Market share and costs of biologic therapies for inflammatory bowel disease in the USA.

BACKGROUND: Real-world data quantifying the costs of increasing use of biologics in inflammatory bowel disease (IBD) are unknown. AIM: To determine the outpatient IBD drug utilization trends, relative market share, and costs in the USA during a 9-year period. METHODS: The Truven MarketScan® Database was analysed for patients with Crohn's disease (CD) and ulcerative colitis (UC) during 2007-2015. National drug codes were used to identify prescription drugs; Healthcare Common Procedure Coding System J-codes were used to capture biologic out-patient infusions. Proportion of drug usage, relative market share and per-member per-year (PMPY) costs were analysed for biologics, immunomodulators, 5-ASAs and corticosteroids. RESULTS: In 415 405 patients (188 842 CD; 195 183 UC; 31 380 indeterminate colitis; 54.67% female), utilization trends show a consistent rise in the market share of biologics during the 9-year study period. The proportion of patients using biologics increased from 21.8% to 43.8% for CD and 5.1%-16.2% for UC. This contrasts a small decrease in immunomodulator and 5-ASA use for CD and relative constancy of other classes including corticosteroids-only use as primary IBD medication from 2007 to 2015. The average biologic-taking patient accounted for $25 275 PMPY in 2007 and $36 051 PMPY in 2015. The average paediatric biologic-taking patient accounted for $23 616 PMPY in 2007 and $41 109 PMPY in 2015. In all patients, the share of costs for biologics increased from 72.9% in 2007 to 85.7% in 2015 (81.7% in 2007 to 94.9% in 2015 in paediatrics). CONCLUSION: The vast majority of costs allocated to out-patient IBD medications in the USA is attributed to increasing use of biologic therapies despite the relative minority of biologic-taking patients.

Combining Therapeutic Drug Monitoring with Biosimilars, a Strategy to Improve the Efficacy of Biologicals for Treating Inflammatory Bowel Diseases at an Affordable Cost.

BACKGROUND: Biologicals provide a tight disease control but not all patients respond favourably to treatment. Some patients do not respond at all (primary non-responders), while other patients respond initially but show loss of response over time (secondary non-responders). Drug concentrations in the serum of patients can be monitored and correlated with biological, clinical or endoscopic response. Therapeutic thresholds have been defined for infliximab and adalimumab. The European Medicines Agency has approved 3 biosimilars of infliximab and new biosimilars are waiting approval. Key Messages: Distinguishing primary non-responders from patients with insufficient drug exposure during induction through drug serum concentration determination will improve drug efficacy. Current algorithms to guide treatment of patients with secondary loss of response take into account that patients with high titers of anti-drug antibodies (ADA) do not respond to dose intensification and that patients with therapeutic drug concentrations cannot be switched to biologicals within class. For patients in clinical remission, the cost of biological treatment can be decreased by dose tapering patients with supra-therapeutic concentrations and/or by switching patients with adequate drug concentrations and no formation of ADA to biosimilar, whereas efficacy can be increased by dose-intensifying patients with low or transient ADA and by switching patients with persistent ADA to biologicals within or out-off class. CONCLUSIONS: As an objective tool, therapeutic drug monitoring can identify patients who are eligible for dose tapering, intensification of treatment, cessation of treatment, switching within- or out-of-class and switching to biosimilar.

Public versus Private Drug Insurance and Outcomes of Patients Requiring Biologic Therapies for Inflammatory Bowel Disease.

Background. Antitumor necrosis factor (anti-TNF) therapy is a highly effective but costly treatment for inflammatory bowel disease (IBD). Methods. We conducted a retrospective cohort study of IBD patients who were prescribed anti-TNF therapy (2007-2014) in Ontario. We assessed if the insurance type was a predictor of timely access to anti-TNF therapy and nonroutine health utilization (emergency department visits and hospitalizations). Results. There were 268 patients with IBD who were prescribed anti-TNF therapy. Public drug coverage was associated with longer median wait times to first dose than private one (56 versus 35 days, P = 0.002). After adjusting for confounders, publicly insured patients were less likely to receive timely access to anti-TNF therapy compared with those privately insured (adjusted hazard ratio, 0.66; 95% CI: 0.45-0.95). After adjustment for demographic and clinical characteristics, publicly funded subjects were more than 2-fold more likely to require hospitalization (incidence rate ratio [IRR], 2.30; 95% CI: 1.19-4.43) and ED visits (IRR 2.42; 95% CI: 1.44-4.08) related to IBD. Conclusions. IBD patients in Ontario with public drug coverage experienced greater delays in access to anti-TNF therapy than privately insured patients and have a higher rate of hospitalizations and ED visits related to IBD.

