An early analysis of cost-utility of baroreflex activation therapy in advanced chronic heart failure in Germany.

BACKGROUND: This study aimed to evaluate cost-utility of baroreflex activation therapy (BAT) using the Barostim neo™ device (CVRx Inc., Minneapolis, MN, USA) compared with optimized medical management in patients with advanced chronic heart failure (NYHA class III) who were not eligible for treatment with cardiac resynchronization therapy, from a statutory health insurance perspective in Germany over a lifetime horizon. METHODS: A decision analytic model was developed using the combination of a decision tree and the Markov process. The model included transitions between New York Heart Association (NYHA) health states, each of which is associated with a risk of mortality, hospitalization, cost, and quality of life. The effectiveness of BAT was projected through relative risks for mortality (obtained by application of patient-level data to the Meta-analysis Global Group in Chronic Heart Failure risk prediction model) and hospitalization owing to worsening of heart failure (obtained from BAT Randomized Clinical Trial). All patients were in NYHA class III at baseline. RESULTS: BAT led to an incremental cost of €33,185 (95% credible interval [CI] €24,561-38,637) and incremental benefits of 1.78 [95% CI 0.45-2.71] life-years and 1.19 [95% CI 0.30-1.81] quality-adjusted life-years (QALYs). This resulted in an incremental cost-effectiveness ratio of €27,951/QALY (95% CI €21,357-82,970). BAT had a 59% probability of being cost-effective at a willingness-to-pay threshold of €35,000/QALY (but 84% at a threshold of €52,000/QALY). CONCLUSIONS: BAT can be cost-effective in European settings in those not eligible for cardiac resynchronization therapy among patients with advanced heart failure.

Cost profiles and budget impact of rechargeable versus non-rechargeable sacral neuromodulation devices in the treatment of overactive bladder syndrome.

OBJECTIVES: Sacral neuromodulation (SNM) is a guideline-recommended third-line treatment option for managing overactive bladder. Current SNM devices are not rechargeable, and require neurostimulator replacement every 3-6 years. Our study objective was to assess potential cost effects to payers of adopting a rechargeable SNM neurostimulator device. METHODS: We constructed a cost-consequence model to estimate the costs of long-term SNM-treatment with a rechargeable versus non-rechargeable device. Costs were considered from the payer perspective at 2015 reimbursement levels. Adverse events, therapy discontinuation, and programming rates were based on the latest published data. Neurostimulator longevity was assumed to be 4.4 and 10.0 years for non-rechargeable and rechargeable devices, respectively. A 15-year horizon was modeled, with costs discounted at 3% per year. Total budget impact to the United States healthcare system was estimated based on the computed per-patient cost findings. RESULTS: Over the 15-year horizon, per-patient cost of treatment with a non-rechargeable device was $64,111 versus $36,990 with a rechargeable device, resulting in estimated payer cost savings of $27,121. These cost savings were found to be robust across a wide range of scenarios. Longer analysis horizon, younger patient age, and longer rechargeable neurostimulator lifetime were associated with increased cost savings. Over a 15-year horizon, adoption of a rechargeable device strategy was projected to save the United States healthcare system up to $12 billion. CONCLUSIONS: At current reimbursement rates, our analysis suggests that rechargeable neurostimulator SNM technology for managing overactive bladder syndrome may deliver significant cost savings to payers over the course of treatment. Neurourol. Urodynam. 36:727-733, 2017. © 2016 Wiley Periodicals, Inc.

Resource implications of running a sacral neuromodulation service: a 10-year experience.

AIM: In this study we reviewed our 10-year experience of the medium- to long-term success of sacral nerve stimulation (SNS) for faecal incontinence, with particular reference to the resource implications of running such a service. METHOD: All patients treated with permanent SNS implants for faecal incontinence from 2001 to 2012 were identified from a prospective database. The patients underwent follow up at 3 and 6 months, with annual review thereafter. They were divided into four groups: group 1, patients optimized after two reviews; group 2, patients optimized after further review; group 3, patients who failed to reach a satisfactory state; and group 4, patients who had a good initial result with subsequent failure. RESULTS: Eighty-five patients underwent permanent SNS with a median follow up of 24 (range: 3-108) months. Group 1 included 30 (35%) patients; group 2 included 27 (32%) patients [median of two (range: 2-6) additional visits]; group 3 included 18 (21%) patients [median of six (range: 3-10) additional visits]; and group 4 included 10 (12%) patients [median interval to failure was 54 (range: 24-84) months]. Twenty-seven per cent of our patients had an unsatisfactory outcome and the cost of follow up for these patients was £36,854 (48.7% of the total follow-up costs). CONCLUSION: The study highlights the significant resource implications of running an SNS service with a large proportion of patients requiring prolonged review, with more than one-quarter having an unsatisfactory outcome at a substantial cost.

