Recommendations for Guidelines on Clinical Trials of Mucoactive Drugs in Chronic Bronchitis and Chronic Obstructive Pulmonary Disease: Pharmacoeconomics

Pharmacoeconomics is increasingly becoming one of the factors affecting regulatory decisions, which can be influenced by cost-containment policies. It is therefore being addressed more frequently in clinical trials. This aspect is particularly relevant when incapacitating diseases are involved, such as CB and COPD.
Variables found in the literature on mucoactive drugs which are relevant to pharmacoeconomic perspectives are the following: number of acute episodes; number of hospitalizations and reduction in hospital days because of acute episodes; days of illness per year due to acute episodes of bronchitis; lost working days; and reduction in antibiotic consumption (days of antibiotic therapy) during exacerbations.
To introduce pharmacoeconomic factors into a clinical trial on mucoactive drugs, the following three components of economic analysis should be considered: (1) establishing effectiveness; (2) estimating QoL or utility; and (3) measuring direct, indirect, and intangible costs. One discrete clinical outcome for mucoactive drugs is clinical effectiveness, specified as the number of exacerbations saved. This outcome becomes the denominator of the cost-effectiveness analysis. The marginal cost of using mucoactive drugs instead of placebo to gain a reduction in exacerbations should be calculated. natural asthma inhalers

Cost-utility analysis, requiring nonmonetary outcome measures such as quality adjusted life years or utilities, needs the evaluation of QoL as indicator. As to cost-benefit analysis requiring expression of therapy outcomes in monetary terms, the only parameter representing benefit appears to be that related to saving on costs, ie, cost correlated with working days gained, with hospital days saved, and with other medical therapies being avoided (eg, antibiotics, bronchodilators).

This entry was posted in Pulmonary Function and tagged airway obstruction, bronchitis, mucoactive drugs, pulmonary function.