The cost burden of Crohn's disease and ulcerative colitis depending on biologic treatment status - a Danish register-based study.

BACKGROUND: Patients diagnosed with inflammatory bowel disease may be treated with biologics, depending on several medical and non-medical factors. This study investigated healthcare costs and production values of patients treated with biologics. METHODS: This national register study included patients diagnosed with Crohn's disease (CD) and ulcerative colitis (UC) between 2003 and 2015, identified in the Danish National Patient Register (DNPR). Average annual healthcare costs and production values were compared for patients receiving biologic treatment or not, and for patients initiating biologic treatment within a year after diagnosis or at a later stage. Cost estimates and production values were based on charges, fees and average gross wages. RESULTS: Twenty-six point one percent CD patients and ten point seven percent of UC patients were treated with biologics at some point in the study period. Of these, 46.4 and 45.5 % of patients initiated biologic treatment within the first year after diagnosis. CD and UC patients treated with biologics had higher average annual healthcare costs after diagnosis compared to patients not treated with biologics. CD patients receiving biologics early had lower production values both ten years before and eight years after treatment initiation, compared to patients receiving treatment later. UC patients receiving biologics early had lower average annual production values the first year after treatment initiation compared to UC patients receiving treatment later. CONCLUSIONS: CD and UC patients receiving biologic treatment had higher average annual healthcare costs and lower average annual production values, compared to patients not receiving biologic treatment. The main healthcare costs drivers were outpatient visit costs and admission costs.

Extraintestinal Manifestations and Other Comorbidities in Ulcerative Colitis and Crohn Disease: A Danish Nationwide Registry Study 2003-2016.

Background: Extraintestinal manifestations (EIMs) in inflammatory bowel disease (IBD) may be a frequent complication to an underlying abnormal immune response. This study investigated the occurrence of EIMs in Crohn disease (CD) and ulcerative colitis (UC) patients using population-based data in Denmark from 2003 to 2016. Methods: In this national registry-based study, incident CD and UC patients between 2003 and 2015 were matched on age and gender with non-IBD controls and followed until 2016. The selected EIMs for this study included 51 different diagnoses divided into biological systems of diseases, which were tested for differences in the timing and occurrence of EIMs. Results: The study cohort included 10,302 patients with CD and 22,144 patients with UC. The highest risk of patients experiencing EIM/comorbidities for the first time before their IBD diagnosis was in the skin and intestinal tract systems. For CD, the odds ratio of having an EIM before or after IBD diagnosis, as compared with controls, was significant in the skin, intestinal tract, hepatopancreatobiliary, musculoskeletal, ocular, renal, and respiratory systems. For UC, the risks were similar before and after UC diagnosis, apart from the nervous system where the odds ratio was significantly higher before the diagnosis of UC, and significantly lower after diagnosis for diseases in the ocular system. Conclusions: EIMs in CD and UC patients may also precede their IBD diagnosis. These findings may indicate a significant diagnostic delay of CD and UC, and the occurrence of known EIMs should prompt physicians to look for patients possibly having underlying IBD.

Cost Burden of Crohn's Disease and Ulcerative Colitis in the 10-Year Period Before Diagnosis-A Danish Register-Based Study From 2003-2015.

BACKGROUND: The diagnostic delay in inflammatory bowel disease (IBD) is well known, yet the costs associated with diagnoses before IBD diagnosis have not yet been reported. This study explored societal costs and disease diagnoses 10 years before Crohn's disease (CD) and ulcerative colitis (UC) diagnosis in Denmark. METHODS: This national register study included patients diagnosed between 2003 and 2015 identified in the Danish National Patient Registry (NPR) and controls who were individually matched on age and sex from the general population. Societal costs included health care services, prescription medicine, home care services, and labor productivity loss. Prediagnostic hospital contact occurring before CD or UC diagnosis was identified using the NPR. Average annual costs per individual were calculated before the patient's first CD or UC diagnosis. A 1-sample t test was then applied to determine significance in differences between cases and controls. RESULTS: Among CD (n = 9019) and UC patients (n = 20,913) the average societal costs were higher throughout the entire 10-year period before the diagnosis date compared with the general population. The difference increased over time and equaled €404 for CD patients and €516 for UC patients 10 years before diagnosis and €3377 and €2960, respectively, in the year before diagnosis. Crohn's disease and UC patients had significantly more diagnoses before their CD and UC diagnosis compared with the general population. CONCLUSIONS: Compared with the general population, the societal costs and number of additional diagnoses among CD and UC patients were substantially higher in the 10-year period before diagnosis.

Patient preferences for medicine administration for acute agitation: results from an internet-based survey of patients diagnosed with bipolar disorder or schizophrenia in two Nordic countries.

