Builders of high
performance
MARKET ACCESS
SOLUTIONS
OPTIMIZATION OF CARDIAC RESYNCHRONIZATION THERAPY DEVICE SELECTION GUIDED BY CARDIAC MAGNETIC
RESONANCE IMAGING: COST-EFFECTIVENESS ANALYSIS Carlos Crespo, Antonio Berruezo, Markus Linhart, Juan Acosta, Mikel Martínez, Aurea Mira, Gabriela Restovic, Joan Sagarra, Bernhard Fahn, Artem Boltyenkov, Luis Lasalvia, Laura Sampietro-Colom
AES 2018 O-44. Mesa de Comunicaciones XI
A X E N T I V A
To estimate the cost-effectiveness and the budget impact of using two cardiac magnetic resonance imaging (cMRI) based algorithms to ascertain CRT defibrillator indication (algorithm I- cMRI plus an innovative software- and algorithm II- cMRI alone) compared with routine clinical practice (without cMRI), in Heart Failure (HF) patients with an indication for cardiac resynchronisation therapy (CRT).
O B J E C T I V E
2
A X E N T I V AMODEL CHARACTERISTIC
COMPARATOR:
• Routine clinical practice
• Optimization algorithm (I & II)*
POPULATION: Primary prevention patients with heart failure, dilated cardiomyopathy, severe
LV dysfunction (LVEF <35%) and wide QRS (>120 ms) who are referred for CRT
MODEL TYPE: RWE & extrapolation with incidence Markov Model with monthly cycles
PERSPECTIVE: Health National System (only direct cost)
EFICIENCY: Cost per Quality-Adjusted Life years (€/QALYs)
TIME HORIZON: LIFE-TIME
DISCOUNT: 3% COSTS (€2018) & 3% EFFECTS
* All High risk patients treated with CRTD and all non-high risk patients treated with CRT 3
A X E N T I V ARATIONAL
4
NYHA I NYHA II
NYHA III NYHA IV
In each state, hospitalization and death are possible.
The health economic mode distinguishes between a short-term (represented by costs and consequences of the process of
device implantation and classification) and a long-term phase (represented by the costs and consequences of the post
implementation follow-up period).
SHORT-TERM* (real) LONG-TERM (extrapolation)
* Risk based on algorithm
A X E N T I V ALONG TERM: MARKOV MODEL
5
NYHA I NYHA II
NYHA III NYHA IV
EVENTS INCLUDED • Device Complications: inappropriate ICD
shocks, lead dysfunction and infection. Battery change
• Hospitalization • All cause death
In each state, hospitalization and death are possible.
NHYA class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath); NHYA class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath); NHYA class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.; NHYA class IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
A X E N T I V AASSUMPTIONS
17
• All cause mortality are based on regression risk equation of Medical treatment (Weibull) adjusted by
CRT-P/CRT-D HR (Woods 2015).
• Hospitalization probability is based on risk equation, independently of the device.
• We did missing's imputation to obtain long-term survival, hospitalization and quality of life. Specific
assumption (Dr. Berruezo team are checking clinical records).
• QRS: based on QRs stimulated (15 cases).
• LVEF final: equal to LVEF basal (3 cases)
• NYHA final equal to the NHYA 12 months (33 cases)
• EQ5D is based on NHYA.
• Drug costs are in ex-Factory price.
• Long term Inappropriate ICD shock probability is based on the short term probability of alive patients.
A X E N T I V A
RESULTS
A X E N T I V AGAUDI-CRT PROBABILITIES
19
ALGORITHM 1 (SOFT): scar mass >10 g and the presence of BZ channel
HIGH NON-HIGH
CRT-D 51 (91%) 81 (65%)
CRT-P 5 (9%) 44 (35%)
TOTAL 56 (100%) 125 (100%)
HIGH; 56;
31%
NON-HIGH; 125; 69%
Source: GAUDI-CRT
ALGORITHM 2: scar mass >10g and BZ mass >5.3 g
HIGH NON-HIGH
CRT-D 57 (92%) 75 (63%)
CRT-P 5 (8%) 44 (37%)
TOTAL 62 (100%) 119 (100%)
HIGH; 62;
34%
NON-HIGH; 119; 66%
A X E N T I V ASHORT-TERM: ALGORITHM I
20
HF PATIENTS CANDIDATE TO CRT
ROUTINE CLINICAL PRACTICE
HIGH RISK CRT-D
CRT-P (underprotected)
NON-HIGH RISK CRT-P
CRT-D (overprotected)
OPTIMIZATION ALGORHYTM
HIGH RISK CRT-D
NON-HIGH RISK CRT-P
HF: Hear Failure
31%
69%
91%
9%
35%
65% 31%
69%
100%
100%
Device complications
Inappropiate ICD shocks Transplant
Survival
Quality of life
For each patient type:
HIGH NON-HIGH
CRT-D 51 (91%) 81 (65%)
CRT-P 5 (9%) 44 (35%)
TOTAL 56 (100%) 125 (100%)
A X E N T I V A
21
HF PATIENTS CANDIDATE TO CRT
ROUTINE CLINICAL PRACTICE
HIGH RISK CRT-D
CRT-P (underprotected)
NON-HIGH RISK CRT-P
CRT-D (overprotected)
OPTIMIZATION ALGORHYTM
HIGH RISK CRT-D
NON-HIGH RISK CRT-P
HF: Hear Failure
34%
66%
92%
8%
37%
63% 34%
66%
100%
100%
For each patient type:
SHORT-TERM: ALGORITHM II
HIGH NON-HIGH
CRT-D 57 (92%) 75 (63%)
CRT-P 5 (8%) 44 (37%)
TOTAL 62 (100%) 119 (100%)
Device complications
Inappropiate ICD shocks Transplant
Survival
Quality of life
LONG-TERM RESULTS
A X E N T I V ARESULTS: COST
At the end of life, Algorithm I cost €20,960, Algorithm II €22,319 and routine clinical practice €28,447.
