Aspetti economici Lorenzo G Mantovani

1. Aspetti economiciLorenzo 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 • Incidence 2-3 events per 1000 py’s • 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 cost 11k Euro’s • Health care 5.5k • Non health care 4.5k • Indirect 1k

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 Framingham (10-year follow up from 1981) 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

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

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. Strokereduction 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 Total 3.6 Euros 2011Daily cost CVD prevention§ 1 Euro New OAC ??Euro Total 3.6??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