Cost-effectiveness of transcatheter versus surgical aortic valve replacement in patients at lower surgical risk: results from the NOTION trial.

AIMS: The aim of this study was to estimate the cost-effectiveness of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) in patients at lower surgical risk. METHODS AND RESULTS: Discounted costs from a societal perspective and effectiveness as quality-adjusted life years (QALYs) were projected to lifetime via a decision-analytic model calibrated to 60-month data from the NOTION trial. The base case assumed a scenario in which any mortality benefit would gradually fade out over time, with other scenarios explored in sensitivity analyses. The incremental cost-effectiveness ratio (ICER) was compared to the country-specific willingness-to-pay (WTP) threshold of 1.13 million Danish kroner (DKK). The base case ICER was DKK 696,264/QALY (around €72,100/QALY via purchasing parity adjustment). Variation in long-term mortality beyond five years led to limited variation of incremental costs (DKK 64,200 to 64,600), but a more pronounced variation in incremental QALYs (0.07 to 0.19 QALYs for most conservative and optimistic assumptions, compared to base case of 0.09 QALYs). All resulting ICERs (range DKK 334,200 to DKK 904,100 per QALY gained) were below the WTP threshold. CONCLUSIONS: TAVI in a cohort of primarily low surgical risk patients was found to be a cost-effective treatment strategy in the Danish healthcare system. Cost-effectiveness analyses in other settings are warranted as are registries given the sensitivity of the model to long-term mortality.

Clinical and Economic Benefits of Upper Airway Stimulation for Obstructive Sleep Apnea in a European Setting.

BACKGROUND: Upper airway stimulation (UAS) is a treatment approach for patients with moderate-to-severe obstructive sleep apnea who cannot adhere to continuous positive airway pressure therapy. OBJECTIVE: The objective was to evaluate added patient benefit and cost-effectiveness of UAS in the German health care system. METHODS: We used a decision-analytic Markov model to project major adverse cardiovascular or cerebrovascular events (myocardial infarction [MI] or stroke), motor vehicle collision (MVC), mortality, quality-adjusted life years (QALYs), and costs. The assumed reduction in the apnea-hypopnea index with UAS compared to no treatment is based on German real-world data. Other input data were derived from the literature, public statistics, and multivariate regression. Cost-effectiveness was evaluated in Euros per QALY gained, both discounted at 3%. RESULTS: UAS was projected to reduce event risks (10-year relative risk for stroke, MI, cardiovascular death, and MVC: 0.76, 0.64, 0.65, and 0.34, respectively), and to increase survival by 1.27 years. While the UAS strategy incurred an additional 1.02 QALYs within the patient lifetime, there were also additional costs of EUR 45,196, resulting in an incremental cost-effectiveness ratio of EUR 44,446 per QALY gained. -Conclusions: In the present model-based analysis, UAS therapy provides meaningful benefit to patient-relevant endpoints and is a cost-effective therapy in the German setting.

Insights from eight years of adoption experience of transcatheter mitral valve repair in Germany: observed utilisation patterns and impact on overall mitral valve procedure volumes.

AIMS: The German healthcare system was among the first to introduce transcatheter mitral valve repair (TMVR) into routine care. The objective of this study was to analyse adoption and utilisation patterns and to estimate the impact of TMVR availability on mitral valve (MV) procedure volumes in the first eight years after commercialisation. METHODS AND RESULTS: Procedure volumes were collected from German Federal Statistics Office databases for TMVR and mitral valve surgery (MVS) from 2008-2015. Procedure volumes were stratified by age group (<65, 65-74, 75-84, ≥85 years). Overall procedure volumes grew from 14,525 to 24,898 (+71%). MVS procedures grew from 14,477 to 20,402 (+41%) (p=0.008). The proportion of TMVR procedures grew from 0.3% (48 procedures) to 18.1% (4,496 procedures) (p=0.008). In 2015, TMVR use reached 5%, 15%, 31%, and 68% of overall MV procedures in the studied age groups (<65, 65-74, 75-84, ≥85 years). MVS volumes grew in all age groups, with the highest increase in the age group <65 (+2,945). CONCLUSIONS: The availability of TMVR has contributed to a pronounced increase in MV procedure volumes in Germany. Simultaneously, MVS procedure volumes continued to grow substantially. The highest increase of TMVR was observed in elderly populations, suggesting referral of patients with MV disease previously left untreated.

