A Critical Look at the Efficacy and Costs of Biologic Therapy for Chronic Rhinosinusitis with Nasal Polyposis.

PURPOSE OF REVIEW: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a highly prevalent disease that results in significant healthcare-related costs as well as costs to society with lost productivity and time. Unfortunately, a significant percentage of patients who suffer with this disease will not find relief from current standard of care medications and surgery. With ongoing efforts to understand the pathophysiology of CRSwNP has come the introduction of monoclonal antibodies, or "biologics," targeting specific elements of the inflammatory pathway in CRSwNP. Despite efficacy, these come at significant cost and, to date, no studies on the cost-efficacy of these biologics in CRSwNP have been published. RECENT FINDINGS: Multiple studies have now demonstrated efficacy for biologics in the treatment of CRSwNP as a primary indication. However, the gains in quality of life and objective measures, while consistent, are small and, arguably, the clinical significance is still unclear. In addition, the high cost of these medications may be hard to justify when evaluated in cost-efficacy studies against standard of care therapy in CRSwNP. Furthermore, while the current literature is most robust in showing the benefit of the biologics in asthma, it does not fully support cost-efficacy for biologics. This review evaluates the current literature regarding efficacy of monoclonal antibodies for the treatment of CRSwNP and considers this efficacy in light of the cost implications to individuals and society.

The socioeconomic cost of chronic rhinosinusitis study.

INTRODUCTION: Chronic rhinosinusitis (CRS) is highly prevalent, affecting 11% of the population. Studies evaluating the socio-economic impact of CRS are mostly limited to the US population. Currently there is no study that has evaluated the socio-economic costs of CRS in the UK. METHODS: A case-control study of patients with CRS and healthy controls was conducted to investigate the wider socio-economic impact of the disease. Data on demographic and socioeconomic characteristics, out-of-pocket expenditure (OOPE), health resource utilisation, productivity losses and health-related quality of life (HRQoL) via the EQ-5D and SNOT-22 instruments, were collected from questionnaires. RESULTS: A total of 139 CRS participants and 67 control participants completed the questionnaires. The average total OOPE per patient extrapolated to a 12-month period was £304.84. Other important findings include significantly higher reported primary care interactions (4.14 vs. 1.16) as well as secondary care interactions (2.61 vs 0.4) in CRS group as compared to controls over three-months. The average total missed workdays was estimated to be 18.7 per patient per year. The estimated incremental healthcare cost of CRS per year is £16.8 billion or £2.8 billion per million inhabitants. Factors predictive of a higher OOPE include higher household occupancy and income and these accounted for only 9.7% of the total variance in total OOPEs. Other socioeconomic, demographic and HRQoL variables were not found to be predictive factors of OOPE. CONCLUSIONS: This study showed that CRS has a significant wider economic burden beyond the immediate direct healthcare costs. CRS participants had a high level of healthcare service use, OOPE and productivity loss. Results from this study will add to the existing limited data both for the UK and abroad and emphasises the need for effective treatments for these patients to reduce the disease impact.

A call for cost-effectiveness analysis for biologic therapies in chronic rhinosinusitis with nasal polyps.

OBJECTIVE: To identify the need for cost-effectiveness analysis of biologic therapies in the treatment of chronic rhinosinusitis (CRS). DATA SOURCES: Clinical trials of monoclonal antibodies (omalizumab, benralizumab, mepolizumab and dupilumab) for nasal polyposis or chronic rhinosinusitis published on PubMed. STUDY SELECTIONS: Clinical trials of biologic therapies in CRS and nasal polyposis. RESULTS: No cost-effectiveness analyses of biologic therapies in CRS have been performed. CONCLUSION: As more clinical trials of biologic therapies for CRS are conducted, there is a need for cost-effectiveness analysis. Future analyses should consider these therapies as part of medical therapeutic options compared with surgery. To increase generalizability, analyses should include samples from allergy and primary care clinics rather than only otolaryngology clinics.

Assessment of cost of illness and quality of life in chronic rhinosinusitis patients with surgical treatment.

