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6 Giugno 2024

GIHTAD (2024) 17:1

ORIGINAL PAPER

The economic and social burden of atopic dermatitis in Italy: 
a Cost-of-Illness analysis

Debora Antonini, Filippo Rumi, Michele Basile, Eugenio Di Brino, Agostino Fortunato, Ludovica Siviero, Americo Cicchetti

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Alta Scuola di Economia e Management dei Sistemi Sanitari (ALTEMS) – Università Cattolica del Sacro Cuore, Roma

Corresponding author:
Debora Antonini
Università Cattolica del Sacro Cuore
Alta Scuola di Economia e Management dei Sistemi Sanitari
Largo F. Vito 100168 Roma – Italy
Email: debora.antonini@unicatt.it
Tel: +39 3927853216


Abstract

Background: Atopic dermatitis, also known as atopic eczema, is a chronic, relapsing inflammatory, and eczematous skin disease. The clinical presentation of atopic dermatitis is characterized by erythematous, pruritic, dry, scaly, and often lichenified skin. The epidemiology of atopic dermatitis can vary greatly among countries, and across different age groups. Currently, atopic dermatitis doesn’t have a resolving treatment. Consequently, the purpose of management is to improve symptoms and achieve long-term disease control. Atopic dermatitis generates a considerable consumption of resources, developing significant economic consequences for patients, healthcare systems, and society. This study aimed to estimate the economic and social burden for atopic dermatitis patients in the Italian context.

Methods: A Cost of Illness analysis was developed.
Two perspectives of analysis were established for the study: the National Health System perspective and the societal perspective. Therefore, direct healthcare and non-healthcare costs, and indirect costs were included in the analysis. Data were identified and measured through the administration of a survey to patients affected by atopic dermatitis.

Results: The annual total cost of a patient for the management of atopic dermatitis is equal to € 7,041.12. Within the overall cost per patient, direct health care costs (€ 3,290.69) accounting for 46.74% of the total expenditure, indirect costs (€ 1,924.92) accounting for 25.93% of the expenditure, and finally out-of-pocket expenses accounting for 27.34% of the expenditure being valued at € 1,825.52.

Conclusion: The Cost of Illness analysis carried out underlines how atopic dermatitis places a significant financial burden on the healthcare system, but even more so on patients affected by this condition. Indirect costs and out-of-pocket expenditures, such as those related to the purchase of drugs, non-pharmacological treatment, and lost working days, represent the most important items of the atopic dermatitis economic and social burden.

Keywords: Atopic dermatitis, atopic eczema, cost of illness, economic burden, social burden.

Introduction

Atopic dermatitis (AD), also known as atopic eczema, is a chronic, relapsing inflammatory, and eczematous skin disease. The clinical presentation of AD is characterized by erythematous, pruritic, dry, scaly, and often lichenified skin [1-4]. The pathogenesis of AD is multifactorial and associated with genetic, immunologic, environmental, and lifestyle factors that disrupt the skin [5-7]. Moreover, the occurrence of AD may also be associated with atopic comorbidities (asthma, food allergies, eosinophilic oesophagitis, and hay fever) and additional comorbidities (depression, anxiety, attention deficit hyperactivity disorder (ADHD) and autoimmune diseases) [2, 3]. Patients affected by AD experience from mild local to severe systemic symptoms, such as itch, pain, and sleep disturbance, resulting in a considerable reduction in the quality of life [4].

The onset of AD most commonly starts in early childhood, with up to 25% of children affected by the condition, where 60% of patients develop atopic dermatitis before one year of age and 90% by five years of age [2, 8]. As most cases of childhood AD resolve in adolescence, AD is less common in adults; however, AD can persist or may also arise in adults [2, 5]. 

The epidemiology of AD can vary greatly among countries, and across different age groups. In 2019, in the USA, the reported prevalence rate for the adult population was equal to 7.3%; for the paediatric population, the prevalence rate was about 14.8% [6]. In 2018, in European countries, the adult prevalence was reported equal to 4.4%, with individual country ranges of 2.2% for Germany to 8.1% for Italy [2, 3].

Currently, atopic dermatitis doesn’t have a resolving treatment. Consequently, the purpose of management is to improve symptoms and achieve long-term disease control. According the European Guideline (EuroGuiDerm) on atopic eczema, the management of AD is characterized by different step-care approaches. Primarily, patient education should encourage gentle skincare, adequate bathing practice, trigger avoidance, and appropriate use of moisturizers and emollients. These actions can provide good efficacy for the treatment of the mildest forms of AD, while they are insufficient treatments for moderate or severe AD forms. In these following cases, the next treatment step includes the use of anti-inflammatory agents, such as topical corticosteroids (TCSs), calcineurin inhibitors (TCIs), and/or phosphodiesterase E4 inhibitors. When the use of anti-inflammatory agents is inadequate, the next treatment step includes adding oral systemic therapy, biologic therapy, and/or phototherapy [1, 9, 10].

