Health state utility values in major depressive disorder treated with pharmacological interventions: a systematic literature review.

BACKGROUND: Major depressive disorder (MDD) is associated with decreased patient well-being and symptoms that can cause substantial impairments in patient functioning and even lead to suicide. Worldwide, MDD currently causes the second-most years lived with disability and is predicted to become the leading cause of disability by 2030. Utility values, capturing patient quality of life, are required in economic evaluations for new treatments undergoing reimbursement submissions. We aimed to identify health state utility values (HSUVs) and disutilities in MDD for use in future economic evaluations of pharmacological treatments. METHODS: Embase, PubMed, Econlit, and Cochrane databases, plus gray literature, were searched from January 1998 to December 21, 2018, with no language or geographical restrictions, for relevant studies that reported HSUVs and disutilities for patients with MDD receiving pharmacological interventions. RESULTS: 443 studies were identified; 79 met the inclusion criteria. We focused on a subgroup of 28 articles that reported primary utility data from 16 unique studies of MDD treated with pharmacological interventions. HSUVs were elicited using EQ-5D (13/16, 81%; EQ-5D-3L: 11/16, 69%; EQ-5D-3L or EQ-5D-5L not specified: 2/16), EQ-VAS (5/16, 31%), and standard gamble (1/16, 6%). Most studies reported baseline HSUVs defined by study entry criteria. HSUVs for a first or recurrent major depressive episode (MDE) ranged from 0.33 to 0.544 and expanded from 0.2 to 0.61 for patients with and without painful physical symptoms, respectively. HSUVs for an MDE with inadequate treatment response ranged from 0.337 to 0.449. Three studies reported HSUVs defined by MADRS or HAMD-17 clinical thresholds. There was a large amount of heterogeneity in patient characteristics between the studies. One study reported disutility estimates associated with treatment side effects. CONCLUSIONS: Published HSUVs in MDD, elicited using methods accepted by health technology assessment bodies, are available for future economic evaluations. However, the evidence base is limited, and it is important to select appropriate HSUVs for the intervention being evaluated and that align with clinical health state definitions used within an economic model. Future studies are recommended to elicit HSUVs for new treatments and their side effects and add to the existing evidence where data are lacking.

The Cost-Effectiveness of the Integration of Nalmefene within the UK Healthcare System Treatment Pathway for Alcohol Dependence.

AIMS: To assess the cost-effectiveness of integrating nalmefene within the treatment pathway for alcohol dependence recommended by the National Institute for Health and Care Excellence in the UK. METHODS: A Markov model, taking a UK NHS perspective, followed a cohort with alcohol dependence and high/very high drinking risk levels (HVHDRLs), who do not require immediate detoxification and who continue at HVHDRLs after initial assessment, for 5 years. Costs and quality-adjusted life years (QALYs) from treatment with nalmefene plus psychosocial support versus psychosocial support alone were modelled. The consequent incidence of alcohol-attributable harmful events and disease progression, with the possibility of requiring other options or recurrent treatment, were captured. RESULTS: Nalmefene plus psychosocial support dominated psychosocial support alone, with lower costs and increased QALYs after 5 years. Savings are driven by the higher response to nalmefene, and the subsequent lower cost accumulation for alternatives. CONCLUSIONS: Nalmefene represents a highly cost-effective treatment option in this population. The analysis shows that integrating nalmefene within the current UK clinical treatment pathway for alcohol dependence could reduce the economic burden on the NHS by limiting harmful events and disease progression.

Cost-effectiveness of nivolumab versus surveillance for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence: a US payer perspective.

