The objective was to assess the cost-effectiveness of beclomethasone with formoterol versus fluticasone propionate with salmeterol, for patients with moderate-to-severe asthma. The authors concluded that beclomethasone with formoterol reduced the costs and increased effectiveness, compared with fluticasone with salmeterol, from the perspective of the Italian National Health Service. On the whole, the methods appear to have been valid and the authors' conclusions are appropriate.

Cost-effectiveness analysis, cost-utility analysis

The objective was to assess the cost-effectiveness of beclomethasone, with formoterol, versus fluticasone propionate, with salmeterol, in patients with moderate-to-severe asthma.

Beclomethasone 100 micrograms (μg) plus formoterol 6μg in a pressurised metered-dose inhaler was compared with fluticasone propionate 125μg plus salmeterol 25μg in a pressurised metered-dose inhaler.

Italy/primary and secondary care.

Analytical approach:

A Markov model, with a one-week cycle length, was developed to assess the cost effectiveness of the interventions. The time horizon was 52 weeks and the authors reported that the perspective of the Italian National Health Service was adopted.

Effectiveness data:

Most of the effectiveness data were from a published study - the Inhaled Combination Asthma Treatment versus Seretide (ICAT-SE) study (Papi, et al. 2007, see 'Other Publications of Related Interest' below for bibliographic details). The ICAT-SE study was a phase III, multinational, multicentre, double-blind, randomised, two-arm parallel-group study. The primary outcome measure was successful asthma control, which was from the original data, from the ICAT-SE study.

Monetary benefit and utility valuations:

The utility values were from published studies, and the mean of the reported values was used in the model.

Measure of benefit:

The summary measures of benefit were the weeks lived with successfully controlled asthma, and quality-adjusted life-weeks or quality-adjusted life-years (QALYs).

Cost data:

The analysis considered asthma treatment costs including drugs, general practitioner (GP) visits, hospital admissions, specialist visits, blood tests and diagnostic tests. The drug dosages were from the ICAT-SE study, while other resource use was estimated, based on interviews with a panel of experts, including one GP and four lung specialists. The drug unit costs were based on their retail prices, while the health care unit costs were based on the Italian fees for health care services. All costs were reported in Euros (EUR).

Analysis of uncertainty:

The estimates and transition probabilities were varied in a univariate analysis. Monte Carlo simulation was used to examine the uncertainty in the model inputs and its impact on the results. These results were displayed on cost-effectiveness isocontour graphs.

Over one year, the average cost per patient was EUR 745.48 with beclomethasone and formoterol, and EUR 804.60 with fluticasone and salmeterol. The number of weeks of successful control was 31.152 with beclomethasone and 29.628 with fluticasone. The number of QALYs gained was 0.8163 with beclomethasone and 0.8131 with fluticasone.

Beclomethasone dominated fluticasone, as it was less costly and more effective.

The probabilistic sensitivity analysis showed that beclomethasone was less costly and more effective in 62.95% of simulations.

The authors concluded that beclomethasone with formoterol reduced the costs and increased effectiveness, compared with fluticasone with salmeterol, from the perspective of the Italian National Health Service.

Interventions:

The rationale for the selection of the comparators was clear - the two treatments were the comparators in the randomised controlled trial, which supplied most of the evidence.

Effectiveness/benefits:

The effectiveness data were largely from a phase III, multicentre, randomised controlled trial, which should have provided valid clinical data, but more details of the trial, including the sample size calculation, would have been useful in assessing its validity. More details of the derivation of the utility values would have allowed an assessment of their validity. The outcome measures (successfully controlled asthma and QALYs) were appropriate, and QALYs capture the impact of asthma on length and quality of life and allow comparisons with other interventions.

Costs:

The relevant costs for the stated perspective were included. The sources for the unit costs and resource use were reported and appear to have been appropriate. The authors acknowledged that there was some uncertainty around the resource use estimates from the expert panel, but these estimates were varied in the sensitivity analysis. The price year was not explicitly reported, but appears to have been 2010. Discounting was appropriately not performed given the short duration of follow-up (one year).

Analysis and results:

The results were clearly reported and discussed. Valid approaches were used to investigate uncertainty. The authors discussed a number of limitations to their analysis. The results of the study should be generalisable to other similar settings, with similar cost structures.

Concluding remarks:

On the whole, the methods appear to have been valid and the authors' conclusions are appropriate.

Funded by a grant from Chiesi Farmaceutici, Italy.

Papi A, Paggiaro P, Nicolini G, et al. Beclomethasone/formoterol vs fluticasone/salmeterol inhaled combination in moderate to severe asthma. Allergy 2007; 62(10): 1128-1188.