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National Collaborating Centre for Primary Care (UK). Post Myocardial Infarction: Secondary Prevention in Primary and Secondary Care for Patients Following a Myocardial Infarction [Internet]. London: Royal College of General Practitioners (UK); 2007 May. (NICE Clinical Guidelines, No. 48.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Appendix DHealth Economic Extractions

What is the cost effectiveness of Cardiac rehabilitation in Post MI?

Ref ID: 21Ades PA, Pashkow FJ, Nestor JR. Cost-effectiveness of cardiac rehabilitation after myocardial infarction. J Cardpulm Rehabil 1997; 17(4): 222–231.
Economic study typeCEA, benefit measure was years of life saved (YLS)
Population, country & perspectiveMales with a post acute MI below the age of 65 years patient or insurance payer
Intervention

Comparison(s)
Cardiac rehabilitation + usual care

No cardiac rehabilitation (usual care which consisted of thrombolytic therapy coronary bypass surgery, cholesterol lowering drugs and smoking cessation).
Source of effectiveness dataPublished review of RCTs
Method of eliciting health valuations (if applicable)Not applicable
Cost components includedDirect medical costs
Currency and cost yearUSA, 1995
Results – cost per patient per alternativeThe net cost for MI was $430 in 1985 and $940 in 1995. The costs of other common interventions were not stated
Results – effectiveness per patient per alternativeCumulative all-cause mortality in the rehabilitation group was reduced by 21.2% at the end of year 1, by 22.9% at the end of 2 years and 16.9% at th end of 3 years of follow-up
Results –incremental cost- effectivenessThe cost per year of life saved was $2,130 in 1985 and the cost per year of l saved (projected) was $4,950 in 1995 (at a 5% discount rate)
Results-uncertaintyVarying the survival rate, the survival probabilities and the rehospitalisation expenses averted
Time horizon & discount rate3 years 5%
Source of fundingNot stated
CommentsQuantities and costs were reported separately, The authors based their analysis of effectiveness on studies with a randomised design, but it is not clear whether these were identified through a systematic search of the medic literature. It should be noted that estimated benefits are unlikely to be generalisable to females of the same age. As acknowledged by the authors, adjustment for quality of life could have been made
Ref ID: 2919Hall JP, Wiseman VL, King MT, Ross DL, Kovoor P, Zecchin RP et al. Economi evaluation of a randomised trial of early return to normal activities versus cardiac rehabilitation after acute myocardial infarction. Heart, Lung & Circula 2002; 11(1): 10–18.
Economic study typeCost consequence analysis. Outcomes were Quality of life (QOL) measures a four measures of return to normal activities (paid and unpaid return to any work and to pre-AMI level of work).
Population, country & perspectiveLow-risk patients after acute myocardial infarction (AMI),
Intervention

Comparison(s)
6 weeks of standard rehabilitation (REHAB, n = 70) (exercise and counselling times a week)

No formal rehabilitation (ERNA, n = 72).
Source of effectiveness dataRCT
Method of eliciting health valuations (if applicable)Not applicable
Cost components includedDirect medical cost and indirect costs
Currency and cost year$AUD, cost year not stated
Results – cost per patient per alternative$21.57/Patient/session for 14 sessions on average direct costs excluding hospital overheads

$28.12/Patient/session for 14 sessions on average total hospital costs.

The net cost that could be saved by the health service by targeting rehabilitation to high-risk patients was approximately $300 (Australian, 1999) per low-risk patient
Results – effectiveness per patient per alternativeThere were no statistically significant differences between the two groups in of the outcomes measured or in the use of other health services
Results –incremental cost- effectivenessNot done (cost minimisation)
Results-uncertaintyNot done
Time horizon & discount rate12 months and discounting was not necessary
Source of fundingPublic
CommentsDid not state the cost year. Good discussion
Ref ID: 280Oldridge N, Furlong W, Feeny D, Torrance G, Guyatt G, Crowe J et al. Econo evaluation of cardiac rehabilitation soon after acute myocardial infarction American Journal of Cardiology 1993; 72(2): 154–161.
Economic study typeCUA, QALYs, cost/QALY
Population, country & perspectivePatients with AMI and mild to moderate anxiety or depression, or both

Perspective not stated but appears to be societal
Intervention

Comparison(s)
Comprehensive cardiac rehabilitation intervention (n = 99)

Usual care (n = 102).
Source of effectiveness dataRCT and review of literature
Method of eliciting health valuations (if applicable)TTO
Cost components includedDirect medical and indirect patient costs
Currency and cost yearUS$ 1991
Results – cost per patient per alternative$480/patient. During 1-year follow-up
Results – effectiveness per patient per alternativeRehabilitation patients had fewer “other rehabilitation visits” (p < 0.0001) an gained 0.052 quality-adjusted life-year more than did the group with usual ca
Results –incremental cost- effectiveness$9,200/quality-adjusted life-year gained with cardiac rehabilitation during the year of follow-up
Results-uncertainty
Time horizon & discount rate12 months and 5%
Source of fundingNot stated
CommentsGenerally a good paper
Ref ID: 297Levin LA, Perk J, Hedback B. Cardiac rehabilitation--a cost analysis. Journal o Internal Medicine 1991; 230(5): 427–434.
Economic study typeCost consequence analysis
Population, country & perspectiveNon-selected post MI patients, societal perspective.

Mortality (total & cardiac) Readmission, non-fatal and total cardiac events
Intervention

Comparison(s)
Comprehensive cardiac rehabilitation programme 147 non-selected MI patien aged less than 65 years (124 men vs. 23 women)

Standard care after myocardial infarction (MI) non-selected MI-population ag less than 65 years (n = 158) (134 men vs. 24 women)
Source of effectiveness dataProspective non- RCT
Method of eliciting health valuations (if applicable)Not applicable
Cost components includedBoth direct and indirect costs (time costs of rehab and lost productivity)
Currency and cost yearSEK 1996
Results – cost per patient per alternativeRehab group SEK 484260 vs. SEK 557770 usual care and difference was SEK 73,500 in favour of the rehabilitated group
Results – effectiveness per patient per alternativeMortality (total & cardiac) did not differ between the groups

Readmission was less in the rehab 13.7 days vs. 19.3 days in the control p<0

They differed in non-fatal reinfaction (17.3 vs. 33.3%), total cardiac events (vs. 53.2%) p=0.001
Results –incremental cost- effectivenessNot calculated because it was a cost consequence analysis
Results-uncertaintyRemained robust
Time horizon & discount rate5 yrs, 0 &10%
Source of fundingNot stated
CommentsEven though the study was not controlled it looked at two real life clinical situations, which make the results more useful for the case for comprehensiv rehabilitation.
Ref ID: 166Taylor R, Kirby B. Cost implications of cardiac rehabilitation in older patients. Coronary Artery Disease 1999; 10(1): 53–56.
Economic study typeReview of economic evaluations including costs of the UK cardiac rehabilitatio programme
Population, country & perspectivePost-MI patients, Societal cost data for UK and effectives data from a Canadi trial
InterventionCardiac rehabilitation
Comparison(s)Usual care
Source of effectiveness dataRCT
Method of eliciting health valuations (if applicable)N/A
Cost components includedBoth direct and indirect patient costs
Currency and cost year£, 1994/5
Results – cost per patient per alternative£140.00 excluding the indirect costs

£207 including indirect costs
Results – effectiveness per patient per alternativeLife year gained per patient 0.022

QALY gained 0.052
Results –incremental cost- effectiveness£6400/life year gained

£2700/QALY gained
Results-uncertaintyNot done
Time horizon & discount rate12 weeks & 5%
Source of fundingNot stated
CommentsDid not state where they derived the cost data from, but gives insight into th situation

What is the effectiveness of adding ACEI versus placebo to improve outcome in patients after MI?