AIM: To evaluate the cost-effectiveness of adjuvant nivolumab compared with surveillance for the treatment of patients with high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection from a US healthcare payer perspective and to investigate the impact of alternative modeling approaches on the cost-effectiveness results. MATERIAL AND METHODS: A four-state, semi-Markov model consisting of disease free, local recurrence, distant recurrence, and death health states was developed to investigate the cost-effectiveness of nivolumab compared with surveillance over a 30-year time horizon. The model used data from the randomized CheckMate 274 trial (NCT02632409) and published literature to inform transitions among health states, and inputs on cost, utility, adverse event, and disease management. Scenario analyses were conducted to investigate the impact of model structure and key assumptions on the results. One-way deterministic and probabilistic sensitivity analysis were conducted to investigate the robustness of the results. RESULTS: Total expected costs were higher with nivolumab ($162,278) compared with surveillance ($63,027). Nivolumab was associated with improved survival (1.61 life-years gained compared with surveillance) and an incremental gain of 0.98 quality-adjusted life-years (QALYs). Although total treatment costs were higher for nivolumab, cost offsets were observed because of delayed or avoided recurrences and deaths experienced with nivolumab compared with observation. The incremental cost-effectiveness and cost-utility ratios were $61,462/life-year and $100,930/QALY. LIMITATIONS: At the time of analysis, CheckMate 274 had limited follow-up on disease-free survival and no overall survival data. The limited evidence necessitated assumptions on modeling survival after each type of recurrence. CONCLUSIONS: Nivolumab is estimated to be a life-extending and cost-effective option for adjuvant treatment of MIUC for patients who are at high risk of recurrence after undergoing radical resection in the United States. Using a threshold of $150,000/QALY, the cost-effectiveness conclusions remained consistent across the scenario and sensitivity analyses conducted.

Challenges, considerations, and approaches for developing a cost-effectiveness model for the adjuvant treatment of muscle-invasive urothelial carcinoma: with a spotlight on nivolumab versus placebo.

AIMS: To present alternative approaches related to both structural assumptions and data sources for the development of a decision analytic model for evaluating the cost-effectiveness of adjuvant nivolumab compared with surveillance in patients with high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection. METHODS AND RESULTS: Alternative approaches related to both structural assumptions and data sources are presented to address challenges and data gaps, as well as discussion of strengths and limitations of each approach. Specifically, challenges and considerations related to the following are presented: (1) selection of a modeling approach (partitioned survival model or state transition model) given the available evidence, (2) choice of health state structure (three- or four-state) to model disease progression and subsequent therapy, (3) modeling of outcomes from subsequent therapy using tunnel states to account for time-dependent transition probabilities or absorbing health states with one-off costs and outcomes applied, and (4) methods for modeling health-state transitions in a setting where treatment has curative intent and available survival data are immature. CONCLUSIONS: Multiple considerations must be taken into account when developing an economic model for new, emerging oncology treatments in early lines of therapy, all of which can affect the model's overall ability to estimate (quality-adjusted) survival benefits over a lifetime horizon. This paper identifies a series of key structural and analytic considerations regarding modeling of nivolumab treatment in the adjuvant MIUC setting. Several alternative approaches with regard to structure and data have been included in a flexible cost-effectiveness model so the impact of the alternative approaches on model results can be explored. The impact of these alternative approaches on cost-effectiveness results are presented in a companion article. Our findings may also help inform the development of future models for other treatments and settings in early-stage cancer.

Cost-effectiveness of tildrakizumab for the treatment of moderate-to-severe psoriasis in the United States.

OBJECTIVE: To evaluate the relative cost-effectiveness of tildrakizumab and other biologic and targeted systemic treatments compared with a mix of topical therapies, phototherapies, and other conventional systemic therapies as first-line treatment for moderate-to-severe plaque psoriasis from a United States payer's perspective. METHODS: A Markov model consisting of health states based on Psoriasis Area Severity Index (PASI) response rate categories and death was developed. The probabilities of achieving PASI responses were derived from a network meta-analysis based on published efficacy data. Health care costs and effectiveness measured in quality-adjusted life-years (QALYs) were estimated. Incremental costs per QALY gained of each biologic/targeted first-line treatment versus a mix of conventional treatments were compared to provide relative cost-effectiveness among biologic and targeted first-line treatments. RESULTS: Over 10 years, the incremental cost per QALY gained compared with a mix of topical therapies, phototherapies, and other oral systemic therapies was lowest for brodalumab, infliximab, apremilast, and tildrakizumab, followed by secukinumab, ixekizumab, guselkumab, adalimumab, ustekinumab, and etanercept. The position of tildrakizumab relative to the other treatments remained the same across multiple scenarios. CONCLUSIONS: Tildrakizumab is among the most cost-effective first-line therapies for moderate-to-severe plaque psoriasis and is more cost-effective than secukinumab, ixekizumab, guselkumab, adalimumab, ustekinumab, and etanercept.

