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Objective: The crisis of opioid use puts a strain on resources in the United States and worldwide. There are 3 US Food and Drug Administration-approved medications for treatment of opioid use disorder: methadone, buprenorphine, and injectable extended-release naltrexone (XR-NTX). The comparative effectiveness and cost vary considerably among these 3 medications. Economic evaluations provide evidence that help stakeholders efficiently allocate scarce resources. Our objective was to summarize recent health economic evidence of pharmacologic treatment of opioid use disorder interventions., Methods: We searched PubMed for peer-reviewed studies in English from August 2015 through December 2019 as an update to a 2015 review. We used the Drummond checklist to evaluate and categorize economic evaluation study quality. We summarized results by economic evaluation methodology and pharmacologic treatment modality., Results: We identified 105 articles as potentially relevant and included 21 (4 cost-offset studies and 17 cost-effectiveness/cost-benefit studies). We found strengthened evidence on buprenorphine and methadone, indicating that these treatments are economically advantageous compared with no pharmacotherapy, but found limited evidence on XR-NTX. Only half of the cost-effectiveness studies used a generic preference-based measure of effectiveness, limiting broad comparison across diseases/disorders. The disease/disorder-specific cost-effectiveness measures vary widely, suggesting a lack of consensus on the value of substance use disorder treatment., Conclusion: We found studies that provide new evidence supporting the cost-effectiveness of buprenorphine compared with no pharmacotherapy. We found a lack of evidence supporting superior economic value for buprenorphine versus methadone, suggesting that both are attractive alternatives. Further economic research is needed on XR-NTX, as well as other emerging pharmacotherapies, treatment modalities, and dosage forms., (Copyright © 2021 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Objectives: To evaluate alternative methods to calculate and/or attribute economic surplus in the cost-effectiveness analysis of single or short-term therapies., Methods: We performed a systematic literature review of articles describing alternative methods for cost-effectiveness analysis of potentially curative therapies whose assessment using traditional methods may suggest unaffordable valuations owing to the magnitude of estimated long-term quality-adjusted life-year (QALY) gains or cost offsets. Through internal deliberation and discussion with staff at the Health Technology Assessment bodies in England and Canada, we developed the following 3 alternative methods for further evaluation: (1) capping annual costs in the comparator arm at $150 000 per year; (2) "sharing" the economic surplus with the health sector by apportioning only 50% of cost offsets or 50% of cost offsets and QALY gains to the value of the therapy; and (3) crediting the therapy with only 12 years of the average annual cost offsets or cost offsets and QALY gains over the lifetime horizon. The impact of each alternative method was evaluated by applying it in an economic model of 3 hypothetical condition-treatment scenarios meant to reflect a diversity of chronicity and background healthcare costs., Results: The alternative with greatest impact on threshold price for the fatal pediatric condition spinal muscular atrophy type 1 was the 12-year cutoff scenario. For a hypothetical one-time treatment for hemophilia A, capping cost offsets at $150 000 per year had the greatest impact. For chimeric antigen receptor T-cell treatment of non-Hodgkin's lymphoma, capping cost offsets or using 12-year threshold had little impact, whereas 50% sharing of surplus including QALY gains and cost offsets greatly reduced threshold pricing., Conclusions: Health Technology Assessment bodies and policy makers will wrestle with how to evaluate single or short-term potentially curative therapies and establish pricing and payment mechanisms to ensure sustainability. Scenario analyses using alternative methods for calculating and apportioning economic surplus can provide starkly different assessment results. These methods may stimulate important societal dialogue on fair pricing for these novel treatments., (Copyright © 2021 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Objectives: To evaluate the incremental cost-effectiveness ratio (ICER) of the addition of bevacizumab to first-line chemotherapy with carboplatin and paclitaxel in patients with non-small cell lung cancer (NSCLC) from the perspective of the Colombian health system., Methods: A Markov model was employed to evaluate the cost-effectiveness of bevacizumab + carboplatin + paclitaxel (BCP) compared with carboplatin + paclitaxel (CP) in the treatment of NSCLS during a 4-year period. The health outcome was the number of life-years gained (LYG) and quality-adjusted life-years (QALYs) obtained from the survival curves reported in a clinical study. Costs were estimated using national tariff and reported in US dollars at a date in 2019. Costs and effectiveness outcomes were discounted at a rate of 3.5% per year. A probabilistic sensitivity analysis was performed on important parameters with a Monte Carlo simulation., Results: The costs of BCP and CP were $30 341 and $11 735, respectively. The LYG for BCP and CP were 0.34 and 0.29, respectively. The QALY for BCP and CP were 0.27 and 0.23. The ICER of BCP versus CP was $ 465 150 QALY. The results of the Monte Carlo simulation showed that CP was cost-effective in 100% of the iterations compared with BCP., Conclusion: The addition of bevacizumab to the scheme carboplatin + paclitaxel compared to carboplatin + paclitaxel for NSCLC is not cost-effective from the point of view of the Colombian health system., (Copyright © 2020. Published by Elsevier Inc.)