No 993
Study Quality:1+ Cost-effectiveness of captopril therapy after myocardial infarction.[see comment]
Author:Tsevat J;Duke D;Goldman L;Pfeffer MA;Lamas GA;Soukup JR;Kuntz KM;Lee TH; 1995
Intervention:Captopril
Comparison:Placebo
Population:Post MI patients with LVD
Perspective:NHS
Study type:CUA
Methods:RCT (SAVE study)
Health valuations:TTO, interviewed 82 patients
Cost components:direct medical
Currency:US$
Cost year:1991
Time horizon:Lifetime
Discount rate:5%
Results- cost:AGELimited benefitPersistent benefit model
50yrs
Captopril$ 3209$32883
Placebo$30369$ 30369
60yrs
Captopril$26128$27382
Placebo$24449$24449
70yrs
Captopril$ 20822$ 22292
Placebo$ 19099$ 19099
80yrs
Captopril$16699$ 18067
Placebo$ 14844$ 14844
Results-effectiveness:AGELimited benefitPersistent benefit model
QALYSQALYS
50yrs
Captopril8.138.34
Placebo8.108.10
60yrs
Captopril6.516.85
Placebo6.336.33
70yrs
Captopril5.075.47
Placebo4.724.72
80yrs
Captopril3.964.33
Placebo3.443.44
Results-ICER:AGELtd benefit ($/QALY)Persistent benefit model ($/QALY)
50yrs6080010400
60yrs90005600
70yrs49004300
80yrs36003700
Results-Uncertainty:For 60-80 years the results are robust to changes in utilities, discount rate, and costs and sensitive in the 50 year olds for the limited benefit model. The persistent benefit model was stable but sensitive to mainly utility changes for the 50 year olds. Worst case analysis showed that the >60yrs results still favour Captopril and for less than 60 years results are
Source of Funding:not stated
Comments:Analysed the results using two models. A) Limited benefit model: assumed mortality will be the same between the intervention post-trial periods. B) Persistent benefit model: assumed differences observed during the trial period will persist for the remaining life time. They also analysed their results by subgroups of age. Appropriate analytical methods were used, and sources of data documented. Data was incorporated as point estimates and parameters subjected to sensitivity analysis.
No984
Study Quality:1+The cost and cardioprotective effects of enalapril in hypertensive patients with left ventricular dysfunction
Author:Cook JR;Glick HA;Gerth W;Kinosian B;Kostis JB; 1998
Intervention:Enalapril
Comparison:Placebo
Population:Patients with elevated blood pressure and LVD
Perspective:SOCIETAL (only direct medical costs were collected)
Study type:CEA & CUA
Methods:RCT (SOLVD study)
Health valuations:From literature
Cost components:Direct medical
Currency:US$
Cost year:1996
Time horizon:life time projection and the 3 year trial observational period
Discount rate:5%
Results-cost:EnalaprilPlacebo
$8499$ 9156
Results-effectiveness:OutcomeEnalaprilPlacebo
Years gained2.842.68
QALYs1.741.62
Results-ICER:not calculated. Enalapril dominated placebo i.e. it costs less and results in more health benefits
Results-Uncertainty:results were very robust and the CEACs showed that there was a less than 10% chance that enalapril treatment will increase the costs compared to placebo. Lifetime projection showed that 94% of the cases enalapril will dominate
Source of Funding:not stated
Comments:placebo reported results of the treatment trial and prevention trial. This report focuses on the prevention trial results. They used standard methodology in their modelling. Sources of effectiveness and cost data well referenced. Data was incorporated as point estimates and subjected to probabilistic sensitivity analysis as well as univariate.
No998
Study Quality:1+Cost-effectiveness of ramipril in patients at high risk for cardiovascular events: a Swiss perspective
Author:Aurbach A;Russ W;Battegay E;Bucher HC;Brecht JG;Schadlich PK;Sendi P; 2004
Intervention:Ramipril
Comparison:Placebo
Population:Patients with increased risk of cardiovascular events
Perspective:NHS
Study type:CEA,
Methods:RCT (HOPE study)
Health valuations:NOT APPLICABLE
Cost components:direct medical
Currency:OTHER (Swiss Franc) CHF
Cost year:2001
Time horizon:4.5yrs
Discount rate:5%
Results-cost:HOPE study all patientsHOPE diabetic subgroup
CHF 71351CHF 74650
Results-effectiveness:HOPE study all patientsHOPE diabetic subgroup
LYG 11.88LYG 19.69
Results-ICER:HOPE study all patientsHOPE diabetic subgroup
ICER 6005/LYG3790/LYG
Results-Uncertainty:did both deterministic and probabilistic sensitivity analysis. Results were sensitive to cost of drug
Source of Funding:Private (Aventis Pharma)
Comments:well reported using standard methodology. Data incorporated as point estimates and subjected to sensitivity analysis Used CEACs to quantify the uncertainty surrounding the ICER. Also did a best case and worst case analysis
No965
Study Quality:1+The cost-effectiveness of ramipril in the treatment of patients at high risk of cardiovascular events: a Swedish sub-study to the HOPE study
Author:Bjorholt I;Andersson FL;Kahan T;Ostergren J; 2002
Intervention:Ramipril
Comparison:Placebo
Population:Patients at high risk of cardiovascular events
Perspective:NHS
Study type:CEA
Methods:RCT (HOPE study)
Health valuations:base case results did not consider quality of life, but in sensitivity analysis they did using TTO
Cost components:direct medical for base case and direct medical and non medical + indirect costs
Currency:OTHER (SKr)
Cost year:1999
Time horizon:4.5 years
Discount rate:3%
Results-cost:Total categoryRamiprilPlacebodifference (Mean SEK)
Total direct medical48957462942663 (NS)
Direct nonmedical14501725−275 (NS)
Indirect costs52525496722582 (NS)
NS= non significant difference
Results-effectiveness:Expected LYG at the end of the study 0.16. Cardiovascular events avoided 3.8%
Results-ICER:BASE CASE RESULTS
Costs related to cardiovascular disease only:
Cost/LYGCost/CVE avoided
Direct medical1660076100
Direct medical+ direct non medical+1610073800
Costs related to all diseases
Cost/LYGCost/CVE avoided
Direct medical5400207300
Direct medical+ direct non medical+54600249600
Using QoL weights
SEK 26600/QALY
SEK 333300/QALY if future costs are included
Results-Uncertainty:the results were sensitive to life expectancy assumptions and QALYs. The primary analysis focused on the health service provider perspective. Additional analysis was done from societal perspective which included direct medical + direct non medical + indirect costs.
Source of Funding:Private (Astra Zeneca and Aventis)
Comments:base case used the health care perspective, but considered societal in further analysis. Data was incorporated as point estimates from the HOPE study appropriate modelling methods were used.
No987
Study Quality:1+Cost-effectiveness of the treatment of heart failure with ramipril: a Spanish analysis of the AIRE study
Author:Hart WM;Rubio-Terres C;Pajuelo F;Juanatey JR; 2002
Intervention:Ramipril
Comparison:Placebo
Population:Post MI with heart failure
Perspective:NHS
Study type:CEA
Methods:RCT (AIRE study)
Health valuations:NOT APPLICABLE
Cost components:Direct medical
Currency:EURO
Cost year:2000
Time horizon:4 yrs
Discount rate:6%
Results-cost:Follow upadd cost on ramipril
1 yreuro 129.2
2yreuro 197.6
3yreuro 435.5
3.8yreuro 399.2
Results-effectiveness:Follow upincremental LYG
1 yr0.027
2yr0.059
3yr0.071
3.8yr0.100
Results-ICER:Follow upcost/LYG
1 yreuro 4784
2yreuro 2286
3yreuro 2763
3.8yreuro 1550
Results-Uncertainty:Two-way sensitivity analysis varying the length of stay and discount rate was done. Results were robust.
Source of Funding:Private (Aventis Pharma)
Comments:The study was well reported. Data sources well referenced and incorporated as point estimates. Appropriate methods were used.
No 959
Study Quality:1+A South African pharmaco-economic analysis of the acute infarction ramipril efficacy (AIRE) study
Author:Anderson AN; Moodley I; Kropman K; 2000
Intervention:Ramipril
Comparison:Placebo
Population:Post MI patients with heart failure
Perspective:NHS
Study type:CEA & CUA
Methods:RCT (AIRE study)
Health valuations:NOT STATED (used data from literature)
Cost components:Direct medical
Currency:OTHER (South Africa Rand)
Cost year:1999
Time horizon:4yrs
Discount rate:5%
Results-cost:Follow upincremental mean costslower limitupper limit
1y183313402465
2y157611472125
3.8y12789491702
Results-effectiveness:Follow upLYG
1y0.027
2y0.090
3.8y0.289
QALYs for<65yrs0.786
QALYs for >65yrs0.932
Results-ICER:FUcost/LYGlower limitupper limit
1y679074963391290
2y175161274323615
3.8y442332845888
COST UTILITY RESULTS
Age groupcost/QALYlower limitupper limit
<65yrs562741777490
>65yrs474435226315
Results-Uncertainty:Results were robust in sensitivity analysis as shown by the confidence intervals
Source of Funding:Private (Hoechst Marion Russell)
Comments:Used QoL weights from the literature and referenced their sources. Data incorporated as point estimates and appropriate methodology was used. Stratified their results according to age and as expected the ICERs were favourable for the elderly than the younger patients.
No 953
Study Quality:1+Economic aspects of treatment with captopril for patients with asymptomatic left ventricular dysfunction in The Netherlands.
Author:Michel BC; Al MJ; Remme WJ; Kingma JH; Kragten JA; van Nieuwenhuizen R; van Hout AB; 1996
Intervention:Captopril
Comparison:Placebo
Population:Post MI with LVD
Perspective:SOCIETAL (but only direct medical costs are reported)
Study type:CEA
Methods:RCT (SAVE & SOLVD study)
Health valuations:NOT APPLICABLE
Cost components:Direct medical
Currency:OTHER (DFI Netherlands)
Cost year:not stated
Time horizon:4yr and 20 year extrapolation
Discount rate:5%
Results-cost:Follow upadditional cost
4years2491
20yrs8723
Follow upadditional cost/additional survivor
4years69126
20yrs68142
Results-effectiveness:Follow upLYG
4yrs0.11
20yrs0.55
Results-ICER:Follow upcost/LYG
4yrs22887
20yrs15799