Patient-reported benefits of bone-anchored transfemoral prostheses as assessed by MedTech20: A general outcome measure for medical products.

BACKGROUND: The medical community demands evidence for the benefits of medical devices such as bone-anchored prostheses (BAPs). MedTech20  is a novel instrument aiming to address general benefits of medical devices. OBJECTIVE: To describe general patient-reported benefits of BAPs measured with MedTech20. STUDY DESIGN: This is a cross-sectional descriptive survey. METHODS: Patients treated in Sweden who had used a BAP for >1 year were mailed the MedTech20  Questionnaire. Responses to each attribute were described, and the MedTech20   Index (0-1), in which a higher figure represents larger benefits from the product, was calculated. Index values were compared based on demographic variables (sex, unilateral or bilateral transfemoral amputation (TFA), and those having experienced any complication of implant parts or the prosthetic connection device). RESULTS: The response rate was 72%. The 62 participants (41 men and 21 women; mean age 57 years) had 11 ± 6.9 mean years of BAP experience. Single attributes stated as highly relevant and with high benefit for BAPs included perceived reliability, perceived safety, sense of control of the disability, facilitation of movement outside home, no discomfort at use, and ease of use. Attributes with less relevance included aid to remember tasks, reduction of barriers to a good sleep, and reduced sense of compromised integrity. The MedTech20  Index was 0.655 ± 0.188 and was not statistically significantly different based on any of the demographic variables. CONCLUSIONS: By using a general measure on attributes of medical devices, this study provides new insights strengthening the evidence regarding the benefits that BAPs provide for patients with TFA who had difficulties with socket-suspended prostheses.

Cost Effectiveness of Nivolumab in Patients with Advanced, Previously Treated Squamous and Non-squamous Non-small-cell Lung Cancer in England.

OBJECTIVE: The aim of this study was to investigate the cost effectiveness of nivolumab versus docetaxel in previously treated, advanced non-small-cell lung cancer (NSCLC) in England and assess how conditional reimbursement within the Cancer Drugs Fund (CDF) can be used to ensure timely patient access to effective treatments. METHODS: Cost-effectiveness models developed for the National Institute for Health and Care Excellence (NICE) TA483 (squamous) and TA484 (non-squamous) technology appraisals were supplemented with updated overall survival (OS), progression-free survival (PFS), and time-to-treatment discontinuation data collected as part of the CDF data collection agreement. Both models were developed by using a partitioned-survival approach based on PFS and OS predictions from CheckMate 017 and CheckMate 057 to estimate the projected proportion of patients in each health state (progression free, progression, death) throughout the model's time horizon. The primary outcomes were estimated costs, quality-adjusted life-years (QALYs), and the resulting incremental cost-effectiveness ratio (ICER) expressed as cost/QALY gained. RESULTS: Base-case ICERs for treating patients with nivolumab versus docetaxel were £35,657/QALY and £38,703/QALY for squamous and non-squamous NSCLC patients, respectively, which are substantially lower than those obtained from what were deemed to be the most appropriate analyses for decision making in the original submissions when run with the same patient access scheme discount: £68,576/QALY and £73,189/QALY gained for squamous and non-squamous NSCLC, respectively. CONCLUSIONS: Nivolumab versus docetaxel is cost effective for treating locally advanced/metastatic NSCLC after prior chemotherapy in adults, regardless of tumour histology or programmed death-ligand 1 expression status.

Comparative cost-effectiveness of tildrakizumab and other commonly used treatments for moderate-to-severe psoriasis.

OBJECTIVES: To compare the cost-effectiveness of tildrakizumab with other commonly used biologics and apremilast as the first-line treatment for moderate-to-severe plaque psoriasis from a US health plan's perspective. METHODS: A 10-year cost-effectiveness model was developed to compare the incremental cost per extra month with a Psoriasis Area and Severity Index (PASI) 75 response. Patients were assumed to receive one of the treatments evaluated as their first-line treatment at the outset of the analysis. Nonresponders (PASI <75) discontinued their current treatment; 25% went on to receive a mix of topical therapies, phototherapies, and other systemic therapies, while 75% received a second-line therapy before receiving a mix of topical therapies, phototherapies, and other systemic therapies. Direct medical costs were calculated based on drug acquisition, administration, and monitoring costs. RESULTS: The incremental cost per extra month a patient had a PASI 75 response was lowest for brodalumab ($3,685), infliximab ($4,102), apremilast ($4,770), and tildrakizumab ($5,150), followed by risankizumab ($5,319), secukinumab ($5,675), guselkumab ($5,784), ixekizumab ($5,900), adalimumab ($5,943), ustekinumab ($6,131), etanercept ($6,618), and certolizumab pegol ($13,476). CONCLUSION: Tildrakizumab was among the most cost-effective first-line treatments for moderate-to-severe psoriasis and was more cost-effective than risankizumab, secukinumab, guselkumab, ixekizumab, adalimumab, ustekinumab, etanercept, and certolizumab pegol.

