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Financial Burden of Atopic Dermatitis Out-of-Pocket Health Care Expenses in the United States

Background Atopic dermatitis (AD) is associated with considerable financial cost. However, the full burden of out-of-pocket (OOP) expenses is not well understood. Objective We sought to characterize the OOP health care expenses associated with AD management. Methods A 25-question voluntary online survey was administered to National Eczema Association members worldwide (n = 113,502). Inclusion criteria (US residents age ≥18 years who either self-reported had AD or were primary caregivers of individuals with AD) were met by 77.3% (1118/1447) of respondents. Results Respondents reported OOP expenses in 3 categories: (1) health care providers and prescriptions, including health care provider visit deductibles (68.7% [686]), prescription co-pays (64.3% [635]), and prescriptions not covered by insurance (48.6% [468]); (2) nonprescription health care products, including moisturizers (94.3% [934]), hygiene products (85.0% [824], allergy medications (75.1% [715]), itch relievers (68.25% [647]), dietary supplements (52.2% [491]), and sleep aids (37.0% [336]); and (3) complementary approaches, including cleaning products (74.7% [732]), clothing/bedding (44.8% [430]), alternative medications (19.0% [180]), and adjunctive therapies (15.9% [150]). The median annual AD OOP expense was US $600 (range, US $0–$200,000), with 41.9% (364) reporting expenditures US $1000 or greater. Conclusions Out-of-pocket expenses place a significant financial burden on individuals with AD. Additional studies are needed to better understand associations and impact of OOP costs.

Out-of-pocket (OOP) expenses are particularly important in the day-to-day lives of AD patients and their families. Although US population-based surveys demonstrated multifactorial increases in overall OOP health expenses related to AD, 12,19 OOP costs are not well characterized from an individual perspective. Few studies investigated the broader complement of health care expenses and OOP economic burden of AD on patients and their caregivers. Furthermore, management of AD and its comorbidities can be challenging. Currently available treatment options have variable long-term effectiveness and safety, which may warrant switching between therapies, use of combination therapy, and use of complementary or adjunctive health care approaches to achieve satisfactory disease control. We hypothesized that individuals with AD have a wide array of unappreciated OOP costs beyond major categories of health care expenses, such as health care provider (HCP) visits and prescription medications. In this study, we sought to characterize and quantify the OOP health care expenses and financial burden associated with AD management.

Study Design
A 25-question voluntary online survey was administered between November 14, 2019, and December 21, 2019, to all National Eczema Association members, including 113,502 unique individuals with AD and nonaffected family members worldwide. To enhance reach, the survey was also advertised on a variety of social media platforms. Electronic informed consent was obtained prior to survey initiation, and respondents who reached the end of the survey were offered an optional opportunity to enter in a drawing to win 1 of 10 US $50 gift cards. Survey responses were not linked in any way to the gift cards. Study inclusion criteria included the following: US residents, adults (age ≥18 years) and either self-reportedly had AD or were primary caregivers of children with AD.

Survey Questions
Diagnosis of AD was determined by an affirmative answer to the question: "Have [you/the person with atopic dermatitis] been diagnosed with atopic dermatitis by a health care provider?" Demographics were collected, including age, sex, race/ethnicity, region of residence, geographical setting, household income, and insurance coverage. Current AD severity (clear, mild, moderate, and severe) and control (very well, moderately well, somewhat, minimally, and not controlled) were determined by patient global assessment, and the number of flare days in the last month (0/1-3/4-7/8-10/ ≥11) was also assessed. Comorbid diseases were assessed by asking about HCP-diagnosed asthma, allergic rhinitis, food allergy, frequent/ persistent skin infections, and anxiety and/or depression.

Data Analysis
Statistical analysis was performed using SAS version 9.4 (SAS Institute, Cary, NC). χ 2 Tests were used for comparisons of categorical variables, including sociodemographic and AD severity and control measures.
Corrected P values of 0.05 or less were considered significant.

Respondent Characteristics
American Indian or Alaskan Native  2A). The median annual estimated OOP expense due to AD was US $600 (range, US $0-$200,000). Forty-two percent (364) of the respondents reported expenditures in excess of US $1000, and 8.5% (74) reported expenditures in excess of US $5000 (Fig. 2B).

