Λειτουργική έναντι ανατοµικής απεικόνισης. Που βρισκόµαστε; Σχέση κόστους οφέλους - PDF

Description
Λειτουργική έναντι ανατοµικής απεικόνισης. Που βρισκόµαστε; Σχέση κόστους οφέλους Periklis A. Davlouros Associate Professor of Cardiology Invasive Cardiology & Congenital Heart Disease Ελληνική εµπειρία?!

Please download to get full document.

View again

of 92
All materials on our website are shared by users. If you have any questions about copyright issues, please report us to resolve them. We are always happy to assist you.
Information
Category:

Crafts

Publish on:

Views: 20 | Pages: 92

Extension: PDF | Download: 0

Share
Transcript
Λειτουργική έναντι ανατοµικής απεικόνισης. Που βρισκόµαστε; Σχέση κόστους οφέλους Periklis A. Davlouros Associate Professor of Cardiology Invasive Cardiology & Congenital Heart Disease Ελληνική εµπειρία?! OCT fiber: 2000 E! IVUS catheter: 840 E! FFR Wire: 630 E! DES: 540 E! BMS: 270 E! KEN PCI E Cost-Effective vs. Cost-Saving Cost-Saving! A treatment option that decreases total costs and improves outcomes. Cost-Effective:! A treatment option that results in benefits sufficiently large compared to the costs, even if it does not save money. What is considered cost-effective (i.e. good value for the money) can differ from country to country 3 Costs Effects Costs Less effective and more expensive Effects Costs Less effective and more expensive Effects Less effective and less expensive Costs Less effective and more expensive More effective and more expensive Effects Less effective and less expensive Costs Less effective and more expensive More effective and more expensive Effects Less effective and less expensive More effective and less expens CE example: Military Tanks! Purchase price vs. Effectiveness Operating radius, top speed, rate of fire, armor protection, and caliber and armor penetration of their guns! A tank's performance in these areas is equal or even slightly inferior to its competitor, but substantially less expensive and easier to produce! Is it cost effective?! Difference in price is near zero, but the more costly competitor would convey an enormous battlefield advantage through special ammunition, radar fire control, and laser range, enabling it to destroy enemy tanks accurately at extreme ranges! Is it cost effective? CE example: Military Tanks! Purchase price vs. Effectiveness Operating radius, top speed, rate of fire, armor protection, and caliber and armor penetration of their guns! A tank's performance in these areas is equal or even slightly inferior to its competitor, but substantially less expensive and easier to produce! Is it cost effective? YES (trade off)! Difference in price is near zero, but the more costly competitor would convey an enormous battlefield advantage through special ammunition, radar fire control, and laser range, enabling it to destroy enemy tanks accurately at extreme ranges! Is it cost effective? CE example: Military Tanks! Purchase price vs. Effectiveness Operating radius, top speed, rate of fire, armor protection, and caliber and armor penetration of their guns! A tank's performance in these areas is equal or even slightly inferior to its competitor, but substantially less expensive and easier to produce! Is it cost effective? YES (trade off)! Difference in price is near zero, but the more costly competitor would convey an enormous battlefield advantage through special ammunition, radar fire control, and laser range, enabling it to destroy enemy tanks accurately at extreme ranges! Is it cost effective? YES (trade off) Effectiveness: QALY! The quality-adjusted life-year (QALY) is a measure of disease burden, including both the quality and the quantity of life lived.! It is used in assessing the value for money of a medical intervention Cost-Effectiveness: QUALY! The QALY is based on the number of years of life that would be added by the intervention Each year in perfect health is assigned the value of 1.0 down to a value of 0.0 for being dead. If the extra years would not be lived in full health, for example if the pt would lose a limb, or be blind