The Budget Impact of Introducing Tildrakizumab to a United States Health Plan for Managing Moderate-to-Severe Plaque Psoriasis.

OBJECTIVE: The aim of this study was to evaluate the budget impact of introducing tildrakizumab for moderate-to-severe plaque psoriasis from a US health plan perspective. METHODS: A budget impact model estimated costs before and after the adoption of tildrakizumab to a hypothetical US health plan with 1 million covered lives over 5 years. Additionally, the model included adalimumab, brodalumab, etanercept, guselkumab, ixekizumab, secukinumab, ustekinumab, and apremilast; biosimilars were not included. Model input data were obtained from the published literature, clinical trials, and prescription data. Market uptake for tildrakizumab was assumed as 1% annually over 5 years. Patients initiating or switching treatments required induction dosing; all others treated required maintenance dosing. The model compared the total annual costs for tildrakizumab versus treatment without tildrakizumab to calculate budget impact in 2018 US dollars. Scenarios exploring alternative assumptions for adverse events and market uptake rates were assessed, and a one-way sensitivity analysis was conducted. RESULTS: Within a health plan of 1 million members with an estimated 1048 patients receiving biologics or apremilast for psoriasis, the total annual health plan cost after introducing tildrakizumab decreased by $5585, $137,025, $205,538, $274,051, and $342,563 in years 1-5, respectively, resulting in a cumulative reduction of $964,763 over 5 years. The impact on total cost was largely due to drug acquisition costs. The incremental per member per month (PMPM) cost reductions were negligible in year 1, $0.01 in year 2, $0.02 in years 3-4, and $0.03 in year 5. Scenario and sensitivity analyses confirmed the model robustness. CONCLUSIONS: The introduction of tildrakizumab with a 1% annual uptake over 5 years has the potential to reduce the cost of treating patients with moderate-to-severe plaque psoriasis for a US health plan.

Cost-effectiveness of C-leg compared with non-microprocessor-controlled knees: a modeling approach.

OBJECTIVE: To estimate the costs and health outcomes of C-Leg and non-microprocessor-controlled (NMC) knees using a decision-analytic model. DESIGN: Data on costs, rates and duration of problems, knee survival, and health-related quality of life were obtained from interviews with patients and prosthetists with experience of both C-Leg and NMC knees. Interview data were assessed in a decision-analytic Markov model to estimate cost-effectiveness from a health care perspective. SETTING: Outpatient. PARTICIPANTS: A population sample of 20 patients currently using the C-Leg and prior experience of nonmicroprocessor knees, and 5 prosthetists. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Incremental cost per quality-adjusted life year (QALY). RESULTS: The mean incremental cost (in 2006 Euros) and QALYs for the C-Leg was 7657 euros and 2.38, respectively, yielding a cost per QALY gained of 3218 euros. CONCLUSIONS: It is important to provide decision-makers with relevant information on costs and health outcomes of different treatment strategies on actual decision problems despite limited evidence. The results of the study, taking into account both costs and a broadly defined health outcome in terms of QALY, show that given existing albeit limited evidence the C-Leg appears to yield positive health outcomes at an acceptable cost.

The influence of metatarsal support height and longitudinal axis position on plantar foot loading.

