Cost-effectiveness of taurolidine locks to prevent recurrent catheter-related blood stream infections in adult patients receiving home parenteral nutrition: a 2-year mirror-image study.

BACKGROUND & AIMS: The use of long-term taurolidine locks (LTTL) seems to be effective in preventing catheter-related blood stream infections (CRBSI), especially in patients on home parenteral nutrition (HPN). This work targets the cost-effectiveness of LTTL in a cohort of adult HPN patients. METHODS: A monocentric mirror-image design study was conducted in our referral centre among long-term HPN patients experiencing recurrent CRBSI. From 7th January 2011, LTTL were started after the third CRBSI episode within 12 months. CRBSI data was prospectively collected until 7th January 2013, in the same way as it had retrospectively been done before initiating LTTL. A cost-effective analysis was conducted to estimate the incremental costs and effects on CRBSI with LTTL. The efficacy of LTTL on CRBSI rate was assessed over 1000 days of catheter use. RESULTS: A total of 31,100 catheter days were analysed in 37 patients (median [interquartile range (IQR)]) aged 58 [42-68] years. The mean ± SD proven CRBSI rate was 3.18 ± 3.51 per 1000 catheter days before the introduction of LTTL and 0.39 ± 1.50 per 1000 catheter days after its introduction (p < 0.0001). Considering both proven and probable CRBSI requiring hospital management, LTTL reduced by (mean [bootstrap CI 95%]) -2.63 [-3.26 to -2.06] infections per patient (from 2.89 [2.31 to 3.49] before to 0.26 [0.13 to 0.41] after) as well as incremental costs by -7 258 [-10 450 to -4 016] € (from 11 176 [8 004 to 14 968] € before to 3 918 [2 390 to 5 445] € after). CONCLUSION: Implementing LTTL to prevent recurrent CRBSI is cost-effective by dramatically decreasing their incidence.

Clinical and economic impact of the taurolidine lock on home parenteral nutrition.

INTRODUCTION: catheter-related bloodstream infections (CRBSI) are one of the most serious concerns in patients on home parenteral nutrition (HPN) which involve high morbidity and cost for the healthcare system. In the last years, taurolidine lock has proven to be beneficial in the prevention of CRBSI; however, the evidence of its efficiency is limited. OBJECTIVE: to determine if taurolidine lock is a cost-effective intervention in patients on HPN. MATERIALS AND METHODS: retrospective study in patients on HPN with taurolidine lock. We compared the CRBSI rate and cost of its complications before and during taurolidine lock. RESULTS: thirteen patients, six (46%) males and seven (54%) females, with a mean age of 61.08 (SD = 14.18) years received taurolidine lock. The total days of catheterization pre and per-taurolidine were 12,186 and 5,293, respectively. The underlying disease was benign in five patients (38.5%) and malignant in eight (61.5%). The CRBSI rate pre vs per-taurolidine was 3.12 vs 0.76 episodes per 1,000 catheter days (p = 0.0058). When the indication was a high CRBSI rate, this was 9.72 vs 0.39 (p < 0.001) in pre and per-taurolidine period respectively. No differences have been observed in the occlusion rates. None of the patients reported any adverse effects. The total cost of CRBSI in the pre-taurolidine period was 151,264.14 euros vs 24,331.19 euros in the per-taurolidine period. CONCLUSIONS: our study shows that taurolidine lock is a cost-effective intervention in patients on HPN with high risk of CRBSI.

Randomised clinical trial: 2% taurolidine versus 0.9% saline locking in patients on home parenteral nutrition.

