Clinical,humanistic, and economic outcomes between drug-eluting stent (DES) and bare metal stent (BMS): 18-month follow-up study

Background: Percutaneous coronary intervention (PCI) is one of the most performed interventions for ischemic heart diseases. In Hong Kong, the total number of patient discharges and deaths for ischemic heart diseases in 2009 was 33,363, including 4,360 deaths. There are over 5,000 cases of PCI yearly. This study aimed to compare clinical, economic, and humanistic outcomes among patients receiving drug-eluting stent (DES) or bare metal stent (BMS) in Hong Kong.

Methods: Patients who received stent implantation between September 15, 2009 and October 11, 2010 in Prince of Wales Hospital, Hong Kong, were recruited and followed for 18 months. Occurrence of major adverse cardiac events (cardiac death, non-fatal MI, TLR and TVR) was employed as the clinical outcome measurements. Improvement in quality-of-life by stent interventions was measured as quality-adjusted life-year (QALY). EQ-5D questionnaire was adopted to assess the QALY gained. Cost-utility analysis and cost-effectiveness analysis for BMS and DES were employed as the economic outcome measurement.

Results: Six hundred and eighty-four patients (DES?=?402; BMS?=?282) were included. From 0–18 months, TLR rate (2.7% vs 3.5%, p?=?.549) and TVR rate (3.7% vs 6.4%, p?=?.111) were lower in the DES group, but without statistical significance. EQ VAS (71.06?±?14.56 vs 71.07?±?16.57, p?=?.998) and utility score (0.81?±?0.17 vs 0.78?±?0.16, p?=?.162) were comparable between DES and BMS group. Overall, the cost per QALY gained was HKD + 1,178,100 and ICER was HKD + 187,000 (1USD?=?7.8 HKD).

Conclusions: No significant difference in TVR, TLR rates, EQ VAS, and utility score was found between the DES and BMS group. The higher cost of index procedure for the DES group was found to be partly offset by reduced cost of follow-up, offering cost-effectiveness in ACS patients, predominantly in STEMI patients. DES was recommended for STEMI patients.     

Potential unrecognised costs of clopidogrel pretreatment in acute coronary syndrome

Abstract

Objective: To examine adherence in clinical practice to the American College of Cardiology/American Heart Association (ACC/AHA) guideline recommendations of observing a 5-day waiting period after clopidogrel administration before undergoing coronary artery bypass graft (CABG) surgery and to examine the costs of waiting.

Methods: This retrospective study used a nationwide inpatient database (Solucient ACTracker) to identify patients who were admitted for acute coronary syndrome (ACS), and who had same-stay CABG. Cost of additional days of stay was estimated using regression analysis.

Results: The recommended 5-day waiting was adhered to in 16.9% (n=3,809) of patients. The percentage of patients with ACS undergoing CABG surgery on day 0 was 14.6%. Adherence to the waiting was higher for teaching and rural hospitals; and in female and elderly patients and urgent admissions.

Conclusions: The recommended 5-day waiting for CABG surgery after clopidogrel treatment is poorly adhered to in clinical practice. This study was unable to determine specific reasons for the low adherence; however, there may be a compromise between the clinically urgent need for revascularisation and increased risk of bleeding, as well as economic costs associated with waiting. The cost of an additional hospital day in this group of patients was approximately £1,400 per day or £7,000 for 5 days. Thus, a full 5-day wait would have a significant economic impact on hospital costs.     

Cost-effectiveness of prasugrel in a US managed care population

Abstract

Objective:

Decision-makers in the US may be interested in the applicability to their populations of cost-effectiveness results generated from clinical trial populations.

Methods:

An economic model estimating the cost-effectiveness of prasugrel plus aspirin relative to clopidogrel plus aspirin for patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) was developed from a managed care organization (MCO) perspective. The model estimated 15-month cardiovascular events or bleeding-related outcomes, life expectancy, and costs for patients who received thienopyridine treatment during and after a PCI following a diagnosis of ACS. Post-ACS event rates for patients treated with clopidogrel were from an MCO. The relative risks of these events with prasugrel compared with clopidogrel were from a head-to-head clinical trial.