€7.487,00
€6.128,00
€1.359,00
€,000
€1000,000
€2000,000
€3000,000
€4000,000
€5000,000
€6000,000
€7000,000
€8000,000
Routine Clin. Prac. vs Algorithm I Routine Clin. Prac. vs Algorithm II Algorithm II vs Algorithm I
Cost
savi
ngs
Positive values shows benefit of Algorithm I (1st & 3rd) and Algorithm II (2nd) 23
A X E N T I V ARESULTS: COST DISTRIBUTION
Implant cost is the highest cost for all alternatives (52% routine clinical practice 43%, Algorithm II and
42% Algorithm I.
25
A X E N T I V ARESULTS: LIFE YEAR
At the end of life, Algorithm I shows 4.32 years, Algorithm II 4.23 years and routine clinical practice 4.16
years.
0,15
0,07 0,08
0,00
0,02
0,04
0,06
0,08
0,10
0,12
0,14
0,16
Routine Clin. Prac. vs Algorithm I Routine Clin. Prac. vs Algorithm II Algorithm II vs Algorithm I
Life
yea
rs g
aine
ds
Positive values shows benefit of Algorithm I (1st & 3rd) and Algorithm II (2nd) 26
A X E N T I V ARESULTS: QUALITY-ADJUSTED LIFE YEAR
At the end of life, Algorithm I shows 3.26 QALYs, Algorithm II 3.20 QALYs and routine clinical practice 3.17
QALYs.
0,09
0,03
0,06
0,00
0,01
0,02
0,03
0,04
0,05
0,06
0,07
0,08
0,09
0,10
Routine Clin. Prac. vs Algorithm I Routine Clin. Prac. vs Algorithm II Algorithm II vs Algorithm I
QAL
Y ga
ined
s
Positive values shows benefit of Algorithm I (1st & 3rd) and Algorithm II (2nd) 27
A X E N T I V AROUTINE CLINICAL PRACTICE: DATA SPLITED
ROUTINE CLINICAL
PRACTICE PROBABILITI COST LIFE YEARS QALY
CRTD HIGH PATIENTS 28.2% €33,296.63 4.45 3.47
CRT-D NON-HIGH PATIENTS (OVERPROTECTED)
44.8% €34,031.97 3.88 2.97
CRT-D 72,9% €33,747.86 4.10 3.16
CRT-P HIGH PATIENTS (UNDERPROTECTED) 2.8% €6,873.98 4.95 3.33
CRT-P NON-HIGH PATIENS 24.3% €14,996.14 4.25 3.16
CRT-P 27,1% €14,167.35 4.32 3.18
GLOBAL 100% €28,447.06 4.16 3.17
29
A X E N T I V A
SENSITIVITY ANALYSIS
A X E N T I V ABIVARIANT ANALYSIS: % UNDER/OVERPROTECTION
Algorithm I is cost-effective for the 77% combinations of % under/overprotection
Positive values shows benefit of Algorithm I vs. alternatives ( Cadet & Royal blue) 32
A X E N T I V ACOST-EFFECTIVENESS PLANE
Algorithm I is less costly and more effective in 71% of cases vs Current Practice and 89% vs Algorithm II
Cases under the threshold shows Algorithm I as cost-effective 33
A X E N T I V AACEPTABILITY CURVE
Algorithm I has the highest probability of being cost-effective (>90% for willingness to pay <€50,000)
34 † Spanish threshold: €30,000 QALY
A X E N T I V A
BUDGET IMPACT
A X E N T I V ABUDGET IMPACT OF ALGORITHM I IN ESC COUNTRIES
Algorithm I allows cost-
saving of €720 million
(318-894).
36 ESC: European Society of Cardiology
Cost-savings per 1000 inhabitants by ESC countries
A X E N T I V A
CONCLUSION
A X E N T I V ACONCLUSION
38
• Algorithm I is less costly to the hospital vs routine clinical
practice and algorithm II.
• Additionally, algorithm I improves life years and quality of life
vs alternatives.
• Algorithm I is highly cost-effective due to is dominant strategy
compared with routine clinical practice and algorithm II.
A X E N T I V A
CONTACT DETAILS: Carlos Crespo, PhD Co-Owner & CEO [email protected] +34 607 712 010
Q & A
A X E N T I V A
REFERENCES
A X E N T I V AREFERENCES
*
41
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*
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*
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