BACKGROUND: The catheter lock solutions 2% taurolidine and 0.9% saline are both used to prevent catheter-related bloodstream infections (CRBSIs) in home parenteral nutrition patients. AIMS: To compare the effectiveness and safety of taurolidine and saline. METHODS: This multicentre double-blinded trial randomly assigned home parenteral nutrition patients to use either 2% taurolidine or 0.9% saline for 1 year. Patients were stratified in a new catheter group and a pre-existing catheter group. Primary outcome was the rate of CRBSIs/1000 catheter days in the new catheter group and pre-existing catheter group, separately. RESULTS: We randomised 105 patients, of which 102 were analysed as modified intention-to-treat population. In the new catheter group, rates of CRBSIs/1000 catheter days were 0.29 and 1.49 in the taurolidine and saline arm respectively (relative risk, 0.20; 95% CI, 0.04-0.71; P = 0.009). In the pre-existing catheter group, rates of CRBSIs/1000 catheter days were 0.39 and 1.32 in the taurolidine and saline arm respectively (relative risk, 0.30; 95% CI, 0.03-1.82; P = 0.25). Excluding one outlier patient in the taurolidine arm, mean costs per patient were $1865 for taurolidine and $4454 for saline (P = 0.03). Drug-related adverse events were rare and generally mild. CONCLUSIONS: In the new catheter group, taurolidine showed a clear decrease in CRBSI rate. In the pre-existing catheter group, no superiority of taurolidine could be demonstrated, most likely due to underpowering. Overall, taurolidine reduced the risk for CRBSIs by more than four times. Given its favourable safety and cost profile, taurolidine locking should be considered as an additional strategy to prevent CRBSIs. TRIAL REGISTRATION: Clinicaltrials.gov, identifier: NCT01826526.

Taurolidine-based catheter lock regimen significantly reduces overall costs, infection, and dysfunction rates of tunneled hemodialysis catheters.

Catheter-related infections and dysfunction are the main catheter complications causing morbidity and mortality in hemodialysis patients. However, there are no consistent data for the choice of catheter lock solutions for tunneled hemodialysis lines. In this prospective, multicenter, randomized, controlled trial, two lock regimens using three commercial catheter lock solutions were compared in 106 hemodialysis patients with a newly inserted tunneled central catheter. In the taurolidine group, TauroLock™-Hep500 was used twice per week and TauroLock™-U25,000 once a week. In the citrate group, a four percent citrate solution was used after each dialysis. Both groups were compared regarding catheter-related infections, catheter dysfunction, and costs. Over a period of 15,690 catheter days, six catheter-related infections occurred in six of 52 patients in the taurolidine group, but 18 occurred in 13 of 54 patients in the citrate group, corresponding to 0.67 and 2.7 episodes of catheter-related infections per 1000 catheter days, respectively (Incidence Rate Ratio 0.25, 95% confidence interval, 0.09 to 0.63). Catheter dysfunction rates were significantly lower in the taurolidine group (18.7 vs. 44.3/1000 catheter days) and alteplase rescue significantly more frequent in the citrate group (9.8 vs. 3.8/1000 catheter days). These differences provided significant catheter-related cost savings of 43% in the taurolidine group vs. citrate group when overall expenses per patient and year were compared. Thus, use of taurolidine-based catheter lock solutions containing heparin and urokinase significantly reduced complications related to tunneled hemodialysis catheters when compared to four percent citrate solution and was overall more cost-efficient.

Access to Addiction Pharmacotherapy in Private Health Plans.

BACKGROUND: An increasing number of medications are available to treat addictions. To understand access to addiction medications, it is essential to consider the role of private health plans. To contain medication expenditures, most U.S. health plans use cost-sharing and administrative controls, which may impact physicians' prescribing and patients' use of addiction medications. This study identified health plan approaches to manage access to and utilization of addiction medications (oral and injectable naltrexone, acamprosate, and buprenorphine). METHODS: Data are from a nationally representative survey of private health plans in 2010 (n=385 plans, 935 products; response rate 89%), compared to the same survey in 2003. The study assessed formulary inclusion, prior authorization, step therapy, overall restrictiveness, and if and how health plans encourage pharmacotherapy. RESULTS: Formulary exclusions were rare in 2010, with acamprosate excluded most often, by only 9% of products. Injectable naltrexone was covered by 96% of products. Prior authorization was common for injectable naltrexone (85%) and rare for acamprosate (3%). Step therapy policies were used only for injectable naltrexone (41%) and acamprosate (20%). Several medications were often on the most expensive tier. Changes since 2003 include fewer exclusions, yet increased use of other management approaches. Most health plans encourage use of addiction pharmacotherapy, and use a variety of methods to do so. CONCLUSIONS: Management of addiction medications has increased over time but it is not ubiquitous. However, health plans now also include all medications on formularies and encourage providers to use them, indicating that they value addiction pharmacotherapy as an evidence-based practice.

