Aspetti economici

Lorenzo G MantovaniDipartimento di Medicina Clinica e ChirurgiaUniversità degli Studi di Napoli Federico II

Centro di Ricerca sulla Sanità PubblicaUniversità degli Studi di Milano Bicocca

Do we need new OAC?

Lorenzo G MantovaniCenter of Pharmacoeconomics

University of Naples

Center for Public Health ResearchUniversity of Milan Bicocca

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?

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?

YES• Incidence 2-3 events per 1000 py’s

• Italy 150k events per year*

*Source: Ministry of Health

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?

YES

• Incident stroke first year cost 11k Euro’s– Health care 5.5k– Non health care 4.5k– Indirect 1k

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?

YES

AND VERY MUCH SO

• Survival is poorer and stroke recurrence rates are higher following AF-related stroke

AF=atrial fibrillation; OR=odds ratio; CI=confidence interval1. 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)

AF=atrial fibrillation; OR=odds ratio; CI=confidence intervalDulli DA, et al. Neuroepidemiology 2003; 22: 118–23

Patie

nts b

edrid

den

on

adm

issio

n (%

)

p<0.000540

30

20

10

0

5041.2%

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)

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?

• 1+ million prevalent subjects• 130.00 new cases per year

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?

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

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

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?

ONLY IN FEW

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?

Now

Soon after?

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?

Depends on price• Italy: 100.000? 300.000? 500.000? 700.000?

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?

According to TA agencies, YES

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?

Again, it will depend on price.

By the way…

CVD prevention in AF patients2001 Daily cost

CVD prevention* 3 EurosVKA (including INR test) 0.6 EuroTotal 3.6 Euros

2011 Daily cost CVD prevention§ 1 EuroNew OAC ??EuroTotal 3.6??Euro

*average of 4-5 medications @ average 0.6-0,7 euro per day§same medications @generic price

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

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