Evolution of mitral valve procedural volumes in the advent of endovascular treatment options: Experience at an early-adopting center in Germany.

OBJECTIVES: Our objectives were to assess the evolution of surgical and endovascular mitral valve procedural volumes and to study utilization and reimbursement effects of transcatheter mitral valve repair (TMVR) at our center and to put these in perspective with the corresponding data at the national level. BACKGROUND: TMVR using the MitraClip system has been available in Germany since 2008 as a complementary treatment option for high-risk or inoperable patients. METHODS: Relevant procedure codes were identified for 2006-2012 and yearly utilization volumes obtained from our center's databases and from the national statistics office. Volumes were analyzed in total, and stratified by treatment approach. Procedure reimbursement at our center was determined for years 2007-2012. RESULTS: At our center, 378 MitraClip procedures were performed from 2008 to 2012. During this period, surgical volumes grew at an average of 10.6% annually (2008: 262; 2012: 392; 49.6% total growth rate). Total surgical and TMVR reimbursement increased from EUR 3.8 million (2007) to EUR 7.9 million (2012). By comparison, mitral valve procedural volumes grew by 56.1% from 2006 to 2012 at the national level, with TMVR constituting 9.1% of 20,328 procedures in 2012. Since the introduction of MitraClip, nationwide surgical procedural volumes grew at an average of 6.3% annually (2008: 14,477; 2012: 18,478; 27.6% total growth rate). CONCLUSIONS: Growth in procedural volumes during 2006-2012 reflects an increasing supply and subsequent demand for mitral valve procedures. The introduction of TMVR has contributed to overall growth, and has not reduced continued growth in surgical volumes. Our center-specific analysis suggests a "halo effect" of an integrated approach to mitral valve disease contributing to additional growth in surgical and overall reimbursement volumes.

Perinatal screening for group B streptococci: cost-benefit analysis of rapid polymerase chain reaction.

OBJECTIVE: To evaluate the costs and benefits of a group B streptococci screening strategy using a new, rapid polymerase chain reaction test in a hypothetical cohort of expectant mothers in the United States. DESIGN: Cost-benefit analysis using the human capital method. We developed a decision model to analyze the costs and benefits of a hypothetical group B streptococci screening strategy using a new, rapid polymerase chain reaction test as compared with the currently recommended group B streptococci screening guidelines-prenatal culture performed at 35 to 37 weeks or risk-factor-based strategy with subsequent intrapartum treatment of the expectant mothers with antibiotics to prevent early-onset group B streptococcal infections in their infants. PARTICIPANTS: A hypothetical cohort of pregnant women and their newborns. INTERVENTIONS: Screening strategies for group B streptococci using the new polymerase chain reaction technique, the 35- to 37-week culture, or maternal risk factors. OUTCOME MEASURES: Infant infections averted, infant deaths, infant disabilities, costs, and societal benefits of healthy infants. RESULTS: A screening strategy using the new polymerase chain reaction test generates a net benefit of $7 per birth when compared with the maternal risk-factor strategy. For every 1 million births, 80 700 more women would receive antibiotics, 884 fewer infants would become infected with early-onset group B streptococci, and 23 infants would be saved from death or disability. The polymerase chain reaction-based strategy generates a net benefit of $6 per birth when compared with the 35- to 37-week prenatal culture strategy and results in fewer maternal courses of antibiotics (64 080 per million births), fewer perinatal infections with early-onset group B streptococci (218/million), and a reduction in 6 infant deaths and severe infant disability per million births. The benefits hold over a wide range of assumptions regarding key factors in the analysis. CONCLUSIONS: Although additional clinical trials are needed to establish the accuracy of this new polymerase chain reaction test, initial studies suggest that strategies using this test will be superior to the other 2 strategies. Using the rapid polymerase chain reaction test becomes less attractive as the cost of the test increases. The test's greatest strengths lie in its ability to identify women and infants at risk at the time of labor, thereby decreasing the number of false-positives and false-negatives seen with the other 2 strategies and allowing for more accurate and effective intrapartum prophylaxis.