Jan B. Pietzsch

Cost-effectiveness and clinical effectiveness of catheter-based renal denervation for resistant hypertension

OBJECTIVES The purpose of this study was to assess cost-effectiveness and long-term clinical benefits of renal denervation in resistant hypertensive patients. BACKGROUND Resistant hypertension affects 12% of hypertensive persons. In the Symplicity HTN-2 randomized controlled trial, catheter-based renal denervation (RDN) lowered systolic blood pressure by 32 ± 23 mm Hg from 178 ± 18 mm Hg at baseline. METHODS A state-transition model was used to predict the effect of RDN and standard of care on 10-year and lifetime probabilities of stroke, myocardial infarction, all coronary heart disease, heart failure, end-stage renal disease, and median survival. We adopted a societal perspective and estimated an incremental cost-effectiveness ratio in U.S. dollars per quality-adjusted life-year, both discounted at 3% per year. Robustness and uncertainty were evaluated using deterministic and probabilistic sensitivity analyses. RESULTS Renal denervation substantially reduced event probabilities (10-year/lifetime relative risks: stroke 0.70/0.83; myocardial infarction 0.68/0.85; all coronary heart disease 0.78/0.90; heart failure 0.79/0.92; end-stage renal disease 0.72/0.81). Median survival was 18.4 years for RDN versus 17.1 years for standard of care. The discounted lifetime incremental cost-effectiveness ratio was

An integrated health-economic analysis of diagnostic and therapeutic strategies in the treatment of moderate-to-severe obstructive sleep apnea.

3,071 per quality-adjusted life-year. Findings were relatively insensitive to variations in input parameters except for systolic blood pressure reduction, baseline systolic blood pressure, and effect duration. The 95% credible interval for incremental cost-effectiveness ratio was cost-saving to

Economic analysis of endovascular interventions for femoropopliteal arterial disease: A systematic review and budget impact model for the United States and Germany

31,460 per quality-adjusted life-year. CONCLUSIONS The model suggests that catheter-based renal denervation, over a wide range of assumptions, is a cost-effective strategy for resistant hypertension that might result in lower cardiovascular morbidity and mortality.

Economic analysis of endovascular drug-eluting treatments for femoropopliteal artery disease in the UK

STUDY OBJECTIVES Obstructive sleep apnea (OSA) is a common disorder associated with substantially increased cardiovascular risks, reduced quality of life, and increased risk of motor vehicle collisions due to daytime sleepiness. This study evaluates the cost-effectiveness of three commonly used diagnostic strategies (full-night polysomnography, split-night polysomnography, unattended portable home-monitoring) in conjunction with continuous positive airway pressure (CPAP) therapy in patients with moderate-to-severe OSA. DESIGN A Markov model was created to compare costs and effectiveness of different diagnostic and therapeutic strategies over a 10-year interval and the expected lifetime of the patient. The primary measure of cost-effectiveness was incremental cost per quality-adjusted life year (QALY) gained. PATIENTS OR PARTICIPANTS Baseline computations were performed for a hypothetical average cohort of 50-year-old males with a 50% pretest probability of having moderate-to-severe OSA (apnea-hypopnea index [AHI] ≥ 15 events per hour). MEASUREMENTS AND RESULTS For a patient with moderate-to-severe OSA, CPAP therapy has an incremental cost-effectiveness ratio (ICER) of

Long-Term Cost-Effectiveness of Upper Airway Stimulation for the Treatment of Obstructive Sleep Apnea: A Model-Based Projection Based on the STAR Trial.

15,915 per QALY gained for the lifetime horizon. Over the lifetime horizon in a population with 50% prevalence of OSA, full-night polysomnography in conjunction with CPAP therapy is the most economically efficient strategy at any willingness-to-pay greater than

Review of U.S. Medical Device Regulation

17,131 per-QALY gained because it dominates all other strategies in comparative analysis. CONCLUSIONS Full-night polysomnography (PSG) is cost-effective and is the preferred diagnostic strategy for adults suspected to have moderate-to-severe OSA when all diagnostic options are available. Split-night PSG and unattended home monitoring can be considered cost-effective alternatives when full-night PSG is not available.