BACKGROUND: Metatarsal supports are effective at decreasing plantar foot pressures at the metatarsal heads, however, little is known about the dependence of this decrease upon height and position. METHODS: Barefoot static stance pressure measurements were recorded during standing in single limb support (n=22). Two metatarsal support heights (5mm, 10mm) were evaluated in six positions at 5mm increments (0, 5, 10, 15, 20, 25 mm) proximal to the metatarsal heads along the longitudinal axis of the foot. The barefoot condition with no metatarsal support served as the control. Mean force was measured for each test condition. The findings of this study are limited to the barefoot (unshod) condition. FINDINGS: Mean plantar force decreased significantly under the second metatarsal head with both 5 and 10mm metatarsal supports compared to the control, and 10mm metatarsal support compared with 5mm metatarsal support (P<0.05) while no statistically significant differences were noted relative to longitudinal axis position. INTERPRETATION: The results of this study suggest that the thickness of a metatarsal support is a determinant factor in regulating plantar loading. Surprisingly, the longitudinal axis location of a metatarsal support does not appear to be as important as clinically presumed since the data showed that the force decrease was similar for all positions from 5 to 25 mm. Thus, the orthotic induced effect of a metatarsal support seems to have a sizable interaction range that has not previously been reported. We speculate that the metatarsal support's fulcrum and lift effect can be sustained at a more proximal position due to the foot's rigidity as a lever and the manner in which a metatarsal support interacts with the plantar aponeurosis.

The Cost Effectiveness of Nalmefene for Reduction of Alcohol Consumption in Alcohol-Dependent Patients with High or Very High Drinking-Risk Levels from a UK Societal Perspective.

AIM: To evaluate costs and health outcomes of nalmefene plus psychosocial support, compared with psychosocial intervention alone, for reducing alcohol consumption in alcohol-dependent patients, specifically focusing on societal costs related to productivity losses and crime. METHODS: A Markov model was constructed to model costs and health outcomes of the treatments over 5 years. Analyses were conducted for nalmefene's licensed population: adults with both alcohol dependence and high or very high drinking-risk levels (DRLs) who do not require immediate detoxification and who have high or very high DRLs after initial assessment. The main outcome measure was cost per quality-adjusted life-year (QALY) gained as assessed from a UK societal perspective. Alcohol-attributable productivity loss, crime and health events occurring at different levels of alcohol consumption were taken from published risk-relation studies. Health-related and societal costs were drawn from public data and the literature. Data on the treatment effect, as well as baseline characteristics of the modelled population and utilities, came from three pivotal phase 3 trials of nalmefene. RESULTS: Nalmefene plus psychosocial support was dominant compared with psychosocial intervention alone, resulting in QALYs gained and reduced societal costs. Sensitivity analyses showed that this conclusion was robust. Nalmefene plus psychosocial support led to per-patient reduced costs of £3324 and £2483, due to reduced productivity losses and crime events, respectively. CONCLUSION: Nalmefene is cost effective from a UK societal perspective, resulting in greater QALY gains and lower costs compared with psychosocial support alone. Nalmefene demonstrates considerable public benefits by reducing alcohol-attributable productivity losses and crime events in adults with both alcohol dependence and high or very high DRLs who do not require immediate detoxification and who have high or very high DRLs after initial assessment.

A Comparison of Markov and Discrete-Time Microsimulation Approaches: Simulating the Avoidance of Alcohol-Attributable Harmful Events from Reduction of Alcohol Consumption Through Treatment of Alcohol Dependence.

BACKGROUND AND OBJECTIVE: When modelling the pathophysiology of a disease, it is important to select a modelling approach that can adequately replicate its course. The objective of this paper was to compare the outcomes obtained by the Markov and discrete-time microsimulation modelling approaches using nalmefene clinical trial data. METHODS: Markov and microsimulation modelling approaches assessing alcohol dependence treatment with psychosocial support with or without nalmefene were compared in terms of the modelled evolution of patients' alcohol consumption and the resulting occurrence of alcohol-attributable harmful events over 1 year. RESULTS: Comparison of the proportion of the modelled population at different levels of alcohol consumption over time revealed systematic differences arising from the different modelling techniques: a lower number of patients reaching abstinence, a higher number of patients at higher drinking levels, and, overall, a smoother evolution of alcohol consumption in the microsimulation. Reasons are discussed in the paper. While the models produced similar occurrences of alcohol-attributable harmful events as a whole, distinct results for the individual events were observed, explained by the specific pathophysiology of occurrence of these events and how their implementation was adapted to fit the limitations of the compared modelling approaches; however, these differences were only statistically significant for one of the eight events. CONCLUSIONS: For a general public health or health economic assessment of alcohol use disorders, it is possible to achieve similar results with the compared approaches. To assess a patients' disease course, taking into consideration alcohol-attributable harmful events, the microsimulation approach may provide more precise results. However, further external validation of the models is needed and this additional precision may be outweighed by the greater computational burden of a microsimulation approach.