OBJECTIVE: Chronic rhinosinusitis (CRS) is a popular and tiring disease with significant impacts on the economy and on the Health-related Quality of Life (HRQOL) of patients. This study aims to estimate the cost of illness (COI) and to assess the Health-related Quality of Life (HRQOL) in patients with CRS who underwent surgery in Vietnam and to analyse the relationship between socio-demographic characteristics and the COI as well as the HRQOL. METHODS: A cross-sectional study was conducted in Ear, Nose, Throat Hospital in Ho Chi Minh City (ENT Hospital HCMC), Vietnam between August and October 2018. The direct medical and non-medical costs, the indirect costs (productivity loss), and the HRQOL of patients with CRS were measured. A subjective assessment of quality of life (QOL) using EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) was used to evaluate the health status of these patients after surgery. Characteristics related with the COI and the HRQOL were identified by multiple regression. RESULTS: A total of 264 inpatients with CRS participated in the study. The mean COI for inpatients with CRS was $812.83 and direct costs accounted for a major proportion (89.32%) of the total cost. In addition, the surgery represented the most significant direct medical cost with 58.57% of the total cost. Most of the patients reported no problems with mobility (89.1%), self-care (93.9%), usual activities (77.2%), and anxiety/depression (64.0%). The mean EQ-5D-5L utility score was 0.76 (SD = 0.17), and the mean Visual Analogue Scale (EQ-VAS) score was 76.57 (SD = 13.34). The results of multiple regression showed that gender, occupations, monthly income, prior surgery and family history of CRS affected the total cost while the HRQOL of patients were related to education, smoking behaviour, exercise behaviour and family history of CRS. CONCLUSIONS: This study showed that although endoscopic sinus surgery (ESS) accounted for the largest expense in the COI, this surgical treatment helped to improve the HRQOL in patients with CRS. The findings provided a reference for policy makers in CRS management as well as for adjustment of costs for patients so as to reduce disease burden and to enhance their QOL.

Economics of Chronic Rhinosinusitis.

PURPOSE OF REVIEW: The objective of this article is to provide an updated review of the economic burden of chronic rhinosinusitis (CRS) and discuss how both medical and surgical interventions impact direct and indirect costs related to CRS. By understanding the economics of CRS, clinicians may improve the patient-centeredness of their care and help distinguish between low and high value interventions. RECENT FINDINGS: Direct costs related to CRS are primarily driven by outpatient physician visits, prescription medical therapy, and endoscopic sinus surgery (ESS). CRS produces large indirect costs and these costs often vary based on the severity of the patients CRS-specific QoL impairment. The overall direct cost related to CRS is estimated to range between $10 and $13 billion per year in the USA. The overall indirect cost related to CRS-related losses in work productivity is estimated to be in excess of $20 billion per year. In the appropriate patients with refractory CRS, ESS provides significant reductions in both direct and indirect costs; however, continued medical therapy alone may be a high value intervention in select patients who have lower severity in their baseline QoL and work productivity.

Rhinitis, not to sniff at.

Already for years we have ample evidence of the severe impact of allergic and non-allergic rhinitis and maybe even more rhinosinusitis on quality of life of our patients and the severe costs these diseases inflict on society. Despite this evidence we have difficulty convincing the politicians, health insurance companies and the public that more attention, research and money is needed to prevent these diseases to occur and to further prevent the sometimes serious sequalae of the disease.

Direct costs of adult chronic rhinosinusitis by using 4 methods of estimation: Results of the US Medical Expenditure Panel Survey.