Results:

The results of the base-case analysis indicated that, in an MCO population, use of prasugrel-based therapy rather than clopidogrel-based therapy at current prices resulted in cost-savings and fewer clinical events over the 15 months after an ACS diagnosis followed by PCI. At possible lower prices for generic clopidogrel-based therapy, the cost-effectiveness ratio for prasugrel-based therapy compared with clopidogrel-based therapy was between $6643 and $13,906 per life-year gained. The results were most sensitive to the relative costs of the two treatments and the cost for hospital stays.

Limitations:

Limitations of the study included lack of follow-up of patients disenrolling from the MCO before the end of the 15-month observation period, the assumption of equal relative risks of events in an MCO as in the clinical trial, and the lack of information on the ratio of cost to charges in the MCO database.

Conclusions:

Use of prasugrel-based therapy compared with clopidogrel-based therapy in ACS patients having a PCI resulted in cost-savings at current prices and favorable cost-effective ratios at likely generic prices for clopidogrel-based therapy because of offsetting savings in the costs of rehospitalization.     

Prasugrel vs clopidogrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention: a model-based cost-effectiveness analysis for Germany,Sweden, the Netherlands,and Turkey

Abstract

Objective:

To evaluate the long-term cost-effectiveness of 12-months treatment with prasugrel vs clopidogrel from four European healthcare systems’ perspectives (Germany, Sweden, the Netherlands, and Turkey).

Methods:

In the TRITON-TIMI 38 trial, patients with an acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) were treated with prasugrel or clopidogrel. Prasugrel reduced the composite end-point (cardiovascular death, MI, or stroke), but increased TIMI major bleeding. A Markov model was constructed to facilitate a lifetime horizon for the analysis. A series of risk equations constructed using individual patient data from TRITON-TIMI 38 was used to estimate risks of clinical events. Quality-adjusted life-years (QALYs) were derived by weighting survival time by estimates of health-related quality-of-life. Incremental cost-effectiveness is presented based on differences in treatments’ mean costs and QALYs for the licensed population in TRITON-TIMI 38, and the sub-groups of UA-NSTEMI, STEMI, diabetes, and the ‘core clinical cohort’ (<75 years, ≥60?kg, no history of stroke or TIA).

Results:

Mean cost of study drug was €364 (Turkey) to €818 (Germany) higher for prasugrel vs clopidogrel. Rehospitalization costs at 12 months were lower for prasugrel due to reduced rates of revascularization, although hospitalization costs beyond 12 months were higher due to longer life expectancy associated with lower rates of non-fatal MI in the prasugrel group. The incremental cost per QALY saved with prasugrel in the licensed population ranged from €6520 (for Sweden) to €14,350 for (Germany). Prasugrel’s cost per QALY was more favourable still in the STEMI and diabetes sub-groups of the licensed population.

Limitations:

Probabilistic analyses of the whole trial population is impractical due to the number of individual patient profiles over which population level results are calculated.

Conclusion:

Among patients undergoing PCI for ACS, treatment with prasugrel compared with clopidogrel resulted in favourable cost-effectiveness profiles from these healthcare systems’ perspectives.     

Original Research A modified method for estimating volume–outcome relationships: application to percutaneous coronary intervention

Objective: The objective of the current study was to propose an alternative method for measuring individual operator and peer volumes to use as predictors for adverse outcomes.

Study design: A retrospective analysis was performed to assess the volume–outcome relationship for percutaneous coronary intervention (PCI) performed in New York State between 1996 and 1999. This relationship was calculated using a modified method whereby physician volume was calculated using the previous year's volume, and hospital volume was calculated after subtracting the operator of interest's annual volume from the total. The primary outcome of interest was in-hospital mortality.

Results: Using the modified method, the odds ratio (OR) of in-hospital mortality was 0.74 (95% confidence interval (CI) 0.55–0.99; p=0.04) for cardiologists who performed 75–174 procedures annually and 0.80 (95% CI 0.61–1.04; p=0.1) for cardiologists who performed ≥175 procedures annually compared with the lowest-volume operators. With the conventional approach to volume measurement, no relationship between cardiologist volume and mortality was found. Patients who underwent PCI in hospitals where their physician's peers had an annual volume of 600–999 or ≥1,000 cases had a significantly reduced odds of mortality (OR = 0.73; 95% CI 0.57–0.92; p=0.01; and OR = 0.77; 95% CI 0.62–0.95; p=0.01) compared with patients treated by physicians with an annual peer volume of <600 cases. The conventional method did not detect any significant correlation between hospital volume and in-hospital mortality.