Introduction: Health care utilization of people with lung cancer (LC) the last year of life, their causes of death and place of death and the associated expenditure have been poorly described together. Then we conducted an observational study., Methods: People with LC covered by the French health Insurance general scheme (77% of the population) who died in 2015 were identified in the national health data system, together with their health care utilization and, in 95% of cases, their causes of death., Results: A total of 22,899 individuals were included (mean age: 68 years, SD±11.4), 72% of whom died in short-stay hospitals (SSH), 4% in hospital-at-home, 8% in Rehab hospital, 2% in skilled nursing homes and 14% at home. One-half of these people had also a chronic respiratory tract disease and 18% another cancer. Hospital palliative care (HPC) was identified for 65% of people, but for only 9% prior to their end-of-life stay. During the last month of life, 49% of people had two or more SSH stays, 15% were admitted to an intensive care unit, 23% received a chemotherapy session (13% during the last 14 days). The main cause of death was cancer for 92% of individuals (LC for 82%) The mean expenditure during the last year of life was €43,329 per individual., Discussion: This study indicates high rates of intensive care unit admissions and chemotherapy during the last month of life and a SSH hospital-centered management with intensive use of HPC mainly during the end-of-life stay., (Copyright © 2020 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)

Introduction: Extant literature lack studies on behavioural training or pharmacotherapy in Indian preschool children. With adverse long term outcomes, effective, safe and affordable early interventions for ADHD are a priority. Aim of this prospective study is to report on short term outcome of preschool ADHD with specific focus on safety and tolerability of medications., Methods: Children with ADHD aged 2.5-6 years were assessed for severity and adverse events at baseline and follow-up using Conner's abbreviated rating scale and Clinical Global Impression-Severity scale. Children with Autism spectrum disorder and those with social quotient less than 50 were excluded. Statistical Analysis included descriptive statistics and Repeated measures ANOVA., Results: Of 56 children recruited, 33.93 %(N = 19) were on behavioural interventions alone, 66.07 %(N = 37) were on a combination of medication and behavioural intervention. All children received treatment according to standard care. The most prescribed drug was clonidine (44.64%), then risperidone (28.7%), methylphenidate (10.7%) and atomoxetine (10.7%). Medication choice was determined by affordability, availability and comorbidity profile. Sedation occurred in 24 % of children on clonidine. Atomoxetine was not well tolerated in 2 children. Methylphenidate was well tolerated. Irrespective of medication choice, all children showed significant improvement at 12 weeks (p < 0.001)., Conclusions: Choice of interventions is largely determined by availability and affordability. There is a need for structured parent behavioural training program deliverable in low resource setting. Anti-ADHD medications should be made available under the NMHP, RBSK program and all government settings in India, to address over-prescription of antipsychotics in preschool ADHD., Competing Interests: Declaration of Competing Interest None., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: The Institute for Clinical and Economic Review (ICER) has gained prominance through its work conducting health technology assessments of pharmaceuticals in the United States., Objective: To understand the influence of industry comments on pharmaceutical value assessments conducted by ICER., Methods: We reviewed 15 ICER reports issued from 2017 through 2019. We quantified ICER's revisions to its cost-effectiveness analysis (CEA) estimates between release of its draft and revised evidence reports and whether ratios shifted across ICER-specified categories of high, intermediate, or low value. We also reviewed industry-submitted comments recommending revision to ICER's CEAs, noting ICER's response as no change, text revised, assumption(s) revised, or conclusion revised. We evaluated each comment in terms of clarity, whether it offered an alternative to ICER's approach, and whether it characterized the expected impact of revision on ICER's analysis., Results: We identified 53 ICER-reported ratios. Of these, 45 (84.9%) changed between the draft and revised report, but 26 changes (57.8%) were small (<10%). Six ratios shifted across value categories. We identified 256 industry comments recommending that ICER revise its CEA. Of these, 159 (62%) lacked clarity, 145 (57%) offered no alternative, and 243 (95%) did not characterize their impact on ICER's estimated ratio. Ninety-one comments (35.5%) caused ICER to revise its assumptions, but only 5 (2.0%) caused ICER to revise its conclusions. Four of these 5 comments characterized their impact on ICER's findings., Conclusions: Changes in ICER's estimates of cost-effectiveness between its draft and revised evidence reports are generally modest. Greater precision in industry comments could increase the influence of industry critiques, thus enhancing the dialogue around pharmaceutical value., (Copyright © 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Background: The first-line bevacizumab plus chemotherapy resulted in a clinical efficacy for Chinese patients with advanced nonsquamous non-small-cell lung cancer (NSCLC). Some economic analyses have carried out various methods to evaluate the cost-effectiveness of bevacizumab as the first-line treatment for NSCLC in other countries. Our objective was to assess the cost-effectiveness of bevacizumab plus chemotherapy compared with chemotherapy alone for the first-line treatment of advanced nonsquamous NSCLC., Methods: A Markov model was applied from the perspective of the Chinese health care system to assess cost-effectiveness. It was based on the clinical trial BEYOND that compared bevacizumab plus carboplatin/paclitaxel (B+CP) with placebo plus carboplatin and paclitaxel (PI+CP) for advanced nonsquamous NSCLC. Ten-year quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) were calculated. One-way sensitivity analysis and probabilistic sensitivity analyses (PSA) were performed., Results: QALYs were 1.17 years in the B+CP group and 0.83 years in the PI+CP group, resulting in a difference of 0.34 years. The ICER was $130,937.09/QALY, which was far beyond the willing-to-pay threshold of $24,314/QALY. At a threshold of $130,584/QALY, addition of bevacizumab had a 50% probability of being cost-effective., Conclusions: Bevacizumab is not cost-effective when combined with chemotherapy for patients with advanced nonsquamous NSCLC based on the Chinese health care system, resulting in a less demand in the Chinese market., (Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Background: Systemic chemotherapy has long been the standard of care for advanced bladder cancer, but its cost implications are poorly understood. The objective of this analysis was to estimate survival and health care costs for patients with stage IV bladder cancer who did or did not receive chemotherapy., Patients and Methods: This was a retrospective cohort study of patients identified in the Surveillance, Epidemiology, and End Results-Medicare database with a new primary diagnosis of stage IV bladder cancer between January 2007 and December 2011. Survival and health care visits and costs following the date of diagnosis were determined for treated and untreated patients. Costs were expressed in 2016 US dollars., Results: A total of 1215 patients were diagnosed with stage IV bladder cancer, of whom 411 (33.8%) were treated with chemotherapy and 804 (66.2%) were untreated. Median overall survival was 10 months longer for treated than for untreated patients: 13.2 (95% confidence interval, 12.3-14.1) months versus 3.2 (95% confidence interval, 3.0-3.5) months. Treated patients had fewer per-patient-per-month (PPPM) health care visits than untreated patients (7.5 vs. 10.2, P < .01) and lower total PPPM health care costs ($10,707 vs. $18,935). Overall mean total lifetime costs were greater for treated than for untreated patients ($139,893 vs. $66,829, P < .05), which was driven by an approximate 4-fold increase in life expectancy for the treated patients., Conclusion: Approximately two thirds of patients diagnosed with stage IV bladder cancer were not treated with systemic chemotherapy. Increasing the percentage of treated patients in this population could potentially extend overall survival while simultaneously lowering PPPM costs., (Copyright © 2018 Merck Sharp & Dohme Corp. and The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: Skin and soft tissue infections (SSTIs) carry significant economic burden, as well as morbidity and mortality, especially when caused by methicillin-resistant Staphylococcus aureus (MRSA). Several new MRSA-active antibiotics have been developed, including semisynthetic glycopeptides (telavancin, dalbavancin and oritavancin). Of these, dalbavancin and oritavancin offer extended dosing intervals., Methods: We performed a systematic review, network meta-analysis and cost analysis to compare the newer glycopeptides to standard care and to each other for the treatment of complicated SSTIs (cSSTI). A search for randomized controlled trials (RCTs) was conducted in Medline, Embase and the Cochrane Central Register of Controlled Trials. We also developed a model to evaluate the costs associated with dalbavancin and oritavancin from the third-party payer perspective., Results: Seven RCTs met the inclusion criteria. Network meta-analyses suggested that the clinical response to telavancin, dalbavancin and oritavancin was similar to standard care (odds ratio (OR) 1.09, 95% confidence interval (CI) 0.90-1.33; OR 0.78, 95% CI 0.52-1.18; and OR 1.06, 95% CI 0.85-1.33, respectively). Head-to-head comparisons showed no difference in clinical response between oritavancin and dalbavancin (OR 1.36; 95% CI 0.85-2.18), oritavancin and telavancin (OR 0.98; 95% CI 0.72-1.31) or dalbavancin and telavancin (OR 0.72; 95% CI 0.45-1.13). Telavancin had a higher incidence of overall adverse events compared to standard care (OR 1.33; 95% CI 1.10-1.61). Compared to telavancin, there were fewer overall adverse events with dalbavancin (OR 0.58; 95% CI 0.45-0.76) and oritavancin (OR 0.71; 95% CI 0.55-0.92). Studies were of high quality overall. Our cost analyses demonstrated that dalbavancin and oritavancin were less costly compared to standard care under baseline assumptions and many scenarios evaluated. The use of dalbavancin could save third-party payers $1442 to $4803 per cSSTI, while the use of oritavancin could save $3571 to $6932 per cSSTI., Conclusions: Dalbavancin and oritavancin demonstrate efficacy and safety comparable to standard care in well-designed RCTs and result in cost savings when standard care is treatment that covers MRSA., (Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