or have to use a wheelchair, then the extra life-years are given a value between 0 and 1 to account for this. Cost-Effectiveness: ICER! The incremental cost-effectiveness ratio (ICER) is an equation used commonly in health economics to provide a practical approach to decision making regarding health interventions. It is typically used in cost-effectiveness analysis.! ICER is the ratio of the change in costs to incremental benefits of a therapeutic intervention or treatment Cost-Effectiveness: ICER! The equation for ICER is:! ICER = (C1 C2) / (E1 E2) where C1 and E1 are the cost and effect in the intervention or treatment group and where C2 and E2 are the cost and effect in the control care group.! Costs are usually described in monetary units while benefits/effect in health status is measured in terms of quality-adjusted life years (QALYs) gained or lost. ICER=$/QUALY A traditionally accepted cutoff of $50,000 per QALY is based on hemodialysis More appropriate cutoff would be the one proposed by the WHO for the US of $150,000 per QALY CE of adding anatomic or functional evaluation to standard Cang! Measure costs of Cang, IVUS, OCT, FFR! Determine outcomes (QUALYs) FAME Study Design Chart Patient with lesions 50% in at least 2 of the 3 major epicardial vessels Indicate all lesions 50% amenable for stenting Randomization Angiography-guided PCI FFR-guided PCI Measure FFR in all arteries with 1 stenosis Stent all indicated stenoses Stent only those stenoses with FFR , 2 and 5-year follow-up Exclusion criteria: LM disease, Previous CABG MI 5 days, unless cardiogenic shock Pregnancy, Life expectancy 2 years The FAME Study Results¹ ² Compared to angiography-only procedures, FAME one-year results show that FFR:! Reduces MACE at one year by 28%.! Reduces mortality and myocardial infarction at one year by 34%.! Is cost saving and does not prolong procedure time.! Decreases amount of contrast agent used.! Results in similar, if not better, functional status. FAME two-year results show that FFR:! Reduces mortality and myocardial infarction (combined) by 34%.! Reduces myocardial infarction alone by 37%.! Is cost saving and improves procedure outcomes. Saves on average $2,066 over one year. 1. Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360(3): TCT (Transcatheter Cardivascular Therapeutics) 2009, Late Breaking Clinical Trials Cost Effectiveness¹ (example Germany) Increm. Cost ( ) ICER of 50,000 /QALY Increm. QALY 1. Siebert U. Cost-Effectiveness and Public Health/Budget-Impact of FFR-Guided PCI in Multivessel Patients in Europe Analysis of the FAME Study Data. EuroPCR, FFR generates more QALYs than angio... FFR is clearly both costsaving and cost-effective Scatter plot of 5,000 estimates of incremental costs and QALYs from FFR compared with angio, for the German population % of the 5,000 points are below the X-axis: 91.0% probability that FFR will be less expensive than angio % of the points are to the right of the Y-axis: 78.2% probability that FFR yields more QALYs than angio. 71.9% of the points are in the South East quadrant: 71.9% probability that FFR is both less expensive AND more effective Results Cost Effectiveness Planes: FFR vs. Angio¹ France UK Italy Increm. Cost ( ) ICER of 50,000 / QALY Increm. QALY Dominant : % Increm. Cost ( ) ICER of 43,700 / QALY (= 30,000 ICER of 50,000 / 500 /QALY) QALY Increm. QALY Increm. QALY % Increm. Cost ( ) % Cost effective: 90% Cost savings: 900 /pat. 90% 600 /pat. 86% 300 /pat. FFR is clearly both costsaving and cost-effective At least a 52% probability that FFR dominates angio (that it is more effective and less expensive). 