OMALIZUMAB INJ,LYPHL

Clinical Criteria Summary

Care provided by a VA/VA Community Care pulmonologist, immunologist, allergist, or designated expert in the management of asthma
Diagnosis of moderate to severe persistent asthma
Pre-treatment serum IgE is 30 to 700 IU/mL
Positive skin tests or in vitro reactivity to common aeroallergens (e.g., dust mites, pet dander, cockroach)
Receiving medium to high dose inhaled corticosteroids and long-acting beta-agonist or other controller medication(s)
Inadequate symptom control (e.g., short-acting beta-agonist use, nighttime awakening due to asthma more than once weekly, limitation with normal activity, Asthma Control Test less than 19) OR asthma exacerbation(s) requiring systemic corticosteroids in the last 12 months
Adherent to asthma medications as evidenced by a review of prescription refill history during the last 12 months
Should be nonsmoking or receiving smoking cessation treatment if smoking
Has an epinephrine pen available at time of injection and for at least 24 hours after injection
Therapy to be initiated in a healthcare setting

Provider has determined that self-administration with prefilled syringe by patient or caregiver is appropriate
No previous history of anaphylaxis to omalizumab or other agents (e.g. food, drugs, biologics, etc.)
At least 3 doses were administered in healthcare setting with no hypersensitivity reactions
The patient and/or caregiver must be trained in and demonstrate the correct subcutaneous injection technique
The patient and/or caregiver are taught to recognize signs and symptoms of anaphylaxis and is able to treat anaphylaxis appropriately

Patient has confirmed Ig-E mediated food allergy and a need for treatment with omalizumab to reduce the risk of type 1 allergic reactions, including anaphylaxis, and prescribed by a specialist in Allergy and Immunology.

Data for use in patients with baseline IgE serum levels up to 1500 IU/mL are available (considered off-label in the US). Use of omalizumab in such patients should be adjudicated locally.
There is limited information on the efficacy and safety of omalizumab in patients who smoke. The decision to use omalizumab in patients who have had unsuccessful attempts at smoking cessation should be made on a case-by-case basis.

Diagnosis of severe chronic spontaneous urticaria (e.g., UAS7 >28 and/or UCT <12)
Unacceptable symptoms despite a therapeutic trial of 1 non-sedating H antihistamine titrated up to 4 times the usual daily dose
Has an epinephrine rescue device available at the time of injection and for at least 24 hours after the injection
Omalizumab therapy is initiated in a healthcare setting

Provider is a VA or VA Community Care allergy specialist, dermatologist or designated expert in the management of allergic conditions

Provider has determined that self-administration with prefilled syringe by patient or caregiver is appropriate
No previous history of anaphylaxis to omalizumab or other agents (e.g., food, drugs, biologics, etc.)
At least 3 doses were administered in healthcare setting with no hypersensitivity reactions
Patient and/or caregiver are taught to recognize signs and symptoms of anaphylaxis and able to treat anaphylaxis appropriately