Disparities in the Use of Sacral Neuromodulation among Medicare Beneficiaries.

PURPOSE: Sacral neuromodulation with the InterStim® has been done to treat urinary and bowel control. There are limited data in the literature on use trends of sacral neuromodulation. We explored disparities in use among Medicare beneficiaries. MATERIALS AND METHODS: We queried a 5% national random sample of Medicare claims for 2001, 2004, 2007 and 2010. All patients with an ICD-9 diagnosis code representing a potential urological indication for sacral neuromodulation were included. Patients who underwent device implantation were identified using CPT-4 codes. Statistical analysis was done with the chi-square and Fisher tests, and multivariate logistic regression using software. RESULTS: A total of 2,322,060 patients were identified with a diagnosis that could potentially be treated with sacral neuromodulation. During the 10-year study period the percent of these patients who ultimately underwent implantation increased from 0.03% to 0.91% (p <0.0001) for a total of 13,360 (0.58%). On logistic regression analysis women (OR 3.85, p <0.0001) and patients younger than 65 years (OR 1.00 vs 0.29 to 0.39, p <0.0001) were more likely to be treated. Minority patients (OR 0.38, p <0.0001) and those living in the western United States (OR 0.52, p <0.0001) were less likely to receive treatment. CONCLUSIONS: Sacral neuromodulation use significantly increased among Medicare beneficiaries in a 10-year period. Patients were more likely to be treated with sacral neuromodulation if they were female, white, younger (younger than 65 years) and living outside the western United States.

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.

Posterior tibial nerve stimulation for fecal incontinence: where are we?

Neurostimulation remains the mainstay of treatment for patients with faecal incontinence who fails to respond to available conservative measures. Sacral nerve stimulation (SNS) is the main form of neurostimulation that is in use today. Posterior tibial nerve stimulation (PTNS)--both the percutaneous and the transcutaneous routes--remains a relatively new entry in neurostimulation. Though in its infancy, PTNS holds promise to be an effective, patient friendly, safe and cheap treatment. However, presently PTNS only appears to have a minor role with SNS having the limelight in treating patients with faecal incontinence. This seems to have arisen as the strong, uniform and evidence based data on SNS remains to have been unchallenged yet by the weak, disjointed and unsupported evidence for both percutaneous and transcutaneous PTNS. The use of PTNS is slowly gaining acceptance. However, several questions remain unanswered in the delivery of PTNS. These have raised dilemmas which as long as they remain unsolved can considerably weaken the argument that PTNS could offer a viable alternative to SNS. This paper reviews available information on PTNS and focuses on these dilemmas in the light of existing evidence.

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.

Outcome and cost analysis of sacral nerve modulation for treating urinary and/or fecal incontinence.

BACKGROUND: Sacral nerve modulation (SNM) is an established treatment for urinary and fecal incontinence in patients for whom conservative management has failed. OBJECTIVE: This study assessed the outcome and cost analysis of SNM compared to alternative medical and surgical treatments. METHODS: Clinical outcome and cost-effectiveness analyses were performed in parallel with a prospective, multicenter cohort study that included 369 consecutive patients with urge urinary and/or fecal incontinence. The duration of follow-up was 24 months, and costs were estimated from the national health perspective. Cost-effectiveness outcomes were expressed as incremental costs per 50% of improved severity scores (incremental cost-effectiveness ratio). RESULTS: The SNM significantly improved the continence status (P < 0.005) and quality of life (P < 0.05) of patients with urge urinary and/or fecal incontinence compared to alternative treatments. The average cost of SNM for urge urinary incontinence was ∈8525 (95% confidence interval, ∈6686-∈10,364; P = 0.001) more for the first 2 years compared to alternative treatments. The corresponding increase in cost for subjects with fecal incontinence was ∈6581 (95% confidence interval, ∈2077-∈11,084; P = 0.006). When an improvement of more than 50% in the continence severity score was used as the unit of effectiveness, the incremental cost-effectiveness ratio for SNM was ∈94,204 and ∈185,160 at 24 months of follow-up for urinary and fecal incontinence, respectively. CONCLUSIONS: The SNM is a cost-effective treatment for urge urinary and/or fecal incontinence.

Sacral neuromodulation for the treatment of fecal incontinence: analysis of cost-effectiveness.