Background: Ibrutinib shows superiority over obinutuzumab with chlorambucil (G-Clb) in untreated patients with chronic lymphocytic leukemia with comorbidities who cannot tolerate fludarabine-based therapy. However, ibrutinib is relatively more expensive than G-Clb. In this study we evaluated the cost-effectiveness of ibrutinib compared with G-Clb from the United Kingdom (UK) health care perspective., Materials and Methods: A 3-state semi-Markov model was parameterized to estimate the lifetime costs and benefits associated with ibrutinib compared with G-Clb as first-line treatment. Idelalisib with rituximab was considered as second-line treatment. Unit costs were derived from standard sources, (dis)utilities from UK elicitation studies, progression-free survival, progression, and death from clinical trials, and postprogression survival and background mortality from published sources. Additional analyses included threshold analyses with ibrutinib and idelalisib at various discount rates, and scenario analysis with ibrutinib as second-line treatment after G-Clb., Results: An average gain of 1.49 quality-adjusted life-years (QALYs) was estimated for ibrutinib compared with G-Clb at an average additional cost of £112,835 per patient. To be cost-effective as per the UK thresholds, ibrutinib needs to be discounted at 30%, 40%, and 50% if idelalisib is discounted at 0%, 25%, and 50% respectively. The incremental cost-effectiveness ratio was £75,648 and £-143,279 per QALY gained for the base-case and scenario analyses, respectively. Sensitivity analyses showed the robustness of the results., Conclusion: As per base-case analyses, an adequate discount on ibrutinib is required to make it cost-effective as per the UK thresholds. The scenario analysis substantiates ibrutinib's cost-savings for the UK National Health Services and advocates patient's access to ibrutinib in the UK., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background and Purpose: The literature firmly establishes that clinical interventions made by pharmacy students on Advanced Pharmacy Practice Experience (APPE) rotations contribute significantly to cost-savings realized by the hosting practice sites. The Accreditation Council for Pharmacy Education (ACPE) specifies the experiential curricula include opportunities for students to learn about, from, and with other members of the healthcare team through interprofessional education activities., Educational Activity: This study assesses clinical and educational interventions contributed by APPE students at a family medicine residency program to determine the extent students were engaged in the interprofessional team and physicians' receptiveness to the recommendations., Findings: Student interventions made from January 2009 to September 2012 were recorded in a Microsoft Excel Spreadsheet. Data was evaluated to determine 1) the most common types of clinical and educational interventions, 2) potential associated cost-savings/avoidance, and 3) provider receptiveness to recommendations based upon acceptance rates. A standardized scheme was utilized to assign a cost savings value according to Midwest America Division of Hospital Corporation of America (HCA) clinical savings standards. Pharmacy students contributed 2868 interventions in 3.5 years. A total of 59.2% of interventions were clinical and accounted for an estimated cost savings of $55,892. The remaining 40.8% of interventions were pharmacy care activities, none were associated with a cost savings and three-fourths were considered educational. Intervention acceptance rate was over 80%, showing providers were very receptive to pharmacy students., Summary: This study lends support that APPE students provide substantial clinical and educational contributions to healthcare providers and patients affiliated with family medicine residency programs. Additionally, healthcare providers and patients are very receptive to pharmacy students as members of the interprofessional team., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Clinical trials play a key role in advancing medical knowledge, improving patient care and promoting economic growth in Europe. We have assessed the clinical trial activity in any respiratory diseases in Europe, with a specific focus on Italy., Methods: Information from public sources (EFPIA, clinicaltrials.gov, clinicaltrialsregister. eu, AIFA) was used to describe clinical trial activity of in respiratory diseases in Europe and by country., Results: In 2015, 3908 clinical trials were reported in Europe, 386 in respiratory diseases (9.9%). Germany was the first country both as absolute number (76 trials) and as percentage within country trials (14%), followed by Poland. Spain, Italy and France were the countries with the lowest number and percentage of trials in respiratory diseases. In 2013, the Italian Drug Agency reported 9 trials with respiratory compounds in Italy (2.1% of overall trials, 12ˆ position in the therapeutic area rank), 33% in phase 2 and 66% in phase 3. No phase 1 or phase 4 trials were reported for respiratory trials. Prevalence of respiratory trials by non-profit sponsors (28.3%) was below the average for the country (38.3%)., Conclusions: Europe has a greater potential for clinical research on drugs for respiratory diseases, particularly in countries with less activity, such as Spain, France and Italy, that should identify and implement actions to increase attractiveness for clinical trials of drugs., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