Results-Uncertainty:both univariate and multivariate sensitivity analysis were done. Univariate showed that results were sensitive to cost of the drug and the occurrence and prevention of heart failure
Source of Funding:not stated
Comments:Data was incorporated as point estimates and appropriate methods of modelling were used. Sources of both effectiveness and cost data were described and referenced. Sensitivity analysis was done and caveats of the study well discussed.
No 948
Study Quality:1+Clinical and economic benefits of ramipril: an Australian analysis of the HOPE study. [see comment]
Author:Smith MG; Neville AM; Middleton JC; 2003
Intervention:Ramipril
Comparison:Placebo
Population:Patients at high risk of cardiovascular diseases
Perspective:NHS
Study type:CEA
Methods:RCT (HOPE study)
Health valuations:NOT APPLICABLE
Cost components:Direct medical
Currency:AU$
Cost year:not stated
Time horizon:5yrs
Discount rate:5%
Results-cost:not given
Results-effectiveness:outcomenumber avoided (95%CI) over 5yrs
Stroke9188 (4305 to 14317)
MI14658 (6765 to 22801)
Revascularisation14317 (4925 to 23678)
Cardiovascular related mortality12534 (6156 to 18655)
Results-ICER:cost/LYS (95%CI)
A$17214 (8338 to 39536)
Results-Uncertainty:Both a univariate and Monte Carlo sensitivity analysis was done. The results were sensitive to risk of cardiovascular death, cost and risk of revascularisation mainly. Structural assumption about the similarity between the Australian population to that used in the HOPE were similar were tested, so was the effect of blood pressure reduction and results remained robust
Source of Funding:not stated, but the author worked for Aventis Pharma
Comments:Did not provide detailed costs data. Used appropriate methodology for incorporating data. They used probabilistic sensitivity analysis to quantify the confidence intervals around the ICER and their findings were robust.
No 946
Study Quality:1+Cost effectiveness of ramipril treatment for cardiovascular risk reduction
Author:Malik IS; Bhatia VK; Kooner JS; 2001
Intervention:Ramipril
Comparison:Placebo
Population:Patients with different risks of mortality. Mortality risks are classified as low (1%), medium (2.44%) high (4.5%) and highest (7%)
Perspective:NHS
Study type:CEA
Methods:RCT (HOPE, AIRE studies)
Health valuations:NOT APPLICABLE
Cost components:direct medical
Currency:£
Cost year:1999–2000
Time horizon:5 yrs to lifetime
Discount rate:6%
Results-cost:not given
Results-effectiveness:authors estimated number of lives gained per year for those on ramipril as well as those eligible for treatment using HOPE study results
Eligible populationLife year gained
Total population>300000012000
Ischemic heart disease14000005600
Stroke6000002400
Diabetes17000006800
Peripheral vascular disease10000004000
Results-ICER:Results5yr20yrs
Base case147002800
Low risk366005300
High risk4000100
Highest risk1300−900 (net saving)
Results-Uncertainty:Results were sensitive to drug cost and cost savings (arising from reduction in events) using arbitrary figures of 50 to 200% of the baseline values.
Source of Funding:Charitable
Comments:The study was well reported using standard methodology including a half year correction factor for the occurrence of events. Data was incorporated as point estimates and sources well referenced. A detailed sensitivity analysis was done.
No 941
Study Quality:1+Cost-effectiveness of ramipril therapy for patients with clinical evidence of heart failure after acute myocardial infarction
Author:Martinez C; Ball SG; 1995
Intervention:Ramipril
Comparison:Placebo
Population:Patients with heart failure after MI
Perspective:NHS
Study type:CEA
Methods:RCT (AIRE study)
Health valuations:NOT APPLICABLE
Cost components:Direct medical
Currency:£
Cost year:1993
Time horizon:4 yrs
Discount rate:6%
Results- cost:Follow upcost/patient
1y11.42
2y12.79
3.8y73.77
Results-effectiveness:Follow upLYG
1y0.027
2y0.090
3.8y0.289
Results-ICER:Follow upcost/LYG
1y425.79
2y147.90
3.8y286.24
Results-Uncertainty:did a two way sensitivity analysis and results were not sensitive to changes in LYG and hospitalisation costs
Source of Funding:not stated
Comments:
No 982
Study Quality:1+Economic evaluation of ramipril in the treatment of patients at high risk for cardiovascular events
Author:Backhouse ME;Richter A;Gaffney L; 2000
Intervention:Ramipril
Comparison:Placebo
Population:Patients at high risk of cardiovascular events
Perspective:NHS
Study type:CEA
Methods:RCT (HOPE study)
Health valuations:NOT APPLICABLE
Cost components:direct medical
Currency:£
Cost year:1999
Time horizon:5yrs
Discount rate:6%
Results- cost:cost/patient
Ramipril: 1426
Placebo: 808
Results-effectiveness:life year gained (LYG)
Ramipril: 7.68
Placebo: 7.57
Results-ICER:£5544/LYG
Results-Uncertainty:Results were not sensitive to assumptions about the timing of the occurrence of events (half cycle correction factor), but rather to assumptions about life expectancy beyond the 5 year trial period. This also dependant on age. (structural assumption being tested in patients stratified by age)
Source of Funding:not stated
Comments:Did a sensitivity analysis focusing on structural assumptions and a subgroup stratified by age. Data incorporated as point estimates using appropriate methodology
No 991
Study Quality:1+Cost-effectiveness analysis of ramipril in heart failure after myocardial infarction: economic evaluation of the Acute Infarction Ramipril Efficacy (AIRE) Study for Germany from the perspective of statutory health insurance
Author:Schadlich PK;Huppertz E;Brecht JG; 1998
Intervention:Ramipril
Comparison:Placebo
Population:Post MI patients with heart failure
Perspective:NHS
Study type:CEA
Methods:RCT (AIRE study)
Health valuations:NOT APPLICABLE
Cost components:direct medical
Currency:OTHER deutschmarks (DM)
Cost year:1993/1995
Time horizon:3.8 yrs
Discount rate:5%
Results- cost:Incremental costs of adding ramipril
Follow upmean cost (DM)
1y223
2y361
3y860
3.8y710
Results-effectiveness:Incremental costs of adding ramipril
Follow upLYG
1y0.027
2y0.090
3y0.170
3.8y0.289
Results-ICER:Cost/LYG
Follow upmean cost (DM)lower limit CI:upper limit CI
1y7−371213624
2y4012−24026863
3y505622036438
3.8y2456−1023623
Negative ICERS indicate savings from ramipril use
Results-Uncertainty:Tested for both methodological and parameter uncertainty. They used Weibull and Kaplan-Mier to quantify the LYG, and a Monte Carlo simulation. Ramipril was found to be cost effective, dominating the alternative in 5% of the cases. 99% of the cases the ICER ranged between -DM2500 to DM8500. Results are sensitive to hospitalisation too.
Source of Funding:Private (Hoechst Marion Russell Germany
Comments:gave detailed description of the methods including an appendix
No 989
Study Quality:1++The economics of TRACE: a cost-effectiveness analysis of trandolapril in post infarction patients with left ventricular dysfunction
Author:LePen C; Lilliu H;Keller T;Fiessinger S; 1998
Intervention:Trandolapril
Comparison:Placebo
Population:Post MI patients with LVD
Perspective:NHS
Study type:CEA
Methods:RCT (TRACE study)
Health valuations:NOT APPLICABLE
Cost components:direct medical
Currency:OTHER (French Francs)
Cost year:1996
Time horizon:2 years
Discount rate:5%
Results- cost:Trandolapril22 080 500
Placebo20 317 300
Difference1 763 200
Results-effectiveness:All-cause mortality
Trandolapril304
Placebo369
Difference65
Mean life expectancy 5.52 years in each group.
Results-ICER:Using raw data from the trial
Cost/life year saved was FF27100
Using the life expectancy at the end of trial discounting both benefits and costs
FF6950/LYS
BOOTHSTRAP results (95% CI)
FF8410 (7990 to 8840)
Results-Uncertainty:the results are robust in sensitivity analysis. Bootstrap results showed that 7.4% of the cases trandolapril dominated placebo and 92.6% of the cases the ICER was positive but still within the acceptable ranges of cost/LYG.
Source of Funding:Private (Hoechst Marion)
Comments:The study was well reported. They tested for methodological uncertainty using different methods to estimate the cost effectiveness (student's T distribution, bootstrap method). Appropriate modelling methods were used. Data sources were referenced, and data was incorporated as point estimates. Probabilistic and univariate sensitivity analysis were done and results were robust.
No 986
Study Quality:1++Cost effectiveness in the treatment of heart failure with ramipril: a Swedish sub study of the AIRE study.
Author:Erhardt C; Ball Sanderson F; Bergentoft P; Martinez C; 1997
Intervention:Ramipril
Comparison:Placebo
Population:Post MI patients with heart failure
Perspective:NHS
Study type:CEA
Methods:RCT (AIRE study)
Health valuations:NOT APPLICABLE
Cost components:direct medical
Currency:OTHER (SEK)
Cost year:1993
Time horizon:3.8yrs
Discount rate:5%
Results- cost:Follow upcost/patient
1yr991
2yrs1579
3.8yrs2826
Results-effectiveness:Follow uplife saved
1yr0.03
2yrs0.09
3.8yrs0.22
Results-ICER:Follow upcost/LYS
1yr33033
2yrs18153
3.8yrs14148
Results-Uncertainty:findings were reported to be robust to many variables (which were not mentioned) including number of live years saved. The model was sensitive to hospital costs
Source of Funding:Private (Astra hassle and Hoechst Marion Russell)
Comments:Tested methodological uncertainty by using both the Weibull method of estimating survival and the Kaplan-Mier method. Did a two-way sensitivity analysis to test parameter uncertainty. Results were reported in two parts. First with only cost discounted and secondly with both costs and effects discounted. In line with NICE recommendations only results reporting discounting for both cost and benefits have been abstracted.