Polypharmacy and Step-up Therapy
Most respondents reported currently using 3 or more prescription therapies (% prevalence [frequency], 57.5% [617]), with 32.1% (344) using 1 to 2 therapies and 10.4% (112) reporting no prescriptions. Those with more prescription therapies were more likely to be White or Asian and have increasing household income, increased disease severity, reduced control, increased number of flare days per month, allergic and infectious comorbidities, and increased number of HCP visits (P ≤ 0.05 for all) (Tables 1 and 2).
Step-up therapy (ie, systemic therapy including injectable, oral, or phototherapy) was used in 41.0% (442) of the respondents. Those requiring step-up therapy were more likely to have increased disease

DISCUSSION
Using a survey-based approach to highlight the perspective of AD patients and caregivers in the United States, we found a wide array of previously unreported OOP expenses in medical, nonmedical, and supportive health care categories (Fig. 2C). Most respondents reported OOP expenses for co-pays and/or deductibles for office visits and prescription medication, moisturizers, OTC itch relievers, allergy medications, hygiene products, dietary supplements, and specialized cleaning supplies; nearly half reported OOP costs for prescription medications not covered by insurance, analgesics, dressings, and transportation/parking; many others reported OOP expenditures for sleep aids, alternative or adjunctive therapies, and specialized clothing. Most individuals had equivalent or higher OOP expenses in the past month when compared with average monthly OOP expenses for AD care, and many reported yearly OOP costs greater than US $1000. A majority of individuals had recently used or were concurrently using at least 3 prescription therapies, with almost half requiring step-up therapy. Together, these results show a significant OOP financial burden for AD, reflecting the real-life efforts of patients to better manage their disease. The majority patients and caregivers reported an OOP expense for an HCP visit for AD in the past 30 days, and nearly all (89.4%) had at least 1 office visit in the last year. In contrast, OOP expenditures for emergency department visits and inpatient hospitalizations were relatively lower among respondents. This is in line with health care utilization findings from a recent US population-based study that showed that the median number of AD-related HCP visits for individuals with AD was approximately 1 per year, and the proportions of AD patients reporting at least 1 urgent care, emergency department visit, and inpatient hospitalization were 8.2%, 9.6%, and 6.7%, respectively. 9 The OOP costs for mental health services were quite low among respondents, which was surprising given the strong association between AD and mental health disorders, including depression, anxiety, and psychological distress. 7,20,21 The mental health burden of AD is underappreciated, and a substantial proportion of individuals with AD with mental health symptoms go undiagnosed. 20 Thus, only a subset of AD patients with mental health comorbidities may seek mental health care. In addition, AD patients with mental health comorbidities may only seek out psychological or psychiatric care if it is well covered by their insurance. Thus, it is important that HCPs, who manage AD regularly, screen for mental health symptoms. Other contributing factors to assess in future studies might include stigma for seeking psychiatric care, impaired access because of lack of referral from the primary provider, and cost considerations (eg, unwilling to pay, too expensive). The most common OOP expenses for OTC health products, and for any therapeutic approach in general, were emollients/moisturizers and hygiene/bathing products. This reflects the results of a similar survey-based study in France, which showed that these were the 2 most commonly used products associated with OOP cost among AD patients (74.4% and 65.2%, respectively). 22 Neither of these categories is routinely reimbursed by health insurance, because they are seen as patient comfort rather than direct medical treatment. However, optimization of moisturization and bathing are universally seen as first-line nonpharmacologic approaches for managing AD. 23 Emollients in particular are critical for increasing skin hydration and addressing the dysfunctional epidermal barrier underlying AD, thereby reducing pruritus, xerosis, erythema, lichenification, and fissuring. However, commonly used moisturizers vary significantly in cost, as well as potential allergenicity and irritancy, without a clear correlation to efficacy. 24 More than 60% of the respondents also reported OOP expenditures for specialized laundry/household cleaning products and specialized clothing. Although some patients report better AD control when avoiding certain chemical and mechanical irritants, well-controlled studies to broadly support these types of costly environmental modification are lacking. 25 Ultimately, given that personal preferences dictate the use of many of these products, HCPs should prioritize patient education, willingness for use, and adherence in the context of affordability to help control OOP cost.
