omalizumab 75mg, 150mg solution for injection (Xolair)

following an abbreviated submission

omalizumab 75mg, 150mg (Xolair ®) solution for injection is accepted for restricted use within NHS Scotland.

Indication under review: omalizumab is indicated in adults, adolescents (12 years of age and older) and children (6 to <12 years of age) with convincing IgE (immunoglobulin E) mediated asthma.

SMC restriction: Use is restricted to patients who are prescribed chronic systemic steroids and in whom all other treatments have failed.  The response to omalizumab treatment should be assessed in all patients at 16 weeks and treatment should be discontinued in patients who have not shown a marked improvement in overall asthma control.

SMC has previously accepted omalizumab (Xolair ®) 150mg powder and solvent for injection for restricted use in adults, adolescents and  children. This submission is for a new solution for injection formulation that will replace the existing formulation. The 150mg solution for injection formulation is bioequivalent to the 150mg powder and solvent for injection formulation and costs the same. The new 75mg strength is half the cost of the 150mg injection and should eliminate wastage that occurred previously with certain doses.