Conclusion: The alternative approach to measuring cardiologist and peer volumes proposed in this study leads to more precise estimates of volume–outcome relationships than the conventional approach.     

Cost-impact of cardiac magnetic resonance imaging with Fast-SENC compared to SPECT in the diagnosis of coronary artery disease in the U.S

Aims: The purpose of this study is to assess the economic cost differences and the associated treatment resource changes between the developing coronary artery disease (CAD) diagnostic tool fast strain-encoded cardiac imaging (Fast-SENC) and the current commonly used stress test single-photon emission computed tomography (SPECT).

Materials and methods: A “payer perspective” model was created first, consisting of long-term and short-term components that used a hypothetical cohort of patients of average age (60.8?years) presenting with chest pain and suspected CAD to assess cost-impact. A cost impact model was then built that assessed likely savings from a “hospital perspective” from substituting Fast-SENC for a portion of SPECTs assuming an average number of annual SPECT tests performed in US hospitals.

Results: In the payer model, using Fast-SENC followed by coronary angiography (CA) and percutaneous coronary intervention (PCI) treatment when necessary is less costly than the SPECT method when considering both direct and indirect costs of testing. Expected costs of the Fast-SENC were between $2,510 and $2,632 per correct diagnosis, while expected costs for the SPECT were between $3,157 and $4,078. Fast-SENC reduced false positives by 50% and false negatives by 86%, generating additional cost savings. The hospital model showed total costs per CAD patient visit of $825 for SPECT and $376 for Fast-SENC.

Limitations: Limitations of this study are that clinical data are sourced from other published clinical trials on how CAD diagnostic strategies impact clinical outcome, and that necessary assumptions were made which impact health outcomes.

Conclusion: The lower cost, higher sensitivity and specificity rates, and faster, less burdensome process for detecting CAD patients make Fast-SENC a more capable and economically beneficial stress test than SPECT. The payer model and hospital model demonstrate an alignment between payer and provider economics as Fast-SENC provides monetary savings for patients and resource benefits for hospitals.     

Comparison of healthcare resource utilization and costs in patients hospitalized for acute coronary syndrome managed with percutaneous coronary intervention and receiving prasugrel or ticagrelor

Abstract

Objective:

To compare healthcare resource utilization (HCRU) and healthcare costs in patients with acute coronary syndrome (ACS) managed with percutaneous coronary intervention (PCI) and treated with prasugrel or ticagrelor.     

Cost of care for new versus recurrent acute coronary syndrome patients

Abstract

Introduction: The economic burden of acute coronary syndrome (ACS) continues long after the acute event has resolved. This study compared ACS-related costs between new and recurrent ACS patients using retrospective claims data from a large US health plan.

Methods: Patients with ACS were identified using ICD-9 codes between the 1st January 2001 and the 30th June 2003. The first diagnosis was defined as the index event. Patient claims were examined 1 year before, and up to 1 year after, the index event. Hospitalisations, revascularisations and costs for new and recurrent cohorts were compared. Multivariate regression was used to examine cost predictors.

Results: In total, 15,508 patients were identified, 82% had new ACS. The new ACS cohort was more likely to have myocardial infarction and be hospitalised for the index event, leading to higher index event costs. However, the recurrent ACS cohort had more re-hospitalisations, longer lengths of inpatient stay and a higher probability of revascularisation during follow-up. The index event cost per patient and per patient-month was higher for new ACS patients. After adjusting for confounding factors, multivariate cost models revealed annualised follow-up medical costs were 9.9% higher (p=0.017) and annualised follow-up pharmacy costs were 8.3% higher (p≤0.0001) for the new ACS cohort.

Conclusion: Newly diagnosed ACS patients had significantly higher adjusted costs in the year following the index event, but recurrent ACS patients still experienced high medical costs. More emphasis by providers and patients on adherence to treatment guidelines may be one step to improving patient outcomes.

*This paper was presented in part at the Academy of Managed Care Pharmacy Annual Meeting, 7th April 2006.     

