Download Xolair (omalizumab)

Xolair (omalizumab)
Line(s) of Business:
HMO; PPO; QUEST Integration
Akamai Advantage
Original Effective Date:
11/18/2003
Current Effective Date:
10/01/2015
POLICY
A. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a
covered benefit provided that all the approval criteria are met and the member has no exclusions to
the prescribed therapy.
FDA-Approved Indications
Asthma
Xolair is indicated for patients 6 years of age and older with moderate to severe persistent asthma who
have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are
inadequately controlled with inhaled corticosteroids. Xolair has been shown to decrease the incidence
of asthma exacerbations in these patients.
Limitations of Use:
 Xolair is not indicated for the relief of acute bronchospasm or status asthmaticus.
 Xolair is not indicated for treatment of other allergic conditions.
Chronic Idiopathic Urticaria (CIU)
Xolair is indicated for the treatment of adults and adolescents (12 years of age and above) with chronic
idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment.
Limitation of Use: Xolair is not indicated for treatment of other forms of urticaria.
B. REQUIRED DOCUMENTATION
The following documentation from the medical record is necessary to initiate the prior authorization
review:
 Allergic asthma, initial therapy:
o Member age
o Current medications (including doses)
o Member current weight
o Pre-treatment serum IgE (IU/mL) levels
o Skin or blood test results confirming the diagnosis of allergic asthma
o Clinical notes documenting failure of environmental controls and immune therapy
o FEV1 results
o Clinical notes documenting treatment of comorbidities
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o



Quality of Life Measures Survey (available at
http://www.hmsa.com/portal/provider/FM.Asthma_Quality_of_Life_Measures_Sur
vey.pdf)
Chronic idiopathic urticaria (CIU), initial therapy:
o Member age
o Clinical notes supporting a diagnosis of CIU for at least 3 months
o Clinical notes supporting trial and failure of all previous antihistamines, including
length of courses
Allergic asthma, continuation of therapy:
o Member age
o Either comparative FEV1 results or Quality of Life Measures Survey
o Current medications (including doses)
CIU, continuation of therapy:
o Member age
o Documentation supporting that the member has responded to therapy
o For members demonstrating a complete response: documentation must support
tapering of dose and/or withholding of therapy beyond the next dosing interval to
see if symptoms return
C. PRESCRIBER RESTRICTION
For allergic asthma, the specialty of the prescriber who recommended Xolair is an allergist,
immunologist, or pulmonologist. For CIU, the specialty of the prescriber who recommended Xolair is
an allergist, immunologist, or dermatologist.
D. INITIAL CRITERIA FOR APPROVAL
1. Allergic Asthma
Authorization of 6 months may be granted to members who are prescribed Xolair when ALL of
the following criteria are met:
a. Prior to initiating therapy, the severity of the member’s asthma is moderate or severe
persistent
b. The member is 6 years of age or older
c. Xolair will be administered in a controlled healthcare setting with access to emergency
medications if needed
d. The member’s asthma is inadequately controlled with the use of an inhaled corticosteroid at
the optimized dose
e. The member’s asthma is inadequately controlled with the use of a long acting beta agonist
at the optimized dose
f. The member’s current weight is less than or equal to 150 kg
g. The member’s pre-treatment IgE level is greater than or equal to 30 IU/mL
h. The prescribed Xolair dose follows FDA-approved dosing recommendations (for dose and
dosing frequency) based on pre-treatment serum IgE levels and body weight (See
prescribing information at www.xolair.com)
i. Prior to initiating therapy, the member has positive skin or in vitro reactivity to at least one
perennial aeroallergen
j. The member has failed environmental controls and standard immune therapy, unless there
is evidence that immune therapy will trigger a severe allergic reaction
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k. The member’s pre-treatment forced expiratory volume (FEV1) is less than 80% of predicted
value
l. The member’s comorbidities have been evaluated and treated
m. The member has a rapid-acting beta2 agonist available for rescue therapy
n. The member has completed a current HMSA Asthma Quality of Life Measures Survey
(available at
http://www.hmsa.com/portal/provider/FM.Asthma_Quality_of_Life_Measures_Survey.pdf)
2. Chronic idiopathic urticaria (CIU)
Authorization of 3 months may be granted to members who are prescribed Xolair when ALL of
the following criteria are met:
a. Prior to initiating therapy, the severity of the member’s CIU is moderate or severe
b. The member is 12 years of age or older
c. Xolair will be administered in a controlled healthcare setting with access to emergency
medications if needed
d. The member has been diagnosed with CIU for 3 months or longer
e. The member has been evaluated for other causes of urticaria
f. The member remained symptomatic despite treatment with at least 2 distinct courses of
different high-dose second generation H1 antihistamines used continuously for at least 2
weeks, unless contraindicated (See Appendix)
g. The member remained symptomatic despite treatment with a first generation H1
antihistamine (eg, hydroxyzine, doxepin) or an H2 antihistamine (eg, ranitidine) in
combination with a high-dose second generation H1 antihistamine used continuously for at
least 2 weeks, unless contraindicated (See Appendix)
E. CONTINUATION OF THERAPY
1. Allergic asthma
Authorization of 6 additional months may be granted to members who were previously
authorized by HMSA when ALL of the following criteria are met. After the first year,
authorization of 12 additional months may be granted to members when ALL of the following
criteria are met:
a. The member has shown improvement (or sustained improvement) in one of the following
measures since initiation of Xolair therapy:
i. Improvement in forced expiratory volume (FEV1)
ii. Decrease in hospitalizations or emergency room visits
iii. Overall increase in quality of life measures based on the HMSA Quality of Life
Measures Survey (available at
http://www.hmsa.com/portal/provider/FM.Asthma_Quality_of_Life_Measures
_Survey.pdf)
b. The member will continue to use inhaled corticosteroids
2. Chronic idiopathic urticaria (CIU)
Authorization of additional 6 months may be granted to members who were previously
authorized by HMSA when either criterion a) or b) below is met. After the first year,
authorization of 12 additional months may be granted to members when either criterion a) or b)
below is met:
a. The member has demonstrated a partial response since initiation of Xolair therapy
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b. The member has demonstrated a complete response since initiation of Xolair therapy AND
symptoms returned when the dose was tapered or withheld beyond the next dosing interval
F. DOSAGE AND ADMINISTRATION
Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted
compendia, and/or evidence-based practice guidelines.