PURPOSE: The cost-effectiveness and budget impact of introducing sacral nerve modulation (SNM) as a treatment for fecal incontinence in Italy were evaluated in a simulation model. METHODS: A decision-analysis model with a Markov submodel was used to represent clinical pathways for treatment of patients with fecal incontinence in a scenario with SNM and a scenario without SNM. Data were obtained from published studies and from an expert panel. Evaluation of resource consumption was conducted from the perspective of the Italian National Health Service, and costs were retrieved from the Italian NHS procedures reimbursement list. The time horizon was 5 years, and a 3% discount rate was applied to costs and outcomes. Effectiveness was measured in symptom-free years and in quality-adjusted life-years (QALYs). Fecal incontinence prevalence data and SNM usage forecasts were used to estimate budget impact over the next 5 years. RESULTS: The incremental cost-effectiveness ratio for introducing SNM was €28,285 per QALY gained for patients with a structurally deficient anal sphincter and €38,662 per QALY gained for patients with intact anal sphincters. If a threshold of €40,000 per QALY gained is set as the level that a decision-maker would regard as cost-effective, the probability that the introduction of SNM will be cost-effective would be 99% for patients with a structurally deficient sphincter and 53% for patients with an intact sphincter. Budget impact analysis showed that introducing SNM would have an estimated budget impact of 0.56% over 5 years on the budget allocated for fecal incontinence treatment. CONCLUSION: Our data show SNM to be an efficient investment with an acceptable incremental cost-effectiveness ratio and a limited impact on the total allocated budget for fecal incontinence.

Clinical and cost effectiveness of sacral nerve stimulation for faecal incontinence.

BACKGROUND: Sacral nerve stimulation (SNS) has better results and safety than other surgical procedures for faecal incontinence. This prospective study assessed the clinical effectiveness and costs of SNS at a single centre. METHODS: Patients who had experienced one or more episodes of faecal incontinence were studied for up to 5 years by continence diary, anorectal manometry and quality of life questionnaires. Direct medical costs were calculated and the cost-effectiveness of the treatment was analysed. RESULTS: Fifty-seven percutaneous nerve evaluations were performed in 47 patients between June 1999 and February 2006; 29 patients underwent permanent implantation. After a median follow-up of 34.7 (range 2.3-81.2) months, 25 of the 29 patients had a significant reduction in incontinence episodes; 14 patients were in complete remission. At 3-year follow-up, the mean reduction in incontinence episodes was 89 per cent. No change was observed in anal manometric values. Patients reported a significant improvement in quality of life. The introduction of SNS has an incremental cost-effectiveness ratio, below the accepted Spanish threshold. CONCLUSION: The introduction of SNS to the management of faecal incontinence within the Spanish setting is both effective and efficient.

Economic evaluation of sacral nerve stimulation for faecal incontinence.

BACKGROUND: Sacral nerve stimulation (SNS) is an established treatment for faecal incontinence in patients who have failed conservative management. This study established the cost-effectiveness of treating patients with SNS compared with non-surgical treatment. METHODS: A decision analysis model was performed. Data from 70 patients were obtained from medical records, bowel habit diaries and Short Form 36 quality of life questionnaires. Direct medical and non-medical costs were ascertained using the 2005/2006 national tariff, national statistics, and medication, pad and device costs. Indirect non-medical costs were also estimated. RESULTS: Incontinence episodes were reduced from a median of 12 per fortnight at baseline to one per fortnight with SNS. Based on direct medical and non-medical costs, the incremental cost-effectiveness ratio (ICER) for SNS was pound25 070 per QALY gained. It cost pound1038 more per year to treat patients with SNS for a median reduction of 286 incontinence episodes, equating to pound3.63 per episode reduced. When indirect non-medical costs were included the ICER was reduced to pound12 959 per QALY gained. CONCLUSION: The ICER of pound25 070 is within the pound30 000 per QALY threshold recommended by the National Institute for Health and Clinical Excellence as an effective use of National Health Service resources with proper justification.

Cost-effectiveness analysis of sacral neuromodulation (SNM) with Interstim for fecal incontinence patients in Spain.

