OBJECTIVE:Recurrent infectious rhinitis (RIR) is a frequent disease among adults and constitutes an economic burden for National Sickness Funds (NSF) that might be prevented by immunostimulant therapy. Cost effectiveness of preventive methods should be documented. The aim of this study was to determine whether the cost of treating patients with ribosomal vaccine (Ribomunyl), an immunostimulant therapy, could be offset by the savings associated with avoided RIR episodes. DESIGN AND SETTING: Using a 'piggy-back' approach, an economic analysis was conducted based on a placebo-controlled clinical trial of 327 patients with at least 3 episodes of RIR in the past year. Patients were recruited during September and October 1994 through 50 French and 2 Belgian specialists (ear, nose and throat; ENT) and were randomised to receive ribosomal vaccine or placebo for a 6-month period covering the entire winter season. Two economic perspectives were analysed: (i) the French NSF; and (ii) the patient (i.e., considering copayments which are not reimbursed by the NSF). MAIN OUTCOME MEASURES AND RESULTS: The placebo-controlled clinical trial demonstrated a significant decrease (p < 0.001) of more than 30% in the cumulative number of RIR episodes with ribosomal vaccine during the 6-month study period. In general, patients receiving the active treatment tolerated it well. Data were collected on the use of medical services (e.g. number of physician visits), antibacterial and other drug courses, as well as the number of sick-leave days for the study participant. Patients treated with ribosomal vaccine visited their general practitioner (GP) less frequently (mean reduction of 33%), had fewer days of antibacterial use (mean reduction of 3.5 days) and took fewer sick-leave days (mean reduction of 6.3%). CONCLUSIONS: Overall, the cost of prevention with ribosomal vaccine was offset by the savings to both the French NSF and to patients (in terms of out-of-pocket expense). Indeed, ribosomal vaccine was deemed to be a cost-saving agent in the prevention of RIR in the French healthcare setting, provided that it is prescribed only for patients who are expected to develop at least 2 episodes of RIR in the coming year.
RCT Entities:
OBJECTIVE: Recurrent infectious rhinitis (RIR) is a frequent disease among adults and constitutes an economic burden for National Sickness Funds (NSF) that might be prevented by immunostimulant therapy. Cost effectiveness of preventive methods should be documented. The aim of this study was to determine whether the cost of treating patients with ribosomal vaccine (Ribomunyl), an immunostimulant therapy, could be offset by the savings associated with avoided RIR episodes. DESIGN AND SETTING: Using a 'piggy-back' approach, an economic analysis was conducted based on a placebo-controlled clinical trial of 327 patients with at least 3 episodes of RIR in the past year. Patients were recruited during September and October 1994 through 50 French and 2 Belgian specialists (ear, nose and throat; ENT) and were randomised to receive ribosomal vaccine or placebo for a 6-month period covering the entire winter season. Two economic perspectives were analysed: (i) the French NSF; and (ii) the patient (i.e., considering copayments which are not reimbursed by the NSF). MAIN OUTCOME MEASURES AND RESULTS: The placebo-controlled clinical trial demonstrated a significant decrease (p < 0.001) of more than 30% in the cumulative number of RIR episodes with ribosomal vaccine during the 6-month study period. In general, patients receiving the active treatment tolerated it well. Data were collected on the use of medical services (e.g. number of physician visits), antibacterial and other drug courses, as well as the number of sick-leave days for the study participant. Patients treated with ribosomal vaccine visited their general practitioner (GP) less frequently (mean reduction of 33%), had fewer days of antibacterial use (mean reduction of 3.5 days) and took fewer sick-leave days (mean reduction of 6.3%). CONCLUSIONS: Overall, the cost of prevention with ribosomal vaccine was offset by the savings to both the French NSF and to patients (in terms of out-of-pocket expense). Indeed, ribosomal vaccine was deemed to be a cost-saving agent in the prevention of RIR in the French healthcare setting, provided that it is prescribed only for patients who are expected to develop at least 2 episodes of RIR in the coming year.