Lifetime Cost Effectiveness of Transcatheter Aortic ValveLifetime Cost Effectiveness of Transcatheter Aortic Valve Replacement Compared with Standard Care Among Inoperable Patients with Severe Aortic Stenosis:Inoperable Patients with Severe Aortic Stenosis: Results from the PARTNER Trial (Cohort B)

Paul TL Chiam

MBBS, MRCP, FESC, FACC, FSCAI

Background

I ti t ith i bl ti t iIn patients with severe, inoperable aortic stenosis, “cohort B” of the PARTNER trial has demonstrated th t d ith t d d TAVR l d tthat, compared with standard care, TAVR led to:

• Improved 12-month survival (70% vs. 50%)

• Substantial and sustained improvement in symptoms, functional status, and quality of life

• Reduced hospitalization for aortic stenosis or its treatment: 22% vs. 44% at one year

Leon M et al NEJM 2010; 363:1597-607Leon M et al. NEJM 2010; 363:1597-607Cohen DJ. AHA Scientific Sessions 2010

Objectives

1 T th h t d l t t f th TAVR1. To compare the short and long-term costs of the TAVR strategy with those of standard care in patients with i bl ti t iinoperable aortic stenosis

2 To project the long-term differences in overall and2. To project the long-term differences in overall and quality-adjusted life expectancy between these groups

3. To estimate the lifetime cost-effectiveness of TAVR compared with standard therapy based on the p pyPARTNER trial results

Methods: Endpoints

P i E d i tPrimary Endpoint• Lifetime Incremental Cost-Effectiveness Ratio ($/LYG)

Secondary Endpoint• Lifetime incremental costs per quality-adjusted life year

gained ($/QALY)

Pre-specified Sensitivity Analyses• Exclusion of non-cardiovascular costs• Exclusion of non-cardiovascular costs• Exclusion of all BAV procedure costs from control group• Price of study device• Price of study device• Removal of QOL improvement observed during follow-up

Methods: In-Trial Costs

TAVR d M d tili ti• TAVR procedure: Measured resource utilization (procedure duration, supplies) multiplied by unit costs

– SAPIEN Valve estimated commercial price = $30,000

• All other costs for index admission: Itemized charges multipliedAll other costs for index admission: Itemized charges multiplied by department-specific cost-to-charge ratios

– Where billing data unavailable regression model (R2 = 0 84) derivedWhere billing data unavailable, regression model (R 0.84) derived from subjects with bills used to impute costs

Follo p hospitali ations Costs from billing data or MedPAR• Follow-up hospitalizations: Costs from billing data or MedPAR (when bills were unavailable)

• Resource based costs: Also included for rehabilitation days, SNF days, outpatient visits, ER visits, outpatient cardiac testing,

d di tiand medications

TAVR Admission Costs

$78 540

$4,978$80,000

$78,540

$30,756$60,000 Mean (median) LOS (days)

$40,000

ICU 4.0 (2.0)Non-ICU 6.1 (5.0)

$42,806$20,000

Total 10.1 (7.0)Post-Procedure 8.6 (6.0)

(N 175)

Hospital Costs:$73,563

$0

(N=175)

$0Index Admission Costs

Procedure Non-ProcedureMD Fees

Results: 12-Month Follow-up Costs

=($26,025)

Total F/U Costs (12 months)Total F/U Costs (12 months)

TAVR $29,352C t l $52 724

= $23,372p<0 001Control $52,724 p<0.001

=$705 =1,870 =$79

Results: Projected Survival

Life ExpectancyLife Expectancy (undiscounted)

TAVR: 3.11 yearsyControl: 1.23 yearsDifference: 1.88 years

Cost-Effectiveness of TAVR vs. Control Lif ti R ltLifetime Results

Cost = $79,837 LE = 1.59 yearsCost = $79,837 LE = 1.59 years

$100,000 per LY$100,000 per LY

ICER = $50,212/LYGICER = $50,212/LYG

$50,000 per LY$50,000 per LY

Cost-Effectiveness of TAVR vs. Control Lif ti R ltLifetime Results

95%

47%

Secondary/Sensitivity Analyses

Incremental Costs

(TAVR Control)