Relationship between modeling technique and reported outcomes: case studies in models for the treatment of schizophrenia.

Complex modeling techniques such as discrete-event simulation and simpler Markov or decision-tree models have been used to estimate the cost-effectiveness of treatment for chronic diseases such as schizophrenia. A systematic literature review of MEDLINE, EconLit, Embase, and the Cochrane Library identified schizophrenia modeling studies presenting incremental cost-effectiveness ratios. The relationship between modeling technique used and reported outcomes was examined. Fifty-four studies reporting results of 69 pairs of drug comparisons were identified. Of the paired-drug comparisons, 27 were conducted in at least two studies; in 14 of the 27, the results agreed (i.e., drug A cost-effective compared with drug B) despite differences in modeling techniques. Thirteen of the 27 paired-drug comparisons had contradictory study results even when the same modeling technique was used. Different modeling techniques did not appear to explain different findings about cost-effectiveness.

The cost-effectiveness and public health benefit of nalmefene added to psychosocial support for the reduction of alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels: a Markov model.

OBJECTIVES: To determine whether nalmefene combined with psychosocial support is cost-effective compared with psychosocial support alone for reducing alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels (DRLs) as defined by the WHO, and to evaluate the public health benefit of reducing harmful alcohol-attributable diseases, injuries and deaths. DESIGN: Decision modelling using Markov chains compared costs and effects over 5 years. SETTING: The analysis was from the perspective of the National Health Service (NHS) in England and Wales. PARTICIPANTS: The model considered the licensed population for nalmefene, specifically adults with both alcohol dependence and high/very high DRLs, who do not require immediate detoxification and who continue to have high/very high DRLs after initial assessment. DATA SOURCES: We modelled treatment effect using data from three clinical trials for nalmefene (ESENSE 1 (NCT00811720), ESENSE 2 (NCT00812461) and SENSE (NCT00811941)). Baseline characteristics of the model population, treatment resource utilisation and utilities were from these trials. We estimated the number of alcohol-attributable events occurring at different levels of alcohol consumption based on published epidemiological risk-relation studies. Health-related costs were from UK sources. MAIN OUTCOME MEASURES: We measured incremental cost per quality-adjusted life year (QALY) gained and number of alcohol-attributable harmful events avoided. RESULTS: Nalmefene in combination with psychosocial support had an incremental cost-effectiveness ratio (ICER) of £5204 per QALY gained, and was therefore cost-effective at the £20,000 per QALY gained decision threshold. Sensitivity analyses showed that the conclusion was robust. Nalmefene plus psychosocial support led to the avoidance of 7179 alcohol-attributable diseases/injuries and 309 deaths per 100,000 patients compared to psychosocial support alone over the course of 5 years. CONCLUSIONS: Nalmefene can be seen as a cost-effective treatment for alcohol dependence, with substantial public health benefits. TRIAL REGISTRATION NUMBERS: This cost-effectiveness analysis was developed based on data from three randomised clinical trials: ESENSE 1 (NCT00811720), ESENSE 2 (NCT00812461) and SENSE (NCT00811941).

Value of information: interim analysis of a randomized, controlled trial of goal-directed hemodynamic treatment for aged patients.

