Predicted clinical and economic burden associated with reduction in access to acute coronary interventional care during the COVID-19 lockdown in two European countries.

AIMS: As a consequence of untimely or missed revascularization of ST-elevation myocardial infarction (STEMI) patients during the COVID-19 pandemic, many patients died at home or survived with serious sequelae, resulting in potential long-term worse prognosis and related health-economic implications.This analysis sought to predict long-term health outcomes [survival and quality-adjusted life-years (QALYs)] and cost of reduced treatment of STEMIs occurring during the first COVID-19 lockdown. METHODS AND RESULTS: Using a Markov decision-analytic model, we incorporated probability of hospitalization, timeliness of PCI, and projected long-term survival and cost (including societal costs) of mortality and morbidity, for STEMI occurring during the first UK and Spanish lockdowns, comparing them with expected pre-lockdown outcomes for an equivalent patient group.STEMI patients during the first UK lockdown were predicted to lose an average of 1.55 life-years and 1.17 QALYs compared with patients presenting with a STEMI pre-pandemic. Based on an annual STEMI incidence of 49 332 cases, the total additional lifetime costs calculated at the population level were £36.6 million (€41.3 million), mainly driven by costs of work absenteeism. Similarly in Spain, STEMI patients during the lockdown were expected to survive 2.03 years less than pre-pandemic patients, with a corresponding reduction in projected QALYs (-1.63). At the population level, reduced PCI access would lead to additional costs of €88.6 million. CONCLUSION: The effect of a 1-month lockdown on STEMI treatment led to a reduction in survival and QALYs compared to the pre-pandemic era. Moreover, in working-age patients, untimely revascularization led to adverse prognosis, affecting societal productivity and therefore considerably increasing societal costs.

Heterogeneity in the systems of pediatric diabetes care across the European Union.

BACKGROUND: It is known that the systems of pediatric diabetes care differ across the member states of the European Union (EU). The aim of this project was to characterize some of the main differences among the national systems. METHODS: Data were collected using two questionnaires. The first one was distributed among leading centers of pediatric diabetes (one per country) with the aim of establishing an overview of the systems, national policies, quality control (QC) and financing of pediatric diabetes care. Responses were received from all 27 EU countries. The second questionnaire was widely disseminated among all 354 International Society for Pediatric and Adolescent Diabetes members with a domicile in an EU country; it included questions related to individual pediatric diabetes centers. A total of 108 datasets were collected and processed from healthcare professionals who were treating more than 29 000 children and adolescents with diabetes. Data on the reimbursement policies were verified by representatives of the pharmaceutical and medical device companies. RESULTS: The collected data reflect the situation in 2009. There was a notable heterogeneity among the systems for provision of pediatric diabetes care across the EU. Only 20/27 EU countries had a pediatric diabetes register. Nineteen countries had officially recognized centers for pediatric diabetes, but only nine of them had defined criteria for becoming such a center. A system for QC of pediatric diabetes at the national level was reported in 7/26 countries. Reimbursement for treatment varied significantly across the EU, potentially causing inequalities in access to modern technologies. CONCLUSIONS: The collected data help develop strategies toward improving equity and access to modern pediatric diabetes care across Europe.

An overview and commentary on retrospective, continuous glucose monitoring for the optimisation of care for people with diabetes.

INTRODUCTION: Normoglycaemia in people with diabetes results in improved outcome. Continuous glucose monitoring provides detailed diagnostic information used to optimise therapy with the goal of achieving normoglycaemia. The objective of this study was to review the published literature evaluating the single device available for blinded, professional clinical use of continuous glucose monitoring; in particular all randomised controlled trials (RCTs) and relevant observational studies. METHODS: Published studies (to 31 March 2009) using the Medtronic MiniMed Continuous Glucose Monitoring System (CGMS System Gold, Medtronic MiniMed, Inc., Northridge, CA) were identified using appropriate search terms in a series of clinical databases including: Medline, Pubmed, Google Scholar and Scientific Web of Knowledge. Other measures were also taken such as reviewing the reference lists. FINDINGS: In addition to an extensive range of non-randomised studies using the device, seven randomised controlled trials were identified, of which five were in children. Although HbA1c was explicitly stated as the primary endpoint in four studies, the studies were only adequately powered to detect large, between-group minimum differences (range 0.5 to 1.0% HbA1c). Only two studies included subjects with type 2 diabetes. Other endpoints included the frequency of hypoglycaemia and hyperglycaemia. Within-group HbA1c decreases were observed in all but one study. The crude, weighted mean improvement in HbA1c across the studies using the device was 0.6% (range 0% to 0.8%). When compared to a control measure the weighted, mean marginal benefit in HbA1c was 0.2%. No studies recorded how the information was utilised to modify treatment, such as changes in dose titration or treatment regimen. CONCLUSIONS: Devices such as the professional CGMS provide detailed diagnostic information. However, any consequent changes in care and outcome can only result from the appropriate application of this information. Although there was a notable improvement in glucose control (HbA1c), existing studies were largely underpowered and did not capture the resulting treatment changes that could lead to improved outcome.