8. What is the effectiveness of adding aspirin versus clopidogrel to improve outcome in patients after MI?

No 1108
Study Quality:1+Clopidogrel versus aspirin for secondary prophylaxis of vascular events: a cost- effectiveness analysis
Author:Schleinitz MD; Weiss JP; Owens DK; 2004
Intervention:Clopidogrel
Comparison:Aspirin
Population:Patients at Risk of Ischemic Events. These included three set of patients, those with prior peripheral vascular disease, prior stroke, prior MI.
Perspective:SOCIETAL
Study type:CUA, using a markov decision model. Outcomes were stroke, reinfaction, mortality, hemorrhagic events
Methods:RCTs, CAPRIE trial for base case, European stroke prevention study, and observational studies
Health valuations:From literature
Cost components:direct medical costs derived from literature, Medicare DRGs, wholesale prices for medication
Currency:US$
Cost year:2002 (using GDP deflator)
Time horizon:Lifetime
Discount rate:3%
Results-cost:lifetime costs
Aspirin $91700
Clopidogrel: $98500
Results-effectiveness:Life expectancy in QALYs
Aspirin: 11.09
Clopidogrel: 10.83
Results-ICER:not calculated. Aspirin dominates clopidogrel
Results-Uncertainty:results were sensitive to the cost and effectiveness of clopidogrel. Even in probabilistic sensitivity analysis, aspirin remained dominant in 88% of the cases.
Source of Funding:Charitable
Comments:The study was well reported with details of how the data was obtained and used in the model. The authors stated they were considering a societal perspective; however, only direct medical costs were included. A detailed breakdown of the cost items was not provided since most of the data were obtained from published studies. This reduces the possibility of replicating the study.
No 1094
Study Quality:1+Cost-effectiveness analysis of clopidogrel versus aspirin in patients with atherothrombosis based on the CAPRIE trial
Author:Annemans L; LaMotte M; Levy E; Lenne X; 2003
Intervention:Clopidogrel
Comparison:Aspirin
Population:Patients with vascular disease with recent stroke, myocardial infarction (MI) or symptomatic peripheral arterial disease
Perspective:NHS, Belgium
Study type:CEA, markov model stroke, vascular and other death, reinfaction, costs, ICERs
Methods:RCT CAPRIE study, and Saskatchewan database
Health valuations:NOT APPLICABLE
Cost components:Direct medical costs derived from literature and Diagnosis-related group (DRG)
Currency:EURO
Cost year:2002
Time horizon:2years
Discount rate:3%
Results- cost:Clopidogrel:Euro 12612 000
Aspirin:Euro 11753 000
Results-effectiveness:clopidogrel:12158 life years
Aspirin:12084 life years
Results-ICER:Euro 13390/LYG using the deterministic model and 14320 euros/LYG 95%CI [6990-26470] using the probabilistic model. Using a willingness to pay threshold figure of 20000 euros/LYG clopidogrel is 86% cost effective.
Results-Uncertainty:results were robust in both deterministic and probabilistic sensitivity analysis. They examined the impact of discount rate (0–6%), cost of adverse and ischemic events and assumptions about life expectancy plus or minus 50%. Monte Carlo probabilistic analysis was done using beta distribution for effects and triangular for costs.
Source of Funding:Private
Comments:The study did not quote the actual effectiveness parameters entered into the model, and some of the cost estimates were from expert opinion. These costs were not examined in sensitivity analysis. Also the study combined together all patients with atherothrombosis which makes it difficult to attribute the results to the population of interest Post MI patients.
No 1101
Study Quality:1++Modeling the long term cost effectiveness of clopidogrel for the secondary prevention of occlusive vascular events in the UK
Author:Karnon J; Brennan A; Pandor A; Fowkes G; Lee A; Gray D; Coshall C; Nicholls C; Akehurst R; 2005
Intervention:Clopidogrel (75 mg/day) for 2 years followed by ASA (325 mg/day, average) for their remaining lifetime.
Comparison:ASA alone (325 mg/day, average) for life.
Population:Patients who were at risk of secondary occlusive vascular events OVEs (non-fatal myocardial infarction, non-fatal stroke or vascular death) who met the inclusion criteria of the CAPRIE study
Perspective:NHS
Study type:CUA, reinfaction, stroke, vascular death, ICERs,
Methods:RCT, CAPRIE study and data from the NHAR UK. London stroke register, Edinburgh Claudication study
Health valuations:derived from literature
Cost components:direct medical costs of treatment and procedures. Costs were derived from the literature, and BNF.
Currency:£
Cost year:2002
Time horizon:lifetime-40 years
Discount rate:6%
Results- cost:2 years of Clopidogrel:£1359628
Lifetime costs of Clopidogrel:£19199554
2 years of ASA:£1388494
Lifetime costs of ASA:£18380509
Results-effectiveness:QALY gainedLife year Gained
Clopidogrel:1200214242
ASA:1196414199
Results-ICER:Cost/QALY: £18888
Cost/LYG: £21489
Clopidogrel would be cost effective in 60% of the cases at £30000/QALY.
Results-Uncertainty:results were not sensitive to all input parameters except for the mean annual risk of vascular events and the relative risk of vascular death. Probabilistic sensitivity analysis showed that clopidogrel is cost effective in 60% of the cases at a threshold value of £30000/QALY.
Source of Funding:Private
Comments:This study is well reported and the authors were very clear in the methodology used and the sources of their input parameters. The only problem however is that their results can not be generalized to the Post MI population per se as they did not report the three conditions separately, stroke, PAD and Post MI.
No 1100
Study Quality:1++Clinical effectiveness and cost-effectiveness of clopidogrel and modified-release dipyridamole in the secondary prevention of occlusive vascular events: a systematic review and economic evaluation.
Author:Jones L;Griffin C;Palmer S;Main C;Orton V;Sculpher M;Sudlow C;Henderson R; Hawkins, N; Riemsma R; 2004
Intervention:Clopidogrel
Comparison:ASA
Population:Patients who experienced an MI
Perspective:NHS
Study type:CUA, reinfaction, stroke, cardiovascular and other death, ICERs
Methods:CAPRIE and the NHAR
Health valuations:form literature
Cost components:direct medical costs hospitalisation, procedures, adverse events and drug costs. Cost data was derived from literature and DRGs, BNF
Currency:£
Cost year:
Time horizon:40 years (lifetime)
Discount rate:3.5%
Results- cost:Results were presented in four scenarios. Two of the scenario considered life treatment including or excluding treatment effect on vascular death. The other two considered 2 year treatment period including or excluding treatment effects on vascular death.
Scenario 1. Life with non vascular death
Clopidogrel: £25773
ASA: £18286
Scenario 2. Life with vascular death
Clopidogrel: £25585
ASA: £18285
Scenario 3. 2 years with non vascular death
Clopidogrel: £19202
ASA: £18284
Scenario 4.2 years with vascular death
Clopidogrel: £19078
ASA: £18182
Results-effectiveness:
Scenario 1. Life with non vascular death
Clopidogrel: 9.10 QALYS
ASA: 8.86 QALYS
Scenario 2. Life with vascular death
Clopidogrel: 8.94 QALYS
ASA: 8.86 QALYS
Scenario 3. 2 years with non vascular death
Clopidogrel: 8.95 QALYS
ASA: 9.90 QALYS
Scenario 4. 2 years with vascular death
Clopidogrel: 8.91 QALYS
ASA: 8.87 QALYS
Results-ICER:
Scenario 1. Life with non vascular death
£31400/QALY.
Probability that clopidogrel is cost effective WTP was £10000/QALY is 0% and 48% at £30000/QALY
Scenario 2. Life with vascular death
£94446/QALY
Probability that clopidogrel is cost effective WTP was £10000/qaly is 0% and 25% at £30000/QALY
Scenario 3. 2 years with non vascular death
£17081/QALY
Probability that clopidogrel is cost effective WTP was £10000/qaly is 17% and 71% at £30000/QALY
Scenario 4.2 years with vascular death
£21448/QALY
Probability that clopidogrel is cost effective WTP was £10000/qaly is 12% and 61% at £30000/QALY
Results-Uncertainty:Results were sensitive to the efficacy of the treatment (if RR observed in CAPRIE were used, which showed increased risk of events with clopidogrel, aspirin would dominate clopidogrel. Results were also sensitive to the inclusion or exclusion of vascular death in the model.
Source of Funding:Public
Comments:Two studies that are relevant for Post MI patients which were included in the HTA have been individually appraised. The authors did an extended economic model focusing on stroke, PAD, MI. Only results of the model reporting on Post MI patients have been reported. The model was well reported with references of the sources of data. The base case analysis included or excluded the effect of the treatment on vascular death in the short and long-term model.

What is the effectiveness of adding aspirin versus aspirin and clopidogrel to improve outcome in patients after MI?

No 1102
Study Quality:1+Using clopidogrel in non-ST-segment elevation acute coronary syndrome patients: A cost-utility analysis in Spain
Author:Latour-Perez J; Navarro-Ruiz A; Ridao-Lopez M; Cervera-Montes M; 2004
Intervention:Clopidogrel + aspirin
Comparison:Aspirin alone
Population:Patients with non-ST-segment elevation acute coronary syndrome
Perspective:SOCIETAL
Study type:CUA, stroke, reinfaction, death, refractory ischemia, bleeding, ICERs.
Methods:RCT, CURE study, the Framingham study, and the Spanish age-sex-specific mortality rates
Health valuations:NOT STATED, values derived from literature
Cost components:direct medical cost, treatment and cost of procedures derived from DRGs and Spanish Ministry of Health
Currency:EURO
Cost year:1999
Time horizon:lifetime
Discount rate:3%
Results-cost:Clopidogrel + ASA: euro 24806
Aspirin: euro 23962
Results-effectiveness:Clopidogrel + ASA: 8.77 QALYs
ASA: 8.70 QALYs
Results-ICER:Euro 12221 95%CI (8392-28041) for men
Euro 10299 for women
Results were presented according to age and base baseline risk of events. The base case results shown above were of a 64 year old medium risk case.
For 40 year old
Low risk: 10846 euros/QALY
Medium risk 7778 euros /QALY
High risk 5272 euros/QALY
80 year old
Low risk: 37726 euros/QALY
Medium risk 23803 euros /QALY
High risk 9831 euros/QALY
Results-Uncertainty:a one way, two way and probabilistic sensitivity analysis was done. Main attention was given to the effect of age, sex and baseline risk. Results were sensitive to age of the patient, the base risk of cardiovascular events, and the precision of the estimated effectiveness of clopidogrel.
Source of Funding:not stated
Comments:The study was well reported used standard acceptable methodology. They did an elaborate sensitivity analysis and sub-group analysis which were helpful. The authors concluded that clopidogrel is cost effective in non-ST-segment elevation, however in the results section authors reported results stratified by men and women in the base case, but it’s not clear in the paper which figures or results applied to men.
No 1103
Study Quality:1+The long-term cost-effectiveness of clopidogrel plus aspirin in patients undergoing percutaneous coronary intervention in Sweden
Author:Lindgren P, Stenestrand U; Malmberg K; Jonsson B; 2005
Intervention:Clopidogrel + Aspirin
Comparison:Aspirin
Population:Patients with unstable coronary artery disease (CAD) undergoing PCI in Sweden
Perspective:SOCIETAL
Study type:CEA, reinfaction, cardiovascular and other death
Methods:RCT, PCI-CURE study, Swedish Register of Heart and Intensive care Admissions (RIKS-HIA)
Health valuations:NOT APPLICABLE
Cost components:direct medical costs and indirect costs, Costs were derived from DRGs and literature
Currency:EURO
Cost year:2004. Converted using PCI
Time horizon:lifetime
Discount rate:3%
Results-cost:Aspirin + Clopidogrel:
Direct costs=2726 euros
Indirect =282 euros
Total=3132 euros
Patients with Diabetes
50 year olds-16 euros