Cost-minimization comparison of darunavir plus ritonavir and lopinavir/ritonavir in HIV-1 infected treatment-naïve women of childbearing age

Background:

Guidelines from the Department of Health and Human Services in the US recommend ritonavir-boosted lopinavir (LPV/r) as a preferred protease inhibitor (PI) for HIV-positive antiretroviral-na?ve pregnant women. These guidelines also cite ritonavir-boosted darunavir (DRV?+?RTV) as an alternative PI in this clinical scenario. The purpose of this analysis was to compare economic outcomes for regimens based on these two treatments.

Study design:

An existing discrete event simulation (DES) model was adapted to conduct a cost-minimization analysis comparing the two regimens in HIV-infected women of childbearing age (WOCBA), from the perspective of a healthcare payer in the US.

Methods:

The DES model was used to represent disease states, health events, healthcare encounters, pregnancy, and treatment choices in HIV-infected WOCBA starting treatment with regimens based on either LPV/r or DRV?+?RTV. It also incorporated parameters for individual patient characteristics, and for antiretroviral (ARV) treatment effectiveness, treatment sequencing, clinical progression, and resource use. Potential events included scheduled physician visits; viral suppression; viral rebound; AIDS-related complications; CHD events; treatment discontinuation and switching; ARV treatment side-effects (SE); and death. The primary outcomes were discounted 5-year and 10-year healthcare costs. Alternative scenarios considered different rates of switching from DRV?+?RTV to LPV/r upon conception.

Results:

Compared with DRV?+?RTV, LPV/r was associated with similar clinical outcomes while offering savings at the 5- and 10-year horizons (of $24,904 and $43,502 per patient, respectively), and in extensive sensitivity analyses. The main driver of the savings was the difference in cost between PIs.

Conclusions:

Starting HIV-infected ARV-treatment-na?ve WOCBA on an LPV/r-based regimen is cost-saving and provides similar patient outcomes compared to a DRV?+?RTV-based regimen.     

A study of regional variation in the inpatient cost of lower extremity amputation among patients with diabetes in the United States

Abstract

Objective:

Understanding of the effects of providers’ cost on regional variation in healthcare spending is still very limited. The objective of this study is to assess cross-state and cross-region variations in inpatient cost of lower extremity amputation among diabetic patients (DLEA) in relation to patient, hospital, and state factors.

Methods:

Patient and hospital level data were obtained from the 2007 US Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project (HCUP). State level data were obtained from the US Census Bureau and the Kaiser Family Foundation websites. Regression models were implemented to analyze the association between in-patient cost and variables at patient, hospital, and state levels.

Results:

This study analyzed data on 9066 DLEA hospitalizations from 39 states. The mean cost per in-patient stay was $17,103. Four out of the five most costly states were located on the East and West coasts (NY and NJ, CA and OR). Age, race, length of stay, level of amputation, in-patient mortality, primary payer, co-morbidities, and type of hospital were significantly correlated with in-patient costs and explained 55.3% of the cost variance. Based on the means of costs unexplained by those factors, the three West coast states had the highest costs, followed by five Midwestern states, and four Southern states, and Kansas were the least costly.

Conclusions:

Over 40% of the variations in DLEA hospital costs could not be explained by major patient-, hospital-, and state-level variables. Further research is needed to examine whether similar patterns exist for other costly surgical procedures among diabetic patients.     

Differences in episode-based care costs for multidetector computed tomographic coronary angiography versus myocardial perfusion imaging for the diagnosis of coronary artery disease

Abstract

Background: Multidetector computed tomography (MDCT) is a novel method for diagnosis and prognosis of coronary artery disease (CAD). The opportunity costs that favour MDCT over other CAD diagnostic methods is currently unknown.

Methods: This study used an episodes of care cost model based on epidemiologic and economic data evaluating individuals without known CAD undergoing MDCT or myocardial perfusion scintigraphy (MPS). It was a multicenter retrospective database review of medical and pharmacy-related claims linked by episodes of care from 2002 to 2005. CAD-related episodes of care costs were examined 1-year downstream for patients after initial MDCT that were matched to patients who underwent MPS.

Results: After adjustment for patient factors, 1-year total CAD-related episodes of care costs for MDCT were 16.4% lower than MPS, by an average of $682 (95% confidence interval $14, $1,350) per patient. While costs per CAD-related episode were similar between MDCT and MPS groups ($4,284 vs. $4,277, p=0.08).

