Analysis of the costs of dialysis and the effects of an incentive mechanism for low-cost dialysis modalities.

BACKGROUND: Treatment costs of end-stage renal disease with dialysis are high and vary between dialysis modalities. Public healthcare payers aim at stimulating the use of less expensive dialysis modalities, with maintenance of healthcare quality. OBJECTIVES: This study examines the effects of Belgian financial incentive mechanisms for the use of low-cost dialysis treatments. METHODS: First, the costs of different dialysis modalities were calculated from the hospital's perspective. Data were obtained through a hospital survey. The balance between costs and revenues was simulated for an average Belgian dialysis programme. Incremental profits were calculated in function of the proportion of patients on alternative dialysis modalities. RESULTS: Hospital haemodialysis is the most expensive modality per patient year, followed by peritoneal dialysis and finally satellite haemodialysis. Under current reimbursement rules mean profits of a dialysis programme are maximal if about 28% of patients are treated with a low-cost dialysis modality. This is only slightly lower than the observed percentage in Belgian dialysis centres in the same period. CONCLUSIONS: In Belgium, the financial incentives for the use of low-cost dialysis modalities only had a modest impact due to the continuing profits that could be generated by high-cost dialysis. Profit neutrality is crucial for the success of any financial incentive mechanism for low-cost dialysis modalities.

Calculating an intervention's (cost-)effectiveness for the real-world target population: the potential of combining strengths of both RCTs and observational data.

Economic evaluations most often use results from randomised controlled trials (RCTs) to model effectiveness. Inconsiderate application of the absolute treatment effect from RCTs may result in unrealistic estimates of an intervention's benefit for the real-world target population. The baseline risk of events in this target population may differ significantly from the baseline risk in the RCT population. An approach to handle this problem is to combine observational data with evidence from RCTs. Reliable administrative or register data can provide an estimate of the real-world baseline risks. In combination with the relative treatment effect from well-performed RCTs this results in an estimate of the absolute benefit for the relevant target population. Applying this approach, one must remain cautious about the validity of the assumption of a constant relative treatment effect.

Legal and organizational aspects of remote cardiac monitoring: the example of implantable cardioverter defibrillators.

The remote monitoring of implantable cardioverter defibrillators (ICDs) recently emerged as an attractive technological innovation that proved to be reasonably safe in partially replacing the in-clinic follow-ups of ICD patients with no or only mild symptoms. Apart from the fact that strong evidence about any additional clinical benefits and/or cost-efficiency are still awaited, legal and organizational hurdles remain in place, hampering any possibility for adoption of remote cardiac monitoring. This paper identifies a number of legal and organizational constraints which urgently need to be addressed. An elaboration of the specific juridical guidance for the interpretation and application of the relevant legislation is called for.

Cost-effectiveness of cardiac resynchronisation therapy for patients with moderate-to-severe heart failure: a lifetime Markov model.

Objective To assess the cost-effectiveness of cardiac resynchronisation therapy (CRT) both with CRT-P (biventricular pacemaker only) and with CRT-D (biventricular pacemaker with defibrillator) in patients with New York Heart Association (NYHA) functional class III/IV from a Belgian healthcare-payer perspective. Methods A lifetime Markov model was designed to calculate the cost-utility of both interventions. In the reference case, the treatment effect was based on the Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure trial. Costs were based on real-world data. Pharmacoeconomic guidelines were applied, including probabilistic modelling and sensitivity analyses. Results Compared with optimal medical treatment, on average 1.31 quality-adjusted life-years (QALY) are gained with CRT-P at an additional cost of €14 700, resulting in an incremental cost-effectiveness ratio (ICER) of about €11 200/QALY. As compared with CRT-P, CRT-D treatment adds on average an additional 0.55 QALYs at an extra cost of €30 900 resulting in an ICER of €57 000/QALY. This result was very sensitive to the incremental clinical benefit of the defibrillator function on top of CRT. Conclusions Based on efficiency arguments, CRT-P can be recommended for NYHA class III and IV patients if there is a willingness to pay more than €11 000/QALY. Even though CRT-D may offer a survival benefit over CRT-P, the incremental clinical benefit appears to be too marginal to warrant a threefold-higher device price for CRT-D. Further clinical research should focus on the added value of CRT-D over CRT-P.

