1. Aspetti economici Lorenzo G Mantovani Dipartimento di Medicina Clinica e Chirurgia Università degli Studi di Napoli Federico II Centro di Ricerca sulla Sanità Pubblica Università degli Studi di Milano Bicocca

2. Do we need new OAC? Lorenzo G Mantovani Center of Pharmacoeconomics University of Naples Center for Public Health Research University of Milan Bicocca

3. Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money? Can we afford it?

4. Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money? Can we afford it?

5. YES Incidence2-3 events per 1000 pys Italy 150k events per year* *Source: Ministry of Health

7. Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money? Can we afford it?

8. YES Incident stroke first year cost11k Euros –Health care5.5k –Non health care4.5k –Indirect1k

11. Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money? Can we afford it?

12. YES

13. AND VERY MUCH SO

14. Survival is poorer and stroke recurrence rates are higher following AF-related stroke AF=atrial fibrillation; OR=odds ratio; CI=confidence interval 1. Lin HJ, et al. Stroke 1996; 27: 1760–4; 2. Dulli DA, et al. Neuroepidemiology 2003; 22: 118–23 AF patients (n=30) Non-AF patients (n=120) 1-year post stroke recurrence 23%8% 30-day post stroke mortality 30%17% 1-year post stroke mortality 63%34% Framingham (10-year follow up from 1981)

15. AF=atrial fibrillation; OR=odds ratio; CI=confidence interval Dulli DA, et al. Neuroepidemiology 2003; 22: 118–23 Patients bedridden on admission (%) p<0.0005 40 30 20 10 0 50 41.2% 23.7% With AF (n=194) Without AF (n=867) Functional outcomes of stroke are significantly worse in patients with AF, and more patients remain bedridden OR for bedridden state following stroke due to AF was 2.23 (95% CI: 1.87, 2.59)

16. Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money? Can we afford it?

18. 1+ million prevalent subjects 130.00 new cases per year

19. Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value fo money? Can we afford it?

20. Stroke reduction of 19% (95% CI 2% to 34%)

21. Risk reduction of 62% (95% CI 48% to 72%) versus placebo

22. Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money? Can we afford it?

23. ONLY IN FEW

27. Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money? Can we afford it?

28. Now

29. Soon after?

30. Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money? Can we afford it?

31. Depends on price Italy: 100.000? 300.000? 500.000? 700.000?

32. Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money? Can we afford it?

33. According to TA agencies, YES

34. Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money? Can we afford it?

35. Again, it will depend on price. By the way…

36. CVD prevention in AF patients 2001Daily cost CVD prevention*3 Euros VKA (including INR test)0.6 Euro Total3.6 Euros 2011 Daily cost CVD prevention§1 Euro New OAC??Euro Total3.6??Euro *average of 4-5 medications @ average 0.6-0,7 euro per day §same medications @generic price

37. Summary 130.000 incident strokes 20.000 incident strokes attributable to AF At least 10.000 preventable in theory, if effective therapies were available Appropriate use of new OAC can make parto of those 10.000 stroke prevented in practice Appropriate use of new OAC is sustainable only if off-patent drugs are widely used for underlying conditions

38. In Lombardy 20.000+ incident strokes 3.000+ incident strokes attributable to AF At least 1.500 preventable in theory, if effective therapies were available Appropriate use of new OAC can make part of those 1.500 stroke prevented in practice Appropriate use of new OAC is sustainable only if off-patent drugs are widely used for underlying conditions