Valuing condition-specific health states using simulation contact lenses.

OBJECTIVE: This article reports on a study that used contact lenses to simulate the effects of a visual impairment caused by age-related macular degeneration (ARMD). The primary objective was to examine the feasibility of using this method of simulation. A secondary objective was to compare the results from this experiment with those obtained from ARMD patients (n = 209) using generic preference-based measures (Health Utilities Index 3 (HUI3) and EUROQOL 5 Dimensions (EQ-5D) and patient time trade-off (TTO). METHODS: Utility values were elicited from healthy participants (n = 108) for three ARMD states simulated using contact lenses. RESULTS: A significant relationship was found between visual acuity and TTO values elicited from our sample population (n = 108). It was stronger than that found for HUI3, EQ-5D, and own TTO values from patients (n = 209). Our sample values informed by the experience of simulation were found to be significantly different from values from patient TTO and generic preference-based measures obtained from patients for the same level of visual impairment. Sociodemographic characteristics did not significantly affect results, although baseline TTO utility values were positively associated with TTO values for simulated states. Nevertheless, the patient population was significantly older than the sample population. CONCLUSIONS: ARMD has a major impact on our sample values TTO health state values. Differences across four visual health severity groups appear larger than those found for a generic preference-based measure and patient TTO values. For conditions that are difficult to describe and imagine, simulation methods may offer an additional tool when combined with usual methods of description for obtaining better informed general population preferences.

An economic evaluation of valsartan for post-MI patients in the UK who are not suitable for treatment with ACE inhibitors.

OBJECTIVES: The overall objective of this study was to estimate the costs and outcomes associated with treatment with valsartan for post-myocardial infarction (post-MI) patients with left ventricular systolic dysfunction, heart failure, or both, who are not suitable for treatment with angiotensin-converting enzyme (ACE) inhibitors, compared to placebo. METHODS: A Markov model, using data drawn from the Valsartan in Acute Myocardial Infarction (VALIANT) trial and other trials, was developed to predict the future health pathways, resource use, and costs for patients who have recently experienced an MI. Patients received either valsartan (mean dose 247 mg) or placebo. Cost data were drawn from national databases and published literature, although health outcome utility weights were derived from existing studies. Patient outcomes were modeled for 10 years, and incremental cost-effective ratios were calculated for valsartan compared with placebo. RESULTS: Over a period of 10 years, a cohort of 1000 patients treated with valsartan experienced 147 fewer cardiovascular deaths, 37 fewer nonfatal MIs, and 95 fewer cases of heart failure than a cohort who received placebo. The incremental cost of valsartan, compared with placebo, was 2680 pound per patient, although the incremental effectiveness of valsartan was 0.5021 quality-adjusted life-years (QALYs) gained per patient. Therefore, the incremental cost per QALY for treatment with valsartan was 5338 pound. When analysis was undertaken using life-years rather than QALYs, the cost per life-year gained was 4672 pound. CONCLUSIONS: For patients who are not suitable for treatment with ACE inhibitors, valsartan is a viable and cost-effective treatment for their management after an MI.

Cost-effectiveness of letrozole versus tamoxifen as initial adjuvant therapy in hormone receptor-positive postmenopausal women with early-stage breast cancer.

BACKGROUND: In Breast International Group (BIG) 1-98, a randomized, double-blind trial comparing 5 years of initial adjuvant therapy with letrozole versus tamoxifen in postmenopausal women with hormone receptor-positive early breast cancer, letrozole significantly improved disease-free survival by 19% and reduced risk of breast cancer recurrence by 28% and distant recurrence by 27%. PATIENTS AND METHODS: A Markov model was used to estimate the incremental cost per quality-adjusted life year (QALY) gained with 5 years of initial adjuvant therapy with letrozole versus tamoxifen from a US health care system perspective. Probabilities and costs of breast cancer recurrence and treatment-related adverse events and health-state utilities were based on published results of BIG 1-98 and other published studies. Costs and QALYs were estimated over the lifetime of a cohort of postmenopausal women with hormone receptor-positive early breast cancer, aged 60 years at initiation of therapy. In our base case, we assumed that benefits of letrozole on risk of breast cancer recurrence are maintained for 5 years after therapy discontinuation ("carry-over effect") and examined the effects of this assumption on results in sensitivity analyses. RESULTS: Under base-case assumptions, letrozole yields an additional 0.409 QALYs versus tamoxifen at an additional cost of $9705, yielding a cost per QALY gained for letrozole versus tamoxifen of $23,743 (95% confidence interval, $14,087-$51,129). Assuming no carry-over effects, letrozole yields 0.264 QALYs at a cost of $10,341, for a cost per QALY gained of $39,098 (95% confidence interval, $23,968- $83,501). CONCLUSION: In postmenopausal women with hormone receptor-positive early breast cancer, initial adjuvant treatment with letrozole is cost-effective from the US health care system perspective.