BACKGROUND: Chronic rhinosinusitis (CRS) is an inflammatory disease that affects 2% to 16% of the US population. Despite its increasing prevalence, there are currently limited data in the literature evaluating the economic burden of this disease. OBJECTIVE: This study aimed to determine the direct health care costs of CRS from the perspective of the US government. METHODS: A prevalence-based approach was used to estimate cost of illness for CRS from the 2011 Medical Expenditure Panel Survey database by using a 4-part model: (1) an estimated sum of all health care expenditures, (2) an attribution model for disease-specific estimation of expenditures, (3) an estimation based on a propensity score model, and (4) estimated disease-specific expenditure by using a linear regression-based approach. A disease prevalence of 3.5% was used. RESULTS: The mean CRS-specific annual expenditure was $5955 (95% CI, $5087-$6823) by using method 1 compared with $5560 (95% CI, $4689-$6431) by using method 2 and $5560 (95% CI, $4653-$6467) by using method 3. The annual expenditure, as estimated by using method 4, was $5589 (95% CI, $4986-$6192). Ambulatory expenses accounted for the largest proportion of expenditures, followed by prescription and in-hospital expenses. CONCLUSIONS: This study provided a range of estimates of the direct medical expenditures associated with CRS. We demonstrated that the economic burden attributable to this disease was an estimated $60.2 to $64.5 billion US dollars in 2011, with a wide variation in the total and incremental direct expenditures depending on the type of estimation model used and the prevalence assumed.

Chronic rhinosinusitis: patient experiences of primary and secondary care - a qualitative study.

OBJECTIVES: To explore the experience of CRS and its management from the perspective of patients with CRS. To our knowledge, this is the first qualitative study exploring sinus disease. DESIGN: Semi-structured qualitative interviews. SETTING: ENT outpatient clinic. PARTICIPANTS: Twenty-one adult patients with CRS: 11 male, 10 female. Patients suffered from a range of types of CRS (including polyps and fungal disease) and differing durations of symptoms (1.5-47 years). Participants were purposively selected. Thematic analysis was used. OUTCOME MEASURES: Patient experience of CRS and its management. RESULTS: Patients had concerns regarding management of their symptoms by both healthcare professionals and themselves, including delays to referral and repeated medications. They reported reduced quality of life and high financial and psychosocial costs associated with living with CRS. CONCLUSIONS: Despite guidelines for CRS treatment, outcomes remain variable leading to dissatisfaction with treatment. Adherence to existing guidelines may result in fewer repeated consultations in primary care and earlier referrals to secondary care.

[Epidemiology of chronic rhinosinusitis, selected risk factors, comorbidities and economic burden]. / Epidemiologie der chronischen Rhinosinusitis, ausgewählter Risikofaktoren und Komorbiditäten, und ihre ökonomischen Folgen.

Chronic rhinosinusitis (CRS) is a relevant and prevalent medical condition in Germany, Europe and the world. If analysed in detail, the prevalence of CRS shows regional and temporary variety. In this review, currently available data regarding the prevalence of CRS is therefore sorted by country and/or region, time point of data collection and the CRS-definition employed. Risk factors like smoking and gastro-oesophageal reflux are discussed regarding their influence on CRS prevalence. Moreover, co-morbidities of CRS, like asthma, conditions of the cardiovascular system and depression are listed and their influence on CRS is discussed. Furthermore, data on CRS prevalence in special cohorts, like immunocompromised patients, are presented. To estimate the economic burden of CRS, current data e.g. from Germany and the USA are included in this review.

The upper respiratory pyramid: early factors and later treatment utilization in World Trade Center exposed firefighters.

BACKGROUND: We investigated early post 9/11 factors that could predict rhinosinusitis healthcare utilization costs up to 11 years later in 8,079 World Trade Center-exposed rescue/recovery workers. METHODS: We used bivariate and multivariate analytic techniques to investigate utilization outcomes; we also used a pyramid framework to describe rhinosinusitis healthcare groups at early (by 9/11/2005) and late (by 9/11/2012) time points. RESULTS: Multivariate models showed that pre-9/11/2005 chronic rhinosinusitis diagnoses and nasal symptoms predicted final year healthcare utilization outcomes more than a decade after WTC exposure. The relative proportion of workers on each pyramid level changed significantly during the study period. CONCLUSIONS: Diagnoses of chronic rhinosinusitis within 4 years of a major inhalation event only partially explain future healthcare utilization. Exposure intensity, early symptoms and other factors must also be considered when anticipating future healthcare needs.