Using threshold values for cost per quality-adjusted life-year gained in healthcare decisions.

BACKGROUND: In many countries, the incremental cost-effectiveness ratio (ICER) is used to assess whether an intervention is worth its costs. At the same time, policy makers often feel uncomfortable with refusing reimbursement of any intervention purely on the basis of the fact that the ICER exceeds a specific threshold value. Reluctance to define a single threshold value for the ICER seems to have been stronger in social security systems than in national healthcare services systems. This study explores how basic differences between healthcare systems impact upon the potential usefulness of an ICER threshold value. METHODS: This study is a narrative review of literature about the theoretical foundations of the ICER threshold value approach and its practical relevance in different types of healthcare systems. RESULTS: A single ICER threshold value cannot be maintained, defined, or measured and should not be used as a policy-making tool. None of the solutions presented up until now to make the ICER threshold approach a valuable policy-making tool overcome the important weaknesses of the approach. CONCLUSIONS: ICERs and ICER threshold values are insufficient for assessing interventions' value for money. Rather, they should be considered as one element in the decision-making process. Complete rationalization of the decision-making process by means of quantitative decision criteria is undesirable and not feasible. Increasing transparency in the criteria used for a decision and explicitness about the relative importance of each criterion should, therefore, be the major goal.

Testing the HTA core model: experiences from two pilot projects.

OBJECTIVES: The aim of this study was to analyze and describe process and outcomes of two pilot assessments based on the HTA Core Model, discuss the applicability of the model, and explore areas of development. METHODS: Data were gathered from HTA Core Model and pilot Core HTA documents, their validation feedback, questionnaires to investigators, meeting minutes, emails, and discussions in the coordinating team meetings in the Finnish Office for Health Technology Assessment (FINOHTA). RESULTS: The elementary structure of the HTA Core Model proved useful in preparing HTAs. Clear scoping and good coordination in timing and distribution of work would probably help improve applicability and avoid duplication of work. CONCLUSIONS: The HTA Core Model can be developed into a platform that enables and encourages true HTA collaboration in terms of distribution of work and maximum utilization of a common pool of structured HTA information for national HTA reports.

Cost effectiveness of drug-eluting stents in Belgian practice: healthcare payer perspective.

BACKGROUND: There has been a steep increase in the number of percutaneous coronary intervention procedures performed for coronary heart disease since their introduction about 30 years ago. Recently, the use of drug-eluting stents (DES) compared with the original bare metal stents (BMS) has increased in many countries. OBJECTIVE: To assess the cost effectiveness of DES versus BMS in a real-world setting from the Belgian healthcare payer perspective. METHODS: We developed a decision analysis model to estimate incremental costs (year 2004 or 2007 values [depending on the underlying variable]) and effectiveness. Incremental effectiveness was calculated by combining relative benefits from published meta-analyses with real-world observations from a Belgian registry. Probabilistic modelling and sensitivity analyses were performed. The model had a 1-year time horizon. Sixteen sub groups were created based on the following characteristics: initial stent type, diabetic status, complex lesion and multi-vessel disease. Scenario analyses were performed for the influence on reinterventions and the duration of clopidogrel use. In each analysis, 1000 Monte Carlo simulations were performed. RESULTS: The incremental costs for switching from BMS to DES are substantial (approximately euro1000), while the benefits, expressed as QALYs, are extremely small (on average <0.001 QALYs gained). This led to very high incremental cost-effectiveness ratios: over euro860 000 per QALY gained in all subgroups and scenario analyses. CONCLUSION: Comparing DES with BMS, no life-years are gained and small quality-of-life improvements are achieved for short periods, resulting in a high likelihood that DES are not cost effective. When there is competition for scarce resources this should be considered when deciding on the reimbursement of this technology.

