Baseline history of patients using selexipag for pulmonary arterial hypertension.

INTRODUCTION: Since its introduction to the market in 2016, selexipag has been an alternative oral therapy among both treatment-naïve patients and those with mono or dual therapy failure; however, limited information is available regarding the presentation and management of patients with pulmonary arterial hypertension (PAH) prior to selexipag initiation. This study examined treatment patterns, healthcare utilization, and costs in the 12 months prior to and the 6 months following selexipag initiation. METHODS: This was a retrospective study of adult commercial and Medicare Advantage with Part D (MAPD) health plan members with a medical or pharmacy claim for selexipag from 1 January 2016 through 31 May 2017, a diagnosis of pulmonary hypertension, and continuous health plan enrollment for 12 months prior to selexipag initiation (baseline period). Treatment patterns, healthcare utilization, and costs were measured over the baseline period and the 6 months following selexipag initiation (among patients with ⩾6 months of follow up). RESULTS: After inclusion and exclusion criteria were applied, 95 patients were included in the analysis. At study start, 57.9% of patients were prescribed combination therapy, increasing to 69.5% immediately prior to selexipag initiation. Approximately 60% of patients had one baseline regimen. Emergency visits and inpatient admissions during the baseline period occurred in 63.2% and 48.4% of patients, respectively. Baseline medical costs rose steadily, increasing 266.8% in commercial and 26.7% in MAPD enrollees from the beginning to the end of the 12-month baseline period. PAH-related healthcare costs accounted for more than 80% of total costs. Mean medical costs in the 6 months following selexipag initiation were US$17,215 in commercial and US$23,976 in MAPD enrollees. CONCLUSIONS: The majority of patients with PAH remained on the same therapy in the 12 months prior to selexipag initiation despite high rates of healthcare utilization and increasing costs. Mean medical costs appeared to decrease after adding or switching to selexipag.

Cost-utility analysis of vortioxetine versus agomelatine, bupropion SR, sertraline and venlafaxine XR after treatment switch in major depressive disorder in Finland.

BACKGROUND: To assess the cost-utility of vortioxetine versus relevant comparators (agomelatine, bupropion SR, sertraline, and venlafaxine XR) in the finnish setting in major depressive disorder (MDD) patients with inadequate response to selective serotonin- /serotonin-norepinephrine reuptake inhibitors. METHODS: A one-year analysis was conducted using a decision tree with a Markov state transition component. The health states were remission, relapse and recovery. A Finnish healthcare payer perspective was adopted. RESULTS: Vortioxetine was less costly and more effective versus all comparators in both direct and societal perspectives. Vortioxetine reduced the average annual direct costs by 4% versus venlafaxine XR and 8% versus sertraline. The greater efficacy associated with vortioxetine was translated into a higher percentage of patients in remission and recovery. The model was most sensitive to changes in remission rates at 8 weeks. CONCLUSION: This cost-utility analysis showed vortioxetine to be a good alternative for MDD patients switching therapy in Finland.

Evaluation of the treatment of methicillin-resistant Staphylococcus aureus bacteremia.

BACKGROUND: Bloodstream infections are a leading cause of death in the United States. Methicillin-resistant Staphylococcus aureus (MRSA) encompasses >50% of all S aureus strains in infected hospitalized patients and increases mortality, length of stay and healthcare costs. The objective of this study was to evaluate the treatment of MRSA bacteremia with daptomycin, linezolid and vancomycin. METHODS: Patients with MRSA bacteremia between June 2008 and November 2010 were reviewed retrospectively. A microbiology laboratory report identified patients with ≥ 1 positive MRSA blood culture. Patients ≥ 18 years receiving daptomycin, linezolid or vancomycin for ≥ 7 consecutive days were included. Polymicrobial blood cultures and patients treated concomitantly with >1 anti-MRSA agent were excluded. RESULTS: Of 122 patients included, 53 received daptomycin, 15 received linezolid and 54 received vancomycin. Clinical and microbiologic cure rates were similar between daptomycin, linezolid and vancomycin (58.5% versus 60% versus 61.1%; 93.6% versus 100% versus 90%, respectively). Thirteen patients (daptomycin 4/24 versus linezolid 1/9 versus vancomycin 8/49, P = 0.5960) had recurrence while 12 patients had re-infection (daptomycin 5/42 versus linezolid 0/9 versus vancomycin 7/49, P = 0.4755). Treatment failure occurred in 11 patients treated with daptomycin, 4 with linezolid and 9 with vancomycin (P = 0.662). Compared with daptomycin and vancomycin, linezolid-treated patients had higher mortality (P = 0.0186). CONCLUSIONS: No difference in clinical or microbiologic cure rates was observed between groups. Daptomycin and vancomycin appear equally efficacious for MRSA bacteremia, whereas linezolid therapy was associated with higher mortality.