The cost-effectiveness of tailored, postal feedback on general practitioners' prescribing of pharmacotherapies for alcohol dependence.

AIMS: The aims of this study were to conduct a randomised controlled trial to evaluate the cost-effectiveness of tailored, postal feedback on general practitioners' (GPs) prescribing of acamprosate and naltrexone for alcohol dependence relative to current practice and its impact on alcohol dependence morbidity. METHODS: Rural communities in New South Wales, Australia, were randomised into experimental (N=10) and control (N=10) communities. Tailored feedback on their prescribing of alcohol pharmacotherapies was mailed to GPs from the experimental communities (N=115). Segmented regression analysis was used to examine within and between group changes in prescribing and alcohol dependence hospitalisation rates compared to the control communities. Incremental cost-effectiveness ratios (ICERs) were estimated per additional prescription of pharmacotherapies and per alcohol dependence hospitalisation(s) averted. RESULTS: Post-intervention changes, relative to the control communities, in GPs' prescribing rate trends in the experimental communities significantly increased for acamprosate (ß=0.24, 95% CI: 0.13-0.35, p<0.001), and significantly decreased for naltrexone (ß = -0.12, 95% CI: -0.17 to -0.06) per quarter. Quarterly hospitalisation trend rates for alcohol dependence, as principal diagnosis, significantly decreased (ß=-0.07, 95% CI: -0.13 to -0.01, p<0.05), compared to control communities. The median ICER per quarterly hospitalisation(s) averted due to intervention was dominant (dominant--$12,750). CONCLUSION: Postal, tailored feedback to GPs on their prescribing of acamprosate and naltrexone for alcohol dependence was a cost-effective intervention, in rural communities of NSW, to increase the overall prescribing of pharmacotherapies with a plausible effect on incidence reduction of hospitalisations for alcohol dependence as principal diagnosis.

Strategies for evaluating the economic value of drugs in alcohol dependence treatment.

BACKGROUND: To assess existing health economic strategies, which are used to evaluate the economic value of drugs to treat alcohol dependence (AD) such as acamprosate, naltrexone and any other pharmaceuticals. METHODS: A systematic literature search on AD treatment economic evaluation studies was performed in multiple electronic bibliographic and economic databases. RESULTS: A total of seven studies were found that involved economic evaluations of pharmacotherapy treatment of AD. It was seen that all individual pharmacotherapy treatment programs including acamprosate, naltrexone and combined treatments have resulted in a net benefit or cost savings. However, the examined studies used different methods to estimate the costs, cost savings, and cost effectiveness of the treatments. CONCLUSIONS: Pharmacotherapy treatment of AD produced marked economic benefits. However, the number of studies on the economic evaluation of pharmacotherapy for AD treatment is limited. The gaps in these studies have also been identified as necessitating more research.

A literature review of cost-benefit analyses for the treatment of alcohol dependence.

The purpose of this study was to conduct a literature review of cost-benefit studies on pharmacotherapy and psychotherapy treatments of alcohol dependence (AD). A literature search was performed in multiple electronic bibliographic databases. The search identified seven psychotherapy studies from the USA and two pharmacotherapy studies from Europe. In the psychotherapy studies, major benefits are typically seen within the first six months of treatment. The benefit-cost ratio ranged from 1.89 to 39.0. Treatment with acamprosate was found to accrue a net benefit of 21,301 BEF (528 €) per patient over a 24-month period in Belgium and lifetime benefit for each patient in Spain was estimated to be Pta. 3,914,680 (23,528 €). To date, only a few studies exist that have examined the cost-benefit of psychotherapy or pharmacotherapy treatment of AD. Most of the available treatment options for AD appear to produce marked economic benefits.