The Inflammatory Bowel Disease Specialty Medical Home: A New Model of Patient-centered Care.

New models of health care have emerged over the past decade. Accountable care organizations and patient-centered medical homes are designed to improve the patient experience, enhance health care quality, and decrease cost. These models have been developed in the primary care domain and have yet to be tested in specialty care. Certain chronic diseases require principal care by a specialist or health care team. The specialty medical home would provide patient-centered care for specific populations of patients whose health care derives from a single chronic disease. This article defines the parameters for a specialty medical home and provides a specific payer-provider experience for the comprehensive care of an inflammatory bowel disease population.

Telephone Consultation as a Substitute for Routine Out-patient Face-to-face Consultation for Children With Inflammatory Bowel Disease: Randomised Controlled Trial and Economic Evaluation.

BACKGROUND: Evidence for the use of telephone consultation in childhood inflammatory bowel disease (IBD) is lacking. We aimed to assess the effectiveness and cost consequences of telephone consultation compared with the usual out-patient face-to-face consultation for young people with IBD. METHODS: We conducted a randomised-controlled trial in Manchester, UK, between July 12, 2010 and June 30, 2013. Young people (aged 8-16 years) with IBD were randomized to receive telephone consultation or face-to-face consultation for 24 months. The primary outcome measure was the paediatric IBD-specific IMPACT quality of life (QOL) score at 12 months. Secondary outcome measures included patient satisfaction with consultations, disease course, anthropometric measures, proportion of consultations attended, duration of consultations, and costs to the UK National Health Service (NHS). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02319798. FINDINGS: Eighty six patients were randomised to receive either telephone consultation (n = 44) or face-to-face consultation (n = 42). Baseline characteristics of the two groups were well balanced. At 12 months, there was no evidence of difference in QOL scores (estimated treatment effect in favour of the telephone consultation group was 5.7 points, 95% CI - 2.9 to 14.3; p = 0.19). Mean consultation times were 9.8 min (IQR 8 to 12.3) for telephone consultation, and 14.3 min (11.6 to 17.0) for face-to-face consultation with an estimated reduction (95% CI) of 4.3 (2.8 to 5.7) min in consultation times (p < 0.001). Telephone consultation had a mean cost of UK£35.41 per patient consultation compared with £51.12 for face-face consultation, difference £15.71 (95% CI 11.8-19.6; P < 0.001). INTERPRETATION: We found no suggestion of inferiority of telephone consultation compared with face-to-face consultation with regard to improvements in QOL scores, and telephone consultation reduced consultation time and NHS costs. Telephone consultation is a cost-effective alternative to face-to-face consultation for the routine outpatient follow-up of children and adolescents with IBD. FUNDING: Research for Patient Benefit Programme, UK National Institute for Health Research.

Vitamin D therapy in inflammatory bowel diseases: who, in what form, and how much?

BACKGROUND: The north­south geographical gradient of inflammatory bowel disease (IBD) prevalence, its epidemiology, the genetic association of vitamin D receptor polymorphisms, and results in animal models suggest that vitamin D plays an important role in the pathogenesis of IBD. AIMS: The purpose of this review was to critically appraise the effectiveness and safety of vitamin D therapy in patients with IBD. METHODS: MEDLINE, Scopus and Google Scholar were searched from inception to May 20, 2014 using the terms 'Crohn's disease', 'ulcerative colitis' and 'vitamin D'. Results: Vitamin D deficiency is common in patients with IBD. Limited clinical data suggest an association between low vitamin D concentration and increased disease activity in both ulcerative colitis (UC) and Crohn's disease (CD). To date, only two small open label trials and one randomized controlled trial have shown a positive effect of vitamin D supplementation on disease activity in patients with CD; no effect has been shown for UC. An optimal vitamin D supplementation protocol for patients with IBD remains undetermined, but targeting serum 25-hydroxy vitamin D [25(OH)D] levels between 30 and 50 ng/mL appears safe and may have benefits for IBD disease activity. Depending on baseline vitamin D serum concentration, ileal involvement in CD, body mass index, and perhaps smoking status, daily vitamin D doses between 1800­10,000 international units/day are probably necessary. CONCLUSION: Increasing preclinical and clinical evidence suggests a role for vitamin D deficiency in the development and severity of IBD. The possible therapeutic role of vitamin D in patients with IBD merits continued investigation.

