Proton Pump Inhibitor Prescription from 2005 to 2007 in An Italian Primary Care Setting: Impact of Generic Drugs Market

Background. Antisecretory drugs for acid-related diseases are the second reimbursable group of drugs in the Italian Healthcare System. To control health costs after the launching of generic lansoprazole in the market (early 2006), several Italian Regional Health Authorities have introduced rules to favour the prescription of less costly generic drugs. Aim. To evaluate the prescription of Proton Pump Inhibitors (PPIs) from Jan 2005 to Dec 2007 in a primary care setting of South Italy. Methods. Analysis has been performed on a database of 100 medical practitioners that have managed an average of 144.000 inhabitants during the observation period. Evaluations performed are the following: 1) PPI prescription (total and separately for Lansoprazole - L; Esomeprazole - E; Pantoprazole - P; Rabeprazole - R; and Omeprazole - O); 2) prevalence of the reimbursement purpose (Gastroprotection - G; Acid- Related Disease - ARD); 3) prevalence of patients with ARD categorized on the basis of PPI prescriptions as drugs box/year (1-3 short treatment - ST; 4-11 long treatment - LT; >12 very long treatment - VLT). Data were expressed as Compound Annual Growth Rate (CAGR). Results. Patients with PPI prescriptions (at least one prescription) in the study population were 7188 (5.52%), 8972 (6.62%) and 10437 (7.40%) in 2005, 2006 and 2007, respectively. Total growth of PPI prescription in the three years expressed as CAGR was 16%, whereas the growth for each molecule was: L +66%; E +9%; P +8; R +4%; O -10%. The reimbursement purpose was significantly higher for G (CAGR +44%) than for ARD (CAGR +8%; p<0.01). In the three years we found an increase of ARD patients with ST (2005: 3687; 2006: 4165; 2007: 4522), LT (2599, 2995, 3231) and VLT (2120, 2944, 3550) with a significant highest CAGR for VLT patients (ST +7.0%; LT +7.5% and VLT +18.7%; p<0.01). Analysis of each PPI prescription showed a highest CAGR for L in VLT patients (78%), while the lowest one was for O in VLT patients (-14%). Conclusion. The launching in the market of generic PPIs has unexpectedly increased the prescription of whole drug class during the period 2005- 2007. This increase appears prevalently related to gastroprotection purpose and to the use of generic lansoprazole. In the three years under examination, we observed a marked increase in a very long duration PPI treatment for acid related diseases that caused a relevant resource consumption. Our data suggest that the appropriateness of PPI prescription after generic PPI introduction should be carefully monitored to distinguish between cost-effective from cost-ineffective PPI treatment.