1. Siebert U. Cost-Effectiveness and Public Health/Budget-Impact of FFR-Guided PCI in Multivessel Patients in Europe Analysis of the FAME Study Data. EuroPCR, 2011. Budget Impact Analysis (example Germany)¹ ( ) 0 million -25 million -50 million -75 million Best-case Worst-case Mean -100 million -125 million Degree of FFR penetration (%) FFR is both cost-effective and provides a positive budget impact in major European markets 1. Siebert U. Cost-Effectiveness and Public Health/Budget-Impact of FFR-Guided PCI in Multivessel Patients in Europe Analysis of the FAME Study Data. EuroPCR, Expected budgetary impact under worst case and best case scenarios of changing the market uptake from zero to 100%. The green line plots the mean between the two. If market uptake rose to 100%, then projected savings over two years could be mE Conclusion! Average, FFR-guided PCI in patients with multivessel, coronary artery disease and an intermediate stenosis is cost saving and leads to better outcomes than angiography-guided PCI¹! Depending on market uptake, introduction of FFR-guided PCI could lead to:! Reduction in death, MI and other major adverse cardiac events! Improved quality of life of patients! Reductions in expenditure! Consistent results across Germany, France, UK and Italy²! May be generalized to other Western European countries 1. Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360(3): Siebert U. Cost-Effectiveness and Public Health/Budget-Impact of FFR-Guided PCI in Multivessel Patients in Europe Analysis of the FAME Study Data. Patras EuroPCR, University Hospital Cost Effectiveness of FFR! The FAME 2 trial is a multicenter, international, randomized study comparing FFR-guided PCI to best medical therapy (MT) in pts with stable CAD.! The study was stopped early because of a significantly higher rate of the composite endpoint of death, MI and urgent revascularization in pts assigned to MT. Trial Design Stable patients with 1, 2, or 3 vessel CAD evaluated for PCI with DES n=1220 Trial Design Stable patients with 1, 2, or 3 vessel CAD evaluated for PCI with DES n=1220 FFR in all target lesions Trial Design Stable patients with 1, 2, or 3 vessel CAD evaluated for PCI with DES n=1220 FFR in all target lesions All FFR 0.80 (n=322) Registry MT 50% randomly assigned to follow-up Trial Design Stable patients with 1, 2, or 3 vessel CAD evaluated for PCI with DES n=1220 FFR in all target lesions Randomized Trial Registry At least 1 stenosis with FFR 0.80 (n=888) All FFR 0.80 (n=322) Randomization 1:1 PCI + MT MT MT 50% randomly assigned to follow-up Trial Design Stable patients with 1, 2, or 3 vessel CAD evaluated for PCI with DES n=1220 FFR in all target lesions Randomized Trial Registry At least 1 stenosis with FFR 0.80 (n=888) All FFR 0.80 (n=322) Randomization 1:1 PCI + MT MT MT 50% randomly assigned to follow-up Primary Endpoint: Death, MI, Urgent Revascularization at 2 years Trial Results FFR-Guided PCI (n=447) % MT (n=441) P-Value Primary Endpoint 0.001 Death Myocardial Infarction Urgent Revascularization 0.001 Free from Angina (1 month) 0.001 De Bruyne, et al. New Engl J Med 2012;367: Methods Freedom from Angina in COURAGE Assumption that the change in utility in the FFR-Guided PCI arm would last 3 years based on data from COURAGE which showed that the improvement in angina with PCI ended at 3 years Weintraub, et al. New Engl J Med 2008;359: Methods! We estimated the utility difference in 2 ways: Improved by PCI (in both arms) and lasted 1 year One month difference declined linearly over 3 years! The Cost-Effectiveness Ratio was calculated as: (Cost FFR-PCI Cost MT ) (Δ QALY FFR-PCI Δ QALY MT ) Results One Year Cost Estimates Per Patient FFR-Guided PCI MT Baseline $8,790 $3,305 Drug-Eluting Stent(s) $4,304 $48 Follow-up $2,584 $5,561 Revascularization $442 $3,928 Total $11,374 $8,866 Baseline costs significantly higher in FFR-guided PCI arm primarily because they received DES. During follow-up, costs significantly greater in MT arm primarily because of the higher revascularization rate. Despite this, at one year, the costs remained significantly higher in the FFR-guided PCI arm Cumulative Costs over 12 Months $5,485 $2,508 The cost difference appears that they continue to narrow with further follow-up Of note, the estimate at one year has a fairly high level of uncertainty because only 11% of patients achieved 1 year followup. Cumulative Costs over 12 Months $5,485 $2,508 % of study population 100% 56% 11% The cost difference appears that they continue to narrow with further follow-up Of note, the