60 year olds-72 euros
80 year olds-374 euros
Patients without Diabetes
50 year olds -211 euros
60 year olds-261 euros
80 year olds-430 euros
Aspirin
Direct costs=2277 euros
Indirect =523 euros
Total=2799 euros
Results-effectiveness:Aspirin + Clopidogrel: 14.16 years
Aspirin alone: 14.12 years
Difference 0.04 years
Patients with Diabetes
50 year olds -0.03
60 year olds-0.04
80 year olds-0.09
Patients without Diabetes
50 year olds -0.03
60 year olds-0.05
80 year olds-0.09
Results-ICER:Direct medical costs: 10993 euros/LYG

Total costs: 8127 euros/LYG

Cost utility was done in sensitivity analysis. 6506 euros/QALY

Patients with Diabetes
50 year olds -dominance
60 year olds-1969 euros/LYG
80 year olds-3961 euros/LYG
Patients without Diabetes
50 year olds -7243 euros/LYG
60 year olds-6929 euros/LYG
80 year olds-4609 euros/LYG

In sensitivity analysis they considered post MI patients that occurred 7 days after admission and combination therapy dominated aspirin alone.
Results-Uncertainty:the model was robust to changes in variables such as costs and discounting.
Source of Funding:Private
Comments:Methodologically the paper was well reported. Sources of effectiveness and cost data were clearly reported and both deterministic and probabilistic sensitivity analysis was done. They also did a sub-group analysis in which the conclusions remained the same with either age or diabetes mellitus. ICERs were more favorable for the younger patients aged 50 years with diabetes mellitus and less favorable for the 70 year olds with or without diabetes. Their model predicted fewer/less events than the CURE study did making their estimates more conservative. Their results can not be generalized to the post MI population
No 1111
Study Quality:1+Long-term cost-effectiveness of clopidogrel given for up to one year in patients with acute coronary syndromes without ST-segment elevation
Author:Weintraub WS; Mahoney EM; Lamy A; Culler S; Yuan Y; Caro J; Gabriel S; Yusuf S; CURE S; 2005
Intervention:Clopidogrel + ASA
Comparison:ASA/placebo
Population:Patients who had experienced an acute coronary syndrome (ACS) without ST-segment elevation
Perspective:NHS
Study type:CEA, outcomes were death, stroke, and myocardial infarction, ICERs
Methods:RCT CURE study, observational data from the Saskatchewan and Framingham Heart study
Health valuations:NOT APPLICABLE
Cost components:direct medical costs 9hospitalisations) and medication costs. These costs were derived from DRGs, Medicare and MEDSTAT data base.
Currency:US$
Cost year:2001
Time horizon:12 months
Discount rate:3%
Results-cost:Using Medicare DRG costs
Clopidogrel: $13019
Placebo: $12578

Using MEDSTAT (private reimbursement) costs
Clopidogrel: $17924
Placebo: $17586
Results-effectiveness:Total number of events using Framingham data
Clopidogrel: 0.5327
Placebo: 0.6026
LYG with clopidogrel: 0.0699
Total number of events using Saskatchewan data
Clopidogrel: 0.3910
Placebo: 0.4592
LYG with clopidogrel: 0.0682
Results-ICER:Using Framingham data
Medicare costs: $9144/LYG and 92.8% probability of being cost effective at $50000/LYG

Using MEDISTAT costs: $ 7654/LYG and 93.4% probability of being cost effective at $50000/LYG

Using Saskatchewan data
Medicare costs: $9343/LYG and 97% probability of being cost effective at $50000/LYG

Using MEDISTAT costs: $ 7833/LYG and 97.6% probability of being cost effective at $50000/LYG

Sub-groups

Using Framingham database
<65 years $5022/LYG
>65years $7569/LYG
Male $2362/LYG
Female $70396/LYG
Diabetes $9857/LYG
No diabetes $5583/LYG
Prior MI $1404/LYG
No prior MI $14171/LYG
Results-Uncertainty:results remained robust in sensitivity analysis even when baseline data from the Saskatchewan database was used.
Source of Funding:not stated
Comments:The authors were very detailed in their reporting of the methods they used. For costing they used three different credible methods and for effectiveness data they used the CURE trial and two observational databases the Framingham and Saskatchewan to estimate life expectancy, which yielded comparable results.
No 1109
Study Quality:1+A cost-effectiveness analysis of combination antiplatelet therapy for high-risk acute coronary syndromes: clopidogrel plus aspirin versus aspirin alone.
Author:Schleinitz MD, Heidenreich PA; 2005
Intervention:Clopidogrel, 75 mg/d, plus Aspirin, 325 mg/d, for 1 year,
Comparison:Aspirin alone
Population:Patients with unstable angina and electrocardiographic changes or non-Q-wave myocardial infarction over a lifetime
Perspective:SOCIETAL
Study type:CUA, reinfaction, stroke, mortality, quality-adjusted life-years (QALYs), hemorrhagic events & ICERs
Methods:RCT, CURE study
Health valuations:derived the values from the literature
Cost components:direct medical costs incurred during hospitalisation incusing nursing care and procedures, wholesale price for medications. Used a GDP deflator to update costs to 2002.
Currency:US$
Cost year:2002
Time horizon:lifetime
Discount rate:3%
Results-cost:Patients treated with aspirin alone costs $127700
Addition of clopidogrel costs $129300
Results-effectiveness:Patients treated with aspirin alone lived 9.51 QALYs
Addition of clopidogrel increased life expectancy to 9.61 QALYs
Results-ICER:The incremental cost-effectiveness ratio for clopidogrel plus aspirin compared with aspirin alone was 15,400 dollars per QALY.

