_e.pdf. Accessed on January 11, 2016.
  10. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2016 [cited 2016 Dec 7]. Available from: http://www.clinicalpharmacology.com/.
  11. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; 2016 [cited 2016 Dec 7]. Available from: http://www.thomsonhc.com/..
  12. Facts & Comparisons, 4.0, accessed 02/04/09.
  13. Genentech, Inc. A Study of Xolair (Omalizumab) in Patients with Chronic Idiopathic Urticaria (CIU) who remain Symptomatic with Antihistamine Treatment (H1). NLM Identifier: NCT00866788. Last updated September 16, 2011. Available at:  http://clinicaltrials.gov/ct2/show/NCT00866788?term=NCT00866788&rank=1. Accessed on January 11,  2016.
  14. Genentech, Inc. A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma (EXCELS). NLM Identifier: NCT00252135. Last updated November 23, 2011.  Available at: http://clinicaltrials.gov/ct2/show/NCT00252135. Accessed on January 11, 2016.
  15. Genentech, Inc. XOLAIR Injection.  Medication Guide.  Reference ID: 3475329. July 2016. Available at:  http://www.fda.gov/downloads/Drugs/DrugSafety/UCM089829.pdf.
  16. Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA). Bethesda, MD. Update 2012. Available at:  http://www.ginasthma.org/guidelines-gina-report-global-strategy-for-asthma.html. Accessed on January 11, 2016.
  17. Ingenix, HCPCS Level II Coding, 2009 Expert.
  18. Ingenix, ICD-9-CM Codes for Physicians – Volumes 1 & 2, Expert, 2009.
  19. Joint Task Force on Practice Parameters. The diagnosis and management of urticaria: a practice parameter part I: acute urticaria/angioedema part II: chronic urticaria/angioedema. Joint Task Force on Practice Parameters. Ann Allergy Asthma Immunol. 2000 Dec;85(6 Pt 2):521-44
  20. Leech S, Grattan C, Lloyd K, et al.; Science and Research Department, Royal College of Paediatrics and Child Health (RCPCH). The RCPCH care pathway for children with urticaria, angio-oedema or mastocytosis: an evidence and consensus based national approach. Arch Dis Child. 2011; 96(2):34-37.
  21. Li JT, Oppenheimer J, Bernstein IL, et al. Attaining optimal asthma control: a practice parameter. Developed by the Joint Task Force on Practice Parameters representing the American Academy of Allergy, Asthma and Immunology; the American College of Allergy, Asthma and Immunology; and the Joint Council of Allergy, Asthma and Immunology. J Allergy Clin Immunol. 2005; 116(5):S3-11. Available at: https://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Practice%20and%20Parameters/attaining-optimal-asthma-control.pdf. Accessed on January 11, 2016.
  22. Managing asthma long term in youths >=12 years of age and adults. In: National Asthma Education and Prevention Program (NAEPP). Expert panel report 3: guidelines for the diagnosis and management of asthma. Bethesda (MD): National Heart, Lung, and Blood Institute; 2007 Aug. p. 326-62. [103 references]; National Guideline Clearinghouse. Accessed 01/27/10.
  23. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. NIH Publication Number 08-5846. October 2007. Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthsumm.pdf. Accessed on January 11, 2016.
  24. National Heart, Lung, and Blood Institute Guidelines for the Diagnosis and Management of Asthma. 2007. Accessed 01/04/11.
  25. National Heart, Lung, and Blood institute. Key Clinical Activities for Quality Asthma Care. Recommendations of the National Asthma Education and Prevention Program in partnership with the Centers for Disease Control and Prevention. Reproduced from the Morbidity and Mortality Weekly Report (MMWR): Recommendations and Reports, Vol. 52/No. RR-6, March 28, 2003.
  26. National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report 2007. NIH Publication No. 07-4051. Originally printed July 1997. Revised June 2002, August 2007.
  27. National Heart, Lung, and Blood Institute; Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma – Summary Report 2007. Accessed 01/26/10.
  28. National Institute for Health and Clinical Excellence (NICE). Omalizumab for treating severe persistent allergic asthma (review of technology appraisal guidance 133 and 201). Technology Appraisal Guidance No. 278. London, UK: NICE; April 2013. Available at: http://www.nice.org.uk/guidance/ta278. Accessed on January 11, 2016.
  29. Walker S, Monteil M, Phelan K, Lasserson TJ, Walters EH. Anti-IgE for chronic asthma in adults and children. Cochrane Database of Systematic Reviews 2003, Issue 3. Art. No.: CD003559. DOI: 10.1002/14651858. CD003559.pub3.
  30. Xolair® prescribing information. Accessed 4/23/14.
  31. Zuberbier T, Asero R, Bindslev-Jensen C, et al; Dermatology Section of the European Academy of Allergology and Clinical Immunology, Global Allergy and Asthma European Network, European Dermatology Forum, World Allergy Organization. EAACI/GA2LEN/EDF/WAO guideline: management of urticaria. Allergy. 2009 Oct;64(10):1427-43.
  32. Zuberbier T, Asero R, Bindslev-Jensen C, et al; Dermatology Section of the European Academy of Allergology and Clinical Immunology, Global Allergy and Asthma European Network, European Dermatology Forum, World Allergy Organization. EAACI/GA2LEN/EDF/WAO guideline: management of urticaria. Allergy. 2009 Oct;64(10):1417-26.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 01/11/17.