G. APPENDIX
High-dose second generation H1 antihistamines are defined as twice daily dosing of standard daily
dosing (listed below):
 Cetirizine (Zyrtec®) 10 mg
 Levocetirizine (Xyzal®) 5 mg
 Fexofenadine (Allegra®) 180 mg
 Loratadine (Claritin®) 10 mg
 Desloratadine (Clarinex®) 5 mg
H. IMPORTANT REMINDER
The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not
intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended
to discourage or prohibit providing other medical advice or treatment deemed appropriate by the
treating physician.
Benefit determinations are subject to applicable member contract language. To the extent there are
any conflicts between these guidelines and the contract language, the contract language will
control.
This Medical Policy has been developed through consideration of the medical necessity criteria
under Hawaii’s Patients’ Bill of Rights and Responsibilities Act (Hawaii Revised Statutes §432E-1.4),
generally accepted standards of medical practice and review of medical literature and government
approval status. HMSA has determined that services not covered under this Medical Policy will not
be medically necessary under Hawaii law in most cases. If a treating physician disagrees with
HMSA’s determination as to medical necessity in a given case, the physician may request that
CVS/caremark reconsider the application of the medical necessity criteria to the case at issue in light
of any supporting documentation.
I.
REFERENCES
1. Xolair [package insert]. South San Francisco, CA: Genentech, Inc.; July 2016.
2. Busse, W. Anti-immunoglobulin E (omalizumab) therapy in allergic asthma. Am J Respir Crit Care
Med. 2001; 164 (8 part 2):S12-S17.
3. FDA Talk Paper. FDA approves first biologic for allergy-related asthma. June 20, 2003.
4. Global strategy for asthma management and prevention. Updated 2011. Available at:
http://www.ginasthma.org/uploads/users/files/GINA_Report2011_May4.pdf
5. Holgate S, et al. Efficacy of omalizumab, an anti-immunoglobulin E antibody, in patients with
allergic asthma at high risk of serious asthma-related morbidity and mortality. Curr Med Res
Opin. 2001; 17(4):233-240.
6. Kaplan A1, Ledford D, Ashby M, Canvin J, Zazzali JL, Conner E, Veith J, Kamath N, et.al J Allergy
Clin Immunol. Omalizumab in patients with symptomatic chronic idiopathic/ spontaneous
urticaria despite standard combination therapy. 2013 Jul;132(1):101-9.
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7. Khan, DA. Chronic urticaria: Standard management and patient education. UpToDate. 2014.
8. Khan, DA. Chronic urticaria: Treatment of refractory symptoms. UpToDate. 2014.
9. Maurer M1, Rosén K, Hsieh HJ, Saini S, Grattan C, Gimenéz-Arnau A, Agarwal S, Doyle R, Canvin
J, Kaplan A, Casale T. N Engl J Med. Omalizumab for the treatment of chronic idiopathic or
spontaneous urticaria. 2013 Mar 7;368(10):924-35. Epub 2013 Feb 24.
10. National Institutes of Health, National Heart, Lung, and Blood Institute, National Asthma
Education and Prevention Program. NAEPP Expert Panel Report 3: Guidelines for the diagnosis
and management of asthma. Bethesda, Maryland: U.S. Department of Health and Human
Services; July 2007.
11. Powell RJ, Du Toit GL, Siddique N, Leech SC, Dixon TA, Clark AT, Mirakian R, Walker SM, Huber
PA, Nasser SM; British Society for Allergy and Clinical Immunology (BSACI). BSACI guidelines for
the management of chronic urticaria and angio-oedema. Clin Exp Allergy. 2007 May;37(5):63150.
12. Practice Parameters for Allergen Immunotherapy. IX. Safety of Immunotherapy. Summary
Statement 12. Ann Allergy: 2003; 90:S1-540. (Third update is in draft as of 10/18/2010.)
13. Saini, S. Chronic urticaria: Clinical manifestations, diagnosis, pathogenesis, and natural history.
UpToDate. 2014.
14. Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and
steroid requirement in allergic asthmatics. Eur Respir J. 2001; 18(2):254-261.
15. Zuberbier T. World Allergy Organ J. A Summary of the New International
EAACI/GA2LEN/EDF/WAO Guidelines in Urticaria. 2012 Jan; 5 Suppl 1:S1-5.
16. Zuberbier T1, Asero R, Bindslev-Jensen C, Walter Canonica G, Church MK, Giménez-Arnau AM,
Grattan CE, Kapp A, Maurer M, Merk HF, et.al. EAACI/GA(2)LEN/EDF/WAO guideline:
management of urticaria. Allergy. 2009 Oct;64(10):1427-43.
Revised: August 2016.
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