Duration of therapy
The marginal costs of the second year of therapy was $31600/QALY,
Third year $61300/QALY
Fourth year $136500/QALY
Fifth year $730000/QALY
Before the end of the third year the efficacy of clopidogrel was reduced by about 25% in the model.
Results-Uncertainty:results were not sensitive to changes in risk reduction and costs of clopidogrel in both deterministic and one way sensitivity analysis.
Source of Funding:Public
Comments:This analysis may not apply to patients with severe heart failure, those undergoing long-term anticoagulant therapy or those recently managed with revascularization. The study did not focus on a particular ACS which might limit its applicability to the Post MI population. Otherwise the study was well reported, proving details of sources of data, how the data was incorporated as well as a clear model structure.
No 1099
Study Quality:1+Cost effectiveness of aspirin, clopidogrel, or both for secondary prevention of coronary heart disease
Author:Gaspoz J; Coxson PG; Goldman PA; Williams LW; Kuntz KM; Hunnink M; Goldman L; 2002
Intervention:Aspirin, clopidogrel,
Comparison:Aspirin or aspirin + clopidogrel
Population:Patients aged 35 to 84 years in which CHD developed and evaluated over a 25 year period.
Perspective:THIRD PAYER
Study type:Deterministic decision analysis, CUA. The outcomes were deaths from coronary/non coronary, MIs
Methods:Framingham heart study, Scandinavian Simvastatin Survey, CURE study, CAPRIE and Antiplatelets T Collaborators
Health valuations:Literature
Cost components:direct medical costs including drug costs and costs of side effects like gastrointestinal. Costs were derived from literature (refs given) and National medical expenditure survey.
Currency:US$
Cost year:2000
Time horizon:25 years
Discount rate:3%
Results-cost:Incremental costs are estimated over the 30 year period in millions.
Aspirin (ASA) for all eligible patients: $8000 000
Addition of Clopidogrel for those that are not eligible for ASA: $14 000 000
Clopidogrel alone for all patients: $156 000 000
Clopidogrel for all + Aspirin for all eligible: $182000 000
Results-effectiveness:Incremental QALYs
Aspirin (ASA) for all eligible patients: 682000 QALYs
Addition of Clopidogrel for those that are not eligible for ASA: 456000 QALYs
Clopidogrel alone for all patients: 632 000 QALYs
Clopidogrel for all + Aspirin for all eligible: 1437 000 QALYs
Results-ICER:Aspirin (ASA) for all eligible patients: $1100/QALY
Addition of Clopidogrel for those that are not eligible for ASA: $31000/QALY
Clopidogrel alone for all patients: $250000/QALY
Clopidogrel for all + Aspirin for all eligible: $130000/QALY
Results-Uncertainty:results were sensitive to the effect of the intervention on revascularisation. Aspirin and clopidogrel will save money if they reduced the rate of revascularisation as much as they did on MI. The cost of clopidogrel was also assessed but the results were not reported as they did not change the conclusions.
Source of Funding:Charitable
Comments:This is a detailed study but does not focus on a particular disease area of CHD, limiting its relevance to post MI patients. Baseline event rates and costs differ for subtypes of CHD which might alter cost effectiveness conclusions. Thus the generalisability of these results to the post MI patients is not clear.
No 1104
Study Quality:++Clopidogrel used in combination with aspirin compared with aspirin alone in the treatment of non-ST-segment-elevation acute coronary syndromes: a systematic review and economic evaluation
Author:Main C; Palmer S; Griffin S; Jones L; Orton V; Sculpher M; 2004
Intervention:Clopidogrel + ASA
Comparison:ASA
Population:patients with non-ST-elevation ACS
Perspective:NHS
Study type:CUA, death from cardiovascular causes, non-fatal myocardial infarction or stroke
Methods:CURE study, PRAIS-UK and NHAR
Health valuations:Quality of life weights were derived from the literature
Cost components:Direct medical costs of treatment, procedures and side effects. Costs data was derived from the literature, BNF and NHS reference costs
Currency:£
Cost year:2002
Time horizon:lifetime
Discount rate:6% for costs and 1.5% for benefits
Results-cost:Clopidogrel + ASA: £12695
ASA:£12225
Results-effectiveness:Clopidogrel + ASA: 8.2795 QALYS
ASA:8.2022 QALYS
Results-ICER:£6078/QALY
Probability of being cost effective at £10000 and £30000 WTP is 32% and 21% respectively.
Sub-groups
For high risk group there was a reduction in the ICER to about £4939/QALY and low risk the ICER increased to £8734/QALY.
The Assessment Group explored the cost effectiveness of using clopidogrel for periods shorter than 1 year. The ICER for 1 month of treatment with clopidogrel compared with standard care alone was calculated to be £824 per QALY with a 6% probability that clopidogrel is cost effective at £30000/QALY. The strategies of using clopidogrel for 3 or 6 months were ruled out by extended dominance, and the ICER for 12 months of treatment with clopidogrel compared with 1 month was £5159 per QALY, with a 83% probability that clopidogrel is cost effective at £30000/QALY.
Results-Uncertainty:The results were most sensitive to the inclusion of additional strategies which assessed alternative treatment durations with clopidogrel for example reducing the treatment duration to 5 years more than doubled the ICERs to about £15000/QALY. Although treatment with clopidogrel for 12 months remained cost-effective for the overall cohort, provisional findings indicate that the shorter treatment durations may be more cost-effective in patients at low risk. Discount rate and impact of the cost of stroke did not affect the baseline ICER.
Source of Funding:Public
Comments:One paper and a company submission met the inclusion criteria for this HTA. The results are in agreement and indicate that there is a benefit in the short term and the ICERs are favorable, the ICERs becomes less favorable in the long-term but remain within acceptable range of cost effectiveness. Authors did a sub-group analysis stratifying results according to low or high risk defined as patients with at least one of the following over 70years, those with an ST-depression on an ECG and diabetes.

10. What is the effectiveness of adding a beta blocker versus placebo to improve outcome in patients after MI?

No 1224
Study Quality:Economic consequences of post infarction prophylaxis with beta blockers: cost effectiveness of Metoprolol
Author:Olsson G; Levin L; Rehnqvist N; 1987
Intervention:Metoprolol (Beta-blocker) 100mg. twice daily treatment started 2 weeks after acute onset of
Comparison:Placebo
Population:Post infarction patients <70 years of age
PerspectiveSwedish societal perspective
StudyCEA, mortality, reinfaction, readmissions, cerebrovascular events, and revascularisation
Methods:Randomised Controlled Trial (RCT) of the Stockholm Metropolol study (66% post MI patients)
Health valuations:N/A
Cost components:costs relates to the health service costs of medication, concomitant medication (digitalis, diuretics), inpatient care, and outpatient clinic & indirect costs sick leave or early retirement
Currency:Swedish Kroner (SEK).
Cost1985
Time horizon:3 years
Discount rate:5%
ResultsMetropolol Kr 118610 (approx £11981) inclusive of indirect costs
Cost/patient:Placebo Kr 137220 (approx £13861) inclusive of indirect costs

Excluding indirect costs

Metropolol Kr 12310 (approx £1243)
Placebo Kr 17120 (approx £1729)
ResultsSignificant differences were found on the reinfaction, cerebrovascular events, coronary bypass
Effectiveness:surgery and reduced hospitalisation in favor of metropolol. There were no significant differences between treatment groups in terms of mortality both total and cardiac, readmission for heart failure, arrhythmias, angina pectoris and leg amputations.
ResultsResults were not synthesized. But metropolol was deemed cost effective on the basis of reduced
Incremental:rates of adverse events and less cost over the three year follow up.
Resultsonly discounting was assessed and the results were robust.
Uncertainty:
Source Funding:not stated
Comments:There was no sensitivity analysis done except for discounting which did not affect the results. They used hospital billing data for costs of inpatient care, this may still be fine given that the healthcare system is state funded or “socialized medicine” They could have done better by synthesizing the results to estimate a cost/LYG or cost/QALY which is more informative to the decision maker.
No 1220
Study Quality:1+Costs and effectiveness of routine therapy with long-term beta-adrenergic antagonists after acute myocardial infarction
Author:Goldman L; Sia ST; Cook EF; Rutherford JD; Weinstein MC; 1988
Intervention:`Beta adrenegernic antagonist started at the end of hospitalisation and continued long-term

thereafter
Comparison:Placebo
Population:Low-risk group, medium-risk group, and high-risk group men aged 45, 55 or 65 years

Risk was defined by estimated cardiac mortality in the 15 year period after MI. First year mortality was estimated to be different from mortality of subsequent years

High risk: first year mortality =13% and subsequent risk for 2–15 years =7.5%
Medium risk: first year mortality =7.5% and subsequent risk for 2–15 years =5%
Low risk: first year mortality =1.5% and subsequent risk for 2–15 years =1.5%
PerspectiveThird payer
StudyCEA, mortality, revascularisation, reinfaction, costs
Methods:Pooled meta-analysis of trial data on beta-blockers and observational studies.
Health valuations:N/A
Cost components:Costs of drugs excluding follow up outcome costs and costs of side effects.
Currency:US$
Cost1987
Time horizon:Lifetime
Discount rate:5%
Results
Cost/patient:not given
Results effectiveness:Incremental life expectancy (% change) assuming the benefits observed in 6 years of treatment will be lost gradually

Low 45yrs: 0.11 (0.4%)
Low 55yrs: 0.10 (0.5%)
Low 65yrs: 0.09 (0.7%)

Medium 45yrs: 0.34 (2%)
Medium 55yrs: 0.34 (2.6%)
Medium 65y: 0.31 (3.1%)
High 45yrs: 0.48 (3.8%)
High 55yrs: 0.47 (4.6%)
High 65yrs: 0.44 (5.5%)
Resultslow-risk group 45yrs: $23457/LYG-----$12855/LYG
Incremental:low-risk group 55yrs: $23446/LYG----$13068/LYG
Low-risk group 65yrs: $23417/LYG----$13571/LYG

Medium-risk group 45yrs: $5890/LYG----$3567/LYG
Medium-risk group 55yrs: $5884/LYG----$3618/LYG
Medium-risk group 65yrs: $5871/LYG----$3737/LYG

High-risk group 45yrs: $3623/LYG---------------$2327/LYG
High-risk group 55yrs: $3619/LYG---------------$2357/LYG
High-risk group 65yrs: $3609/LYG---------------$2427/LYG

NOTE: The first figures are for a conservative model which assumed that treatment benefits will persist for 6 years when treatment is being given. Once the treatment is stopped, the benefits are lost immediately.

