Economic assessment of adjustable maintenance treatment with budesonide/formoterol in a single inhaler versus fixed treatment in asthma.
OBJECTIVE
To compare the costs and effectiveness of adjustable maintenance dosing with budesonide/formoterol in a single inhaler versus fixed dosing in adults with asthma.


METHODS
In this prospective, randomised, open-label, parallel-group, multicentre trial conducted in Germany, patients with asthma received budesonide/formoterol 160 microg/4.5 microg in a single inhaler (Symbicort Turbuhaler with two inhalations twice daily for a 4-week run-in period. Patients were then randomised to either adjustable maintenance dosing (one inhalation twice daily, stepping up to four inhalations twice daily for 1 week if asthma worsened; n=1679) or fixed dosing (two inhalations twice daily; n=1618) for 12 weeks. The primary efficacy variable was the change in health-related quality of life (HR-QOL), measured using the Asthma Quality of Life Questionnaire (standardised) during the randomised treatment period. Resource utilisation data were collected in parallel and combined with German unit costs to estimate direct and indirect costs (year 2001 values).


RESULTS
Both treatment regimens were equally effective in maintaining HR-QOL and asthma control during the randomised treatment period. However, overall, patients in the adjustable maintenance dosing group took fewer daily inhalations of budesonide/formoterol than those in the fixed-dosing group (mean: 2.63 vs 3.82 inhalations; p<0.001). Adjustable maintenance dosing was associated with significantly lower asthma-related direct costs compared with fixed dosing (mean: 221 euro vs 292 euro; p<0.001). This pattern was maintained when patients were stratified into those with peak expiratory flow (PEF) of 60% to <80% predicted normal and those with PEF of>/=80% predicted normal and when total costs were considered.


CONCLUSIONS
Adjustable maintenance dosing with budesonide/formoterol in a single inhaler maintained HR-QOL in adult patients with asthma at a significantly lower cost than fixed dosing.
Institute for Social Medicine, Epidemiology and Health Economics, Charité University Medical Center, Berlin, Germany. Bernd.brueggenjuergen@charite.de
Bernd
B
Brüggenjürgen
Dagmar
D
Selim
Peter
P
Kardos
Kai
K
Richter
Claus
C
Vogelmeier
Stephanie
S
Roll
Wolfgang
W
Meyer-Sabellek
Roland
R
Buhl
Stefan N
SN
Willich
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001249:Asthma / Q000188:drug therapy* / Q000191:economics*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use*; D019819:Budesonide / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use; D005260:Female; D000068759:Formoterol Fumarate; D005858:Germany; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D011320:Primary Health Care / Q000191:economics*; D011788:Quality of Life
D001993:Bronchodilator Agents; D004338:Drug Combinations; D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate