CSHCN 2008 > Physician > Benefits and Limitations

24.3.17.15 Omalizumab

Omalizumab (procedure codes 1-J2357) is a benefit of the CSHCN Services Program when medically necessary for the treatment of clients 12 years of age and older with severe asthma and must be prior authorized. Clients under 12 years of age may be considered for authorization in exceptional circumstances. Procedure code 1-J2357 must be used to request prior authorization and the exact dosage must be indicated.

Doses and dosing frequency are determined by body weight and by serum IgE level (IU/ml) measured before the start of the treatment.

Authorization of omalizumab is based on the following medical necessity criteria:

•Diagnosis of asthma.

•12 years of age and older.

•Documentation of positive skin test or RAST to a perennial (not seasonal) aeroallergen within the past 36 months.

•Total IgE level greater than 30 IU/ml but less than 700 IU/ml within the past 12 months.

•Documentation of appropriate dose of inhaled steroid prescribed (roughly equivalent to greater than or equal to 660 micrograms/day of fluticasone (adult) or comparable dose of other inhaled steroid.

•Documentation of patient compliance with inhaled steroid regimen.

•Clinical evidence of inadequate asthma control. This evidence may include:

•Dependence upon continuous systemic steroid, maximal inhaled steroid regimen with frequent systemic steroid pulses.

•Significantly declining pulmonary function test or frequent hospitalizations for severe asthma exacerbations in the face of adequate maximal standard therapy and client has to have been on daily therapy for persistent asthma for at least one year, with daily use of beta agonist.

•A pulmonary function test (performed in the last year) must demonstrate a forced expiratory volume (FEV) 1.0 less than 80 percent of predicted in conjunction with FEV 1.0/FVC ratio < 0.7 of pulmonary function test; and test results demonstrating on the same test a 12 percent or greater post bronchodilator improvement of FEV 1.0.

Providers may submit documentation that the client is unable to perform the pulmonary function test in lieu of test results. Provider must document that the client is not currently smoking, pregnant/intending pregnancy, or breast feeding.

Omalizumab approvals are for intervals of three months at a time. Clients must be fully compliant with their omalizumab regime in order to qualify for any additional authorizations. The provider must submit a statement documenting full compliance with the requests for each renewal in order to qualify for any additional authorizations. After nine continuous months of authorizations, the provider must submit documentation of satisfactory clinical response to omalizumab in order to qualify for additional authorizations.

Refer to: Appendix B, "CSHCN Services Program Authorization Request for Omalizumab".