Alcohol dependence treatments: comprehensive healthcare costs, utilization outcomes, and pharmacotherapy persistence.

OBJECTIVES: To determine the healthcare costs associated with treatment of alcohol dependence with medications versus no medication and across the 4 medications approved by the US Food and Drug Administration (FDA). STUDY DESIGN: Retrospective claims database analysis. METHODS: Eligible adults with alcohol dependence were identified from a large US health plan and the IMS PharMetrics Integrated Database. Data included all medical and pharmacy claims at all available healthcare sites. Propensity score-based matching and inverse probability weighting were applied to baseline demographic, clinical, and healthcare utilization variables for 20,752 patients, half of whom used an FDA-approved medication for alcohol dependence. A similar comparison was performed among 15,502 patients treated with an FDA-approved medication: oral acamprosate calcium (n = 8958), oral disulfiram (n = 3492), oral naltrexone (NTX) hydrochloride (n = 2391), or extended-release injectable naltrexone (XR-NTX; n = 661). Analyses calculated 6-month treatment persistence, utilization, and paid claims for: alcoholism medications, detoxification and rehabilitation, alcohol-related and nonrelated inpatient admissions, outpatient services, and total costs. RESULTS: Medication was associated with fewer admissions of all types. Despite higher costs for medications, total healthcare costs, including inpatient, outpatient, and pharmacy costs, were 30% lower for patients who received a medication for their alcohol dependence. XR-NTX was associated with greater refill persistence and fewer hospitalizations for any reason and lower hospital costs than any of the oral medications. Despite higher costs for XR-NTX itself, total healthcare costs were not significantly different from oral NTX or disulfiram, and were 34% lower than with acamprosate. CONCLUSION: In this largest cost study to date of alcohol pharmacotherapy, patients who received medication had lower healthcare utilization and total costs than patients who did not. XR-NTX showed an advantage over oral medications in treatment persistence and healthcare utilization, at comparable or lower total cost.

The effect of alcohol treatment on social costs of alcohol dependence: results from the COMBINE study.

BACKGROUND: The COMBINE (combined pharmacotherapies and behavioral intervention) clinical trial recently evaluated the efficacy of pharmacotherapies, behavioral therapies, and their combinations for the treatment of alcohol dependence. Previously, the cost and cost-effectiveness of COMBINE have been studied. Policy makers, patients, and nonalcohol-dependent individuals may be concerned not only with alcohol treatment costs but also with the effect of alcohol interventions on broader social costs and outcomes. OBJECTIVES: To estimate the sum of treatment costs plus the costs of health care utilization, arrests, and motor vehicle accidents for the 9 treatments in COMBINE 3 years postrandomization. RESEARCH DESIGN: A cost study based on a randomized controlled clinical trial. SUBJECTS: : The study involved 786 participants 3 years postrandomization. RESULTS: Multivariate results show no significant differences in mean costs between any of the treatment arms as compared with medical management (MM) + placebo for the 3-year postrandomization sample. The median costs of MM + acamprosate, MM + naltrexone, MM + acamprosate + naltrexone, and MM + acamprosate + combined behavioral intervention were significantly lower than the median cost for MM + placebo. CONCLUSIONS: The results show that social cost savings are generated relative to MM + placebo by 3 years postrandomization, and the magnitude of these cost savings is greater than the costs of the COMBINE treatment received 3 years prior. Our study suggests that several alcohol treatments may indeed lead to reduced median social costs associated with health care, arrests, and motor vehicle accidents.

Revisiting the cost-effectiveness of the COMBINE study for alcohol dependent patients: the patient perspective.