Rhinitis Disease Burden and the Impact of Social Determinants of Health.

Social determinants of health (SDHs) have a substantial impact on patient care and outcomes globally, both in low- to middle-income countries and in high-income countries. In the clinic, lack of availability of diagnostic tools, inequities in access to care, and challenges obtaining and adhering to prescribed treatment plans may further compound these issues. This article addresses a case of rhinitis in the context of SDHs and inequities in care that may affect various communities and populations around the world. SDHs may include various aspects of one's financial means, education, access to medical care, environment and living situation, and community factors, each of which could play a role in the rhinitis disease manifestations, diagnosis, and management. Allergic and nonallergic rhinitis are considered from this perspective. Rhinitis epidemiology, disease burden, and risk factors are broadly addressed. Patient evaluation, diagnostic tests, and management options are also reviewed, and issues related to SDHs are noted. Finally, inequities in care, knowledge gaps, and unmet needs are highlighted. It is critical to consider SDHs and care inequities when evaluating and treating patients for rhinitis and other allergic conditions.

The Inflation Reduction Act: Implications for Medicare spending and access to biologic therapies for chronic rhinosinusitis with nasal polyposis and asthma.

KEY POINTS: In 2021, Medicare spending on biologics was $926 million in Part B (FFS) and $1.3 billion in Part D (FFS/MA). Between 2017 and 2021, annual Medicare spending on biologics increased by approximately 200%. Between 2023 and 2025, Medicare Part D OOP costs for biologics will decrease by an estimated 50%-60%.

Chronic rhinosinusitis: epidemiology and cost.

Chronic rhinosinusitis (CRS) is one of the most common chronic diseases and is associated with a high socioeconomic burden from direct and indirect costs. Its estimated prevalence ranges widely, from 2 to 16%. It is more common in female subjects, aged 18-64 years, and in southern and midwestern regions of the United States. CRS is more prevalent in patients with comorbid diseases such as asthma, chronic obstructive pulmonary disease, and environmental allergies. Few studies examine patient ethnicity, socioeconomic status, geographic location, and cultural factors in CRS populations. This article provides an overview of the epidemiology, racial variations, and economic burden of CRS.

Aspirin-exacerbated respiratory disease: burden of disease.

Aspirin-exacerbated respiratory disease (AERD) is characterized by adult onset of asthma, chronic rhinosinusitis (CRS), nasal polyposis, and aspirin sensitivity. In this syndrome, each disease component has deleterious effects on the patient's health and quality of life. Latest figures from the Centers for Disease Control indicate 8.2% of the U.S. population has asthma and among adult asthmatic patients, up to 9% have AERD. Approximately 13% of the population suffers from CRS and 15% of patients with CRS with nasal polyposis have AERD. A review of the impact that each component of AERD has on patients will delineate the considerable burden of AERD, especially when considering the cumulative effects of the tetrad.

High costs and burden of illness in acute rhinosinusitis: real-life treatment patterns and outcomes in Swedish primary care.

BACKGROUND: Few studies have investigated the impact of acute rhinosinusitis on disease-specific quality of life, and disease costs have not been studied previously in Scandinavia. AIMS: To study symptoms, treatment patterns, quality of life and costs in adults with acute rhinosinusitis. METHODS: This was an observational study in primary care. Patients aged 18-80 years seeking care for acute rhinosinusitis were evaluated using the Major Symptom Score (MSS) on days 0 and 15. Recommended and used treatments, quality of life and costs were assessed by questionnaires including EQ-5D™ and a visual analogue scale (VAS) on the same days. RESULTS: 150 patients were enrolled; 143 provided follow-up data. The proportion of MSS responders was 91%. Mean MSS decreased from 8.4 on day 0 (N = 150) to 1.9 on day 15 (N = 143). Patients reporting pain/discomfort and problems with usual activities decreased from 88.4% to 31.5% and from 43.2% to 1.4%, respectively, and mean VAS increased from 58.7 to 79.5. Intranasal corticosteroids were the most recommended and/or prescribed drugs. Total cost for an episode was 10,260 SEK (€1,102), of which 75% were indirect costs. CONCLUSIONS: With treatment dominated by intranasal corticosteroids, a high proportion of responders and good symptom relief were seen. Acute rhinosinusitis seems to cause a high burden on quality of life and also a high cost for society.