Figures after the dotted lines are for the best guess model which assumes that the benefits observed during the 6 years will be lost gradually once the treatment is stopped.
Results Uncertainty:Univariate sensitivity analysis was done and results were robust to assumptions about the baseline mortality despite a tendency of less favorable ICERs when mortality risk was reduced. Costs of beta Blockers was almost doubled and made ICERs less favorable but they remained cost effective.
Source Funding:Not stated
Comments:Authors did not include the outcome costs/savings as a result of the intervention and costs of treating side-effects of therapy. The assumption they made that these will cancel out each other was too strong. However it is more likely that the cost savings from reduced adverse outcomes may outweigh the cost of treating adverse events. They also applied the same magnitude of relative mortality reduction to the various age and mortality groups. They stated that they did a meta-analysis but the study inclusion criteria for the pooled estimates of efficacy are not fully known making the validity of the pooled estimates uncertain. Overall this study needs to be interpreted with caution.
What is the effectiveness of adding calcium channel blocker versus placebo to improve outcome after MI?
No 1263
Study Quality:+Economic benefits of amlodipine treatment in patients with coronary artery disease
Author:Casciano R; Doyle JJ; Chen J; Arikian S; Casciano J; Kugel H; Arocho R; 2002
Intervention:Amlodipine
Comparison:Placebo
Population:Patients with CAD in the USA
PerspectiveThird-party payer
Study type:CC A, and outcomes were CABG, PCTA, stroke, heart failure, mortality, unstable angina and MI
Methods:RCT, PREVENT study and the NASHES III data set in USA
Health valuations:N/A
Cost components:direct medical costs were inpatient costs, physician services and follow-up costs. DRGs,), the Medicare-based physician fee schedule, and the Redbook
CurrencyUS$
Cost year1999
Time horizon:3 years
Discount rate3%
Results costexpected per patient costs over the 3-year period of the analysis was $14,117 for amlodipine and $16,683 for placebo
Results effectiveness:The use of amlodipine to prevent the progression of coronary artery disease (CAD) was both effective in reducing hospitalisation and the episodes of revascularisation. There were about 200 vs. 300 CVD related hospitalisation during the three-year follow up.
Results incremental:not done it was cost-consequences analysis was conducted
Results UncertaintyThe estimated costs were robust to variations carried out in all the sensitivity analyses. None of the alternative scenarios favored placebo patients
Source Funding:Private
Comments:The study was well reported with appropriate methods. It appears that all the relevant categories of costs have been included in the study. Details on the cost data were reported and the price year was given. Sensitivity analysis was done, both univariate and a Monte Carlo simulation varying the cost data within +/− 10% of the initial values and probability values within the 95% confidence intervals. The study could have been improved by synthesizing benefits and costs and also considering quality of life issues.
No 1265
Study Quality:+A cost-effectiveness evaluation of amlodipine usage in patients with coronary artery disease in Sweden
Author:Doyle JJ; McGuire A; Arocho R; Arikian S; Casciano J; Svangren P; Kim R; Kugel H; 2002
Intervention:Amlodipine
Comparison:Placebo
Population:Patients with CAD in Sweden
PerspectiveSwedish health care system
Study type:CEA, hospitalisation for angina, hospitalisation for MI, hospitalisation for CHF, PTCA, CABG, death
Methods:PREVENT study and authors assumptions adjusted according to Swedish data
Health valuations:N/A
Cost components:Direct medical costs with resource consumption estimated by experts using Delphi techniques. Costs were derived from General Hospitals and Pharmaceuticals Specialties in Sweden
CurrencySwedish Kroner (SEK)
Cost year2000
Time horizon:3 years
Discount rate:3%
Results cost:estimated costs per patient over the 3-year period were SEK 26,600 in the intervention group and SEK 27,400 in the control group. Thus, amlodipine was associated with cost-savings of SEK 800. These results were robust to all variations carried out in the sensitivity analyses
Results effectiveness:patients given amlodipine experienced 469 hospitalizations per 1000 patients while placebo had 647/1000. 18% fewer hospitalizations attributable to amlodipine.
Results incremental:not calculated because the treatment was dominant over placebo, that is, it was more effective and less costly. Treatment with amlodipine was effective in reducing hospitalisation events. It also resulted in cost-savings from the perspective of the Swedish health care system. i.e. a cost saving of SEK 4300/hospitalisation avoided
Results Uncertaintythe model was robust in both univariate and multivariate sensitivity analysis
Source of Funding:Private
Comments:The study was well reported using appropriate methodology. Key assumptions of the model were tested in sensitivity analyses. It appears that all the relevant categories of costs have been included in the analysis. The authors noted that hospitalisation costs used in the analysis were average estimates and great variation may exist due to the length of stay, type of treatment and type of hospital. However to better evaluate the benefits of amlodipine quality-of-life issues should have been addressed.
No 1264
Study Quality:+The economic efficiency of amlodipine in the treatment of coronary atherosclerosis: an analysis based on the PREVENT study
Author:Cathomas G; Erne P; Schwenkglenks M; Szucs TD; 2002
Intervention:amlodipine
Comparison:placebo
Population:Patients with angiographically documented coronary heart disease (CHD) in Switzerland
PerspectiveHealth insurance companies
Study type:CEA. Fatal myocardial infarction, stroke, vascular deaths and bleedings per 1,000 patients
Methods:PREVENT study
Health valuations:N/A
Cost components:Direct medical costs
CurrencySwiss francs (Sfr)
Cost yearnot stated
Time horizon:3 years
Discount rate5%
Results costThe total costs per 100 patients were Sfr 639,323 for amlodipine and Sfr 505,672 for placebo. The additional costs (Sfr) 133,651) observed in the amlodipine group mainly arose from the high initial drug costs
Results effectiveness:The annual mortality rates were 4.5% in the amlodipine group and 6.2% in the placebo group, but this difference was not statistically significant, (p=0.57) The adjusted life expectancy calculated using the DEALE approach was 18.43 years. Thus, the discounted life-years gained due to amlodipine therapy over placebo was 0.083 years per patient
Results incremental:cost per life-year gained was Sfr 14,650.
Results Uncertainty:there was little sensitivity analysis done which was robust.
Source of Funding:not stated
Comments:PREVENT study showed that there was no statistically significant difference in terms of survival between the amlodipine and placebo groups. A sensitivity analysis to investigate the effects of varying the difference in fatal events between the treatment groups would have been useful. Quality of life issues were not discussed. It appears that all the relevant categories of cost have been included in the analysis. The unit costs and the quantities of resources used were sometimes reported separately. The sources of the data for both costs and resource consumption were reported. The costs were treated deterministically, although sensitivity analyses were conducted on those categories of costs that appeared to be more subject to uncertainty. Appropriate discounting was performed. The price year was not mentioned, the economic analysis was conservative, as potential cost-savings due to lower hospitalisation episodes and fewer rehabilitation measures were not accounted for in the analysis.

23. What is the effectiveness of adding eplerenone versus placebo to improve outcome in patients after MI?

No 1354
Study Quality:1+Scottish medicines Consortium new product assessment form submission:
Author:Pfizer Ltd
Intervention:Eplerenone
Comparison:Placebo
Population:Post MI patients with left ventricular dysfunction and heart failure (LVDF)
PerspectiveNHS
Study type:CUA
Methods:RCT EPHESUS study
Health valuations:NOT STATED
Cost components:direct medical costs (DRG related)
Currency£
Cost year2002
Time horizon:16 months
Discount rate6%
Results costEplerenone: £3400

Placebo: 2768
Difference: £632
Results effectiveness:QALY lost

Eplerenone: 0.41

Placebo: 0.48

Difference: 0.07
Results incremental:£9048/QALY gained
Results UncertaintyResults were stable in sensitivity analysis. There is a 92% chance that Eplerenone is cost effective using a willingness to pay threshold of £20000/QALY.
Source Funding:Private (stakeholder submission)
Comments:This was a stakeholder submission by Pfizer. The submission document had a checklist at the end. The document does not show disaggregated resource use, but it appears the original documents had the information and is referred to on the checklist. In the absence of any other published economic evaluation from the UK perspective, these results can be relied upon as they compare favorably with other drug interventions used for patients post MI.
No 1339
Study Quality:1+Cost-effectiveness of eplerenone compared with placebo in patients with myocardial infarction complicated by left ventricular dysfunction and heart failure.
Author:Weintraub WS Zhang Z; Mahoney EM ;Kolm P; Spertus JA; Caro J;I shak J;Goldberg 2005 R; Tooley J; Willke R; Pitt B;
Intervention:Eplerenone
Comparison:Placebo
Population:Post MI patients with LDV and HF
PerspectiveTHIRD PAYER
Study type:CEA
Methods:RCT and observational data from Framingham, Saskatchewan database & Worcester Heart Attack Registry
Health valuations:NOT APPLICABLE
Cost components:Direct medical costs using DRG as used in the Medicare Program
CurrencyUS$
Cost year2001
Time horizon:16 months and lifetime
Discount rate3%
Results costEplerenone $13494

Placebo $12104

Difference $1391 (95% CI 695-$2165)
Results effectiveness:QALYs lost

Framingham 0.3940 compared to placebo 0.4616

Saskatchewan 0.2253 compared to placebo 0.2682

Worcester 0.4528 compared to placebo 0.5435
Results incremental:Assuming no added costs from life years saved
Framingham$21072/QALY
Saskatchewan$30349/QALY
Worcester$17374/QALY
Assuming added costs from life years saved are included
Framingham$29469/QALY
Saskatchewan$43301/QALY
Worcester$23724/QALY
Subgroups using Framingham data. Cost per life year gained
Base case$13718 and 96.6% probability that eplerenone is cost effective
Age <65 years$13709 (92.1%)
Age >65 years$15409 (87.3%)
Male$16903 (89.6%)
Female$11873 (91.7%)
Diabetes$42160 (55.2%)
Non-Diabetics$10999 (99%)
Prior MI$21279 (78.4%)
No previous MI$10818 (97.3%)
Results Uncertainty:Results were robust in probabilistic sensitivity analysis for the different sources of data used. The results also remained cost effective for different subgroups.
Source Funding:Private
Comments:This study was detailed and used three different data sources to estimate what would happen after the trial period. placebo to improve outcome in patients after MI?