GUIDELINE UPDATE INFORMATION:

12/15/04

New Medical Coverage Guideline.

01/01/05

Annual HCPCS code update, consisting of J2357 and C9217. Deleted miscellaneous code J3490.

01/01/06

CPT code update deleted expired code 90782, added new code 90772.

02/15/06

Reviewed. Update description, deleted precautions, deleted expired HCPCS code C9217. Deleted ICD-9 codes: 975.7, 493.82, 493.8, 493.12, 493.1, 493.11, 493.2, 493.21, 493.22, 493.9, 493.91, 493.92. Updated references and related links. Corrected FEV1 and PEF values for moderate to severe asthma definition in when services are covered as per the Heart, Lung and Blood Institute guidance.

01/01/07

MCG revised to include Medicare Part D as a program exception.

02/15/07

Reviewed. Reformatted, edited and updated websites and references.

06/15/07

Reformatted guideline; updated references.

12/15/07

Review and revision to guideline; consisting of maintaining current coverage and limitations, adding black box warning under “Dosage/Administration” section, updating references.

03/15/08

Revision to guideline; consisting of adding “moderate to high dose inhaled corticosteroid” to criteria under POSITION STATEMENT, added note regarding combination therapy trial, added tables comparing inhaled corticosteroid dosages, removed several ICD-9 codes and updated references.

01/01/09

Annual HCPCS coding update: deleted code 90772; added code 96372.

03/15/09

Review and revision; consisting of reformatting and updating references.

03/15/10

Review and revision; consisting of updating the position statement to include requirement of demonstration of asthma symptom persistence despite inhaled corticosteroids AND combination therapy with long acting beta agonists or leukotriene inhibitors and added a baseline pretreatment IgE requirement. Added additional warnings.

02/15/11

Review and revision to guideline; consisting of added additional brand drug name examples of long acting Beta 2 agonist products to the position statement. Added seasonal and food allergies to the experimental or investigational use statement. Removed extrinsic asthma status asthmaticus and acute exacerbation from the ICD-9 codes. Added ICD-10 code for allergic asthma.

02/15/12

Review and revision to guideline; consisting of adding dosage max and chronic urticarial to the exclusion list.

02/15/13

Review and revision to guideline; consisting of adding requirements for initiation of therapy and continuation of therapy

11/15/13

Revision to guideline; consisting of reformatting position statement, adding approval duration, and updating program exceptions.

02/15/14

Review and revision to guideline; consisting of reformatting and revising position statement, dosing/administration, precautions/warning and references.

06/15/14

Revision to guideline; consisting of position statement, dosing/administration, billing/coding, references.

10/01/15

Revision consisting of update to Program Exceptions section.

11/01/15

Revision: ICD-9 codes deleted.

01/15/16

Revision: ICD10 codes updated.

03/15/16

Review and revision; consisting of position statement, description, references.

06/15/16

Revison to guideline; consisting of position statement.

07/15/16

Revison to guideline; consisting of position statement.

10/15/16

Revision to guideline; consisting of position statement and dosing.

02/15/17

Review and revision to guideline; consisting of updating references.

Date Printed: June 26, 2017: 01:26 AM