The objective was to elicit patient preferences for medicine administration method in the management of acute agitation episodes among patients diagnosed with bipolar disorder or schizophrenia. The patients' experiences of acute agitation episodes and their management of episodes were also explored. Data were collected via an anonymous, internet-based survey of residents in Denmark or Sweden with schizophrenia or bipolar disorder (October 2014 to December 2014). Inclusion criteria were having a diagnosis of schizophrenia or bipolar disorder, and being above 18 years of age. The questionnaire included questions about preferences for medication attributes, experiences with pharmacological treatment for agitation and involvement in treatment plans. A total of 237 diagnosed patients (61 with schizophrenia; 176 with bipolar disorder) completed the questionnaire. Agitation episodes were experienced by 90% of the respondents. In total, 83% of the respondents reported having received treatment with tablets. When patients were presented with the attributes of an inhalation method, respondents stated that the fast onset of action, low risk of adverse reactions and least invasive form of drug delivery were positive attributes of treatment with inhalation. Inhalation is a new delivery route for treatment of acute agitation in patients diagnosed with bipolar disorder or schizophrenia. Inhalation is the preferred treatment method for acute agitation among Danish and Swedish patients with bipolar disorder or schizophrenia.

The effect of the medicine administration route on health-related quality of life: Results from a time trade-off survey in patients with bipolar disorder or schizophrenia in 2 Nordic countries.

BACKGROUND: Agitation episodes are common among patients with schizophrenia or bipolar disorder. Oral and intramuscular administration methods are commonly used in pharmacological treatment of acute agitation. Recently, an innovative inhalation product with loxapine(Adasuve®)has become available for treatment of acute agitation episodes associated with bipolar disorder or schizophrenia. The objective for the present study was to investigate the impact of the pharmacological treatment's administration methods on the health-related quality of life (HRQoL) in patients with bipolar disorder or schizophrenia in Denmark and Sweden using a time trade-off (TTO) approach. METHODS: The TTO methodology was used to examine the HRQoL impact of administration method of pharmacological treatment of acute agitation. Data were collected via an internet-based survey, using an existing panel of respondents with schizophrenia or bipolar disorder. RESULTS: Respondents considered living with schizophrenia/ bipolar disorder, having one yearly agitation episode treated with inhaler better than living with the same conditions and receiving treatment with tablet or injection. The utility value was 0.762 for inhalable treatment, 0.707 for injection and 0.734 for tablet treatment. CONCLUSIONS: Patients' preference for treatment delivery options showed that inhalation was associated with a significant utility gain when compared to injection or tablets. Inhalable loxapine may be a new tool for control of agitation episodes for strengthening the patient provider alliance when taking patient's preference for delivery method into consideration.

Revisiting the cost-effectiveness of universal HPV-vaccination in Denmark accounting for all potentially vaccine preventable HPV-related diseases in males and females.

OBJECTIVE: The purpose of this study was to assess the consequences of a national immunization program with HPV vaccine for both boys and girls in Denmark, including the prophylactic effects on all potentially vaccine preventable HPV-associated diseases in male and female. METHODS: The study focussed on the quadrivalent vaccine which protects against HPV type 6, 11, 16 and 18, and the vaccine's protection against genital warts, cervical intraepithelial neoplasia, cervical cancer, anogenital cancer (anal, penile, vaginal and vulvar cancer) and head and neck cancer (oral cavity, oropharyngeal, hypopharyngeal and laryngeal cancer) were included in the analyses. In general, the analysis was performed in two phases. First, an agent-based transmission model that described the HPV transmission without and with HPV vaccination was applied. Second, an analysis of the incremental costs and effects was performed. The model did not include naturally-acquired immunity to HPV in the simulations. RESULTS: In the base case result (i.e. vaccination of girls only, 85% vaccination rate, private market price at € 123 per dose ex. VAT) an ICER of 3583 €/QALY (3-dose regime) is estimated when all HPV-related diseases are taken into account. Vaccination of girls & boys vs. vaccination of girls only an ICER of 28,031 €/QALY (2-dose regime) and 41,636 €/QALY (3-dose regime) is estimated. CONCLUSIONS: Extension of the current HPV programme in Denmark to include boys and girls is a cost effective preventive intervention that would lead to a faster prevention of cancers, cancer precursors and genital warts in men and women.

Incidence and cost of anal, penile, vaginal and vulvar cancer in Denmark.