Living with inflammatory bowel disease: A Crohn's and Colitis Canada survey.

BACKGROUND: Despite improvements in therapies for inflammatory bowel diseases (IBDs), patient quality of life continues to be significantly impacted. OBJECTIVE: To assess the impact of IBD on patients and families with regard to leisure, relationships, mental well-being and financial security, and to evaluate the quality and availability of IBD information. METHODS: An online survey was advertised on the Crohn's and Colitis Canada website, and at gastroenterology clinics at the University of Alberta Hospital (Edmonton, Alberta) and University of Calgary Hospital (Calgary, Alberta). RESULTS: The survey was completed by 281 IBD patients and 32 family members. Among respondents with IBD, 64% reported a significant or major impact on leisure activities, 52% a significant or major impact on interpersonal relationships, 40% a significant or major impact on financial security, and 28% a significant or major impact on planning to start a family. Patient information needs emphasized understanding disease progression (84%) and extraintestinal symptoms (82%). There was a strong interest in support systems such as health care insurance (70%) and alternative therapies (66%). The most common source of information for patients was their gastroenterologist (70%); however, most (70%) patients preferred to obtain their information from the Crohn's and Colitis Canada website. CONCLUSIONS: The impact of IBD on interpersonal relationships and leisure activities was significant among IBD patients and their families. Understanding the disease, but also alternative treatment options, was of high interest. Currently, there is a discrepancy between interest in information topics and their availability. Respondents reported a strong desire to obtain information regarding disease progression, especially extraintestinal symptoms.

[Integrated management of patients with chronic inflammatory bowel disease in the Rhine-Main Region: results of the first integrated health-care project IBD in Germany]. / Integrierte Versorgung von Patienten mit chronisch-entzündlichen Darmerkrankungen im Rhein-Main-Gebiet: Ergebnisse der ersten integrierten Versorgung CED in Deutschland.

INTRODUCTION: In our previous studies investigating the drug therapy in patients suffering from inflammatory bowel disease (IBD) in the Rhein-Main region, Germany, we detected serious discrepancies between treatment reality and treatment guidelines. Consecutively, patient outcome in this cohort was compromised. Following this pilot project a network between primary deliverers of care for IBD patients and one large health-care insurance company [BKK Taunus (Gesundheit), the second largest insurance company in Hessen, Germany] was established. PATIENTS AND METHODS: An analysis of treatment and socioeconomic data from 220 IBD patients (Crohn's disease - CD = 96, ulcerative colitis - UC = 124) entering the integrative health-care programme between 1.1.-30.9.2009 was performed. RESULTS: Remission rates for CD and UC in the integrated health-care programme could be improved from 60 - 73 % (CD) and from 61 - 79 % (UC). Guideline-conform treatment was observed in 81 % of patients with CD and 85 % with UC, respectively. Although medication costs increased, total costs could be cut by 162 304.- €, as secondary costs for hospitalisation and days off work could be reduced. CONCLUSION: The study shows that networking of deliverers of care for IBD patients with health insurances provides an excellent possibility to optimise medical treatment and can cut down costs significantly.

Inflammatory bowel disease surgery in the biologic therapy era.

PURPOSE OF REVIEW: The relationship between surgery and biologic agents in the management of patients with inflammatory bowel disease continues to be a source of interest for both surgeons and clinicians. RECENT FINDINGS: The role of biologic agents in patients with varying presentations of Crohn's disease or ulcerative colitis continues to evolve. However, the currently available biologic therapies are clearly not the panacea we have desired because they have only marginally decreased the frequency with which operative intervention is required and may have increased the risk for infectious postoperative complications in the nonelective setting. Compared to surgery, biologic agents are also significantly more costly and may not provide any greater gain in quality of life. SUMMARY: Future studies must focus on the use of surgery and emerging biologic agents as complementary therapies designed to safely control inflammatory disease while providing objective value.