Conclusions: Patients without known CAD who undergo MDCT as an initial diagnostic test, compared to MPS, incurred fewer CAD-related episodes of care and lower overall CAD-related costs.     

Economic impact of contrast-induced acute kidney injury associated with invasive cardiology: role of iso-osmolar contrast media in Germany,Italy, Poland,and Spain

Objective:

Iso-osmolar Iodixanol is associated with a lower rate of contrast-induced acute kidney injury (CI-AKI) in patients at increased risk compared to low-osmolar contrast media (LOCM). The aim of this study was to assess the financial consequences of CI-AKI risk reduction in patients undergoing coronary angiography (CA) with or without percutaneous coronary intervention (PCI) in German, Italian, Polish and Spanish hospitals.

Methods:

This budget impact analysis (BIA) compared a scenario with iodixanol to a scenario without, where only LOCM were used, in patients at increased risk of CI-AKI over a 3-year horizon. A meta-analysis based on a systematic review observed a lower rate of CI-AKI with iodixanol compared to LOCM (Risk Reduction?=?0.46) in patients with underlying impaired renal function (serum creatinine ≥1.6?mg/dl and estimated glomerular filtration rate ≤50?ml/min/1.73 m²). Contrast media and CI-AKI hospitalization costs were included in the analysis and unit costs were obtained from published literature, official sources or, when available, from hospital data. In the absence of country-specific data, resource utilization for a CI-AKI hospitalization was obtained by interviews with local clinicians in each country. The percentage of patients who received iodixanol was assumed to increase over time.

Results:

Based on a percentage of patients at increased risk of CI-AKI equal to 20% in Germany, 24% in Italy, 23% in Poland and 10% in Spain, results showed that the introduction of iodixanol would bring a 3-years cumulative net percentage saving on the total hospital budget of 29%, 34%, 25%, and 33% in the four countries respectively.

Conclusion:

The results of the analysis for the four countries showed that iodixanol use in patients at increased risk of CI-AKI undergoing CA with or without PCI may bring considerable savings on the hospital’s budget, due to the associated reduction in CI-AKI incidence.     

Costs and effectiveness of fingolimod versus alemtuzumab in the treatment of highly active relapsing-remitting multiple sclerosis in the UK: re-treatment,discount, and disutility

Objective: Patients with relapsing-remitting multiple sclerosis (RRMS) treated with disease modifying therapies (DMTs) who continue to experience disease activity may be considered for escalation therapies such as fingolimod, or may be considered for alemtuzumab. Previous economic modeling used Markov models; applying one alternative technique, discrete event simulation (DES) modeling, allows re-treatment and long-term adverse events (AEs) to be included in the analysis.

Methods: A DES was adapted to model relapse-triggered re-treatment with alemtuzumab and the effect of including ongoing quality-adjusted life year (QALY) decrements for AEs that extend beyond previous 1-year Markov cycles. As the price to the NHS of fingolimod in the UK is unknown, due to a confidential patient access scheme (PAS), a variety of possible discounts were tested. The interaction of re-treatment assumptions for alemtuzumab with the possible discounts for fingolimod was tested to determine which DMT resulted in lower lifetime costs. The lifetime QALY results were derived from modeled treatment effect and short- and long-term AEs.

Results: Most permutations of fingolimod PAS discount and alemtuzumab re-treatment rate resulted in fingolimod being less costly than alemtuzumab. As the percentage of patients who are re-treated with alemtuzumab due to experiencing a relapse approaches 100% of those who relapse whilst on treatment, the discount required for fingolimod to be less costly drops below 5%. Consideration of treatment effect alone found alemtuzumab generated 0.2 more QALYs/patient; the inclusion of AEs up to a duration of 1 year reduced this advantage to only 0.14 QALYs/patient. Modeling AEs with a lifetime QALY decrement found that both DMTs generated very similar QALYs with the difference only 0.04 QALYs/patient.

Conclusions: When the model captured alemtuzumab re-treatment and long-term AE decrements, it was found that fingolimod is cost-effective compared to alemtuzumab, assuming application of only a modest level of confidential PAS discount.     