Cost-effectiveness of human papillomavirus vaccination in Belgium: do not forget about cervical cancer screening.

OBJECTIVES: The cost-effectiveness of adding a human papillomavirus (HPV) vaccination program in 12-year-old females to the recommended cervical cancer screening in Belgium is examined. Moreover, the health and economic consequences of a potential decline in screening uptake after initiation of a HPV vaccination program are investigated. METHODS: A static Markov model is developed to estimate the direct effect of vaccination on precancerous lesions and cervical cancers. RESULTS: Vaccination is estimated to avoid 20 percent of the cervical cancers occurring in a 12-year-old girls' cohort and to cost 32,665 euro per quality-adjusted life-year (QALY) gained (95 percent credibility interval [CrI]: 17,447 euro to 68,078 euro), assuming a booster injection after 10 years, a limited duration of protection and discounting costs and effects at 3 percent and 1.5 percent, respectively. Assuming lifelong protection, HPV vaccination is estimated to cost 14,382 euro (95 percent CrI: 9,238 euro to 25,644 euro) per QALY gained, while avoiding 50 percent of the cervical cancer cases. In the base-case, a 10 percent reduction in screening compliance after vaccination obliterates the effect of vaccination on cervical cancer cases avoided, whereas further declines in the level of screening compliance even turned out to be detrimental for the cohort's health, inducing a mean loss in QALYs and life-year gained compared with the situation prevaccination. CONCLUSIONS: An HPV vaccination program should only be considered if the level of screening after vaccination can be maintained.

Cost-effectiveness of statins in the primary prevention of cardiovascular disease: a systematic review and economic analysis for Belgium.

OBJECTIVES: 8% of total drug spending by the Belgian government goes to statins. The aim of this study is to determine the cost-effectiveness of statins for the primary prevention of cardiovascular disease (CVD) in middle-aged Belgian populations. METHODS AND RESULTS: Economic evaluations were identified in a systematic literature search and were critically appraised. Furthermore, because prices decreased drastically, a previously published model was adapted applying recent cost data from the Belgian national health insurance. Eleven full economic evaluations were identified. Nine studies compared statins with no treatment and presented heterogeneous results. If alternative interventions, such as smoking cessation or low-dose aspirin treatment were included in the analysis, statin therapy became less cost-effective. Prescribing the cheapest statin on the Belgian market (< Euro 90 medication cost per year) resulted in an incremental cost of Euro 29,173 per life-year gained (LYG) in a male high-risk group aged 60 compared to low-dose aspirin. The incremental cost in a male moderate-risk group aged 50 was Euro 87,022/LYG. Low-dose aspirin was more cost-effective ranging from Euro 3,854/LYG to Euro 29,509/LYG compared to smoking cessation therapy. Smoking cessation therapy was the most cost-effective intervention, providing savings compared to no treatment. CONCLUSIONS: In Belgium, the cost-effectiveness of statins for the primary prevention of CVD is rather elevated in comparison with low-dose aspirin, even if the cheapest statin is prescribed. From an economic point of view, prevention with low-dose aspirin is more cost-effective and may present a first choice in primary prevention. Smoking cessation, which is a dominant strategy, should be encouraged at all times.

Cost-effectiveness analyses of drug eluting stents versus bare metal stents: a systematic review of the literature.