Atopic dermatitis (AD) generates a considerable consumption of health and non-health resources. This leads to the development of significant economic consequences for patients and their families, as well as for healthcare systems and society [11, 12]. Therefore, to provide a better understanding of the impact of atopic dermatitis in Italy, the aim of this study was to estimate the economic and social burden for AD patients in the Italian context.

Methods

To assess the economic and social burden of atopic dermatitis in the Italian context, the present study developed a Cost of Illness analysis (COI) [13-16] in 2022. Two perspectives of analysis were established for the study: the National Health System (NHS) perspective and the social perspective. Following this two-analysis perspective, the study included both direct healthcare and non-healthcare costs, and indirect costs. The time horizon established for this study was one year.

Data collection

Data on direct and indirect resources were collected through the administration of a survey of patients with AD in Italy from January to May 2022. Before the survey was administered, written informed consent was obtained from all participants and the format of the questionnaire was validated. This validation process involved a group of clinical experts of the condition reviewing and evaluating the questionnaire to ensure that it effectively captured relevant information related to the costs of atopic dermatitis in the Italian context. Following the validation of the questionnaire, which aimed to involve as many patients with the condition under investigation as possible, the survey was uploaded online and administered by the National Atopic Dermatitis Association (AnDEA) through the Typeform platform. More in detail, a survey access link was created through the Typeform platform. Afterwards, AnDEA proceeded to share the survey link to all patients involved in the association; then each patient was free to participate or not in the survey.

The survey submitted to AD patients was structured in two different sections, with a total number of 19 questions. The first section featured 7 questions, aimed to identify and measure all direct health and non-health resources reported by patients for the management and the monitoring of AD. More in detail, the first section of the questionnaire it was investigated: which treatments are used by patients for managing atopic dermatitis; the number of visits made by patients; the days of hospitalization due to atopic dermatitis; the laboratory tests carried out by patients; the use of emollients or specific products due to the disease; the symptoms related to the condition; the presence of any additional health conditions. The second section, characterized by the presence of 12 questions, explored the main characteristics of the population (age, sex, region of residence, employment status, presence of caregiver, etc.), to identify all the indirect costs generated by the disease. For further details on the individual questions, please refer to the supplementary materials (Table S.1 – supplementary material).

Data analysis

Coherently to the NHS and social perspective, the study included both direct healthcare and indirect resources. Direct healthcare inputs include all the resources directly attributable to the cure of the patients [15], namely pharmacological intervention, non-pharmacological treatments (creams, specific products, etc.), follow-up examinations (i.e., blood chemistry and radiographic examinations), hospitalizations, and follow-up visits. To estimate the right number direct healthcare inputs, and in particular the follow-up examination, undertaken by patients in one-year, within the survey were asked to them to indicate the number of tests performed in the last 3 months. Consequently, to define the total number of examinations performed in a year, the value of each test category carried out in the 3 months was multiplied by the 4 quarters in a year.

In addition to these parameters, following the social perspective, indirect resources, namely the loss of productivity generated by patients due to atopic dermatitis, were included in the model.

The productivity loss was defined according to the “human capital approach”. In the human capital approach, the time loss of the patient due to the condition is strictly related to their potential earnings in the future [17]. Therefore, to assess the productivity loss by patients, the number of weekly working hours of 40 and 52 weeks was fixed. As a result, a total of 2,080 annual working hours were considered. In addition, the analysis took into account, for a more detailed assessment of productivity loss, the benefits provided by Law 104/92, i.e., the “Framework Law for Assistance, Social Integration and Rights of Disabled Persons.”
Law 104/92 aims to ensure full respect for human dignity and the rights of freedom and autonomy of the disabled person, promoting his or her full integration in the family, school, work, and society. With this purpose, Article 33 of Law 104/92 provides for employees who have to care for their aged or disabled family members the possibility of taking paid time off from work, that is, 3 days of leave per month [18]. Therefore, based on the answers provided on the ownership of Law 104/92, appropriate adjustments were made to the lost workdays in the analysis.

Data, collected by administering the survey, were entered from the Typeform questionnaires into a standardized Excel form and analyzed through the use of descriptive statistics. Results are expressed as mean ± standard deviation, median or percentage, as deemed appropriate.

Cost analysis

The economic valorization of direct healthcare inputs was estimated through the use of Italian national tariff schedules, and all available sources in the literature reporting costs related to the Italian healthcare context. Specifically, for an adequate and complete assessment of drug therapy and the average dosage used by patients for the treatment of AD, the Italian Drug Agency (AIFA) transparency lists [19, 20] and the Summaries of Product Characteristics (SmPC) were used, respectively. 

More in detail, the Ex-Factory price available, or computable, within the AIFA transparency lists was used to define the unit cost of the specific drug treatment. For blood chemistry tests, and outpatient or visits, the “Nomenclatore tariffario delle prestazioni di assistenza specialistica ambulatoriale” [21] was used. To assess the hospitalization costs, the “Tariffario delle prestazioni di assistenza ospedaliera per acuti – Sistema Diagnosis Related Group (DRG)” [22] was used, identifying for each hospitalization reported within the questionnaire the appropriate tariff.