Cost-benefit analysis in occupational health: a comparison of intervention scenarios for occupational asthma and rhinitis among bakery workers.

OBJECTIVES: Use of cost-benefit analysis in occupational health increases insight into the intervention strategy that maximises the cost-benefit ratio. This study presents a methodological framework identifying the most important elements of a cost-benefit analysis for occupational health settings. One of the main aims of the methodology is to evaluate cost-benefit ratios for different stakeholders (employers, employees and society). The developed methodology was applied to two intervention strategies focused on reducing respiratory diseases. METHODS: A cost-benefit framework was developed and used to set up a calculation spreadsheet containing the inputs and algorithms required to calculate the costs and benefits for all cost elements. Inputs from a large variety of sources were used to calculate total costs, total benefits, net costs and the benefit-to-costs ratio for both intervention scenarios. RESULTS: Implementation of a covenant intervention program resulted in a net benefit of €16 848 546 over 20 years for a population of 10 000 workers. Implementation was cost-effective for all stakeholders. For a health surveillance scenario, total benefits resulting from a decreased disease burden were estimated to be €44 659 352. The costs of the interventions could not be calculated. CONCLUSION: This study provides important insights for developing effective intervention strategies in the field of occupational medicine. Use of a model based approach enables investigation of those parameters most likely to impact on the effectiveness and costs of interventions for work related diseases. Our case study highlights the importance of considering different perspectives (of employers, society and employees) in assessing and sharing the costs and benefits of interventions.

Incremental health care utilization and expenditures for chronic rhinosinusitis in the United States.

OBJECTIVES: I determined incremental increases in health care expenditures and utilization associated with chronic rhinosinusitis (CRS). METHODS: Patients with a reported diagnosis of CRS were extracted from the 2007 Medical Expenditure Panel Survey medical conditions file and linked to the consolidated expenditures file. The patients with CRS were then compared to patients without CRS to determine differences in health care utilization (office visits,emergency facility visits, and prescriptions filled), as well as differences in health care expenditures (total health care costs, office visit costs, prescription medication costs, and self-expenditures) by use of demographically adjusted and comorbidity-adjusted multivariate models. RESULTS: An estimated 11.1+/-0.48 million adult patients reported having CRS in 2007 (4.9%+/-0.2% of the US population). The additional incremental health care utilizations associated with CRS relative to patients without CRS for office visits, emergency facility visits, and number of prescriptions filled were 3.45+/-0.42, 0.09+/-0.03, and 5.5+/-0.8, respectively (all p

Contemporary Incremental Healthcare Costs for Chronic Rhinosinusitis in the United States.

OBJECTIVE/HYPOTHESIS: Determine contemporary incremental increases in healthcare expenditures and utilization associated with chronic rhinosinusitis (CRS). STUDY DESIGN: Cross-sectional analysis of national health care survey data. METHODS: Patients reporting a diagnosis of CRS were extracted from the 2018 Medical Expenditure Panel Survey medical conditions file and linked to the consolidated expenditures file. CRS patients were then compared to non-CRS patients determining differences in healthcare utilization for office visits, emergency facility visits, and prescriptions filled as well as differences in total healthcare costs, office-based costs, prescription medication costs, and self-expenditures using demographically and comorbidity adjusted multivariate models. Results were compared to 2007, adjusted for inflation. RESULTS: An estimated 7.28 ± 0.36 million adult patients reported CRS in 2018 (3.0 ± 0.1% of the adult U.S. population). The additional incremental healthcare utilizations associated with CRS relative to non-CRS patients for office visits, emergency facility visits, and number of prescriptions filled were 4.2 ± 0.6, 0.10 ± 0.03, and 6.0 ± 0.9, respectively (all P ≤ .003). Similarly, additional incremental healthcare expenditures associated with CRS for total health care expenses, office-based visit expenditures, prescription expenditures, and self-expenditures were $1,983 ± 569, $772 ± 139, $678 ± 213, and $68 ± 17, respectively (all P ≤ .002). Increases in total (+$1,062) and office based expenditures (+$360) compared to 2007 were significant. CONCLUSION: CRS continues to be associated with a substantial incremental increase in healthcare utilization and expenditures. These expenditures have significantly outpaced inflation expected increases. The national healthcare costs of CRS have increased to an estimated $14.4 billion per year. LEVEL OF EVIDENCE: 3 Laryngoscope, 131:2169-2172, 2021.