OBJECTIVE: Most cost and cost-effectiveness studies of substance abuse treatments focus on the costs to the provider/payer. Although this perspective is important, the costs incurred by patients should also be considered when evaluating treatment. This article presents estimates of patients' costs associated with the Combined Pharmacotherapies and Behavioral Interventions (COMBINE) alcohol treatments and evaluates the treatments' cost-effectiveness from the patient perspective. STUDY DESIGN: A prospective cost-effectiveness study of patients in COMBINE, a randomized controlled clinical trial of 9 alternative alcohol treatment regimens involving 1383 patients with diagnoses of primary alcohol dependence across 11 US clinic sites. We followed a microcosting approach that allowed estimation of patients' costs for specific COMBINE treatment activities. The primary clinical outcomes from COMBINE are used as indicators of treatment effectiveness. RESULTS: The average total patient time devoted to treatment ranged from about 30 hours to 46 hours. Time spent traveling to and from treatment sessions and participation in self-help meetings accounted for the largest portion of patient time costs. The cost-effectiveness results indicate that 6 of the 9 treatments were economically dominated and only 3 treatments are potentially cost-effective depending on patient's willingness to pay for the considered outcomes: medical management (MM) + placebo, MM + naltrexone, and MM + naltrexone + acamprosate. CONCLUSIONS: Few studies consider the patient's perspective in estimating costs and cost-effectiveness even though these costs may have a substantial impact on a patient's treatment choice, ability to access treatment, or treatment adherence. For this study, the choice of the most cost-effective treatment depends on the value placed on the outcomes by the patient, and the conclusions drawn by the patient may differ from that of the provider/payer.

Comparison of healthcare utilization among patients treated with alcoholism medications.

OBJECTIVES: To determine in a large claims database the healthcare utilization and costs associated with treatment of alcohol dependence with medications vs no medication and across 4 US Food and Drug Administration (FDA)-approved medications. STUDY DESIGN: Claims database analysis. METHODS: Eligible adults with alcohol dependence claims (n = 27,135) were identified in a commercial database (MarketScan; Thomson Reuters Inc, Chicago, Illinois). Following propensity score-based matching and inverse probability weighting on demographic, clinical, and healthcare utilization variables, patients who had used an FDA-approved medication for alcohol dependence (n = 2977)were compared with patients who had not (n =2977). Patients treated with oral naltrexone hydrochloride(n = 2064), oral disulfiram (n = 2076), oral acamprosate calcium (n = 5068), or extended-release injectable naltrexone (naltrexone XR) (n = 295) were also compared for 6-month utilization rates of alcoholism medication, inpatient detoxification days, alcoholism-related inpatient days, and outpatient services, as well as inpatient charges. RESULTS: Patients who received alcoholism medications had fewer inpatient detoxification days (706 vs 1163 days per 1000 patients, P <.001), alcoholism-related inpatient days (650 vs 1086 days, P <.001), and alcoholism-related emergency department visits (127 vs 171, P = .005). Among 4 medications, the use of naltrexone XR was associated with fewer inpatient detoxification days (224 days per 1000 patients) than the use of oral naltrexone (552 days, P = .001), disulfiram (403 days, P = .049), or acamprosate (525 days, P <.001). The group receiving naltrexone XR also had fewer alcoholism-related inpatient days than the groups receiving disulfiram or acamprosate. More patients in the naltrexone XR group had an outpatient substance abuse visit compared with patients in the oral alcoholism medication groups. CONCLUSION: Patients who received an alcoholism medication had lower healthcare utilization than patients who did not. Naltrexone XR showed an advantage over oral medications in healthcare utilization and costs.

Cost and cost-effectiveness of the COMBINE study in alcohol-dependent patients.