The effects of a pharmaceutical treatment have until now been evaluated by the field of Health Economics on the patient health benefits, expressed in Quality-Adjusted Life Years (QALYs) versus the monetary costs. However, there is also a Human Health burden associated with this process, resulting from emissions that originate from the pharmaceutical production processes, Use Phase and End of Life (EoL) disposal of the medicine. This Human Health burden is evaluated by the research field of Life Cycle Assessment (LCA) and expressed in Disability-Adjusted Life Years (DALYs), a metric similar to the QALY. The need for a new framework presents itself in which both the positive and negative health effects of a pharmaceutical treatment are integrated into a net Human Health effect. To do so, this article reviews the methodologies of both Health Economics and the area of protection Human Health of the LCA methodology and proposes a conceptual framework on which to base an integration of both health effects. Methodological issues such as the inclusion of future costs and benefits, discounting and age weighting are discussed. It is suggested to use the structure of an LCA as a backbone to cover all methodological challenges involved in the integration. The possibility of monetizing both Human Health benefits and burdens is explored. The suggested approach covers the main methodological aspects that should be considered in an integrated assessment of the health effects of a pharmaceutical treatment., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Individuals' frequent and consistent interaction with medications can serve as a unifying element to help coordinate individuals' health care services. Despite its potential to improve coordination of heath care, initiation of medication therapy from the perspective of individuals' experiences remains largely unexamined., Objectives: The objectives for this study were to describe the viewpoints of consumers, physicians, pharmacists, and social workers regarding initiation of medication therapy in terms of: (1) activation and engagement, (2) information processing, and (3) economic factors., Methods: Data were collected via mailed survey methodology from random samples of 400 adults, 400 physicians, 400 pharmacists, and 400 social workers residing in Minnesota. Responses to open-ended questions were coded using content analysis and summarized with descriptive statistics., Results: The findings showed that consumer views of (1) activation and engagement, (2) information processing, and (3) economic factors differed from the views of physicians, pharmacists, and social workers. Consumers typically view initiation of medication therapy within the context of their overall lives. Physicians view it as a biomedical puzzle in which diagnosis, drug product selection, and risk assessment are main concerns. Pharmacists view it as a health care systems puzzle in which insurance coverage, cost, and risk management are main concerns. Social workers view it as a social systems puzzle in which access to care, cost, and social support are main concerns., Conclusions: Initiation of medication therapy is a disjointed experience for many consumers. The best timing for providing information about prescription drugs to individuals depends largely on what kinds of thoughts and impressions they have about a new therapy at various stages of the medication use process. The findings from this study can be useful for (1) developing consumer-centered approaches for medication use and (2) coordinating health care through the integration of the medication experience using consumer viewpoints., (Copyright © 2014 Elsevier Inc. All rights reserved.)

It is difficult to define the true cost of a burns injury, however there has always been a consensus that the costs associated with burns care are high. This study aims to achieve an accurate calculation of the cost of acute burns care in an Australian context. A retrospective review of 20 adult burn patients treated at our Centre was performed. An itemized price list was prepared based on items, services and equipment actually utilized in the care of burns patients. Case records were reviewed for a count of quantities to calculate costs for each item. Regression analysis was performed to produce a cost vs %TBSA curve for cost prediction. A cost breakdown was also performed for analysis of the most significant areas of expenditure and their trends with %TBSA. The cost calculated for an average adult burns patient was AU$71,056 (US$73,532). The total cost of all 20 patients was AU$2,449,112 (US$2,534,464). %TBSA injured was confirmed as the primary determinant of cost. Hospital length of stay, operative costs, dressings and staffing were found to be the most significant components of cost and increased most prominently with %TBSA. Compared to our findings, expenditure for prevention and education programs is minimal. There is limited conclusive evidence that changes in management protocols have had successful impact on the cost of burns treatment. Future progress in burns management may effect factors such as hospital length of stay, however until such changes, resource allocation should recognize the importance of prevention and its success at reduction of injury severity for real reductions in cost of burns care., (Crown Copyright © 2012. Published by Elsevier Ltd. All rights reserved.)