estimate at one year has a fairly high level of uncertainty because only 11% of patients achieved 1 year followup. Results Quality of Life at 1 Month Angina (%) FFR-Guided PCI MT p-value Class 0.001 Class 0.001 Utility Change 0.001 The % of pts with mild or no angina was significantly greater at one month in the FFR-Guided PCI arm. This resulted in a significantly greater change in utility from baseline to one month in the FFR-Guided PCI arm of compared to essentially no improvement (0.003) in the MT arm. FFR-Guided PCI Cost-Effectiveness FFR-Guided PCI Cost-Effectiveness In-trial results FFR-Guided PCI Cost-Effectiveness In-trial results $2,500 / QALY FFR-Guided PCI Cost-Effectiveness In-trial results $2,500 / QALY = $53,000 / QALY FFR-Guided PCI Cost-Effectiveness In-trial results $2,500 / QALY = $53,000 / QALY Three Year Projection $2,500 / QALY FFR-Guided PCI Cost-Effectiveness In-trial results $2,500 / QALY = $53,000 / QALY Three Year Projection $2,500 / QALY = $32,000 / QALY FFR-Guided PCI Cost-Effectiveness In-trial results $2,500 / QALY = $53,000 / QALY Three Year Projection $2,500 / QALY = $32,000 / QALY In-trial results, based on the cost difference at one year and assuming that the utility change (or benefit of PCI) ended at one year Assuming that the cost difference at 1 yr stayed the same out to 3 yrs. We assumed that the utility difference declined in a linear fashion so that at 3 years there was no longer a benefit to FFR-Guided PCI. This more realistic estimate showed that the costeffectiveness ratio was $32,000 per QALY... Cost-Effectiveness CE Benchmarks: Hemodialysis $50,000 / QALY WHO GDP std $150,000 / QALY $150,000 / QALY $50K-150K / QALY $50,000 / QALY Traditionally accepted cutoff of $50,000 per QALY based on hemodialysis More appropriate cutoff would be the one proposed by the WHO for the US of $150,000 per QALY The COURAGE trial, which compared an angio-guided PCI strategy to MT, found that the CE ratio was at least $168K/QALY if not higher, and therefore not CE Cost-Effectiveness CE Benchmarks: Hemodialysis $50,000 / QALY WHO GDP std $150,000 / QALY $150,000 / QALY $50K-150K / QALY $50,000 / QALY Study Comparators CE Ratio COURAGE Angio-Guided PCI vs Medical Therapy $168,000 / QALY Traditionally accepted cutoff of $50,000 per QALY based on hemodialysis More appropriate cutoff would be the one proposed by the WHO for the US of $150,000 per QALY The COURAGE trial, which compared an angio-guided PCI strategy to MT, found that the CE ratio was at least $168K/QALY if not higher, and therefore not CE Cost-Effectiveness CE Benchmarks: Hemodialysis $50,000 / QALY WHO GDP std $150,000 / QALY $150,000 / QALY $50K-150K / QALY $50,000 / QALY Study Comparators CE Ratio COURAGE FAME 1 Angio-Guided PCI vs Medical Therapy Angio-Guided PCI vs FFR-Guided PCI $168,000 / QALY FFR-Guided PCI is Dominant ( $ / QALY) In the FAME 1 trial, FFR-Guided strategy was dominant, meaning it cost less money and improved outcomes Fame-2 Cost-Effectiveness CE Benchmarks: Hemodialysis $50,000 / QALY WHO GDP std $150,000 / QALY $150,000 / QALY $50K-150K / QALY $50,000 / QALY Study Comparators CE Ratio COURAGE FAME 1 Angio-Guided PCI vs Medical Therapy Angio-Guided PCI vs FFR-Guided PCI $168,000 / QALY FFR-Guided PCI is Dominant ( $ / QALY) FAME 2 FFR-Guided PCI vs Medical Therapy $32,000 / QALY FAME 2: the cost-effectiveness ratio of an FFR-guided PCI strategy compared to MT is favorable at $32,000/QALY Limitations! This study is limited by the short time horizon.! Cost-effectiveness estimates have wide confidence limits due to Model assumptions Parameter uncertainty Statistical uncertainty Conclusion: Conclusion:! FFR-Guided PCI has higher initial cost than medical therapy. Conclusion:! FFR-Guided PCI has higher initial cost than medical therapy. The cost gap narrows by 50% at one year. Conclusion:! FFR-Guided PCI has higher initial cost than medical therapy. The cost gap narrows by 50% at one year. Conclusion:! FFR-Guided PCI has higher initial cost than medical therapy. The cost gap narrows by 50% at one year.! Angina and quality