Geographic Variations in Healthcare Utilization and Expenditure for Chronic Rhinosinusitis: A Population-Based Approach.

OBJECTIVES/HYPOTHESIS: Chronic rhinosinusitis (CRS) is a common and costly health problem in the United States. A better understanding of healthcare resource utilization (HCRU) and healthcare expenditure (HCE) pertaining to CRS is required. The objective of this study is to investigate geographic variations in HCRU and HCE for CRS. STUDY TYPE/DESIGN: Retrospective study of administrative database. METHODS: Patients meeting pre-defined diagnostic criteria for CRS with continuous 1-year pre-index and 2-year post-index data were identified on IBM® Marketscan Research Databases over a 5-year period (2013-2017). Data pertaining to demographics, HCRU, and HCE were analyzed according to geographic region. Multivariable generalized linear models accounted for age, sex, baseline medication utilization, and co-morbidities. RESULTS: About 237,969 patients were included. Antibiotics were the most commonly prescribed medication (95%). Surgery rate (11%), immunotherapy (9.2%), oral steroid use (66%), and antibiotic utilization (mean 6.3 prescriptions) were highest in the South. However, visits with an otolaryngologist were considerably higher in the Northeast (62%). The Northeast region had the highest mean HCE ($2,449), which was 13% greater than HCE for the North Central region ($2,172). HCRU and HCE were higher in urban areas across all metrics, with 2-year HCE being 18% greater in urban areas ($2,374 vs. $2,019). Significant geographic variation in HCE was observed even after adjusting for covariates. CONCLUSION: Significant geographic variations in HCRU and HCE exist for CRS even after adjusting for covariates. Future studies are needed to help direct quality improvement and cost-saving efforts as well as efficient resource allocation in an era of value-based care. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:2641-2648, 2021.

Allergic rhinitis and the common cold--high cost to society.

UNLABELLED: The common cold and allergic rhinitis constitute a global health problem that affects social life, sleep, school and work performance and is likely to impose a substantial economic burden on society because of absence from work and reduced working capacity. This study assesses the loss of productivity as a result of both allergic rhinitis and the common cold in the Swedish working population. METHODS: Four thousand questionnaires were sent to a randomized adult population, aged 18-65 years, in Sweden, stratified by gender and area of residence (metropolitan area vs rest of the country). The human capital approach was used to assign monetary value to lost productivity in terms of absenteeism (absence from work), presenteeism (reduced working capacity while at work) and caregiver absenteeism (absence from work to take care of a sick child). RESULTS: Thousand two hundred and thirteen individuals responded, response rate 32%. The mean productivity loss was estimated at 5.1 days or euro 653 per worker and year, yielding a total productivity loss in Sweden of euro 2.7 billion a year. Of the total costs, absenteeism (44%) was the dominant factor, followed by presenteeism (37%) and caregiver absenteeism (19%). Poisson regression analyses revealed that women, people in the 18-29 year age group, and respondents with 'doctor-diagnosed asthma' reported more lost days than the rest of the group. CONCLUSION: In Sweden, the cost of rhinitis is euro 2.7 billion a year in terms of lost productivity. A reduction in lost productivity of 1 day per individual and year would potentially save euro 528 million.