Cost-effectiveness of omalizumab for the treatment of chronic spontaneous urticaria

Background: Chronic spontaneous urticaria (CSU) is a skin disease with itchy hives and/or angio-oedema that last for at least 6 weeks without an obvious external trigger. Objectives: To determine the cost-effectiveness of omalizumab relative to standard of care (SoC; up to four times the daily dose of H1-antihistamines) in the Netherlands from a societal perspective. Methods: The Markov model used consisted of five healt

Indirect costs of disease; an international comparison

Results of economic evaluations are often strongly influenced by estimates of indirect costs. International comparability of these estimates may contribute to rational decision-making in health care policy. Hence, estimates should be international comparable. Comparability of these results between countries may be hampered due to variation in methodology, data sources, valuation of production losses, and social security arrangements. Furthermore differences in epidemiology, demography and economic environment may cause variation in the level and the distribution by diagnosis of indirect costs. In this study indirect costs of disease for the Netherlands are compared with estimates for Sweden and the United States. We found large differences: both in the share of indirect costs in GDP as in the constituting elements, absence from work, disability and mortality. The level of indirect costs due to absence from work and the distribution according to diagnosis are quite similar for the two European countries. The costs of disability are particularly high for the Netherlands. Comparison of disability costs between the three countries is hampered due to lack of quantitative information on the influence of social insurance arrangements on the level of indirect costs and the distribution by diagnosis. The large number of deaths at young age in the U.S. is responsible for the higher mortality costs compared to the two European countries

Systematic review of available evidence on 11 high-priced inpatient orphan drugs

__Background__: Attention for Evidence Based Medicine (EBM) is growing, but evidence for orphan drugs is argued to be limited and inferior. This study systematically reviews the available evidence on clinical effectiveness, costeffectiveness and budget impact for orphan drugs. __Methods__: A systematic review was performed in PubMed, Embase, NHS EED and HTA databases for 11 inpatient orphan drugs listed on the Dutch policy rule on orphan drugs. For included studies, we determined the type of study and various study characteristics. __Results__: A total of 338 studies met all inclusion criteria. Almost all studies (96%) focused on clinical effectiveness of the drug. Of these studies, most studies were case studies (41%) or observational studies (39%). However, for all orphan diseases at least one experimental or quasi-experimental study was found, and a randomized clinical trial was available for 60% of the orphan drugs. Eight studies described the cost-effectiveness of an orphan drug; an equal number described an orphan drug’s budget impact. __Conclusions__: Despite the often heard claim that RCTs are not feasible for orphan drugs, we found that an RCT was available in 60% of o

Orphan drugs expenditure in the Netherlands in the period 2006-2012

Background: The relatively low budget impact of orphan drugs is often used as an argument in reimbursement decisions. However, overall, the budget impact of orphan drugs can still be substantial. In this study, we assess the uptake and budget impact of orphan drugs in the Netherlands.Methods. We examined the number of orphan drugs, the number of patients and budget impact of orphan drugs in the Netherlands in the period 2006 to 2012, both for inpatient and outpatient orphan drugs. Budget impact was provided in absolute numbers and relative to total pharmaceutical spending.Results: The number of orphan drugs and patients treated increased substantially over the period studied. Overall, budget impact increased substantially over a period of six years, both in absolute terms (326% increase) as well as relative to total pharmaceutical spending (278% increase). Growth rates decreased over time. In 2012, 17% of available drugs had an individual budget impact of more than 10 million per year.Conclusions: Individual budget impact of or

Efficacy and cost-effectiveness of an experimental short-term inpatient Dialectical Behavior Therapy (DBT) program: Study protocol for a randomized controlled trial

__Abstract__ Background: Borderline Personality Disorder (BPD) is a serious psychiatric condition associated with substantial mortality, burden and public health costs. DBT is the treatment model with the largest number of published research articles showing effectiveness. However, some patients are not sufficiently engaged in outpatient treatment while presenting severe parasuicidal behavior, making hospitalization necessary. The Center for Personality Disorders Jelgersma developed an intensive 12-week inpatient DBT program that (i) rapidly reduces core borderline symptoms like suicidal behavior, (ii) minimizes the negative effects of an inpatient setting, and (iii) enhances compliance with outpatient treatment. We evaluate the (cost-) effectiveness of this experimental program.Methods/design: Seventy patients, aged 18 to 45 years with a primary diagnosis of BPD, showing a chronic pattern of parasuicidal gestures and/or reporting high degrees of severity of other borderline symptoms, are randomly allocated to the control and intervention groups. Subjects in the control group receive standard outpatient DBT, provided in one of three regular mental health settings in GGZ Rivierduinen. Subjects in the intervention group receive 12 weeks of intensified inpatient DBT plus six months of standard DBT, provided in the Center for Personality Disorders Jelgersma. The primary outcome is the number of suicide attempts/self-harming acts. Secondary outcomes are severity of other borderline complaints, quality of life, general psychopathological symptoms and health care utilization and productivity costs. Data are gathered using a prospective, two (group: intervention and control) by five (time of measurement) repeated measures factorial design.Participants will complete three-monthly outcome assessments in the course of therapy: at baseline, and 12, 24, 36 and 52 weeks after the start of the treatment. The period of recruitment started in March 2012 and the study will end in December 2014.Discussion: Highly suicidal outpatient patients can pose a dilemma for mental health care professionals. Although hospitalization seems inevitable under some circumstances, it has proven to be harmful in its own right. This paper outlines the background and methods of a randomized trial evaluating the possible surplus value of a short-term inpatient DBT program