Modeling the economic impact of linezolid versus vancomycin in confirmed nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus.

INTRODUCTION: We compared the economic impacts of linezolid and vancomycin for the treatment of hospitalized patients with methicillin-resistant Staphylococcus aureus (MRSA)-confirmed nosocomial pneumonia. METHODS: We used a 4-week decision tree model incorporating published data and expert opinion on clinical parameters, resource use and costs (in 2012 US dollars), such as efficacy, mortality, serious adverse events, treatment duration and length of hospital stay. The results presented are from a US payer perspective. The base case first-line treatment duration for patients with MRSA-confirmed nosocomial pneumonia was 10 days. Clinical treatment success (used for the cost-effectiveness ratio) and failure due to lack of efficacy, serious adverse events or mortality were possible clinical outcomes that could impact costs. Cost of treatment and incremental cost-effectiveness per successfully treated patient were calculated for linezolid versus vancomycin. Univariate (one-way) and probabilistic sensitivity analyses were conducted. RESULTS: The model allowed us to calculate the total base case inpatient costs as $46,168 (linezolid) and $46,992 (vancomycin). The incremental cost-effectiveness ratio favored linezolid (versus vancomycin), with lower costs ($824 less) and greater efficacy (+2.7% absolute difference in the proportion of patients successfully treated for MRSA nosocomial pneumonia). Approximately 80% of the total treatment costs were attributed to hospital stay (primarily in the intensive care unit). The results of our probabilistic sensitivity analysis indicated that linezolid is the cost-effective alternative under varying willingness to pay thresholds. CONCLUSION: These model results show that linezolid has a favorable incremental cost-effectiveness ratio compared to vancomycin for MRSA-confirmed nosocomial pneumonia, largely attributable to the higher clinical trial response rate of patients treated with linezolid. The higher drug acquisition cost of linezolid was offset by lower treatment failure-related costs and fewer days of hospitalization.

Modeling economic implications of alternative treatment strategies for acute bacterial skin and skin structure infections.

OBJECTIVE: The economic implications from the US Medicare perspective of adopting alternative treatment strategies for acute bacterial skin and skin structure infections (ABSSSIs) are substantial. The objective of this study is to describe a modeling framework that explores the impact of decisions related to both the location of care and switching to different antibiotics at discharge. METHODS: A discrete event simulation (DES) was developed to model the treatment pathway of each patient through various locations (emergency department [ED], inpatient, and outpatient) and the treatments prescribed (empiric antibiotic, switching to a different antibiotic at discharge, or a second antibiotic). Costs are reported in 2012 USD. RESULTS: The mean number of days on antibiotic in a cohort assigned to a full course of vancomycin was 11.2 days, with 64% of the treatment course being administered in the outpatient setting. Mean total costs per patient were $8671, with inpatient care accounting for 58% of the costs accrued. The majority of outpatient costs were associated with parenteral administration rather than drug acquisition or monitoring. Scenarios modifying the treatment pathway to increase the proportion of patients receiving the first dose in the ED, and then managing them in the outpatient setting or prescribing an oral antibiotic at discharge to avoid the cost associated with administering parenteral therapy, therefore have a major impact and lower the typical cost per patient by 11-20%. Since vancomycin is commonly used as empiric therapy in clinical practice, based on these analyses, a shift in treatment practice could result in substantial savings from the Medicare perspective. CONCLUSIONS: The choice of antibiotic and location of care influence the costs and resource use associated with the management of ABSSSIs. The DES framework presented here can provide insight into the potential economic implications of decisions that modify the treatment pathway.

Antibiotic treatment patterns across Europe in patients with complicated skin and soft-tissue infections due to meticillin-resistant Staphylococcus aureus: a plea for implementation of early switch and early discharge criteria.