OBJECTIVES: Drug eluting stents (DES) used to treat coronary lesions reduce rates of in-stent restenosis and therefore the need for repeat revascularization compared to bare metal stents (BMS). DES, however, are considerably more expensive than BMS. We evaluated whether DES are a cost-effective alternative for BMS. METHODS: Reports of Health Technology Assessment agencies were assessed and a systematic review of economic evaluations comparing DES with BMS was performed. RESULTS: Nineteen full economic evaluations were identified. Some studies indicate that DES may be cost-effective or even cost-saving in specific patients, when used for coronary lesions with a high propensity of restenosis such as long lesions, lesions in narrow vessels, or in patients with diabetes. Other studies mention DES is not cost effective at all with ICERs of more than 200,000 Canadian dollar per QALY gained. One of the main determining factors is the influence of protocol mandated angiographic follow-up in RCTs. The risk for a re-intervention using BMS ranges from 5% to 14% in registries and is much smaller than reported in RCTs (up to 30%). As a result, the absolute reduction in repeat revascularization by DES compared to BMS is smaller in real life. Moreover, using DES instead of BMS does not increase survival or decrease myocardial infarctions. The combination of (a) a higher cost (>euro700) for DES versus BMS; (b) no life-years gained; (c) a relatively small absolute reduction in repeat procedures; and (d) a small improvement in QoL for a short period (less than 0.15 during the first month after the re-intervention), results in unfavourable cost-effectiveness ratios. CONCLUSIONS: Although several studies conclude that DES may be cost effective in large subgroups of patients, under real-world conditions, the cost-effectiveness of DES is unfavourable in comparison with BMS.

A simple risk score for the assessment of absolute fracture risk in general practice based on two longitudinal studies.

The aim of this prospective study was to develop a risk score, based on putative risk factors in current guidelines, which can be used to identify women at high risk of fractures in general practice. The study sample included 4157 women >/=60 yr of age (mean +/- SD: 74.1 +/- 9.1 yr), with a median follow-up of 8.9 yr of the Rotterdam Study (ERGO), and 762 women >/=65 yr of age (mean +/- SD: 76.0 +/- 6.7.yr), with a median follow-up of 6.0 yr of the Longitudinal Aging Study Amsterdam (LASA). Potential risk factors were those proposed in risk scores of three recent guidelines on osteoporosis: age, family history of fractures, prior fracture, low body weight/body mass index (BMI), serious immobility, rheumatoid arthritis, current smoking, alcohol consumption >2 units daily, prevalent vertebral fracture, and systemic corticosteroid use. Five-year absolute risk of hip fracture was 3.9% in the Rotterdam Study and 3.1% in LASA, and 10-yr absolute risk of hip fracture was 8.4% in the Rotterdam Study. Using Cox regression analysis, age (70-79 and 80+ versus <60-69) and four other risk factors were included in the risk profiles of hip fractures and fragility fractures: any prior fracture after age 50, body weight <64 kg, use of a walking aid as a proxy measure of serious immobility, and current smoking. Estimated 10-yr absolute risk of hip fracture ranged from 1.4% in women, age 60-69 years, without any of these predictors to 29% in women, >/=80 yr of age, having two or more positive risk factors. A simple risk score can satisfactorily identify older women at high risk of osteoporotic fractures in general practice. Future studies are needed to validate this score.

Femoral neck BMD is a strong predictor of hip fracture susceptibility in elderly men and women because it detects cortical bone instability: the Rotterdam Study.

UNLABELLED: We studied HSA measurements in relation to hip fracture risk in 4,806 individuals (2,740 women). Hip fractures (n = 147) occurred at the same absolute levels of bone instability in both sexes. Cortical instability (propensity of thinner cortices in wide diameters to buckle) explains why hip fracture risk at different BMD levels is the same across sexes. INTRODUCTION: Despite the sexual dimorphism of bone, hip fracture risk is very similar in men and women at the same absolute BMD. We aimed to elucidate the main structural properties of bone that underlie the measured BMD and that ultimately determines the risk of hip fracture in elderly men and women. MATERIALS AND METHODS: This study is part of the Rotterdam Study (a large prospective population-based cohort) and included 147 incident hip fracture cases in 4,806 participants with DXA-derived hip structural analysis (mean follow-up, 8.6 yr). Indices compared in relation to fracture included neck width, cortical thickness, section modulus (an index of bending strength), and buckling ratio (an index of cortical bone instability). We used a mathematical model to calculate the hip fracture distribution by femoral neck BMD, BMC, bone area, and hip structure analysis (HSA) parameters (cortical thickness, section modulus narrow neck width, and buckling ratio) and compared it with prospective data from the Rotterdam Study. RESULTS: In the prospective data, hip fracture cases in both sexes had lower BMD, thinner cortices, greater bone width, lower strength, and higher instability at baseline. In fractured individuals, men had an average BMD that was 0.09 g/cm(2) higher than women (p < 0.00001), whereas no significant difference in buckling ratios was seen. Modeled fracture distribution by BMD and buckling ratio levels were in concordance to the prospective data and showed that hip fractures seem to occur at the same absolute levels of bone instability (buckling ratio) in both men and women. No significant differences were observed between the areas under the ROC curves of BMD (0.8146 in women and 0.8048 in men) and the buckling ratio (0.8161 in women and 0.7759 in men). CONCLUSIONS: The buckling ratio (an index of bone instability) portrays in both sexes the critical balance between cortical thickness and bone width. Our findings suggest that extreme thinning of cortices in expanded bones plays a key role on local susceptibility to fracture. Even though the buckling ratio does not offer additional predictive value, these findings improve our understanding of why low BMD is a good predictor of fragility fractures.