Cost-Effectiveness of Endobronchial Valve Therapy for Severe Emphysema: A Model-Based Projection Based on the VENT Study

To study the economic impact on payers and providers of the four main endovascular strategies for the treatment of infrainguinal peripheral artery disease.

Cost-Effectiveness of Deep Brain Stimulation for Advanced Parkinson's Disease in the United States.

Objectives To estimate the clinical and economic impact of drug-eluting endovascular treatment strategies for femoropopliteal artery disease compared with current standard of care. Design Systematic literature search to pool target lesion revascularisations (TLR). Model-based per-patient cost impact and quasi-cost-effectiveness projection over 24 months based on pooled TLRs and current reimbursement. Setting The UKs National Health Service (NHS). Participants Patients presenting with symptomatic femoropopliteal disease eligible for endovascular treatment. Interventions Current National Institute for Health and Care Excellence (NICE) guideline-recommended treatment with percutaneous transluminal balloon angioplasty (PTA) and bailout bare metal stenting (BMS) versus primary BMS placement, or drug-coated balloon (DCB), or drug-eluting stent (DES) treatment. Primary and secondary outcome measures 24-month per-patient cost impact to NHS (primary outcome). Secondary outcomes: pooled 24-month TLR rates; numbers needed to treat (NNTs); cost per TLR avoided and estimated incremental cost-effectiveness ratio (ICER) in £ per quality-adjusted life year (QALY). Results N=28 studies were identified, reporting on 5167 femoropopliteal lesions. Over 24 months, DCB, DES and BMS reduced TLRs of de novo lesions from 36.2% to 17.6%, 19.4% and 26.9%, respectively, at an increased cost of £43, £44 and £112. NNTs to avoid 1 TLR in 24 months were 5.4, 6.0 and 10.8, resulting in cost per TLR avoided of £231, £264 and £1204. DCB was estimated to add 0.011 QALYs, DES 0.010 QALYs and BMS 0.005 QALYs, resulting in estimated ICERs of £3983, £4534 and £20 719 per QALY gained. A subset analysis revealed more favourable clinical and economic outcomes for a 3.5 µg/mm2 DCB with urea excipient, compared with the rest of DCBs. A modest reduction of 10% in DCB and DES prices made drug-eluting treatments dominant. Conclusions Widespread adoption of drug-eluting endovascular therapies for femoropopliteal disease would add meaningful clinical benefit at reasonable additional costs to the NHS. Based on currently available data, DCBs offer the highest clinical and economic value.

The cost-effectiveness of meniscal repair versus partial meniscectomy: A model-based projection for the United States

STUDY OBJECTIVES Upper airway stimulation (UAS) is a new approach to treat moderate-to-severe obstructive sleep apnea. Recently, 12-month data from the Stimulation Treatment for Apnea Reduction (STAR) trial were reported, evaluating the effectiveness of UAS in patients intolerant or non-adherent to continuous positive airway pressure therapy. Our objective was to assess the cost-effectiveness of UAS from a U.S. payer perspective. DESIGN A 5-state Markov model was used to predict cardiovascular endpoints (myocardial infarction [MI], stroke, hypertension), motor vehicle collisions (MVC), mortality, quality-adjusted life years (QALYs), and costs. We computed 10-year relative event risks and the lifetime incremental cost-effectiveness ratio (ICER) in

Bayesian assessment of overtriage and undertriage at a level I trauma centre

/QALY, comparing UAS therapy to no treatment under the assumption that the STAR trial-observed reduction in mean apnea-hypopnea index from 32.0 to 15.3 events/h was maintained. Costs and effects were discounted at 3% per year. SETTING U.S. healthcare system; third-party payer perspective. PARTICIPANTS 83% male cohort with mean age of 54.5 years. INTERVENTIONS UAS vs. no treatment. MEASUREMENTS AND RESULTS UAS substantially reduced event probabilities over 10 years (relative risks: MI 0.63; stroke 0.75; MVC 0.34), and was projected to add 1.09 QALYs over the patients lifetime. Costs were estimated to increase by