This retrospective observational medical chart review aimed to describe country-specific variations across Europe in real-world meticillin-resistant Staphylococcus aureus (MRSA) complicated skin and soft-tissue infection (cSSTI) treatment patterns, antibiotic stewardship activity, and potential opportunities for early switch (ES) from intravenous (i.v.) to oral formulations and early discharge (ED) from hospital using standardised data collection and criteria and economic implications of these opportunities. Patients were randomly sampled from 12 countries (Austria, Czech Republic, France, Germany, Greece, Ireland, Italy, Poland, Portugal, Slovakia, Spain and the UK), aged ≥18 years, with documented MRSA cSSTI, hospitalised between 1 July 2010 and 30 June 2011, discharged alive by 31 July 2011. Of 1502 patients, 1468 received MRSA-targeted therapy. Intravenous-to-oral switch rates ranged from 2.0% to 20.2%, i.v. length of therapy from 10.1 to 18.6 days and hospital length of stay (LoS) from 15.2 to 25.0 days across Europe. Of 341 sites, 82.9% had antibiotic steering committees, 23.7% had i.v.-to-oral switch antibiotic protocols and 12.9% had ED protocols for MRSA cSSTI. ES and ED eligibility ranged from 12.0% (Slovakia) to 56.3% (Greece) and from 10% (Slovakia) to 48.2% (Portugal), respectively. Potential cost savings per ED-eligible patient ranged from €414 (Slovakia) to €2703 (France). MRSA cSSTI treatment patterns varied widely across countries, but further reductions in i.v. therapy, hospital LoS and associated costs could be realised. These data provide insight into clinical practice patterns across diverse European healthcare systems and identify potential opportunities for local clinicians and policy-makers to improve clinical care and cost-effectiveness of this therapeutic area.

Comparative cost-effectiveness of alternative empiric antimicrobial treatment options for suspected enterococcal bacteremia.

OBJECTIVES: Enterococcus species are the fourth leading cause of bacteremia. Resistance rates are rising and delays in appropriate initial antimicrobial therapy have been associated with increased mortality. Empiric treatment of patients with suspected enterococcal bacteremia varies and significant cost differences exist between alternatives. The objective of this study was to determine the cost-effectiveness of various empiric treatments for patients with suspected enterococcal bacteremia. METHODS: A decision-analytic model was constructed from the hospital perspective to assess the cost-effectiveness of alternative empiric treatment options for enterococcal bacteremia, including antimicrobials active against vancomycin-resistant enterococcus (VRE). The model was populated from available literature sources and included resistance patterns, associated mortality with early versus delayed effective treatment, and the cost of treatment. Univariate sensitivity analyses tested the robustness of the model to determine the degree to which model uncertainties influenced outcomes. We also undertook a probabilistic sensitivity analysis varying parameters in 10,000 Monte Carlo simulations. MAIN RESULTS: The incremental cost-effectiveness ratio was $791 and $749/quality-adjusted-life-year utilizing empiric daptomycin and linezolid, respectively. The model also predicted an incremental cost/life saved of $11,703 by utilizing empiric daptomycin and $11,084 with linezolid utilization. Ampicillin was dominated (i.e., less effective and associated with increased costs) by both VRE-active agents and vancomycin. A probabilistic Monte Carlo sensitivity analysis showed that an agent with VRE activity had a 100% chance of being cost-effective at traditionally used willingness-to-pay thresholds. The decision-analytic model was sensitive to variations in E. faecium mortality and short-term postdischarge survival rates. CONCLUSION: Results of our model showed that empiric utilization of an antimicrobial with activity against VRE may be a cost-effective option for the treatment of suspected enterococcal bacteremia when compared with vancomycin or ß-lactam therapy.

Out-of-pocket costs and prescription reversals with oral linezolid.

OBJECTIVE: To determine the relationship between benefit design, out-of-pocket costs, and prescription reversals, and the impact of reversals on rehospitalizations and total healthcare costs among Medicare members prescribed oral linezolid. STUDY DESIGN: Medicare members from a national health plan prescribed oral linezolid posthospitalization for skin and soft tissue infection (SSTI) or pneumonia were followed retrospectively. METHODS: Members were identified by an oral linezolid prescription between June 1, 2007, and April 30, 2011, where the index event was a prescription fill or reversal less than 2 days before or 10 days after discharge. Associations between out-of-pocket costs and reversal, and between reversal and rehospitalization 30 days postindex, were compared for prescription fills versus reversals. A generalized linear model calculated adjusted total healthcare costs per member controlling for age, sex, geographic region, and clinical characteristics. RESULTS: Reversal rates rose progressively from 2% for members with out-of-pocket costs of $0 to 27% for members with out-of-pocket costs higher than $100 (P < .0001). Infection-related rehospitalizations were 23% versus 9% for members with a prescription reversal versus a fill (P < .0001). While postdischarge prescription drug costs were $1228.78 lower (P <.0001), adjusted mean medical costs were $2061.69 higher (P = .0033) and total healthcare costs were $1280.93 higher (P = .0349) for reversal versus fill members. CONCLUSIONS: Higher out-of-pocket costs were associated with higher rates of reversal, and reversals were associated with higher rates of rehospitalization and adjusted total healthcare costs among Medicare members prescribed oral linezolid posthospitalization for SSTI or pneumonia.

