OBJECTIVES. In October 2019, the reimbursement criteria of vitamin D(vitD) analogs for the prevention and treatment of vitD-deficiency in adults were refined by AIFA through the publication of Note-96. In the first 15 months from Note’s adoption, 30% decrease in drug-related consumptions and expenditures compared to previous periods was observed. The study aimed to verify whether this reduction was related to greater appropriateness in vitD analogs use.

METHODS. A retrospective analysis of Local Health Unit’s administrative databases was conducted, including 491,000 health-assisted individuals. All adult patients with ≥1 prescription of drugs included in Note-96(cholecalciferol, cholecalciferol/calcium, calcifediol) or in Note-79 (bisphosphonates, teriparatide, strontium ranelate, raloxifene, denosumab, and bazedoxifene, whose reimbursements are for primary and secondary prevention of osteoporotic fractures), during 12 months before and after the establishment of Note-96 (31/10/2019), were included. According to Health-db monitoring system, two indicators of prescription appropriateness, designed to measure the difference between clinical practice and recommendations, were proposed: 1)% of patients treated with osteoporosis drugs plus vitD; 2)% of patients treated with vitD without hypovitaminosis tested in the last 12 months (excluding patients defined by Note-79).

RESULTS. Considering 12 months pre- and post-Note-96, the percentage of patients treated with osteoporosis drugs plus vitD, as by Note-79, decreased from 70.2% to 60.4%, respectively. The quote of patients treated with vitD without testing its level during the last 12 months remained unchanged: 55.8% pre- and 55.7% post-Note-96 establishment. The total number of subjects treated with vitD decreased significantly from 87,368 to 47,241 with a consequent reduction of expenditure (-1.1 million €: -44.8%).

CONCLUSIONS. The introduction of Note-96 led to vitD consumption and expenditure reduction, but not to an improvement of its prescription appropriateness, which decreased, especially in association with osteoporosis drugs. The periodic monitoring of prescription appropriateness indicators allows improving the prescription adequacy, the patient's health, and healthcare resources consumption.