Sacral nerve stimulation for urinary dysfunction: the first year of the Scottish national service.

Sacral nerve stimulation (SNS) has become an established treatment option for patients with intractable detrusor overactivity and non-obstructive urinary retention. The Scottish Sacral Nerve Stimulation service was established in April 2010 to provide a service for the population of Scotland. We report our experience from the first year of this new national service. All patients referred for SNS from the inception of the service in April 2010 until the end of March 2011 were studied. During the one-year period, there were 50 referrals. Thirty-three percutaneous nerve evaluations, eight tined lead tests and 16 permanent implantation procedures were performed during this period. Morbidity was low and both incontinence and quality-of-life questionnaires demonstrated statistically significant improvements (International Consultation on Incontinence Questionnaire [ICIQ-SF], P = 0.005; Incontinence Impact Questionnaire [IIQ 7], P = 0.0007; Urogenital Distress Inventory [UDI 6], P = 0.0002). Referral pattern was skewed towards the west of Scotland with some health boards producing no referrals during the year. Results from the first year of the service have shown that it is a safe and efficient procedure with significant improvement in incontinence, voluntary voiding and quality-of-life parameters. The limitation of funding for permanent implants inevitably impacts on the role of the technique as a management option in these patients.

Cost-effectiveness analysis of sacral neuromodulation for faecal incontinence in The Netherlands.

AIM: Sacral neuromodulation (SNM) plays a major part in the algorithm of management of faecal incontinence, but there are limited data on its cost-effectiveness. This study aimed to analyse this and the quality-adjusted life-years (QALYs) associated with two different treatment algorithms. The first (SNM-) included use of an artificial sphincter [dynamic graciloplasty (DGP) (50%) and artificial bowel sphincter (ABS) (50%)]. The second (SNM+) included SNM (80% of cases) and artificial sphincter (DGP 10%; ABS 10%) The incidence of sphincteroplasty was assumed to be equal in both algorithms. METHOD: A Markov model was developed. A hypothetical cohort of patients was run through both strategies of the model. A mailed EuroQoL-5D questionnaire was used to determine health-related quality of life. Costs were reproduced from the Maastricht University Medical Centre prospective faecal incontinence database. The time scale of the analysis was 5 years. RESULTS: The former treatment protocol cost €22,651 per patient and the latter, after the introduction of SNM, cost €16,473 per patient. The former treatment protocol resulted in a success rate of 0.59 after 5 years, whereas with the introduction of SNM this was 0.82. Adhering to the former treatment protocol yielded 4.14 QALYs and implementing the latter produced 4.21 QALYs. CONCLUSION: The study demonstrated that introducing SNM in the surgical management algorithm for faecal incontinence was both more effective and less costly than DGP or ABS without SNM. This justifies adequate funding for SNM for patients with faecal incontinence.

Comparison of patients undergoing a two-stage sacral nerve stimulation procedure: is there a cost benefit for a single-stage procedure?

AIMS: Sacral neurostimulation (SNS) involves a two-stage procedure to assess outcomes prior to permanent implantation. Stage 1 involves placement of a sacral lead that is externalized and tested for 2 weeks. Stage 2 is the implantation of a pulse generator in responders (≥ 50% improved). This study's purpose was to determine the overall response rate, costs of a two-staged versus single-stage approach, and explore predictors of a positive response. METHODS: A prospective database of 145 patients undergoing SNS was analyzed. Demographics, history, and operative data were collected from the medical records. Cost data were collected from our institutions' reported average reimbursement for all stages of Interstim implantation and explantation in 2008. Wilcoxon rank test were used for analysis. RESULTS: Of 145 patients, 131 (90.3%) progressed to Stage 2 and 14 (9.7%) had removal. Explanted patients were older (mean 63 years) than implanted patients (56 years); however, this was not statistically significant. Total Medicare and Blue Cross/Blue Shield (BCBS) reimbursement for a two-stage procedure was calculated at $21,428/case and $26,968. Implanting the lead and generator as a single-stage would cost Medicare and BCBS $20,696 and $21,602, respectively. Since 9.7% were explanted, overall cost saving might be significant: a single-stage approach would yield savings of $3,655/case (BC/BS) over a two-stage approach (after the cost of explantation is factored in). CONCLUSIONS: The majority of patients tested with SNS would benefit from a single-stage procedure (90.3%). This would reduce operative and anesthesia risks, time lost from work, and burden on patients and providers.