A practical guide to community-acquired MRSA.

As the number of CA-MRSA skin and soft tissue infections continues to grow, it's important to know which patients are at greatest risk and which evidence-based treatment protocols to turn to when needed.

Economic evaluation of agomelatine relative to other antidepressants for treatment of major depressive disorders in Greece.

BACKGROUND: Major depressive disorder (MDD) constitutes an important public health problem, as it is highly prevalent in the industrialized world and it is associated with substantial economic consequences for patients, health care providers, insurance and social security organizations and employers. To conduct an economic evaluation comparing agomelatine with other commonly used alternatives for treating patients with major depressive disorder (MDD) in Greece. METHODS: An existing international Markov model designed to evaluate the cost-effectiveness of agomelatine was adapted to the Greek setting. It reflects six different health states, in which patients may move on a monthly basis. The analysis was undertaken from a societal perspective. Transition probabilities, utilities and costs assigned to each health state were extracted from the published literature, government sources and expert opinion. Data reflects the year 2012 and was discounted using a rate of 3.5%. Probabilistic analysis was undertaken to deal with uncertainty. RESULTS: Base case analyses revealed that agomelatine is a dominant therapy for MDD relative to escitalopram, fluoxetine and sertraline, and it appeared to be cost-effective compared to venlafaxine (ICER: €547/QALY). Agomelatine remained a dominant treatment against generic sertraline and fluoxetine, and it appeared to be a cost-effective alternative compared to generic venlafaxine and escitalopram (ICER: €1,446/QALY and €3,303/QALY, respectively). Excluding the indirect cost from the analysis, agomelatine remained a cost-effective alternative over all comparators. In the probabilistic sensitivity analysis agomelatine was dominant in 44.5%, 89.6%, 70.6% and 84.6% of simulated samples against branded venlafaxine, escitalopram, fluoxetine and sertraline, respectively. CONCLUSION: The present evaluation indicates that agomelatine is either a dominant or a cost-effective alternative relative to branded or generic alternatives, in Greece.

Retigabine as add-on treatment of refractory epilepsy--a cost-utility study in a Swedish setting.

OBJECTIVES: To calculate comparative incremental cost-effectiveness ratios (cost per quality-adjusted life year, QALY) and net marginal benefits for retigabine as add-on treatment for patients with uncontrolled focal seizures as compared to add-on lacosamide treatment and no add-on treatment, respectively. MATERIALS & METHODS: Calculations were performed using a validated decision-tree model. The study population consisted of adult patients with focal-onset epilepsy in published randomized placebo-controlled add-on trials of retigabine or lacosamide. Healthcare utilization and QALY for each treatment alternative were calculated. Probabilistic sensitivity analysis was performed using the specification of this model as a basis for Monte Carlo simulations. 2009 prices were used for all costs. RESULTS: Results were reported for a 2-year follow-up period. Retigabine add-on treatment was both more effective and less costly than lacosamide add-on treatment, and the cost per additional QALY for the retigabine no add-on (standard) therapy comparison was estimated at 2009€ 15,753. Using a willingness-to-pay threshold for a QALY of € 50,000, the net marginal values were estimated at 2009€ 605,874 for retigabine vs lacosamide and 2009€ 2,114,203 for retigabine vs no add-on, per 1,000 patients. The probabilistic analyses showed that the likelihood that retigabine treatment is cost-effective is at least 70%. CONCLUSIONS: The estimated cost per additional QALY, for the retigabine vs no add-on treatment comparison, is well within the range of newly published estimates of willingness to pay for an additional QALY. Thus, add-on retigabine treatment for people with focal-onset epilepsy with no/limited response to standard antiepileptic treatment appears to be cost-effective.

Cost-effectiveness of linezolid in methicillin-resistant Staphylococcus aureus skin and skin structure infections.