An integrated model of care for inflammatory bowel disease sufferers in Australia: development and the effects of its implementation.

BACKGROUND: Psychological comorbidities are associated with poor outcome and increased healthcare utilization in patients with inflammatory bowel disease (IBD). However, a model of care addressing the biopsychosocial dimension of disease is not routinely applied in IBD. This review describes the development of such a model and the effects of its implementation in a hospital-based cohort of patients with IBD. METHODS: Three different approaches were used: 1) collecting baseline epidemiological data on mental health comorbidities; 2) raising awareness of and targeting mental health problems; 3) examining the effects of the model implementation. RESULTS: High rates of anxiety and depressive symptoms (36% and 13%, respectively) that are maintained over time were identified in IBD patients presenting at a metropolitan teaching hospital. Patients with documented psychological comorbidities were more likely to be hospitalized than those without (odds ratio [OR] = 4.13, 95% confidence interval [CI]: 1.25, 13.61). Improvements in disease activity, anxiety, depression, quality of life, and coping have been noted when cognitive-behavioral therapy (CBT) was provided to patients. A drop in the use of opiates (P = 0.037) and hospitalization rates (from 48% to 30%) in IBD patients has been noted as a result of introduction of the changed model of care. In addition, the mean total cost of inpatient care was lower for IBD patients than controls (US$12,857.48 [US$15,236.79] vs. US$ 30,467.78 [US$ 53,760.20], P = 0.005). CONCLUSION: Our data to date suggest that an integrated model of care for patients with IBD may yield superior long-term outcomes in terms of medication use and hospitalization rates and reduce healthcare costs.

Role of biological therapy for inflammatory bowel disease in developing countries.

Inflammatory bowel disease (IBD) has become a global disease. Its incidence in developing countries is rising. In Asia, this has been attributed to the rapid modernisation and westernisation of the population. As IBD emerges in developing nations, there is a need to reconcile the most appropriate treatment for these patient populations from the perspectives of both disease presentation and cost. In the West, biological agents are the fastest-growing segment of the prescription drug market. They typically cost several thousand to several tens of thousands of dollars per patient per year. The healthcare systems in developing countries will struggle to afford such expensive treatments. Developing countries cover two-thirds of the earth's surface and are home to 3-5 billion inhabitants, constituting three-quarters of all humanity. If IBD emerges to the same extent in those countries as it has in the West, the need for biological therapy will increase dramatically, and the pharmaceutical industry, healthcare providers, patient advocate groups, governments and non-governmental organisations will have to discuss how to handle this. The authors propose that this dialogue should begin now with regard to (1) the major needs of patients with complicated IBD in developing countries, (2) the potential need for biological therapy in developing countries to treat IBD, (3) the necessary infrastructure for selecting patients with IBD who need biological therapy, and (4) medical/ethical issues limiting the use of biological therapy.

The pharmacoeconomics of biologic therapy for IBD.

The past decade has been marked by the introduction and expanding use of biologic therapies for the induction and maintenance of response in patients with IBD. Although widely heralded for their efficacy, these agents have also stirred controversy over the potential economic impact that they will have upon the world's health-care systems. Traditional cost analyses had shown that IBD medication costs contributed minimally towards the overall costs associated with the disease; however, these studies were all conducted before the introduction of biologic therapies. At that time, a small minority of patients accounted for a disproportionately large percentage of the overall costs, suggesting that cost-savings could be realized if interventions decreased the utilization of health-care resources and associated costs. More recent studies have been heterogeneous in their design and findings-some have suggested that cost-savings realized due to a decrease in the utilization of health-care services may offset the higher costs of biologic agents. Incorporation of data on indirect cost-savings and quality of life improvements into ongoing and future analyses is required to allow for more accurate analyses of overall costs and cost-savings.

Pharmacoeconomic considerations for inflammatory bowel disease in the era of biological therapies.

