Osteoporosis: The Picture in Italy Congresso Ortomed Firenze, 10-12 Dicembre 2015 Osteoporosis: The Picture in Italy Sergio Ortolani U.O. di Malattie del Metabolismo Osseo e Reumatologia Istituto Auxologico Italiano IRCCS Milan, Italy

Italian Demography Among European countries Italy has one of the highest proportion of elderly and very elderly persons in its demographic composition (20% over 60, 4% over 80) Therefore, fragility fractures due to osteoporosis are a major public health issue and their prevention should be a priority for the National Health System

How NHS faces osteoporosis in Italy Diagnosis: Bone densitometry is paid for by NHS for subjects at increased risk of osteoporosis, can be repeated not less than 18 months later Treatments: All the drugs of proved efficacy are paid by NHS, both in secondary and in primary prevention, but several complex limitations apply, based on previous fractures, clinical risk factors, T-scores etc. Guidelines: Several at different levels: local, regional, national. Reasonable in general, not always coherent, frequently counter-intuitive, so they are rarely used.

Osteoporosis can be effectively treated Several treatments with proven efficacy are available: Vertebral fracture risk: -40% / -70% Hip fracture risk: -30% / -50% Peripheral fracture risk: -15% / -30% Treatments are easy to use, with different routes of administration and long dosing intervals. NOTE: in comparison, treatments lowering cholesterol or blood pressure can only reduce the risk of major cardiovascular events by approximately 25% to 45%

Critical Points and Inefficiencies Despite the potential for effective interventions, bone fragility remains in Italy an underdiagnosed and undertreated condition. As a result, the absolute number of fragility fractures continues to increase, with only a marginal reduction in the incidence of hip fractures for the oldest age ranges. Major sources of inefficiencies are: Poor treatment adherence Missed treatment of subjects with evidence of very high fracture risk

Treatment Adherence in Italy According to the 2014 Annual report of the Ministry of Health on drug use in Italy (OsMed 2014), less than 50% of the patients reach the critical level of 80% adherence to osteoporosis treatments. This wastes all the costs incurred in assessing the non- compliant patients In addition, after a long run of yearly increments in the use of osteoporosis drugs, we see a decrement in the last three years.

Use of osteoporosis drugs in Italy (2005-2014)

ABSOLUTE NUMBER AND INCIDENCE OF HIP FRACTURES ITALIA 2007-2012 Con la collaborazione del Ministero della Salute – Direzione generale del Sistema Informativo Coordinamento e Sviluppo NSIS

SOME CHANGES IN EPIDEMIOLOGY OF HIP FRACTURE IN ITALY FROM 2007 TO 2012 AGE 70-84 AGE > 85 Inhabitants +3,2% +25,5% Number of fractures -7,3% +16,6% Yearly incidence (Cases/10.000 inhabitants) -10,1% -7,1%

Missed Treatment in Very High Risk Patients, Before and After a Fracture In Italy (as in many European countries) less than 30% of the patients receives an osteoporosis treatment after a hip fracture (from: OsMed 2014, AIFA, Ministry of Health, 2015) A study presented in 2014 by Ambrosetti, (based on data records from ASL Milano 1 and Milano 2, over 1.5 million inhabitants) showed that only 10,5% of the patients suffering a hip fracture had been previously treated for osteoporosis (946 patients out of 9019) A preliminary survey indicates that more than 75% of these patients met the criteria to have a bone densitity scan and/or to receive osteoporosis treatment under the current rules.

Treatment of Patients at Very High Risk of Fracture is Highly Efficient In patients with major fragility fracture the use of osteoporosis drug is highly cost-effective, as the NNT is very low. Moreover, in these cases the diagnosis is easier and relative inexpensive compared to patients with lower fracture risk. In order to improve the level of treatment in these patients we need to implement the concept of “fracture unit” in the Orthopaedics Departments and to motivate General Practitioners to be more involved in the management of osteoporosis.

Attivare la terapia nelle fratture da fragilità La terapia farmacologica nei Pazienti con fratture da fragilità è economicamente molto conveniente perché il rischio di nuove fratture è alto e il NNT è basso. Il percorso diagnostico e terapeutico in questi Pazienti va iniziato in Ospedale e va esplicitato nella lettera di dimissione (concetto di «fracture liason»). Alcune esperienze estere hanno dimostrato che includendo questo aspetto nei criteri per il pieno rimborso del valore del DRG aumenta sensibilmente il tasso di trattamento.