Linezolid is a novel oxazolidinone antibacterial agent with a broad clinical application, especially in methicillin-resistant Staphylococcus aureus skin and soft-tissue infections and skin and skin-structure infections. Pharmacoeconomic advantages include decreased hospital duration, reduction in intravenous antibiotic use and early discharge opportunities that contribute to an overall reduction in healthcare resources. Linezolid's oral formulation has a pharmacokinetic profile that is similar to its intravenous formulation, which creates opportunities for early discharge not available to comparators like vancomycin and daptomycin. Both vancomycin and daptomycin require intravenous therapy, which compounds the resources required in treating methicillin-resistant S. aureus skin and soft tissue/skin and skin structure infections. Pharmacoeconomic studies have demonstrated an overall reduction in total direct costs to the payer in favor of linezolid over its comparators. Its overall reduction in healthcare utilization makes it an appropriate alternative to the standard therapy, vancomycin.

Pharmacotherapy for methicillin-resistant Staphylococcus aureus nosocomial pneumonia.

OBJECTIVE: To review the evidence for pharmacologic agents available in the treatment of nosocomial methicillin-resistant Staphylococcus aureus (MRSA) pneumonia. DATA SOURCES: A search of PubMed (1975-July 2012) was conducted using a combination of the terms methicillin-resistant Staphylococcus aureus, pneumonia, nosocomial, vancomycin, linezolid, telavancin, ceftaroline, tigecycline, and quinupristin/dalfopristin. STUDY SELECTION AND DATA EXTRACTION: Randomized comparative clinical trials, meta-analyses, and review articles published in English were included. A manual review of the bibliographies of available literature was conducted and all relevant information was included. Observational and in vitro studies were incorporated as indicated. DATA SYNTHESIS: Pharmacotherapy for the treatment of nosocomial MRSA pneumonia is limited. Vancomycin has been the treatment of choice for several years. Linezolid has demonstrated similar efficacy to vancomycin in randomized clinical trials and recent data have suggested that it may be superior in some cases, although there are limitations to this conclusion. Telavancin has also demonstrated similar clinical efficacy to vancomycin; however, the drug is not commercially available in the US. Other agents with MRSA activity include ceftaroline, clindamycin, quinupristin/dalfopristin, and tigecycline, although the evidence for their use in nosocomial pneumonia is limited. CONCLUSIONS: Based on the currently available evidence and cost-effectiveness, vancomycin should continue to be the drug of choice for most patients with nosocomial MRSA pneumonia. Linezolid is a reasonable alternative for patients with treatment failure while receiving vancomycin, isolates with vancomycin minimum inhibitory concentrations over 2 µg/mL, allergic reactions, or vancomycin-induced nephrotoxicity.

Treatment of methicillin-resistant Staphylococcus aureus infections with a minimal inhibitory concentration of 2 µg/mL to vancomycin: old (trimethoprim/sulfamethoxazole) versus new (daptomycin or linezolid) agents.

BACKGROUND: Guidelines recommend that agents other than vancomycin be considered for some types of infection due to methicillin-resistant Staphylococcus aureus (MRSA) when the minimum inhibitory concentration (MIC) to vancomycin is 2 µg/mL or more. Alternative therapeutic options include daptomycin and linezolid, 2 relatively new and expensive drugs, and trimethoprim/sulfamethoxazole (TMP/SMX), an old and inexpensive agent. OBJECTIVE: To compare the clinical efficacy and potential cost savings associated with use of TMP/SMX compared to linezolid and daptomycin. METHODS: A retrospective study was conducted at Detroit Medical Center. For calendar year 2009, unique adults (age >18 years) with infections due to MRSA with an MIC to vancomycin of 2 µg/mL were included if they received 2 or more doses of TMP/SMX and/or daptomycin and/or linezolid. Data were abstracted from patient charts and pharmacy records. RESULTS: There were 328 patients included in the study cohort: 143 received TMP/SMX alone, 89 received daptomycin alone, 75 received linezolid alone, and 21 patients received a combination of 2 or more of these agents. In univariate analysis, patients who received TMP/SMX alone had significantly better outcomes, including in-hospital (p = 0.003) and 90-day mortality (p < 0.001) compared to patients treated with daptomycin or linezolid. Patients receiving TMP/SMX were also younger (p < 0.001), had fewer comorbid conditions (p < 0.001), had less severe acute severity of illness (p < 0.001), and received appropriate therapy more rapidly (p = 0.001). In multivariate models the association between TMP/SMX treatment and mortality was no longer significant. Antimicrobial cost savings associated with using TMP/SMX averaged $2067.40 per patient. CONCLUSIONS: TMP/SMX monotherapy compared favorably to linezolid and daptomycin in terms of treatment efficacy and mortality. Use of TMP/SMX instead of linezolid or daptomycin could potentially significantly reduce antibiotic costs. TMP/SMX should be considered for the treatment of MRSA infection with MIC of 2 µg/mL to vancomycin.