Burden of illness of hip fractures in elderly Dutch patients

Summary: Patients with hip fractures experience reduced health-related quality of life and have a reduced life expectancy. Patients’ utilization of healthcare leads to costs to society. The results of the study can be used in future economic evaluations of treatments for hip fractures. Purpose: Hip fractures are associated with high mortality, reduced quality of life, and increased healthcare utilization, leading to an economic burden to society. The purpose of this study is to determine the burden of illness of hip fractures in elderly Dutch patients for specific time periods after surgery. Methods: Patients with a hip fracture above the age of 65 were included in the study. In the 1-year period after surgery, patients were asked to complete a set of questionnaires pre-injury (retrospectively), and 1 week, 1 month, 3 months, 6 months and 12 months after surgery. The set of questionnaires included the Euroqol 5D (EQ-5D-3L), the iMTA Medical Consumption Questionnaire (iMCQ) and iMTA Productivity Cost Questionnaire (iPCQ). Health-related quality of life was calculated using Dutch tariffs. Costs were calculated using the methodology described in the Dutch costing manual. Results: Approximately 20% of patients with a hip fracture died within 1 year. Health-related quality of life was significantly reduced compared to pre-injury values, and patients did not recover to their pre-injury values within 1 year. Total costs in the first year after injury were €27,573, of which 10% were due to costs of the procedure (€2706). Total follow-up costs (€24,876) were predominantly consisting of healthcare costs. Monthly costs decreased over time. Conclusions: Hip fractures lead to a burden to patients, resulting from mortality and health-related quality of life reductions, and to society, due to (healthcare) costs. The results of this study can be used in future economic evaluations

A noticeable difference? Productivity costs related to paid and unpaid work in economic evaluations on expensive drugs

Productivity costs can strongly impact cost-effectiveness outcomes. This study investigated the impact in the context of expensive hospital drugs. This study aimed to: (1) investigate the effect of productivity costs on cost-effectiveness outcomes, (2) determine whether economic evaluations of expensive drugs commonly include productivity costs related to paid and unpaid work, and (3) explore potential reasons for excluding productivity costs from the economic evaluation. We conducted a systematic literature review to identify economic evaluation

Effectiveness of step-down versus outpatient dialectical behaviour therapy for patients with severe levels of borderline personality disorder

__Background:__ Step-down dialectical behaviour therapy (DBT) is a treatment consisting of 3 months of residential DBT plus 6 months of outpatient DBT. The program was specifically developed for people suffering from severe borderline personality disorder (BPD). The present study examines the effectiveness and cost-effectiveness of stepdown DBT compared to 12 months of regular, outpatient DBT. __Methods:__ Eighty-four participants reporting high levels of BPD-symptoms (mean age 26 years, 95% female) were randomly assigned to step-down versus standard DBT. Measurements were conducted at baseline and after 3, 6, 9 and 12 months. The Lifetime Parasuicide Count and BPD Severity Index (BPDSI) were used to assess suicidal behaviour, non-suicidal self-injury (NSSI) and borderline severity. Costs per Quality Adjusted Life Year (QALY) were calculated using data from the EQ-5D-3L and the Treatment Inventory Cost in Psychiatric Patients (TIC-P). __Results:__ In step-down DBT, 95% of patients started the program, compared to 45% of patients in outpatient DBT. The probability of suicidal behaviour did not change significantly over 12 months. The probability of NSSI decreased significantly in step-down DBT, but not in outpatient DBT. BPDSI decreased significantly in both groups, with the improvement leveling off at the end of treatment. While step-down DBT was more effective in increasing quality of life, it also cost significantly more. The extra costs per gained QALY exceeded the €80,000 threshold that is considered acceptable for severely ill patients in the Netherlands. __Conclusions:__ A pragmatic randomized controlled trial in the Netherlands showed that 9 months of step-down DBT is an effective treatment for people suffering from severe levels of BPD. However, step-down DBT is not more effective than 12 months of outpatient DBT, nor is it more cost-effective. These findings should be considered tentative because of high noncompliance with the treatment assignment in outpatient DBT. Furthermore, the longterm effectiveness of step-down DBT, and moderators of treatment response, remain to be evaluated

Presentation and validation of the Abbreviated Self Completion Teen-Addiction Severity Index (ASC T-ASI): A preference-based measure for use in health-economic evaluations

Economic evaluations of new youth mental health interventions require preference-based outcome measures that capture the broad benefits these interventions can have for adolescents. The Abbreviated Self Completion Teen-Addiction Severity Index (ASC T-ASI) was developed to meet the need for such a broader measure. It assesses self reported problems in seven important domains of adolescents’ lives, including school performance and family relationships, an

Let's go back to work: survival analysis on the return-to-work after depression

Absence from work due to mental disorders is substantial. Additionally, long-term absence from work is associated with a reduced probability of return-to-work (RTW). Major depressive disorder (MDD) is a prevalent condition in Dutch occupational health care settings. An early estimate of the prognosis regarding RTW in patients with MDD could serve both as a point of departure for the identification of high-risk cases and as an instrument to monitor the course of the disorder and of RTW. In the current study, we aimed to assess the added value of health-related quality of life (HRQoL) and severity of depression to predict the time to RTW