CONTEXT: The COMBINE (Combined Pharmacotherapies and Behavioral Intervention) clinical trial recently evaluated the efficacy of medications, behavioral therapies, and their combinations for the outpatient treatment of alcohol dependence. The costs and cost-effectiveness of these combinations are unknown and of interest to clinicians and policy makers. OBJECTIVE: To evaluate the costs and cost-effectiveness of the COMBINE Study interventions after 16 weeks of treatment. DESIGN: A prospective cost and cost-effectiveness study of a randomized controlled clinical trial. SETTING: Eleven US clinical sites. PARTICIPANTS: One thousand three hundred eighty-three patients having a diagnosis of primary alcohol dependence. INTERVENTIONS: The study included 9 treatment groups; 4 groups received medical management for 16 weeks with naltrexone, 100 mg/d, acamprosate, 3 g/d, or both, and/or placebo; 4 groups received the same therapy as mentioned earlier with combined behavioral intervention; and 1 group received combined behavioral intervention only. MAIN OUTCOMES MEASURES: Incremental cost per percentage point increase in percentage of days abstinent, incremental cost per patient of avoiding heavy drinking, and incremental cost per patient of achieving a good clinical outcome. RESULTS: On the basis of the mean values of cost and effectiveness, 3 interventions are cost-effective options relative to the other interventions for all 3 outcomes: medical management (MM) with placebo ($409 per patient), MM plus naltrexone therapy ($671 per patient), and MM plus combined naltrexone and acamprosate therapy ($1003 per patient). CONCLUSIONS: To our knowledge, this is only the second prospective cost-effectiveness study with a randomized controlled clinical trial design that has been performed for the treatment of alcohol dependence. Focusing only on effectiveness, MM-naltrexone-acamprosate therapy is not significantly better than MM-naltrexone therapy. However, considering cost and cost-effectiveness, MM-naltrexone-acamprosate therapy may be a better choice, depending on whether the cost of the incremental increase in effectiveness is justified by the decision maker.

Acamprosate in the treatment of alcohol dependence: clinical and economic considerations.

Acamprosate has been commercially available in the USA since 2004 to treat alcohol dependence. Its safety and efficacy have been demonstrated in a number of clinical trials worldwide, which overall have shown significant improvements in abstinence compared with placebo. As with all alcoholism pharmacotherapies, acamprosate is used in conjunction with psychosocial interventions. One frequently described mechanism stipulates that acamprosate supports abstinence by normalizing the often protracted dysregulation of NMDA-mediated glutamatergic neurotransmission that follows chronic heavy alcohol use and withdrawal. This article reviews the clinical safety and efficacy of acamprosate, as well as results from recent pharmacoeconomic and human laboratory studies. These data elucidate the economic benefits of acamprosate, as well as its effects on cognition and alcohol-related sleep disturbances.

Measuring economic outcomes of alcohol treatment using the Economic Form 90.

OBJECTIVE: This article assesses the ability of the economic outcome measures in the Economic Form 90 to detect differences across levels of alcohol dependence as measured by the Alcohol Dependence Scale. METHOD: We used baseline data from the Combining Medications and Behavioral Interventions (COMBINE) Study, a large, multisite clinical trial, to assess the extent to which the economic items on the Economic Form 90 instrument can detect differences across levels of alcohol dependence. RESULTS: After adjusting for differences in demographic characteristics, the Economic Form 90 can detect significant differences across a range of dependence severity levels for the economic outcomes of inpatient medical care, emergency-department medical care, behavioral health care, being on parole or probation, and missed workdays, conditional on being employed. We did not detect significant differences across dependence severity for employment status, outpatient medical care, other criminal justice involvement, or motor vehicle accidents. CONCLUSIONS: The Economic Form 90 can identify differences in many economic outcomes associated with differing levels of alcohol dependence. This suggests that the Economic Form 90 may be useful in assessing changes in economic outcomes that result from changes in alcohol dependence.

A critical review of pharmacoeconomic studies of acamprosate.

AIMS: This review assessed the published data on the cost-effectiveness of acamprosate for the treatment of alcohol dependence. METHODS: Four Markov modelling studies have assessed the therapeutic benefit and economic impact of acamprosate on the treatment of alcohol dependence. These have evaluated both short-term and long-term outcomes and have used German, Belgian, and Spanish costings. A fifth prospective cohort study collected real outcomes and data on expenditure during a 1 year study follow-up period. RESULTS: All five studies have produced consistent results, showing the use of acamprosate, which enhances abstinence rates, to reduce the total costs of treatment and thus be dominant over other rehabilitation strategies not involving pharmacotherapy. In all of the studies, the principal cost-driver is hospitalization. Although there is a short-term increase in treatment costs associated with drug acquisition, these are recovered from long-term savings attributable to reduced hospitalization and rehabilitation costs.

