| Sumario: | Omalizumab is being reviewed for the treatment of adults and adolescents (12 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. Omalizumab is available as a 150 mg single-use vial of sterile powder for reconstitution for subcutaneous injection at a cost of 612 per vial (Ontario Drug Benefit Formulary Exceptional Access Program, January 2016). At the recommended dose of 150 mg to 375 mg administered subcutaneously every two or four weeks, the annual cost of omalizumab ranges from 7,956 to 47,736. Omalizumab was originally submitted to the CADTH Common Drug Review (CDR) for this indication in April 2005; however, a final recommendation by the Canadian Expert Drug Advisory Committee (CEDAC) was not issued since a request for reconsideration from the manufacturer was deemed to include new information requiring resubmission. Omalizumab was subsequently resubmitted by the manufacturer to CDR in October 2005, resulting in a CDEC recommendation of Do not Reimburse. The reasons for the recommendation were that three of the four blinded randomized controlled trials suggested no statistically significant improvements in acute asthma exacerbations leading to hospitalizations, emergency room visits, or physician visits, and only one of the trials was in a patient population treated with inhaled corticosteroids (ICS) with a long-acting beta2-agonist (LABA). Although all of the trials reported that omalizumab improved quality of life, CDEC noted that, at the submitted price, omalizumab was not cost-effective. In 2015, omalizumab was reviewed by CDEC for adults and adolescents with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment. It received a recommendation of Reimburse with Clinical Criteria and Conditions, with one of the conditions being a substantial price reduction.
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