14. What is the effectiveness of adding omega 3 supplements versus placebo to improve outcome in patient after MI?

No 1315
Study Quality:1+Cost-effectiveness Analysis of Omacor for Myocardial infarction Survivors in the UK, 2004
Author:
Intervention:n3- PUFA
Comparison:No supplement
Population:Post MI patients
PerspectiveNHS
Study type:CUA
Methods:RCT, GISSI-P trial
Health valuations:taken from literature and references given
Cost components:direct medical costs of drugs and events with assumptions spelt out clearly
Currency£
Cost year2003
Time horizon:four years and lifetime
Discount rate3.5%
Results cost4 year results: £1789148 vs £1140143

Lifetime model: £6471024 vs £5700588
Results effectiveness:4 year results: 2839 vs 2797 QALYs

Lifetime model: 9309 vs 9102 QALYs
Results incremental:4 year results: 15189/QALY

Lifetime model: 3717/QALY
Results UncertaintyThe results of the model were sensitive but remained robust to the assumptions about costs, discount rates and proportions of patients receiving post MI treatment.
Source of Funding:Private
Comments:They provided results for other comparisons including Vitamin E, and a combination of Vitamin E with n3-PUFA. Results were presented using life years gained and death avoided. For the purpose of this review only the results which use the NICE reference case were considered, that is the cot utility results. Only results of n3-PUFA compared to placebo were used and other comparators were not included because they were not relevant. This study was appropriately reported using standard methods. However the sources of subsequent MI costs and those of stroke were not clear. They assessed these in sensitivity analysis but again failed to give specify the source of the ranges used (200% increase).
No 1334
Study Quality:1+Cost-effectiveness analysis of n-3 polyunsaturated fatty acids (PUFA) after myocardial infarction: results from Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto (GISSI)-Prevenzione Trial
Author:Franzosi MG;Brunetti M;Marchioli R;Marfisi RM;Tognoni G;Valagussa F;GISSI-2004 Prevenzione I;
Intervention:n3-PUFA
Comparison:No supplements
Population:Post MI patients with no age restriction
PerspectiveTHIRD PAYER
Study type:CEA
Methods:RCT, GISSI-P trial
Health valuations:NOT APPLICABLE
Cost components:direct medical costs using Italian reimbursement DRGs rates. They used resource consumption data from the trial reports.
CurrencyEURO
Cost year1999
Time horizon:42 months (3.5 years)
Discount rate5%
Results costn3-PUFA euro 5223

Placebo euro 4406
Results effectiveness:n-3-PUFA resulted in significant in the primary combined endpoint including mortality. See the clinical evidence report. This translated to 0.0332 (95% CI 0.0303–0.361) life years gained
Results incremental:Base case results Euro 24603/LYG
Best case scenario: euro 15721/LYG

Worse case scenario: euro 52524/LYG
Results UncertaintyCosts of n3-PUFA, best worst case scenarios were tested in sensitivity analysis. The results were most sensitive to cost of n3-PUFA but remained cost effective especially that they modelled an expected price fall. The worst case scenario will change the conclusion about cost effectiveness if the payer was willing to pay upto US$50000.
Source of Funding:Private
Comments:This paper was well reported. They could have done better buy reporting the impact of the treatment on quality of life. The authors compared their results with those of other interventions. versus placebo to improve outcome in patients after MI?

19. What is the effectiveness of adding vitamin K antagonist versus placebo to improve outcome in patient after MI?

No 1198
Study Quality:1+Costs and effects of long-term oral anticoagulant treatment after myocardial infarction
Author:Van Bergen PFMM;Jonker JJC;van Hot BA;van Domburg RT;Azar AJ;Hofman, 1995
Intervention:Warfarin
Comparison:Placebo
Population:non selected Post MI patients,
PerspectiveSOCIETAL
StudyCEA
Methods:REVIEW of the ASPECT trial data
Health valuations:NOT APPLICABLE
Cost components:Stated societal perspective but only collected direct medical costs related to major cardiologic events, anticoagulation treatment, hospital readmissions obtained from the Dutch Hospitals
CurrencyDutch Dfl
Cost1994
Time horizon:3yrs
Discount rate:5%
ResultsAnticoagulation: average Dfl 9878 and total costs are Dfl 17621613
Cost/patient:Placebo: average Dfl 10784 and total costs are Dfl 19222590
ResultsWarfarin treatment resulted in
Effectiveness:a 10% (95% CI: −11% to 27%) reduction of death

53% (95% CI: 41% to 62%) reduction of recurrent MI

40% (95% CI: 10% to 60%) reduction of cerebrovascular events

and an increase in the relative risk of bleeding complications of 3.9 (95% CI: 2.3 to 6.4).
Results Incremental:Authors did not sythesise costs and benefits; therefore it is a cost minimisation study. The total costs of warfarin were $519.00 cheaper for the warfarin arm.
Results Uncertainty:Results of sensitivity analysis shows that changes in costs of the main variables will not affect the conclusions
Source Funding:Public/private
Comments:Although the study showed cost savings as a result of warfarin treatment, there was a 400% increase in major bleeding events which was not incorporated in the model and thus weakens the model results.

20. What is the effectiveness of adding vitamin K antagonist versus aspirin to improve outcome in patients after MI?

No 1197
Study Quality:1+A cost-effectiveness analysis of aspirin versus oral anticoagulants after acute myocardial infarction in Italy: equivalence of costs as a possible case for oral anticoagulants
Author:Gianetti J; Gensini G; De CR; 1998
Intervention:Aspirin
Comparison:Warfarin
Population:Patients having had an acute myocardial infarction
PerspectiveNHS, Italy
StudyCEA, re-infarction, PCTA, CABG, major bleeding, cerebrovascular events, AV Thromboembolism
Methods:RCT ASPECT study, APT collaboration
Health valuations:NOT APPLICABLE
Cost components:Direct medical and treatment costs. Costs were derived from literature and DRGs Treatment costs were estimated for two DRG pricing schemes: the mean price and the daily price multiplied by mean length of stay
Currency:OTHER (Italian Lira) and European currency
Cost1994
Time horizon:3 years
Discount rate:no discounting was done
Results Cost/patient:The total cost of therapy per patient/year, was ECU277.56 (warfarin) and ECU62.53 (aspirin).The cost of morbidity per patient per year, using DRG mean total costs, was ECU1, 873.32 (warfarin) and ECU2,125.4 (aspirin). The cost of morbidity per patient per year, using the product of DRG mean cost per day and mean length of stay, was ECU1,848.06 (warfarin) and ECU2, 074.01 (aspirin)
Results Effectiveness:Results are presented graphically as aspirin/warfarin efficacy ratio. This was found to be close to 0.68
Results Incremental:Results were not synthesized therefore it was a cost minimisation analysis. The total cost per patient per year, using DRG mean total costs, was ECU2, 150.8 or $2,731.4 (warfarin), and ECU2,187.9 or $2,778.9 (aspirin). The total cost per patient per year, using the product of DRG mean cost per day and mean length of stay, was ECU2,125.2 or $2,699.0 (warfarin), and ECU2,136.6 or $2,713.9 (aspirin).
Results Uncertainty:Two way sensitivity analyses was done on the efficacy of warfarin/aspirin and the cumulative costs of both drugs. Results were sensitive to variations in the aspirin-warfarin efficacy ratio. Warfarin is no longer the cost-effective strategy in Italy once an efficacy ratio of approximately
Source Funding:not stated
Comments:The study was well reported but had some weaknesses which were identified. The authors reported aspirin-warfarin efficacy ratio of about 0.68 which was based on indirect comparisons. This showed that warfarin was as cheap and effective as aspirin. Recent data WARIS 11 has shown an efficacy ratio of 0.81. Using this recent data it would appear cumulative costs of Aspirin are cheaper than those of Warfarin. The study did not report on the true variability of cost items and only an arbitrary value of 5% was imposed.

Health Economics Extraction for Question 15 Statins and Fibrates

No 1453
Study Qualities:1+Cost-effectiveness of gemfibrozil for coronary heart disease patients with low levels of high-density lipoprotein cholesterol: the Department of Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial
Author:Nyman JA;Martinson MS;Nelson D;Nugent S;Collins D;Wittes J;Fye CL;Wilt TJ;Robins SJ;Bloomfield R;VA-HIT Study Group; 2002
Intervention:Gemfibrozil
Comparison:Placebo
Population:Patients with coronary heart disease, low HDL-C levels, and low LDL-C levels
Perspective:THIRD PAYER
Study type:CUA/CEA
Methods:RCT, VA-HIT trial. A markov model was used
Health valuations:NOT STATED used values from time trade off (ref 8) from the paper
Cost components:Direct medical costs. Sources of costs were documented including DRGs
Currency:US$
Cost year:1998
Time horizon:lifetime
Discount rate:Did not discount base case results but used 0%, 3% & 5% in sensitivity analysis
Results- cost:Results were reported for 55, 65 and 75 year old males reflecting the population of the trial. Also results were reported according to the price of gemfibrozil used.
1) Negotiated price by VA was $46.75/yr
2) Wholesale price $956.96/yr
Using negotiated prices for all age groups treatment with gemfibrozil results in savings
Placebogemfibrozil
Age 55:$13464$17428
Age 65:$10462$14434
Age 75:$8284$12193
Results-effectiveness:
Life expectancy
PlaceboGemfibrozil
Age 55:22.523.15
Age 65:17.4518.07
Age 75:13.3613.98
Results-ICER:Reported for both cost effectiveness and cost utility
Age 55: $6607/LYG
Age 65: $6403/LYG
Age 75: $6305/LYG

Cost utility results
Age 55: $7480/QALY
Age 65: $7217/QALY
Age 75: $7239/QALY
Results-Uncertainty:Results remained robust to assumptions about discounting used 0–5% and age. Utility did not affect the results as well.

When discounting was done at 5% ICERs ranged from about $12000/QALY for an 85 year old to about $17000 for a
Source of Funding:Charitable
Comments:this was a detailed study which used appropriate methodology. They showed that gemfibrozil was cost effective for men in the various age groups considered.
Copyright © 2007, National Collaborating Centre for Primary Care.
Cover of Post Myocardial Infarction
Post Myocardial Infarction: Secondary Prevention in Primary and Secondary Care for Patients Following a Myocardial Infarction [Internet].
NICE Clinical Guidelines, No. 48.
National Collaborating Centre for Primary Care (UK).

NICE (National Institute for Health and Care Excellence)

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