Acamprosate for the adjunctive treatment of alcohol dependence.

OBJECTIVE: To review the literature related to the treatment of alcohol dependence with acamprosate, a synthetic compound structurally similar to the naturally occurring amino acid, homotaurine. DATA SOURCES: Primary literature and review articles were identified by MEDLINE search (1966-June 2003). Abstracts from recent meetings were also reviewed. DATA SYNTHESIS: Acamprosate has been marketed in 24 countries. Although the precise mechanism of acamprosate in the treatment of alcohol-dependent patients is unclear, it may restore the balance between inhibitory and excitatory neurotransmission in the central nervous system. European trials have shown consistent increases in abstinence rates compared with placebo when acamprosate use was paired with appropriate psychosocial and behavioral therapies. Decreased direct and indirect healthcare costs associated with acamprosate treatment have also been reported. CONCLUSIONS: Acamprosate is a promising medication for the treatment of alcohol dependence in the US.

Cost-effectiveness of adjuvant treatment with acamprosate in maintaining abstinence in alcohol dependent patients.

An open prospective cohort study was performed in Germany in order to evaluate the costs of treating alcohol dependence under real-world conditions. Eight hundred and fourteen recently detoxified alcohol-dependent patients were provided with psychosocial rehabilitation support. In addition, 540 alcohol-dependent patients treated with adjuvant acamprosate therapy were compared with 274 patients without pharmacotherapy. Real costs were assessed over a period of one year. Of the patients who were treated with acamprosate, 33.6% remained abstinent compared to only 21.1% in the standard cohort. The mean total costs per patient treated with acamprosate were EUR 1,631.49 per year. In the standard cohort, total costs were EUR 2,068.83. This difference is highly significant (p = 0.012). Direct costs amounted to 76.9% of the total costs, with a 27% difference between the cohorts (p < 0.001). There was no difference in indirect costs between the two groups (p = 0.324). This real-cost study confirms the favourable cost-effectiveness of acamprosate previously suggested by pharmaco-economic modelling studies.

[Adjuvant drug treatment of alcoholism with acamprosate: between sectoral budgets and disease management]. / Die adjuvante Arzneimitteltherapie der Alkoholkrankheit mit Acamprosa--Zwischen sektoraler Budgetierung und Disease Management.

OBJECTIVE: On the basis of several controlled clinical investigations the cost-effectiveness of acamprosate as adjuvant therapy of alcohol-dependent patients has yet been evaluated. These optimal conditions cannot be found in the daily ambulant practice and results in asking which of the alternatives, "standard plus acamprosate" or "standard without acamprosate", is more cost-effective in maintaining abstinence in alcohol dependent patients under realistic conditions. PATIENTS AND METHODS: In an open multi-centre study, medical care, costs and therapeutic outcome was prospectively documented. Prior to enrolling, all patients were obliged to undergo a detoxification procedure. At a mean age of 45 years the patients suffered an average of ten years from alcohol dependence. 521 patients were documented in the acamprosate cohort and 265 patients in the cohort "other therapy" over one year. Two thirds of the participating patients were male. RESULTS: At 33.6 % the rate of abstinence was remarkably higher in the acamprosate cohort in comparison to the cohort "other" at 21.1 % abstinent patients. The mean total costs per patient and year amounted to DM 3191 in the acamprosate-cohort and were significantly lower than in the cohort "other" with DM 4046. Effectiveness-adjusted costs of DM 9500 per successfully treated patient in the acamprosate-cohort were superior to the cohort "other", amounting to DM 19 148 per successfully treated patient. CONCLUSION: The described economic benefits may be utilised under conditions of an adequate disease management.