Methicillin-resistant Staphylococcus aureus (MRSA) can cause severe infections in patients undergoing haemodialysis. Routine periodic testing of haemodialysis patients and attempting to decolonize those who test positive may be a strategy to prevent MRSA infections. The economic value of such a strategy has not yet been estimated. We constructed a Markov computer simulation model to evaluate the economic value of employing routine testing (agar-based or PCR) at different MRSA prevalence, spontaneous clearance, costs of decolonization and decolonization success rates, performed every 3, 6 or 12 months. The model showed periodic MRSA surveillance with either test to be cost-effective (incremental cost-effectiveness ratio ≤$50 000/quality-adjusted life-year) for all conditions tested. Agar surveillance was dominant (i.e. less costly and more effective) at an MRSA prevalence ≥10% and a decolonization success rate ≥25% for all decolonization treatment costs tested with no spontaneous clearance. PCR surveillance was dominant when the MRSA prevalence was ≥20% and decolonization success rate was ≥75% with no spontaneous clearance. Routine periodic testing and decolonization of haemodialysis patients for MRSA may be a cost-effective strategy over a wide range of MRSA prevalences, decolonization success rates, and testing intervals., (© 2011 The Authors. Clinical Microbiology and Infection © 2011 European Society of Clinical Microbiology and Infectious Diseases.)

Objective: To identify Japanese patients' perceptions of the costs and benefits of their medications by administering a questionnaire validated in Western patients and to compare the association between the perception levels and non-adherence to medication in the two non-adherent patient types, intentional, and unintentional., Methods: Japanese patients with chronic diseases were given a questionnaire and interviewed, and the validity and reliability of the scales generated were assessed. Logistic regression was used to analyse the association between individual perception levels and non-adherence to the medication regimen., Results: From 151 responses, two kinds of scales were generated following a report of Western patients; the necessity scale showed satisfactory reliability (Cronbach's alpha 0.79) but the concerns scale did not. Individual levels of perception of the necessity of medications were associated with unintentional non-adherence (the higher the level, the lower the odds ratio 1.0, 0.56, 0.40, and 0.15), while they were not associated with intentional non-adherence., Conclusion: Japanese patients' perceptions of the benefits of medications, but not the costs were similar to those of Western patients, and these perceptions were likely to be different between intentionally and unintentionally non-adherent patients., Practice Implications: Strategies to improve non-adherence should be designed according to the non-adherent type.

Objective: Research demonstrates that interventions targeting multiple settings within a child's life are more effective in treating or preventing conduct disorder. One such program is the Incredible Years Series, which comprises three treatment components, each focused on a different context and type of daily social interaction that a child encounters. This article explores the cost-effectiveness of stacking multiple intervention components versus delivering single intervention components., Method: The data involved 459 children, ages 3 to 8, who participated in clinical trials of the Incredible Years Series. Children randomized to one of six treatment conditions received one or more of the three following program components: a child-based program, a parent training program, and a teacher-based program instructing teachers in classroom management and in the delivery of a classroom-based social skills curriculum., Results: Per-child treatment costs and child behavior outcomes (observer and teacher reported) were used to generate cost-effectiveness acceptability curves; results suggest that stacking intervention components is likely cost-effective, at least for willingness to pay above $3,000 per child treated., Conclusions: Economic data may be used to compare competing intervention formats. In the case of this program, providing multiple intervention components was cost-effective.

Objectives: Suboptimal compliance and failure to persist with drug treatments are important determinants of therapeutic nonresponse and are of potential economic significance. The present article aims to describe the methodologies that may be appropriate for integrating noncompliance and nonpersistence in economic evaluations., Methods: MEDLINE and NHS-EED were searched for economic evaluations published in the period between 1997 and 2005. Articles were included if they explored the dependence of cost-effectiveness results on varying levels of some form of compliance-related measure. The different methodologies used were reviewed and articles were appraised critically. Alternative methodological approaches are proposed, illustrated by an example of the impact of different persistence rates on a treatment's cost-effectiveness., Results: Ten articles were selected for inclusion. These were generally scant on detail relating to how compliance/persistence was assessed and what the impact was on health outcomes. The methods used included Markov models and decision analyses. Markov models allow for persistence to be included directly in the analysis, as patients transit during each cycle. Net-benefit regression models are well suited for analyzing prospective and retrospective studies where patient-level data are available, whereas discrete event simulations have the potential to offer more flexibility., Conclusions: Compliance and/or persistence are not included routinely in pharmacoeconomic analyses, despite their potential impact. Where compliance and/or persistence are included, a lack of methodological rigor and consistency in definitions often limits the usefulness of the analyses. The analytical techniques discussed in this article should serve as a basis for developing guidelines on appropriate methodology.