The biological therapies have revolutionized the ability to treat patients with inflammatory bowel disease. While these therapies have proven efficacy, they are not without significant medication expense. This has raised the question of whether society can afford these new therapies. Costs associated with inflammatory bowel disease have focused traditionally on direct costs of disease, with the greatest contributions due to surgeries and hospitalization. Initial investigations suggest that biologics can reduce healthcare utilization and their associated costs. Additionally, the importance of indirect costs and improvements in quality of life must also be considered when examining the cost efficiency of these new therapeutic modalities, which may result in a cost savings for our healthcare system.

Patterns of complementary and alternative medicine use in a population of pediatric patients with inflammatory bowel disease.

Complementary and alternative medicine use is prominent in the United States. The use of complementary and alternative therapies appears to be common in patients with inflammatory bowel disease, but few studies have been completed in children. We sought to examine the extent that children with inflammatory bowel disease in the Greater Philadelphia area (Philadelphia County and the surrounding counties in Delaware, New Jersey, and Pennsylvania) use alternative therapies. We paid particular attention to the specific types of therapies used and whether certain demographic and disease associated factors influence the degree of usage. In this study, we questioned the families of all children diagnosed with inflammatory bowel disease, aged 6 to 16 years and living within Philadelphia and its surrounding counties, who were followed at 1 of the 2 academic pediatric gastroenterology programs that served the area. More than 80% of surveys were returned. Fifty-one percent (95% C.I. 45% to 56%) of patients surveyed reported some form of alternative medicine use within the previous year. Univariate analysis revealed increased use among patients who had Crohn disease, who used the Internet for research on their disease, who reported poor quality of life and had increased school absences in the past year. Therapies associated with alternative medicine use included biological and immunomodulatory therapy. Regression analysis revealed positive associations between use of alternative therapies and expenditure on nonprescription treatments, poor quality of life, Internet research, and the need for calorie supplementation, whereas there was a negative association with history of prior surgery for inflammatory bowel disease.

Estimating the marginal value of 'better' research output: 'designed' versus 'routine' data in randomised controlled trials.

We recently completed a study which demonstrated that the costs of health technology assessment (HTA) by randomised controlled trial (RCT) can be reduced by substituting routine datasets for data designed and collected specifically for a trial. This cost reduction, however, had the effect of reducing the quality of the research output. In the present study we attempted to tease out the values attached to the 'better' information provided by designed data RCTs using a mock grants committee. Two valuation techniques, implied values and willingness to pay, were used. Ex ante valuations were determined by comparing alternative research proposals - a more costly version using designed data and a cheaper version using routine data. Ex post valuations were determined by comparing results of both versions. The exercise was performed on four exemplar studies. Overall, the committee expressed a general lack of trust towards routine data both ex ante and ex post and placed high values on the better information from the designed data studies - particularly information on preferences. This suggests that currently available routine datasets are not perceived to be able to provide efficient alternatives to designed data for RCTs.

Work losses related to inflammatory bowel disease in the United States: results from the National Health Interview Survey.

BACKGROUND: U.S. studies using varying methodologies have reported different estimates for the indirect, or nonmedical cost per person with inflammatory bowel disease (IBD). Our analysis contributes to this literature by using the 1999 sample of the National Health Interview Survey (NHIS) to estimate the work-loss effect of IBD on work in the United States and the associated cost to society. METHODS: A weighted logistic regression model was used to estimate the OR of being out of the labor force as determined by predictive variables, including having been diagnosed with IBD, with or without symptoms. Controls included health status indicators and demographic variables. For those people in the labor force, a second analysis was performed to determine the relative influence of the same variables on working less than 12 months versus the entire year. SUDAAN 8.0 was used to generate population estimates, systematically correcting for survey design. RESULTS: Of IBD patients who had experienced symptoms in the past 12 months, 31.5% reported being out of the labor force (OR = 2.14, relative to the non-IBD group). We estimated the excess in the nonparticipation rate attributable to IBD with symptoms in the past 12 months in the United States to be 12.3%. Based on this, the indirect cost of nonparticipation attributable to IBD in 1998/1999 was more than $3.6 billion U.S. dollars (USD) or $5228 USD per person with IBD and symptoms. According to the second weighted logistic regression, for those who are in the labor force, having IBD had no association with the duration of work. CONCLUSIONS: By using directly observed data in our analysis, this method of estimation can be used to predict the overall paid-employment burden of IBD.