Focused Ultrasounds ExAblate® system 2000 Prof. Filippo Bartoccioni Clinical Governance and Training systems San Camillo Forlanini Hospital Rome, Italy

What Focused Ultrasounds are? Ultrasound is a form of energy that passes through skin, muscle, fat and other soft tissue. Provides a therapeutic effect by raising the temperature of the tissue target

ExAblate® system 2000 destroys tissue target (without affecting any of the other tissues) 1. MR guided focused ultrasound technology controls the treatment and the effect on the tissue. 2. Magnetic Resonance Imaging (MRI)

How the MR guided FUS works? Uses the MR images to identify where the tumor is and what portion has been treated It also provides real time feedback about temperature changes Uterine fibroids surgery

How to verify if the clinical procedure is economically compatible with the tariff system in force? BREAK EVEN POINT: calculation of the approximate sales volume required to just cover costs, below which production would be unprofitable and above which it would be profitable. Break-even analysis focuses on the relationship between fixed cost, variable cost, and profit. Fixed Costs Price – Variable costs B.E.P. =

What the economic analysis shows? 1. Fixed costs Cost ExAblate® system 2000 € 1.320.000 Maintenance annual full-risk € 90.000

2. Variable Costs 1. Material consumables 2. Staff 200 €/surgery 2. Staff 600-800€/surgery 3. Intermediate performance 4.Indirected costs 5.Hospitalization costs 25-45 €/surgery (diagnostic imaging and laboratory) 200-400 € /surgery (cleaning, sterilization, utilities) 200 € /day (not provided)

Who is eligibible to be treated? 1 GOSP (sugery database) the number of interventions of uterine fibroids in the years 2008, 2009. 138, 108 respectively 2 Hypothetical percentage of patients actually eligible. We consider 2 scientific reports: 16%1 35%2 3 We therefore considered 35% for eligible to treatment. 1 Eligility and Accessibility of MRgFUS for the tratment of uterine leiomyomas (Behera, Fertil Steril 2010 Oct;94(5):1864-8) 2 Cost-Effectiveness of MRgFU for the treatment of uterine fibroids (O’Sullivan, Int J Technol Assess Health Care 2009 Jan; 25(1):14-25)

How to calculate the Break Even Point? In our case: 123 patients/year Eligibility of treatment: 35% OVER-ESTIMATED ANNUAL PRODUCTION CAPACITY Maximum Reimbursement for each surgery € 2.459 43 cases/year

1461 € 1.320.000 + € 90.000,00 Break Even Point 1461/43= 34 years Fixed Costs B.E.P. = Price - Variable costs Total Fixed Costs = 1.320.000 + 90.000 Price (Reimburse for single surgery) = 2.459 Variable costs for single surgery = 1.494 € 1.320.000 + € 90.000,00 BEP = (€ 400,00 + € 615,72 + € 200,00 + € 27,20 +€ 251,30) € 2.459,00 - 1461 1461/43= 34 years

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93/year € 90.000,00 Annual Break Even Point BEP/year = € 2.459,00 - Annual Fixed Costs B.E.P. = Price - Variable costs Total Annual Fixed Costs = 90.000,00 Price (Reimburse for single surgery) = 2.459,00 Variable costs for single surgery = 1.494,22 € 90.000,00 BEP/year = (€ 400,00 + € 615,72 + € 200,00 + € 27,20 +€ 251,30) € 2.459,00 - 93/year

Conclusions ? We should not buy this technology We can not afford to keep it even if it was a present