1872 Comparison of ﬁxed-dose combinations for asthma the launch of budesonide ⁄ formoterol in Germany (June 2001) were excluded. Treatment outcomes The predeﬁned primary end-point was the probabil- ity of full treatment success vs. partial or no treat- ment success over 12 months following ﬁrst prescription of an ICS ⁄ LABA combination therapy. Treatment success was deﬁned a priori according to primary or secondary criteria as described in Table 1. All events were assumed to be asthma related if a code for asthma diagnosis (ICD-10 codes J45–J46) was recorded on the same date. In case there was no link to diagnosis for an event, an algorithm was used to deﬁne whether an event was related to asthma. Hospitalisations, referrals and oral corticosteroid (OCS) prescriptions were assumed to be related to asthma if they occurred within the 7 days before or after an event with a recorded diagnosis of asthma. Referrals associated with asthma were deﬁned as all referrals to either a pneumologist or an allergologist. Secondary outcomes included asthma exacerba- tions, SABA use, overall OCS prescriptions and asthma-related referrals and hospitalisations ⁄ emer- gency room visits. Asthma exacerbations were deﬁned as any event (prescription, hospitalisation, sick note or referral) with a diagnosis of acute severe asthma status (ICD-10 code J46) or any asthma-related OCS prescription occurring within the 7 days before or the 7 days after an event with recorded diagnosis of asthma or acute lower respiratory tract infection (ICS-10 codes J45, J46, J22), or any referral or hospi- talisation occurring within 7 days before or after an event with recorded diagnosis of asthma or acute lower respiratory tract infections. In cases where two or more acute exacerbations occurred within 7 days, it was counted as only one episode. The proportion of patients that did not renew their initial prescription was investigated as a measure of dis- continuations. Cost analysis The health economic evaluation was conducted from a third-party payer perspective and compared costs related to each therapy in terms of medications and other asthma-related healthcare resource use. Unit costs for asthma medications were estimated from producer sales prices using a program provided by IMS. For budesonide ⁄ formoterol and salmeterol ⁄ ﬂu- ticasone, 2007 ⁄ 2008 prices were obtained from the Rote Liste (http://www.rote-liste.de). Costs for physi- cian consultations and outpatient procedures were obtained from the Einheitbewertungsmaßstab sched- ules and costs for hospitalisations came from the German reﬁned diagnosis-related groups (http:// www.g-drg.de/) (Table 2). Table 1 Deﬁnition of treatment success in the year following initiation of budesonide ⁄ formoterol or salmeterol ⁄ ﬂuticasone therapy, according to primary and secondary criteria Category Full success Partial success No success Primary success criteria Average SABA consumption of < 0.5 doses* per day and No addition of asthma medication (leukotriene antagonist, theophylline, omalizumab, fenoterol + ipratropium combination) between 10 and 52 weeks after index date or any switch to alternative ICS ⁄ LABA ﬁxed combination or ICS + LABA An otherwise successfully treated patient who has an average SABA consumption between 0.51–2 doses per day Average SABA consumption of more than two doses ⁄ day or Addition of asthma medication between 10 and 52 weeks after index date or switch to alternative ICS ⁄ LABA ﬁxed combination or ICS + LABA Secondary success criteria As for the primary deﬁnition and No asthma-related OCS prescription and No asthma-related referrals or hospitalisations As for the primary deﬁnition and ⁄ or 1–2 OCS prescriptions and No asthma-related referrals or hospitalisation As for the primary deﬁnition and ⁄ or > Two OCS prescriptions and ⁄ or At least one asthma-related referral or hospitalisation *Expressed in dry powder inhaler equivalents. ICS, inhaled corticosteroid; LABA, long-acting b2-agonist; OCS, oral corticosteroid; SABA, short-acting b2-agonist. ª 2008 Ingenix Pharmaceutical Services (UK) Ltd. Journal compilation ª 2008 Blackwell Publishing Ltd Int J Clin Pract, December 2008, 62, 12, 1870–1879