Primary prevention of cardiovascular disease: cost-effectiveness comparison.

OBJECTIVES: The aim of this study was to evaluate the cost-effectiveness of four risk-lowering interventions (smoking cessation, antihypertensives, aspirin, and statins) in primary prevention of cardiovascular disease. METHODS: Using data from the Framingham Heart Study and the Framingham Offspring study, we built life tables to model the benefits of the selected interventions. Participants were classified by age and level of risk of coronary heart disease. The effects of risk reduction are obtained as numbers of death averted and life-years saved within a 10-year period. Estimates of risk reduction by the interventions were obtained from meta-analyses and costs from Dutch sources. RESULTS: The most cost-effective is smoking cessation therapy, representing savings in all situations. Aspirin is the second most cost-effective (euro 2,263 to euro 16,949 per year of life saved) followed by antihypertensives. Statins are the least cost-effective (euro 73,971 to euro 190,276 per year of life saved). CONCLUSIONS: A cost-effective strategy should offer smoking cessation for smokers and aspirin for moderate and high levels of risk among men 45 years of age and older. Statin therapy is the most expensive option in primary prevention at levels of 10-year coronary heart disease risk below 30 percent and should not constitute the first choice of treatment in these populations.

Alendronate or alfacalcidol in glucocorticoid-induced osteoporosis.

BACKGROUND: Treatment with glucocorticoids is associated with bone loss starting soon after therapy is initiated and an increased risk of fracture. METHODS: We performed a randomized, double-placebo, double-blind clinical trial of 18 months' duration among patients with a rheumatic disease who were starting glucocorticoids at a daily dose that was equivalent to at least 7.5 mg of prednisone. A total of 201 patients were assigned to receive either alendronate (10 mg) and a placebo capsule of alfacalcidol daily or alfacalcidol (1 microg) and a placebo tablet of alendronate daily. The primary outcome was the change in bone mineral density of the lumbar spine in 18 months; the secondary outcome was the incidence of morphometric vertebral deformities. RESULTS: A total of 100 patients received alendronate, and 101 received alfacalcidol; 163 patients completed the study. The bone mineral density of the lumbar spine increased by 2.1 percent in the alendronate group (95 percent confidence interval, 1.1 to 3.1 percent) and decreased by 1.9 percent in the alfacalcidol group (95 percent confidence interval, -3.1 to -0.7 percent). At 18 months, the mean difference of change in bone mineral density between the two groups was 4.0 percent (95 percent confidence interval, 2.4 to 5.5 percent). Three patients in the alendronate group had a new vertebral deformity, as compared with eight patients in the alfacalcidol group (of whom three had symptomatic vertebral fractures) (hazard ratio, 0.4; 95 percent confidence interval, 0.1 to 1.4). CONCLUSIONS: During this 18-month trial in patients with rheumatic diseases, alendronate was more effective in the prevention of glucocorticoid-induced bone loss than was alfacalcidol. (ClinicalTrials.gov number, NCT00138983 [ClinicalTrials.gov].).

Adult obesity and number of years lived with and without cardiovascular disease.