BACKGROUND: Besides being a causative agent for genital warts and cervical cancer, human papillomavirus (HPV) contributes to 40-85% of cases of anal, penile, vaginal and vulvar cancer and precancerous lesions. HPV types 16 & 18 in particular contribute to 74-93% of these cases. Overall the number of new cases of these four cancers may be relatively high implying notable health care cost to society. The aim of this study was to estimate the incidence and the health care sector costs of anal, penile, vaginal and vulvar cancer. METHODS: New anogenital cancer patients were identified from the Danish National Cancer Register using ICD-10 diagnosis codes. Resource use in the health care sector was estimated for the year prior to diagnosis, and for the first, second and third years after diagnosis. Hospital resource use was defined in terms of registered hospital contacts, using DRG (Diagnosis Related Groups) and DAGS (Danish Outpatient Groups System) charges as cost estimates for inpatient and outpatient contacts, respectively. Health care consumption by cancer patients diagnosed in 2004-2007 was compared with that by an age- and sex-matched cohort without cancer. Hospital costs attributable to four anogenital cancers were estimated using regression analysis. RESULTS: The annual incidence of anal cancer in Denmark is 1.9 per 100,000 persons. The corresponding incidence rates for penile, vaginal and vulvar cancer are 1.7, 0.9 and 3.6 per 100,000 males/females, respectively. The total number of new cases of these four cancers in Denmark is about 270 per year. In comparison, the total number of new cases cervical cancer is around 390 per year. The total cost of anogenital cancer to the hospital sector was estimated to be 7.6 million Euros per year. Costs associated with anal and vulvar cancer constituted the majority of the costs. CONCLUSIONS: Anogenital cancer incurs considerable costs to the Danish hospital sector. It is expected that the current HPV vaccination program will markedly reduce this burden.

The burden of rotavirus disease in Denmark 2009-2010.

BACKGROUND: This study sought to determine the incidence and the burden of severe diarrheal disease in Denmark with emphasis on rotavirus (RV) disease. METHODS: This study was designed as a national prospective disease surveillance of children <5 years of age hospitalized for acute gastroenteritis in Denmark during March 2009 to April 2010, using rapid RV and adenovirus antigen detection. RESULTS: A total of 3100 hospitalizations annually among Danish children <5 years of age can be attributed to acute gastroenteritis and 1210 (39%) of these to RV disease. The majority of RV-associated hospitalizations occur among children ≤ 24 months of age (RV-associated hospitalization rate: 7.7/1000 children ≤ 24 months of age and 3.8/1000 children <5 years of age). Although the well-known seasonal pattern of RV was evident with a peak during the spring months of March through April, our active surveillance demonstrated RV-associated hospitalizations throughout the year. Genotyping of a subset of RV-samples demonstrated high frequency of G1 (39%) and G4 (32%). Adenovirus was detected in 350 acute gastroenteritis-associated hospitalizations (11.2%). CONCLUSION: In conclusion, we present national disease burden data on severe cases of gastroenteritis and specifically RV-associated disease and demonstrate that RV is indeed ubiquitous in the population and can be considered a major health burden among young Danish children.

Cost-effectiveness analysis of escitalopram compared with paroxetine in treatment of generalized anxiety disorder in the United Kingdom.

BACKGROUND: Generalized anxiety disorder (GAD) is associated with substantial economic burden. OBJECTIVE: To assess, from a societal perspective, the cost-effectiveness of escitalopram and paroxetine in the treatment of GAD in the UK. METHOD: A decision analytic model with a 9 month time horizon was adapted to the UK setting. Model inputs included drug- and nondrug-specific probabilities from head-to-head trial data, published literature, and expert opinion. Main outcome measures were success (response after 12 wk of treatment and no relapse during the following 24 wk) and costs. Resource use was based on National Institute for Health and Clinical Excellence guidance for GAD patient management, and estimated unit costs came from standard national sources. Human capital approach was used to estimate costs of absence from work. The analysis was performed from the societal perspective. RESULTS: Escitalopram-treated patients were associated with 14.4% higher first-line treatment success and significantly lower discontinuation rates due to adverse events than were those treated with paroxetine. Treatment with escitalopram yielded lower expected costs with greater effectiveness compared with paroxetine. These clinical advantages led to less sick leave and resource use as a result of lower switch rates and use of secondary care. Total expected 9 month costs were 1408 pounds sterling (2560 US dollars) lower for escitalopram-treated patients than for paroxetine-treated patients. Sensitivity analyses on key parameters demonstrated robustness of the model. CONCLUSIONS: Escitalopram appears to be cost-effective compared with paroxetine in the treatment of GAD in the UK.

Tularemia outbreak investigation in Kosovo: case control and environmental studies.

A large outbreak of tularemia occurred in Kosovo in the early postwar period, 1999-2000. Epidemiologic and environmental investigations were conducted to identify sources of infection, modes of transmission, and household risk factors. Case and control status was verified by enzyme-linked immunosorbent assay, Western blot, and microagglutination assay. A total of 327 serologically confirmed cases of tularemia pharyngitis and cervical lymphadenitis were identified in 21 of 29 Kosovo municipalities. Matched analysis of 46 case households and 76 control households suggested that infection was transmitted through contaminated food or water and that the source of infection was rodents. Environmental circumstances in war-torn Kosovo led to epizootic rodent tularemia and its spread to resettled rural populations living under circumstances of substandard housing, hygiene, and sanitation.