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Abstract
Background Asthma treatment with omalizumab is very expensive. The transfer of omalizumab dispensing from community to hospital pharmacy in April 2012 increased spending. This turned the spotlight on prescription practice.
Purpose To assess the difference in pharmaceutical spending related to omalizumab after the transfer to hospital dispensing, and to check whether use corresponded to the approved indications.
Materials and methods Omalizumab spending was assessed in Granada during 2 periods of time: 1st, from April 2011 to March 2012, and 2nd, from April 2012 to March 2013. Afterwards, prescriptions were evaluated in 72 patients who began or continued omalizumab in April 2012. Data were obtained from the clinical history when the patient started the treatment. The variables we examined are indicated in the SPC: diagnosis, age, skin or in vitro allergen-specific testing (ASST), forced expiratory volume in 1 second (FEV1), nocturnal symptoms (NS) and prevalence of exacerbations, pre-treatment with inhaled glucocorticoids (ICS) and long-acting beta-agonists (LABA), and dose determined by body weight and total serum IgE level (SEIL).
Results Cost. Spending first period: 709.331 €. Spending second period: 1,254,655 €. Increase in spending: 545,324 € (76.87%).
Prescription adequacy level. 67 of 72 patients (89.33%) were diagnosed with severe asthma and the other 5 (5.94%) with other illnesses. All patients except one were older than 6 years. Positive ASST: 46 patients (63.88%), and negative or unmeasured ASST: 29 patients (37.5%). FEV1 <80%: 25 patients (34.72%), and FEV1 >80% or unmeasured in 47 patients (65.27%). All the patients (100%) had NS and frequent exacerbations. 91.66% of patients had already been treated with ICS and LABA. In accordance with SEIL, the range approved goes from 30 to 1500 IU/ml, but only 40 patients were in this range (55.55%) whereas the other 32 patients were out of range or the SEIL was not measured. The dose had been chosen correctly in 11 patients (11.27%).
Conclusions Only 2 of 72 patients complied with all requirements indicated in the SPC. The great cost and the increased spending in Granada (Spain) on omalizumab suggest that all Services involved in prescribing and dispensing this medicine must unite to achieve rational drug use.
No conflict of interest.