OBJECTIVE: To determine the differences in number of years lived free of cardiovascular disease (CVD) and number of years lived with CVD between men and women who were obese, pre-obese, or normal weight at 45 years of age. RESEARCH METHODS AND PROCEDURES: We constructed multistate life tables for CVD, myocardial infarction, and stroke, using data from 2551 enrollees (1130 men) in the Framingham Heart Study who were 45 years of age. RESULTS: Obesity and pre-obesity were associated with fewer number of years free of CVD, myocardial infarction, and stroke and an increase in the number of years lived with these diseases. Forty-five-year-old obese men with no CVD survived 6.0 years [95% confidence interval (CI), 4.1; 8.1] fewer than their normal weight counterparts, whereas, for women, the difference between obese and normal weight subjects was 8.4 years (95% CI: 6.2; 10.8). Obese men and women lived with CVD 2.7 (95% CI: 1.0; 4.4) and 1.4 years (95% CI: -0.3; 3.2) longer, respectively, than normal weight individuals. DISCUSSION: In addition to reducing life expectancy, obesity before middle age is associated with a reduction in the number of years lived free of CVD and an increase in the number of years lived with CVD. Such information is paramount for preventive and therapeutic decision-making by individuals and practitioners alike.

The polypill: at what price would it become cost effective?

INTRODUCTION: A promising concept in cardiovascular disease prevention (the polypill) was introduced in 2003. Although the polypill may seem as an effective intervention, data on its costs and cost effectiveness remain unknown. The aim of this study was to determine the maximum price of the polypill for it to be a cost effective alternative in the primary prevention of cardiovascular disease. METHODS: Data on the hypothetical effects of the polypill were taken from the literature. Using data from the Framingham heart study and the Framingham offspring study, life tables were built to model the assumed benefits of the polypill. Using a third party payer perspective and a 10 years time horizon, the authors calculated what should be the maximum drug cost of the polypill for it to be cost effective (using a 20,000 euro/year of life saved threshold) in the primary prevention of cardiovascular disease among populations at different levels of absolute risk of coronary heart disease and age. RESULTS: To be cost effective among populations at levels of 10 year coronary heart disease risk over 20% (high risk), the annual cost of medication for the polypill therapy should be no more than 302 euro or 410 euro for men at age 50 and 60 years respectively. For cost effective prevention in populations at levels of coronary heart disease risk between 10% and 20% the costs should be two to three times lower. CONCLUSION: Although the polypill could theoretically be a highly effective intervention, the costs of the medication could be its caveat for implementation in the primary prevention of cardiovascular disease.

Physical activity and life expectancy with and without diabetes: life table analysis of the Framingham Heart Study.

OBJECTIVE: Physical activity is associated with a reduced risk of developing diabetes and with reduced mortality among diabetic patients. However, the effects of physical activity on the number of years lived with and without diabetes are unclear. Our aim is to calculate the differences in life expectancy with and without type 2 diabetes associated with different levels of physical activity. RESEARCH DESIGN AND METHODS: Using data from the Framingham Heart Study, we constructed multistate life tables starting at age 50 years for men and women. Transition rates by level of physical activity were derived for three transitions: nondiabetic to death, nondiabetic to diabetes, and diabetes to death. We used hazard ratios associated with different physical activity levels after adjustment for age, sex, and potential confounders. RESULTS: For men and women with moderate physical activity, life expectancy without diabetes at age 50 years was 2.3 (95% CI 1.2-3.4) years longer than for subjects in the low physical activity group. For men and women with high physical activity, these differences were 4.2 (2.9-5.5) and 4.0 (2.8-5.1) years, respectively. Life expectancy with diabetes was 0.5 (-1.0 to 0.0) and 0.6 (-1.1 to -0.1) years less for moderately active men and women compared with their sedentary counterparts. For high activity, these differences were 0.1 (-0.7 to 0.5) and 0.2 (-0.8 to 0.3) years, respectively. CONCLUSIONS: Moderately and highly active people have a longer total life expectancy and live more years free of diabetes than their sedentary counterparts but do not spend more years with diabetes.