1. Cost-effectiveness of LAA Closure
CRT 2016
February 20-23, 2016
Washington, DC, USA
Cost-effectiveness of LAA Closure
Sameer Gafoor1,2 .
1CVC Frankfurt: Jennifer Franke, Simon Lam, Stefan Bertog, Laura Vaskelyte,
Ilona Hofmann, Markus Reinartz, Horst Sievert
2Swedish Heart and Vascular: Ming Zhang, John Petersen II, Eric Lehr, Madalena Petrescu, Nimish Muni,
Paul Huang, Darryl Wells, Adam Zivin, Eric Williams, Robert Bersin,
Glenn Barnhart, Samuel Youssef, Pat Ryan, Irina Penev, Amanda Ray,
Michelle Batjargal, Thearry Deap, Zachary Newhart, David Mazza, Heather Garcia
CVC: CardioVascular Center Frankfurt, Frankfurt, Germany
Swedish Heart and Vascular: Swedish Medical Center, Seattle, WA, USA

2. No relevant disclosures for this presentation.

3. A step back…

5. How much is this costing us?
Review of 184 population studies
2010: 33.5 million cases, 5 million new/year
US: 1.2 million cases in 2010 to 2.6 million by 2030
Why is prevalence increasing
Other interventions and medications that increase lifespan
0.5-1%, more with age
2010: 596.2/100,000 men and 373.1/100,000 female

6. What about hospitalizations?
3,960,011 hospitalizations with afib as primary diagnosis from
Majority with Medicare/Medicaid as primary payer (70%)
South: 38.5%, Midwest 24.9%, Northeast 22.2%, West 14.4%
Co-morbidities of HTN, DM, COPD
Length of stay is 3 days
From , Decrease in going home (80% now 70%) and now more likely to facility (8.1% to 11.5%)

7. Trend by region increasing

8. Inpatient cost of AF 2001: $6410, 2010: $8439
2001: $6410, 2010: $8439
Highest with CHF and valve disorders
More with age

9. LOS higher with CHADS2 score

10. Cost of Hospitalization up with CHADS2 score

11. What is a cost-effectiveness analysis?
Relative costs from each course of action
Gives you a ratio
Numerator is cost associated with health gain
Denominator is gain in health associated
Common outcomes
Quality-adjusted life years
ICER = Incremental cost-effectiveness ratio Cost per QALY is important (<$50,000/QALY in US, €30,000/QALY in Europe)

12. What is a cost-utility analysis?
Usually four quadrants with a cost-effectiveness plane (costs on y axis, QALY gained on x axis)
I. less effective II: more effective &
& more expensive more expensive
III. Less effective IV. More effective &
& less expensive less expensive

13. What about patients who are candidates for warfarin?

14. Model at 20 years lifespan, events possible every 3 months

15. Model at 20 years lifespan, events possible every 3 months

16. Clinical inputs from literature
LAAC
Warfarin
NOAC
Aspirin
None
RR ischemic stroke (rel warfarin) post-therapy
0.95
0.33 (rel to no therapy)
0.92
0.78 (rel no tx) 1
RR hemorrhagic stroke (rel warfarin)
0.15
1.00 (rel to HAS-BLED)
0.48
0.50
RR post-therapy major bleeding
0.55 NA
0.5 (rel warf)
% major bleed hem. CVA
41.8%
RR extracranial hem (rel warfarin)
1.25
0.30
Annual risk of systemic embolism
0.20%
0.40%
1.96 (rel warf)
RR MI (rel warfarin)
1.47%/yr
0.97
2.00
Risk of minor bleeding
Based on regimen
7.70%
8.70%
1.40%

17. (lower utility = worse off)
With LAAC, less likely to have a disabling/fatal stroke (lower utility = worse off)
(lower utility = worse off)

18. Add up the costs

19. Add up the costs

20. Cost over time

21. Time to effectiveness at 5, 10, 15, 20y

22. At 3 years, LAAC has more QALY than warfarin and at 5 years more QALY than NOAC
For cost/QALY comparison, to reach <$50,000, it takes 7 years for LAAC vs. warfarin and 5 for LAAC vs. NOAC
In a way – instead of numbers needed to treat (NNT), think of years to be more cost-effective (Time to cost-effectiveness)

23. At 20y, LAAC is more effective and less expensive than warfarin

24. At 20y, LAAC is more effective and less expensive than NOAC

25. At 20y, NOAC is more effective, but more expensive than warfarink

26. What did we learn
LAAC cost-effective to warfarin at 7 years; NOAC takes 16 years
LAAC had fewer disabling strokes
LAAC is more effective and less expensive
Adherence is an issue in NOAC

27. What about patients contraindicated for warfarin?

28. Methods 3 studies CEA from German perspective 20 year time horizon
ASAP – watchman device
ACTIVEA – aspirin and clopidogrel
AVERROES – apixaban
CEA from German perspective 20 year time horizon

29. Flowchart (LAAC until death or 20 years)

30. % chance with LAAC, Aspirin, Apixaban
Relative risk of ischemic stroke
0.23 (relative to no therapy)
0.78 (relative to no therapy)
0.37 (relative to aspirin)
Annual risk of systemic embolism
0.12%
0.4%
0.1%
RR of hemorrhage
1.1
0.65
1.16
% hemorrhage that is ICH
21.2%
17.8%
25%
% hemorrhage that is GIB
52%
41.7%
27.3%
Annual risk AMI
0.86%
0.9%
0.8%

31. Costs Event Cost (euro) G-DRG LAAC device, proc €9,136 F95A
Minor isch. stroke
€8,249
B39C
Major isch stroke
€31,829
B39A, B42A
Minor hem stroke
€4,357
B70D, B70E
Major hem stroke
€16,802
B70A, B, B44C
TIA
€3,999
B69ABCD
Major GIB
€2,096
G69A,67BC, G73Z
Major other bleed
€1,301
D62Z
Cost of functional independence post-stroke/qtr
€875 NA
Cost of Moderate disability post-stroke/qtr
€2,745
Cost of Severe disability post-stroke/qtr
€4,285
Quarterly cost of aspirin
€11
Quarterly cost of apixaban
€292

32. Over 20 years… costs/year

33. What happens with the ICER at 10 years?
Incremental Cost-effectiveness ratio
Baseline risk (8.6% stroke risk)
LAAC €15,837  4.82 QALY  dominates over aspirin (€21,077) or apixaban (€18,869) alone
High risk patient (10.9% stroke risk)
LAAC €19,236  4.53 QALY  dominates over aspirin (€29,021) or apixaban (€25,596) alone
Low risk patient (2.2% stroke risk)
LAAC €12,529  5.03 QALY  ICER €46K-€51K
Not so great, but this is the CHADS2 <1 patient!

34. How does ICER look on a graph at 10 years?

35. Why does this work?
LAAC has more QALY than aspirin at 2 years and apixaban at 4 years
LAAC dominant (cost-saving and more effective) over both aspirin and apixaban by 7 years
Adherence to aspirin and apixaban is a big deal  in AVERROES, 17.9% of apixaban group discontinued therapy
Adherence is guaranteed with LAAC
Limitations: 1 event/3 month cycle, from RCT, German costs only, only with studies that were listed, and only for Watchman

36. Future work
Cost-effectiveness incorporated in the decision-making tool
Use of this data in other countries and by US payors
Expansion of this to younger patients with longer lifespans – more likely to be cost-effective