Incremental Life Years

(TAVR Control)

ICER($/LY)(TAVR – Control) (TAVR – Control)

Base Case $79,837 1.59 50,212

QALYs $79,837 1.29 61,889*

QALYs assuming no $79 837 0 96 83 163*gQOL improvement $79,837 0.96 83,163*

Exclude non-CV costs $53,837 1.59 33,860, ,

Study device = $20,000 $69,390 1.59 43,642

Study device = $40,000 $90,284 1.59 56,782

Exclude BAV costs $82,623 1.59 51,964$ , ,

* $/QALY

Published Cost Effectiveness Estimates

$300

$250

nds)

$200

Y ($thou

san

$150

ear or QALY

$100

per Life Ye

$50Dollars 

$0aspirin MI prevention

rosuvastatin high‐CRP

ICD prim prev

CRT‐D v. medical Rx

dabigatran AF

PARTNER Cohort B

AF ablation vs. AAD

dialysis PCI stable CAD

LVAD destination 

Rx

Limitations

• Still early experience for TAVR device and procedure; care may become more efficient in futurecare may become more efficient in future

• Care of control group patients in trial may have differed g p p yfrom care of similar pts in community practice

Lif ti l i ti l l t j ti b d th• Lifetime analysis, particularly cost projections beyond the trial period, associated with some uncertainty

• Uniquely old and high-risk patient population; results cannot be extrapolated to other groupsp g p

Summary of Findings

TAVR i t d ith i d d i i t f• TAVR was associated with index admission costs of ~$78,000, including estimated physician fees

• Although follow-up costs were ~$23,000/pt lower with TAVR vs. standard care (mainly due to reduced CV ( yhospitalizations), overall 1-year costs remained substantially higher with TAVRy g

• Based on observed data from PARTNER, we project that TAVR will result in an increased life expectancy ofTAVR will result in an increased life expectancy of ~1.9 years compared with standard care and an iCER of $50 200 per life year gained$50,200 per life-year gained

• Results were minimally impacted by major sensitivity analyses

Conclusions

For patients with severe aortic stenosis whoFor patients with severe aortic stenosis who are unsuitable for surgical AVR, TAVR

significantly increases life expectancy at an i t l t lif i d llincremental cost per life year gained well

within accepted values for commonly used p ycardiovascular technologies

Economic Evaluation of Transcatheter Aortic ValveEconomic Evaluation of Transcatheter Aortic Valve Implantation:

Is TAVI a cost‐effective treatment for  patients who are l bl f l l lineligible for surgical aortic valve replacement

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TAVI CEA Poster at TCT 2012TAVI CEA Poster at TCT 2012Oxford Outcomes, Medtronic

Background:Background:

•Working with Oxford Outcomes (UK) we compared the cost‐effectiveness studies performed on TAVI versus medical management in patients ineligible for surgery across a range of jurisdictions and health care systems

•A systematic literature search was conducted to retrieve published cost‐ff d l feffectiveness models for TAVI

•Data extraction on all relevant papers was based on the BMJ internationally recognised and respected checklist in order to review the methods of eachrecognised and respected checklist in order to review the methods of each model and to systematically illustrate similarities or differences 

•The results and key parameters of the analyses were also compared and y p y pcontrasted to identify the core drivers to the cost‐effectiveness of TAVI

Paper was submitted for publication to Heart Journal in December 2012Paper was submitted for publication to Heart Journal in December 2012

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Results: Economic outputs across CE modelspWatt et al Reynolds et al Gada et al SHTG Doble et al. Neyt et al.

Country England & Wales United StatesUnited States

Scotland  Canada  Belgium States 

PerspectiveUK National 

Health serviceNational health 

care system

National health care 

system

Scottish Heath and social work

Third party payer

Healthcare payer

Costs (MM) £5,000 $69,903Not 

reported£13,971 $57,963 Not reported

( ) $Not

$Costs (TAVI) £30,200 $149,740Not 

reported£28,654 $88,991 Not reported

Incremental costs £25,200 $79,837 $59,503 £14,683 $31,028 €33,200

QALYs (MM) 0.80 1.20Not 

reported1.53 Not reported Not reported

NotQALYs (TAVI) 2.36 2.78

Not reported

2.18 Not reported Not reported

Incremental QALYs 1.56 1.59 1.78 0.65 0.60 0.74

ICER (COST/QALY) £16,700 $50,212 $52,733 £22,603  CAN$51,324 €44,900

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ICER(2012 USD equivalent)