Linezolid-containing regimens for the treatment of drug-resistant tuberculosis in South African children.

BACKGROUND: Treatment options for drug-resistant tuberculosis (DR-TB) are limited. Linezolid has been successfully used to treat DR-TB in adults, but there are few case reports of its use in children for TB. The reported rate of adverse events in adults is high. METHODS: We conducted a retrospective review of children with DR-TB treated with linezolid-containing regimens from February 2007 to March 2012 at two South African hospitals. RESULTS: Seven children (three human immunodeficiency virus [HIV] infected) received a linezolid-containing regimen. All had culture-confirmed DR-TB; five had previously failed second-line anti-tuberculosis treatment. Four children were cured and three were still receiving anti-tuberculosis treatment, but had culture converted. None of the non-HIV-infected children experienced adverse events while receiving linezolid. Three HIV-infected children had adverse events, one of which was life-threatening; linezolid was permanently discontinued in this case. Adverse events included lactic acidosis (n = 1), pancreatitis (n = 2), peripheral neuropathy (n = 1) and asymptomatic bone marrow hypoplasia (n = 1). CONCLUSION: Linezolid-containing regimens can be effective in treating children with DR-TB even after failing second-line treatment. Adverse events should be monitored, especially in combination with medications that have similar adverse effects. Linezolid remains costly, and a reduced dosage and duration may result in fewer adverse events and lower cost.

Cost avoidance using linezolid for methicillin-resistant Staphylococcus aureus infections in a specialist diabetes foot clinic.

OBJECTIVES: An audit was performed to determine whether linezolid (Zyvox, Pharmacia Limited, Sandwich, UK) was being used in accordance with local guidelines and if this had an effect on admissions for diabetes foot ulceration. METHODS: Seven hundred and four patient records from 2005 to 2010 in the Diabetes Foot Clinic, Royal Infirmary of Edinburgh were audited for methicillin-resistant Staphylococcus aureus (MRSA) infections, admissions and antibiotic use. RESULTS: Seventeen percent (n = 119) of patients had proven MRSA infections. Of these, 28% (n = 33) were prescribed linezolid, 94% (n = 31) for up to 14 days and none for >28 days. Eight (24%) had repeated courses. Ninety-one percent (n = 30) either avoided admission or were discharged early with resolution of infection. Four out of 33 patients had reversible blood abnormalities. The total cost for linezolid over this period was £58 000. However, 420 bed days, costing £500/day, were avoided, producing a total saving of £210 000 on inpatient costs. CONCLUSIONS: Linezolid guidelines reduced lengths of stay, inpatient costs and overuse of this expensive but effective treatment.

Cost effectiveness of lacosamide in the adjunctive treatment of patients with refractory focal epilepsy in Belgium.

OBJECTIVES: Lacosamide is an anti-epileptic drug, indicated as adjunctive therapy for patients with focal seizures with or without secondary generalization. This study aims to assess the cost effectiveness of standard anti-epileptic drug therapy plus lacosamide 300 mg/day compared with standard therapy alone from the perspective of the Belgian healthcare payer. METHODS: The treatment pathway of a hypothetical cohort of 1000 patients over 2 years was simulated using a decision tree. Data about health state probabilities, seizure frequency and utility values were taken from lacosamide trials or from the literature. Effectiveness measures included the number of seizures avoided and the number of quality-adjusted life-years gained. Unit costs were taken from national references. Resource use was estimated by a panel of eight neurologists with extensive experience in epilepsy. The price year was 2008. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: Over a 24-month period, standard anti-epileptic drug therapy plus lacosamide led to a reduction of seven seizures, an increase of 0.038 quality-adjusted life-years and a cost decrease of &U20AC;3619 per patient compared with standard therapy alone. Using a willingness to pay of &U20AC;30 000 per quality-adjusted life-year, the net monetary benefit of standard anti-epileptic drug therapy plus lacosamide amounted to &U20AC;4754. The probability of standard anti-epileptic drug therapy plus lacosamide being cost effective was 97.3%, 99.8%, 99.9% and 100% at 6, 12 , 18 and 24 months, respectively. CONCLUSION: In patients with difficult-to-treat epilepsy, standard anti-epileptic drug therapy plus lacosamide appears to be a cost-effective option in Belgium.