of life are significantly improved by FFR- Guided PCI compared to medical therapy, while some PCIs are avoided... Conclusion:! FFR-Guided PCI has higher initial cost than medical therapy. The cost gap narrows by 50% at one year.! Angina and quality of life are significantly improved by FFR- Guided PCI compared to medical therapy, while some PCIs are avoided... Conclusion:! FFR-Guided PCI has higher initial cost than medical therapy. The cost gap narrows by 50% at one year.! Angina and quality of life are significantly improved by FFR- Guided PCI compared to medical therapy, while some PCIs are avoided...! FFR-Guided PCI appears to be economically attractive in cost-effectiveness analysis. FFR Classification: IA in the ESC/EACTS Guidelines 1. Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360(3):213-24 IVUS ICER: What s the scenario?! Universal use of IVUS guided PCI vs Angiography ! The treatment population in the model is based on the patient population examined in a recent meta-analysis by Ahn et al.! IVUS DES implantation to date! Both acute and chronic CAD patients going through either IVUS-guided or angiography-guided PCI with DES! Ahn et al. also included patients with diabetes mellitus, renal insufficiency (creatinine clearance 60 ml/min), ACS, or smoking history, who represent patients at a high risk of post-pci adverse cardiac events IVUS cost-effectiveness: Italy About 71 % of the simulations fell into the south east quadrant, implying that IVUS use is a dominant option. The remaining 29 % fell into the north east quadrant; however, the resulting ICERs were always below 18,000. From an Italian healthcare payer perspective, the choice PCI guided by both IVUS and angiography is always the optimal strategy given the 25,000 WTP threshold. IVUS ICER: What s the scenario?! Universal use of IVUS guided PCI vs. Angiography! Universal use of IVUS guided PCI vs. FFR guided PCI Why not substitute FFR with IVUS?! If IVUS guided PCI costs are similar to FFR costs! AND IVUS guided PCI benefits are similar to FFR benefits! Then IVUS guided PCI would be an equally to FFR good value for money strategy!!! Why not substitute FFR with IVUS?! If IVUS guided PCI costs are similar to FFR costs IVUS catheter: 840 E FFR Wire: 630 E + Adenosine So what do FFR/IVUS have in common? Avoid unnecessary interventions If you want to treat a lesion, use IVUS; if you don t, use FFR Why not substitute FFR with IVUS?! IVUS guided PCI costs may be rather higher compared to FFR guided PCI costs Why not substitute FFR with IVUS?! If IVUS guided PCI costs are higher to FFR guided PCI costs! Then IVUS guided PCI benefits should be higher than FFR guided PCI benefits! For IVUS guided PCI to be an attractive alternative to FFR guided PCI Outcomes of PCI in Intermediate CAD: FFR Guided Vs. IIVUS Guided Nonrandomized, retrospective study Chang-Wook Nam, et al. JACC: Cardiovascular Interventions, 2010, Outcomes of PCI in Intermediate CAD: FFR Guided Vs. IVUS Guided Chang-Wook Nam, et al. JACC: Cardiovascular Interventions, 2010, Outcomes of PCI in Intermediate CAD: FFR Guided Vs. IIVUS Guided IVUS-guided lesion selection resulted in almost 3 times as many treated lesions without any difference in the event rate Chang-Wook Nam, et al. JACC: Cardiovascular Interventions, 2010, IVUS ICER: What s the scenario?! Universal use of IVUS guided PCI vs. Angiography! Universal use of IVUS guided PCI vs. FFR guided PCI Functional Angioplasty: Incorporation of FFR and IVUS Into Daily Practice! The issue of superiority/non-inferiority might be irrelevant...! The FFR value and IVUS-measured parameters should not be considered an equivalent comparison, because these are complementary and not competitive... What does IVUS better than FFR? PCI op
Related Search
Similar documents
View more...
We Need Your Support
Thank you for visiting our website and your interest in our free products and services. We are nonprofit website to share and download documents. To the running of this website, we need your help to support us.

Thanks to everyone for your continued support.

No, Thanks