$26,800 $50,200 $54,000 $37,200 $42,400 $53,000

Results: Standardised cost‐effectiveness resultsResults: Standardised cost effectiveness results 2012 USD$

USD 60,000

USD 50,000

USD 40,000

USD 30,000

USD 20,000

USD 10,000

USD 0

,

19

USD 0Watt et al Reynolds et al Gada et al SHTG Doble et al. Neyt et al

Legend: Blue bars – Lifetime horizon, purple bar – 20 year time horizon, green bar – 3 year time horizon 

UK TAVI Cost Effectiveness Analysis UpdateUK TAVI Cost Effectiveness Analysis UpdateJanuary 2013

• Recently published CEA, UK perspective

• Initial Results with Historical Data ‐ ICER is estimated at £35,956 per QALY gained which is marginally above the level usually considered cost‐effective in the UK (£20,000–(£30,000 per QALY).

• Late Results with Recently Published Data ‐ICER is estimated at £19 000 per QALY gainedICER is estimated at £19,000 per QALY gained which is well below the level usually considered cost‐effective in the UK (£20,000–£30 000 QALY)£30,000 per QALY).– Evaluated group had lower adverse event by 25%

• Recommendation is:– No further CEA needed for TAVI inoperable patients

– Continued data collection via registries to inform future decision making 

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CoreValve ADVANCE Study:  Cost Utility Analysisy y y

• Methods: Prospective, single arm, international study March 2010 – July 2011international study March 2010  July 2011• 1015 patients, 44 centers and 12 countries 

worldwide

• HrQol evaluated at baseline, 1 month, 6 months, d 1 i SF 12 h i l (PCS d t land 1 year using SF‐12 – physical (PCS and mental 

(MCS) and EQ‐5D

• Patient Group: “real world” registry data inoperable and high surgical risk patientsinoperable and high surgical risk patients

• Comparison/Control: PARTNER B Standard therapy

O t ome/Effe ts• Outcome/Effects:– These data demonstrate that TAVI with the CoreValve 

System is cost effective, when health economic metrics are applied to the real‐world ADVANCE Study. 

– The average cost per QALY gained for an ADVANCE study patient was £11,265 and this rises to £13,778 when applied to the subgroup with EuroSCORE ≥ 20% in the study — both of these figures are well within the benchmark used by national regulatory bodies in the UK and elsewhere.

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Brecker et al. Transcatheter aortic valve implantation for inoperable patients with severe aortic stenosis: A United Kingdome based cost utility analysis based on patient level data from the ADVANCE Study. Oral Presentation. EuroPCR 2013 Paris France.

ConclusionsConclusions• Cost effectiveness evaluations on TAVI in the treatment of 

patients ineligible for surgical AVR have been reported from  four different countries – UK, US, Belgium and Canada. 

• In those countries thresholds discount rates medical costsIn those countries, thresholds, discount rates, medical costs and health care systems are different. 

• There was wide variation in the device costs and the other• There was wide variation in the device costs, and the other costing methods. There was less variation in the total TAVI related QoL benefitrelated QoL benefit. 

D it th diff j i di ti TAVI i t Despite the differences across jurisdictions, TAVI is a cost‐effective treatment in comparison with optimal medical management in patient unsuitable for surgical replacementmanagement in patient unsuitable for surgical replacement

ConclusionsConclusions

• 12‐months costs and QALY were similar for TAVI vs AVR• However, differences were seen between TF and TAHowever, differences were seen between TF and TA 

approaches

• TF appeared economically attractive as compared to AVR in the PARTNER A trial with modest benefit in quality‐adjusted q y jlife expectancy

• TA resulted in higher 12‐month costs and a trend towards reduced quality‐adjusted life expectancy as compared with AVR

• Costs analyses will change (in favor of TAVI) as results of TAVI i ll d f d i dimprove overall and as cost of devices decrease