Objective: To delineate the relationship, including similarities and differences, between medication therapy management (MTM) and contemporary pharmacist-provided services, including patient counseling, disease management, and pharmaceutical care, to facilitate the continued evolution of commonly used language and a standard of practice across geographic areas and practice environments., Summary: Incorporation of MTM services into the array of Medicare-funded services affords an opportunity for pharmacists to develop direct patient care services in the community. Defining the role of MTM within the scope of pharmacist-provided patient care activities, including patient counseling, disease management, and all currently provided pharmacy services is essential to the delineation of a viable and sustainable practice model for pharmacists. The definitions of each of these services are offered, as well as comparisons and contrasts of the individual services. In addition to Medicare-eligible patients, MTM services are appropriate for anyone with medication-related needs. MTM is offered as an all-encompassing model that incorporates the philosophy of pharmaceutical care, techniques of patient counseling, and disease management in an environment that facilitates the direct collaboration of patients, pharmacists, and other health professionals., Conclusion: Defining the role of MTM within the current patient care models, including patient counseling, disease management, and all who provide pharmacy services, is essential in delineating a viable and sustainable practice model for pharmacists.

Drug therapy is essential when caring for elderly patients, but clearly it is a double-edged sword. Elderly patients are at high risk of having drug interactions, but the prevalence of these interactions is not well documented. Several types of interactions exist: drug-drug, drug-disease, drug-food, drug-alcohol, drug-herbal products, and drug-nutritional status. Factors such as age-related changes in pharmacokinetics and pharmacodynamics, frailty, interindividual variability, reduced homoeostatic mechanisms, and psychosocial issues need to be considered when drug interactions are assessed. Software can help clinicians to detect drug interactions, but many programmes have not been updated with the evolving knowledge of these interactions, and do not take into consideration important factors needed to optimise drug treatment in elderly patients. Any generated recommendations have to be tempered by a holistic, geriatric, multiprofessional approach that is team-based. This second paper in a series of two on prescribing in elderly people proposes an approach to categorise drug interactions, along with strategies to assist in their detection, management, and prevention.

Objective: Noncompliance is considered as a widespread but often neglected problem all over the world. In order to promote compliance, it is essential to first know the current drug use situation. Therefore, this study aims to investigate the level of drug compliance in patients of a primary healthcare centre and identify factors which affect the patients' drug compliance in Turkey., Methods: The cross-sectional study was executed in 2003 in Ilica Health Centre; a total of 280 patients took part in the study. The patients were visited at home and a questionnaire was applied in order to obtain information on compliance., Results: Overall 204 (72.8%) of patients were compliant and 76 (27.2%) were noncompliant. According to patients, the main reason for primary noncompliance was poverty., Conclusion: Compliance with prescription is needed to get favourable results in treatments. The results show that even in urban areas drug compliance is still an important problem in Turkey., Practice Implications: The findings of this study may contribute to develop programmes to improve patient compliance in Turkey. The aims of these programs should include reducing the barriers, such as lack of social security, which prevent access to the prescribed drugs.

There is wide individual variation in drug responses and adverse effects. As the main causes of the variation in drug responses, attention has focused on the genetic polymorphisms that encode metabolic enzymes regulating pharmacodynamics and receptors modulating the affinity with the responsive sites. Tailor-made drug therapy analyzes genetic polymorphisms involved in drug responses before drug administration and selects drugs and doses suitable for the individual genetic background. Establishment of tailor-made drug therapy is expected to contribute to medical economy by avoiding wasteful drug administration. To promote such medical practice, it is necessary to use simple genetic testing that is clinically convenient. Currently, genetic testing using real-time PCR has been frequently employed at laboratories with its clinical application anticipated. As to the many genes involved in drug responses, to date, the application of patient genetic information to tailor-made drug therapy has been achieved at the practical level. Information on pharmacogenetics will be a critical factor in medical practice in the near future.

Decisions about which health-care interventions represent adequate value to collectively funded health-care systems are as widespread as they are unavoidable. In the case of new pharmaceuticals, many countries now require formal cost-effectiveness analysis to inform this decision-making process. This requires evidence on parameters associated with health-related utilities, treatment effects, resource use, and costs, for which data from available regulatory trials are invariably absent or highly uncertain. This uncertainty results from a number of factors including the predominance of intermediate end points in the clinical evidence-base and the limited period of follow-up of patients in clinical studies. Despite these imperfections in the evidence base, decisions about whether new pharmaceuticals are sufficiently cost-effective for reimbursement cannot be side-stepped. Data limitations do, however, require the use of rigorous analytical methods to support decision making. Probabilistic decision models and value of information analysis offer a means of structuring decision problems, synthesizing all available data, characterizing the uncertainty in the decision, quantifying the cost of uncertainty, and establishing the expected value of perfect information. This analytical framework is important because it addresses two fundamental questions about new pharmaceuticals. First, is the product expected to be cost-effective on the basis of existing evidence? Second, is additional research concerning the product itself cost-effective? In addressing these questions, the analytical framework can establish when sufficient evidence exists to sustain a claim for a new pharmaceutical to be cost-effective.

