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

2. 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

3. 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)

4. 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

5. 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. =

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

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

8. 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)

9. 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

10. 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 =
Price (Reimburse for single surgery) =
Variable costs for single surgery =
€ € ,00
BEP =
(€ 400,00 + € 615,72 +
€ 200,00 + € 27,20 +€ 251,30)
€ 2.459,00 -
1461
1461/43= 34 years

11. ?

12. 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 = ,00
Price (Reimburse for single surgery) = ,00
Variable costs for single surgery = ,22
€ ,00
BEP/year =
(€ 400,00 + € 615,72 +
€ 200,00 + € 27,20 +€ 251,30)
€ 2.459,00 -
93/year

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