These data highlight significant OOP expenses for health-related categories that are not routinely recommended or discussed during standard AD care encounters. The majority of respondents reported expenditures for OTC dietary supplements and a sizeable proportion of money spent on alternative, nonwestern medical care or adjunctive approaches. Although there is some evidence to suggest a positive role for certain types of complementary and alternative  medicine (CAM) in improving the symptoms of AD, current data are largely insufficient to make widely applicable evidence-based recommendations. 26,27 Previous studies showed that CAM use in AD patients is not uncommon and is associated with a longer disease duration, increased severity, and history of multiple previous conventional treatments. 28 Our data highlight the real-life considerations of patients who struggle with controlling the symptoms of AD and use treatment approaches that may not be currently proven and/or recommended. Health care providers should make a renewed effort to understand the patient perspective (eg, motivations, expectations, benefits), review the most up-to-date evidence regarding CAM use, and assist in crafting a fiscally responsible care plan.
Reflecting the marked impairment in health-related quality of life, AD patients assume high OOP costs for disease management. 29 However, studies examining the total burden of OOP expenses for AD patients in the United States are scarce. A survey-based study of a large managed care organization in 1997 estimated the total OOP cost per patient year to be US $314 (US $500 in 2019), with medications and household products being the top categories of expenditure. 30 The total OOP cost for US AD patients was estimated to be US $371-$489 per person year in 2010 and 2012 (US $435-$573 in 2019) based on the results of the National Health Interview Survey, which did not include specific breakdown of OOP cost categories. 12 Although not directly comparable because of differences in insurance structure and health care costs, recent surveys of large European countries showed similar OOP expenses when converted to US dollars, with moisturizers and hygiene products occupying the top categories of expenditure. 22,31 Our data revealed a median annual cost of US $600, with the most common areas of expenses for moisturizers, hygiene and household products, and deductibles for outpatient care and medications. This figure is likely more accurate than previous estimates given that our study was the first to directly survey AD patients and caregivers across the United States.
Atopic dermatitis is a highly heterogenous disorder with variable severity, lesional distribution, symptoms, and disease course. Furthermore, AD patients also experience a chronic disease course punctuated by intermittent flares, which necessitate different treatment approaches. These features likely contribute to polypharmacy, complicated treatment regimens, and alternative treatments among patients with AD. 32 Our data demonstrate considerable prescription polypharmacy among AD patients, especially for those with increased severity, poorer control, increased HCP visits, and private or Medicare insurance. Many respondents reported OOP expenses for prescription medications regardless of insurance coverage. Atopic dermatitis patients are likely to benefit from simplification of the treatment regimen by deprescribing ineffective or redundant treatments 33 and transitioning to streamlined step-up therapy as warranted. Indeed, our data show much room for improvement in the use of step-up therapy among those with the highest disease burden (ie, increased severity, flares, and HCP visits). Additionally, most individuals also reported expenditures for OTC allergy, anti-itch, and pain medications. Although treatments in these categories may have a legitimate role in managing symptoms and comorbidities associated with AD, the use of certain therapies (eg, oral antihistamines for chronic treatment of AD) may not be aligned with evidence-based guidelines and are likely to further increase polypharmacy and contribute to excessive OOP financial burden. Although combination treatment may be warranted in some cases, HCPs should be sensitive to treatment efficacy, patient safety, evidence-based recommendations, and OOP costs when considering the treatment plan.
Strengths of this study include a large cohort of AD patients and caregivers distributed across the United States assessing real-world, OOP expenses for necessary AD care. The inclusion of 22 unique categories of OOP expenses, including HCP office visits, prescription therapies, nonprescription products, complementary approaches, and care coordination, allowed for a detailed understanding and accurate estimate of the OOP financial burden. Limitations include the cross-sectional nature of this study and inability to assess longitudinal changes in costs, treatments, and health care utilization. Selection bias is possible, because this was an Internet-based survey administered to members of the National Eczema Association and not the US population at large, although the respondent demographics indicate a variety of individuals with different insurance status, household income, and disease severity spread fairly evenly throughout the country. Self-reporting of costs and utilization may not be as accurate as a claims-based approach; however, this is offset by the ability to gather data directly from patients and caregivers about disease severity and comprehensive OOP costs. Diagnosis of AD was confirmed by self-reporting, which was previously validated in other types of studies. 34,35 Future studies are necessary to confirm these findings and better understand associations of OOP costs and their impact on family finances. In addition, more studies incorporating patient-reported outcomes in cost analysis are needed to better understand predictors of OOP expenses.
In conclusion, OOP expenses for individuals with AD are broad and occupy a number of unique health care categories. Health care providers and patients should be cognizant of these costs and engage in shared decision making to create a treatment plan that minimizes financial burden.