When does economic model type become a decisive factor in health technology appraisals? Learning from the expanding treatment options for relapsing–remitting multiple sclerosis

Objectives: Specific economic model types often become de facto standard for health technology appraisal over time. Markov and discrete event simulation (DES) models were compared to investigate the impact of innovative modeling on the cost-effectiveness of disease-modifying therapies (DMTs) in relapsing–remitting multiple sclerosis (RRMS). Fingolimod was compared to dimethyl fumarate (DMF; in highly active [HA] RRMS), alemtuzumab (in HA RRMS) and natalizumab (in rapidly evolving severe RRMS). Comparator DMTs were chosen to reflect different dosing regimens.

Materials and methods: Markov and DES models used have been published previously. Inputs were aligned in all relevant respects, with differences in the modeling of event-triggered attributes, such as relapse-related retreatment, which is inherently difficult with a memoryless Markov approach. Outcomes were compared, with and without different attributes.

Results: All results used list prices. For fingolimod and DMF, incremental cost-effectiveness ratios (ICERs) were comparable (Markov: £4206/quality-adjusted life year [QALY] gained versus DES: £3910/QALY gained). Deviations were observed when long-term adverse events (AEs) were incorporated in the DES (Markov: £25,412 saved/QALY lost, versus DES: £34,209 saved/QALY lost, fingolimod versus natalizumab; higher ICERs indicate greater cost-effectiveness). For fingolimod versus alemtuzumab, when relapse-triggered retreatment was included in the DES, large cost differences were observed (difference between incremental cost is £35,410 and QALY is 0.10).

Limitations: UK payer perspective, therefore societal approach was not considered. Resource utilization and utilities for both models were not derived from the subpopulations; as the focus is on model type, input limitations that apply to both models are less relevant.

Conclusions: Whilst no model can fully represent a disease, a DES allows an opportunity to include features excluded in a Markov structure. A DES may be more suitable for modeling in RRMS for health technology assessment purposes given the complexity of some DMTs. This analysis highlights the capabilities of different model structures to model event-triggered attributes.     

Resource utilization and healthcare costs for acute coronary syndrome patients with and without diabetes mellitus

Abstract

Objective:

This study compared differences in healthcare costs and resource utilization for acute coronary syndrome (ACS) patients with and without diabetes mellitus (DM).

Methods:

A retrospective cohort study of a large, US employer-based claims database identified adults hospitalized for ACS between 01/01/2005 and 12/31/2006 and categorized them based on DM status. Resource utilization and costs during the index hospitalization and in the 12-month follow-up period were compared for ACS patients with and without DM using the propensity score stratification bootstrapping method, adjusting for differences in demographic and clinical characteristics.

Results:

Of 12,502 patients who met selection criteria, 3,040 (24%) had a history of DM and 9,462 (76%) did not. Patients with DM were older, female, and had higher rates of previous cardiovascular and renal diseases. After the propensity score stratification, patients with DM incurred higher index hospitalization costs ($32,577 vs. $29,150, p?<?0.01) as well as higher total follow-up healthcare costs ($35,400 vs. $24,080, p?<?0.01), including higher inpatient ($17,278 vs. $11,247, p?<?0.01), outpatient ($12,357 vs. $8,853, p?<?0.01), and pharmacy costs ($5,765 vs. $3,980, p?<?0.01).

Limitations:

General limitations exist with any retrospective claims database analysis including potential diagnostic or procedural coding inaccuracies. Additionally, the patient population was representative of a working-age population with employer-sponsored health insurance and results may not be generalizable to other patient populations.

Conclusions:

DM is significantly associated with increased healthcare resource utilization and costs for ACS patients.     

Adherence to guidelines for sensitivity analysis: cost-effectiveness analyses of dual oral antiplatelet therapy

Abstract

Objective: Cost-effectiveness analyses of new treatments for cardiovascular disease frequently require input parameters whose values are known with uncertainty due to limited data. The objective of this paper is to examine the extent to which published sensitivity analyses addressing this uncertainty adhere to Health Technology Assessment (HTA) guidelines.