BACKGROUND: A randomized, controlled trial, intended to include 460 patients, is currently studying peroperative goal-directed hemodynamic treatment (GDHT) of aged hip-fracture patients. Interim efficacy analysis performed on the first 100 patients was statistically uncertain; thus, the trial is continuing in accordance with the trial protocol. This raised the present investigation's main question: Is it reasonable to continue to fund the trial to decrease uncertainty? To answer this question, a previously developed probabilistic cost-effectiveness model was used. That model depicts (1) a choice between routine fluid treatment and GDHT, given uncertainty of current evidence and (2) the monetary value of further data collection to decrease uncertainty. This monetary value, that is, the expected value of perfect information (EVPI), could be used to compare future research costs. Thus, the primary aim of the present investigation was to analyze EVPI of an ongoing trial with interim efficacy observed. METHODS: A previously developed probabilistic decision analytic cost-effectiveness model was employed to compare the routine fluid treatment to GDHT. Results from the interim analysis, published trials, the meta-analysis, and the registry data were used as model inputs. EVPI was predicted using (1) combined uncertainty of model inputs; (2) threshold value of society's willingness to pay for one, quality-adjusted life-year; and (3) estimated number of future patients exposed to choice between GDHT and routine fluid treatment during the expected lifetime of GDHT. RESULTS: If a decision to use GDHT were based on cost-effectiveness, then the decision would have a substantial degree of uncertainty. Assuming a 5-year lifetime of GDHT in clinical practice, the number of patients who would be subject to future decisions was 30,400. EVPI per patient would be €204 at a €20,000 threshold value of society's willingness to pay for one quality-adjusted life-year. Given a future population of 30,400 individuals, total EVPI would be €6.19 million. CONCLUSIONS: If future trial costs are below EVPI, further data collection is potentially cost-effective. When applying a cost-effectiveness model, statements such as 'further research is needed' are replaced with 'further research is cost-effective and 'further funding of a trial is justified'. TRIAL REGISTRATION: ClinicalTrials.gov NCT01141894.

Modular socket system versus traditionally laminated socket: a cost analysis.

BACKGROUND: Using the new modular socket system (MSS) to produce a prosthetic socket directly on the patient has the potential of being easier and quicker to manufacture but also incurring higher costs. OBJECTIVES: The purpose of the study was to compare the costs of manufacturing a transtibial prosthetic socket using either a MSS or a standard laminated socket (PC). STUDY DESIGN: Concurrent controlled trial. METHODS: A total of 20 patients at two orthopaedic facilities were followed with regards to the cost of manufacturing a prosthetic socket using either MSS or PC. Time aspects and material costs were considered in the cost analysis. Other factors studied include delivery time and number of visits. For the cost analysis, only direct costs pertaining to the prosthetic socket were considered. RESULTS: The total cost of MSS was found to be significantly higher (p < 0.01) compared to PC. However, the production and time cost was significantly lower. Delivery time to the patient was 1 day for MSS compared to 17 days for PC. CONCLUSIONS: Our study shows that the direct prosthetic cost of treating a patient using MSS is significantly higher than treating a patient using PC. However, the MSS prosthesis can be delivered significantly faster and with fewer visits. Further studies taking the full societal costs of MSS into account should therefore be performed. CLINICAL RELEVANCE: This study shows that the direct prosthetic cost of treating a patient with Modular Socket System is significantly higher than treating a patient with plastercasting with standard laminated socket. However, the Modular Socket System prosthesis can be delivered significantly faster and with fewer visits.

Cost-effectiveness of clean air administered to the breathing zone in allergic asthma.

INTRODUCTION: Airsonett Airshower (AA) is a novel non-pharmaceutical treatment for patients with perennial allergic asthma that uses a laminar airflow directed to the breathing zone of patients during sleep. It has been shown that AA treatment in addition to optimized standard therapy significantly increases asthma-related quality of life among adolescent asthmatics. However, the cost-effectiveness of AA treatment has not yet been assessed. As reimbursement decisions are increasingly guided by results from the cost-effectiveness analysis, such information is valuable for health-care policy-makers. OBJECTIVE: The objective of this study was to estimate the cost-effectiveness of adding AA treatment with allergen-free air during night sleep to optimized standard therapy for adolescents with perennial allergic asthma compared with placebo. MATERIALS AND METHODS: A probabilistic Markov model was developed to estimate costs and health outcomes over a 5-year period. Costs and effects are presented from a Swedish health-care perspective (QALYs). The main outcome of interest was cost per QALY gained. RESULTS: The Airshower strategy resulted in a mean gain of 0.25 QALYs per patient, thus yielding a cost per QALY gained of under euro35 000 as long as the cost of Airshower is below euro8200. CONCLUSIONS: Adding AA treatment to optimized standard therapy for adolescents with perennial allergic asthma compared with placebo is generating additional QALYs at a reasonable cost. However, further studies taking more detailed resource use and events such as exacerbations into account would be needed to fully evaluate the cost-effectiveness of AA treatment.