INTRODUCTION: Fecal incontinence (FI) is a condition with a high impact on the psychological and social life of healthy people. Interstim, the sacral neuromodulation (SNM) therapy, has shown higher effectiveness and safety rates than surgical procedures like dynamic graciloplasty or artificial anal sphincter in patients with intact anal sphincter (IAS) and after sphincteroplasty in patients with structurally deficient anal sphincter (SDAS). OBJECTIVE: To assess the cost-effectiveness of FI management in two scenarios - with and without SNM - and to estimate the potential budget impact of its progressive introduction in the Spanish setting. METHODS: Two decision analytical models were developed (IAS and SDAS patients) representing the possible clinical paths for each of the scenarios (with and without SNM), as well as its clinical and economic consequences in the mid-to long term with a Markov model. Clinical and resource use data were retrieved from the literature and validated by a clinician expert panel. Effectiveness was measured with both QALYs and symptom-free years (SFY). A 3% discount rate was used for future costs and benefits (time horizon = 5 years). Prevalence figures were combined with Interstim sales forecasts to estimate the total number of patients to receive therapy over the next 5 years and the associated budget impact. RESULTS: The introduction of Interstim in the therapeutic management of FI has an associated cost-effectiveness of euro16 181 (IAS patients) and euro22 195 (SDAS patients) per QALY gained. The progressive introduction of Interstim in 75 to 100 patients/year will have an estimated budget impact of 0.1% of incremental costs in patients with FI. CONCLUSIONS: Introducing Interstim in the management of FI in IAS and SDAS patients in the Spanish setting has shown to be an efficient measure with an incremental cost-effectiveness ratio below the accepted Spanish threshold (around euro35 000/QALY), and with a relatively low additional cost for the Spanish NHS.

Outcome and cost analysis of sacral nerve stimulation for faecal incontinence.

BACKGROUND: Sacral nerve stimulation (SNS) may be successful in treating incapacitating faecal incontinence. The technique is expensive, and no cost analysis is currently available. The aim of this study was to assess clinical outcome and analyse cost-effectiveness. METHODS: Thirty-six consecutive patients underwent a two-stage SNS procedure. Outcome parameters and real costs were assessed prospectively. RESULTS: SNS was tested successfully in 33 of 36 patients, and 31 patients were stimulated permanently. In the first stage, eight of 36 patients reported minor complications (pain, infection or electrode dislocation), resulting in a cost of euro 4053 (range euro 2838-7273) per patient. For the second stage (permanent stimulation), eight of 33 patients had an infection, pain or loss of effectiveness, resulting in a cost of euro 11,292 (range euro 7406-20,274) per patient. Estimated costs for further follow-up were euro 997 per year. The 5-year cumulative cost for SNS was euro 22,150 per patient, compared with euro 33,996 for colostomy, euro 31,590 for dynamic graciloplasty and euro 3234 for conservative treatment. CONCLUSION: SNS is a highly cost-effective treatment for faecal incontinence. Options for further reduction of SNS costs include strict patient selection, treatment in an outpatient setting and using cheaper devices.

Long-term cost of fecal incontinence secondary to obstetric injuries.

INTRODUCTION: Anal incontinence is eight times more frequent in females than in males because of injuries sustained at childbirth. The aim of the present study was to determine the long-term costs associated with anal incontinence related to obstetric injuries. METHODS: Sixty-three patients with anal incontinence caused by obstetric sphincter injuries answered questionnaires regarding previous treatments, symptoms, and use of protective products. Of the patients, 31 were treated surgically, 11 with biofeedback, 6 with a combination of surgery and biofeedback, and 15 conservatively. Treatments and their respective costs were obtained from patient records, patient questionnaires, billing database, and Health Care Financing Administration's 1996 inpatient database. Costs were expressed in 1996 dollars. RESULTS: The mean incontinence score changed from 26 at evaluation to 16 at follow-up (P < 0.001). The average cost per patient was $17,166. Evaluation and follow-up charges totaled $65,412, and physiologic assessment accounted for 64 percent of these costs. Treatment charges totaled $559,341, and physician charges accounted for 18 percent of these charges. CONCLUSIONS: Fecal incontinence after childbirth results in substantial economic costs, and treatment is not always successful. New treatment modalities, such as artificial bowel sphincter or dynamic graciloplasty, should be assessed to determine their cost-effectiveness.

Spina bifida: the personal and financial cost of incontinence.

Spina bifida is a congenital defect in the spinal column in which one or more vertebrae fail to form. The effect of spina bifida on continence is usually complicated by the effect of hydrocephalus on the ability to learn and master the necessary skills to overcome the problems. The childhood and adolescence of some individuals who have spina bifida has been ruined by professionals who chose to ignore the wider implications of severe congenital disability and its effects upon the child's education, personal and social development, and the quality of family life. A holistic approach to management, from birth onwards, should facilitate the interdisciplinary cooperation which is vital if these human tragedies are to be avoided.