Research design and methods: A systematic review of published cost-effectiveness analyses was performed for an example drug treatment scenario, dual oral antiplatelet therapy compared with aspirin alone following acute coronary syndromes and/or percutaneous coronary intervention. The following medical literature databases were searched for articles published from January 1997 to June 2007: PubMed, Cochrane Collaboration, EMBASE and the Health Economic Evaluation Database (HEED). Evidence tables were created to show the sensitivity of the cost-effectiveness estimates to changes in the input parameter values, as well as the data sources used for the reference-case and sensitivity analysis input parameter values. The extent to which the sensitivity analyses adhered to HTA guidelines were also examined.

Results: Cost-effectiveness ratios were most sensitive to changes in the efficacy of dual antiplatelet therapy and reference-case model assumptions about costs beyond the trial period. Although alternative values tested in the sensitivity analysis for some input parameters were based on observed ranges or distributions, alternative values tested for many other input parameters were assumed without justification.

Conclusions: Sensitivity analyses in the cost-effectiveness studies of dual oral antiplatelet therapy were not fully adherent with HTA guidelines. In particular, long-term costs and benefits were not always included in the sensitivity estimates, the impact of differential effects on death and myocardial infarction was not explored, and justification for the alternative parameter values tested was not always provided.     

The healthcare burden of disease progression in medicare patients with functional mitral regurgitation

Abstract

Objective: This retrospective database analysis estimated the incremental effect that disease progression from non-clinically significant functional mitral regurgitation (nsFMR) to clinically significant FMR (sFMR) has on clinical outcomes and costs.

Methods: Medicare Fee for Service beneficiaries with nsFMR were examined, defined as those with a heart failure diagnosis prior to MR. Patients were classified as ischemic if there was a history of: CAD, AMI, PCI, or CABG. The primary outcome was time to sFMR, defined as pulmonary hypertension, atrial fibrillation, mitral valve surgery, serial echocardiography, or death, using a Cox hazard regression model. Annualized hospitalizations, inpatient hospital days, and healthcare expenditures were also modeled.

Results: Patients with IHD had higher risk (Hazard Ratio?=?1.22 [1.14–1.30]) for disease progression compared to patients without. The progression cohort had significantly more annual inpatient hospitalizations (non-IHD?=?1.32; IHD?=?1.40) than the non-progression cohort (non-IHD?=?0.36; IHD?=?0.34), and significantly more annual inpatient hospital days (non-IHD?=?13.07; IHD?=?13.52) than the non-progression cohort (non-IHD?=?2.29; with IHD?=?2.08). The progression cohort had over 3.5-times higher costs vs the non-progression cohort, independent of IHD (non-IHD?=?$12,798 vs $46,784; IHD?=?$12,582 vs $49,348).

Conclusion: Treating FMR patients earlier in their clinical trajectory may prevent disease progression and reduce high rates of healthcare utilization and expenditures.     

The cost implications of an early versus delayed invasive strategy in acute coronary syndromes: the TIMACS study

Background:

The Timing of Intervention in Acute Coronary Syndromes (TIMACS) trial demonstrated that early invasive intervention (within 24 hours) was similar to a delayed approach (after 36 hours) overall but improved outcomes were seen in patients at high risk. However, the cost implications of an early versus delayed invasive strategy are unknown.

Methods and results:

A third-party perspective of direct cost was chosen and United States Medicare costs were calculated using average diagnosis related grouping (DRG) units. Direct medical costs included those of the index hospitalization (including clinical, procedural and hospital stay costs) as well as major adverse cardiac events during 6 months of follow-up. Sensitivity and sub-group analyses were performed. The average total cost per patient in the early intervention group was lower compared with the delayed intervention group (?$1170; 95% CI ?$2542 to $202). From the bootstrap analysis (5000 replications), the early invasive approach was associated with both lower costs and better clinical outcomes regarding death/myocardial infarction (MI)/stroke in 95.1% of the cases (dominant strategy). In high-risk patients (GRACE score ≥141), the net reduction in cost was greatest (?$3720; 95% CI ?$6270 to ?$1170). Bootstrap analysis revealed 99.8% of cases were associated with both lower costs and better clinical outcomes (death/MI/stroke).

Limitations:

We were unable to evaluate the effect of community care and investigations without hospitalization (office visits, non-invasive testing, etc). Medication costs were not captured. Indirect costs such as loss of productivity and family care were not included.

Conclusions:

An early invasive management strategy is as effective as a delayed approach and is likely to be less costly in most patients with acute coronary syndromes.