Background: Pharmacogenetics is the science of the influence of heredity on pharmacological response., Issues: The cost of severe adverse drug reactions in individuals has been estimated in the US alone to be in excess of US$4 billion. It has been argued that in a significant proportion of cases, the efficacy and toxicity profiles of drug therapy would be substantially improved in individuals if characteristics due to genetic variation were taken into account. Methods are now available, which make screening for susceptibility feasible., Conclusions: There are several therapeutic areas in which screening may give rise to significant improvements in outcome with cost-benefits to both the individual and the community. However, there is currently a lack of data on which cost-benefit analysis can be based. The challenge is to provide this information for new drugs, and for drugs with established therapeutic roles.

Acute bronchitis and acute exacerbations of chronic bronchitis, common illnesses encountered by general and family physicians, account for approximately 14 million physician visits per year. The pattern of antibiotic prescribing for these infections varies from country to country, but there is no clear rationale for these antimicrobial choices. A recent meta-analysis of all randomized, placebo-controlled trials of patients treated with antibiotics for acute exacerbations of chronic bronchitis concluded that a small but statistically significant improvement could be expected in antibiotic-treated patients. Haemophilus influenzae is the most commonly isolated organism from sputum in patients with acute exacerbations of chronic obstructive lung disease but other Haemophilus species, Streptococcus pneumoniae, and Moraxella catarrhalis may also be found. High-risk patients can be defined as being elderly, with significant impairment of lung function, having poor performance status with other comorbid conditions, having frequent exacerbations, and often requiring oral corticosteroid medication. Well-defined clinical trials measure efficacy of a drug but not the effectiveness in a real world situation. Future studies of new antimicrobials should examine their efficacy in patients with an increased risk of true bacterial infection.

Time is an inherent feature of many medical applications. These applications can also benefit from the support of object database management systems which better capture the semantics of the complex objects that arise in the medical domain. In this paper, we present a uniform behavioral temporal object model which includes a rich and extensible set of types and behaviors to support the various features of a medical application. We concentrate here on the application of pharmacoeconomic medical trials. Pharmacoeconomics is a field of medical economics in which the costs and outcomes of alternative treatments are assessed and compared, in order to establish which is the most appropriate treatment for a particular illness in a particular setting. We describe in detail the histories and timelines features of our temporal model and show how they can effectively be used to model a pharmacoeconomic trial. We then give an instance of a pharmacoeconomic trial as it would appear in the temporal object model and show, using queries, how a series of different behaviors could be used to retrieve various components of the instance. These components could then be used to assess the alternative treatments involved in the trial and determine their cost-effectiveness.

The difference in mean costs between a placebo and a drug treated group is used for the pharmacoeconomic evaluation of a new drug. The distribution of costs without treatment (null hypothesis) is determined through hospital records. The sampling properties are established by simulation. The results of the simulation allow determination of a break point of differences corresponding to a given level of significance. For power determination, using this break point, clinical hypotheses are used to generate the distribution of costs under treatment (alternative hypothesis).

The purpose of this study was to quantify the social and financial burden imposed by osteoarthritis in France. Six million new diagnoses of osteoarthritis are reported each year in France. The number of physician visits for osteoarthritis totals 8.7 million per year, for a total cost of 950 million French francs (FF). The cost of drugs prescribed to treat osteoarthritis is 965 million FF. Total annual cost of laboratory tests, roentgenograms, and rehabilitation therapy is 330 million French francs per year. The annual number of hospital admissions for osteoarthritis is 93,000. Duration of the hospital stay ranges from 11 to 16 days according the site involved. Hospital costs (in public and private institutions) total 1.7 billion French francs per year. Total direct costs related to osteoarthritis are 4 billion French francs per year. Indirect costs are the costs related to days of work lost. Sick leave benefits total 556 million FF and the production costs for the national economy are estimated at 1.6 billion French francs per year. Direct costs (4 billion FF) and indirect costs (at least 600 million FF) related to osteoarthritis represent an enormous burden for the French economy and national health care system. Novel treatments capable of substantially decreasing these costs would be of great value.