To enhance the value of out-of-pocket expenses, the average cost incurred by patients for the purchase of non-pharmacological products and for visits was estimated through the analysis of the data provided within the survey. Specifically, to investigate these two cost items, the following questions were asked: “Please indicate the average monthly expense for purchasing specific products for your condition”; “Please fill out the following table specifying how many visits you have made in the last three months and the visit cost”.

The valorization of the productivity loss due to the condition, following the available literature, was done considering four worker categories with different salary wages. More in detail, the four categories identified are head manager, middle manager, office workers, and freelancers [23].

Results

Population

From the administration of the survey, 126 questionnaires were collected and analysed. The sample is composed by 90 (71.4%) women, 27 (21.4%) men, and 9 (7.2%) boys and girls under 14 years of age. The average age of the sample is 32.54 years (Table 1). In addition to this information, the survey administered defined the patients’ region of residence. Specifically, 21% (25) of patients reported Lombardy as their region of residence, 15% (18) Lazio, 9% (11) Emilia-Romagna, 9% (11) Puglia, 9% (10) Piedmont, 5% (6) Campania, 5% (6) Tuscany, 4% (5) Sicily, 4% (5) Veneto, 3% (4) Abruzzo, 3% (4) Marche, 3% (3) Calabria, 3% (3) Sardinia, 2% (2) Umbria, and 1% (1) Basilicata, 1% (1) Liguria, 1% (1) Friuli-Venezia Giulia and 1% (1) Trentino.

Table 1. Patient characteristics

Total responders (n) 126
Men (n, %) 27 (21.4%)
Women (n, %) 90 (71.4%)
Boy up to 14 years (n, %) 5 (4.0%)
Girl up to 14 years (n, %) 4 (3.2%)
Average age (median, SD) 32.54 (33.00, 12.25)
Min (n. year) 2
Max (n. year) 57
Average age men (median, SD) 29.41 (30.00, 14.47)
Average age women (median, SD) 33.48 (33.00, 11.43)
Average age pediatric sample (median, SD) 7.00 (7.00, 3.28)

Concerning symptoms, anxiety was present in 54 (42.86%) patients of the sample, discouragement in 73 (57.94%) patients, feelings of helplessness in 50 (39.68%) patients, loss of sleep in 68 (53.97%) patients, itching in 114 (90.48%) patients, and discomfort in 61 (48.41%) patients. In addition, more than 50% of the sample reported having at least one comorbidity, of which the most common are: allergic rhinitis, reported by 65.08% (41) patients; food allergies, shown by 65.08% (41) of surveyed patients, and allergic contact dermatitis listed by 53.97% (34) of patients.

Concerning the treatments used by the sample for the management of atopic dermatitis, 96.03% stated that they used moisturising, emollient or lenitive creams, 87.30% used dedicated cleansers, 74.60% topical cortisone therapy (creams, ointments, etc.), 44.44% supplements, 20.63% phototherapy, while 52.38% used protective devices (e.g. pillow covers, mattress covers, room humidifier). Only 21.43% of the respondents stated that they were undergoing treatment with biological drugs.

Regarding the condition monitoring, 58.62% of patients stated within the survey that they had performed laboratory tests in the past 3 months. Additionally, the administration of the survey stated that 76 (64.96%) patients carry out the visits for condition monitoring privately, while the remaining 35.04% referred to carrying out their visits in the public sector.

To assess the patient’s employment status, only 115 questionnaires were eligible. More in detail, with an overall response rate of 91.27%, 64 (55.65%) patients are employees, 7 (6.09%) are unemployed job seekers, 3 (2.61%) are unemployed and not looking for work, 18 (15.65%) are freelancers, while 23 (20.00%) patients are students. Regarding the ownership of Law 104/92, 97.44% of respondents reported to be no beneficiaries of Law 104/92, while the remaining 2.56% stated to be beneficiaries.

Cost of Illness analysis

Direct healthcare costs

Coherently with the direct healthcare cost definition, the survey identified and measured the following cost inputs: pharmacological treatments, blood chemistry, radiographic examinations, hospitalizations, and visits.

Table S.2 in the supplementary material lists the detailed pharmacological treatments utilized by patients. Data were stratified considering the number of pharmacological treatments used by each patient. The total cost for each pharmacological treatment purchased was defined according to information provided by the sample under examination, the average dosage, and the unitary cost of each pharmacological treatment. More in detail, the total annual cost per patient incurred by the Italian NHS to acquire the first pharmacological treatment for the sample was determined equal to € 6,701.77. The total annual cost per patient sustained to purchase the second drug was estimated equal to € 1,799.74. Finally, the total annual cost per patient incurred to buy the third pharmacological treatment was determined equal to € 966.12. Finally, to assess the economic burden of AD in Italy, the average total annual cost per patient related to pharmacological treatments was determined. Specifically, it was found to be equal to € 3,155.88.

Table 2 shows blood chemistry and radiographic examinations. For each cost driver identified, the number of patients in each test category, the number of examinations performed per year, the total annual mean cost per patient, and the total annual mean cost were reported. To estimate the right number of blood and radiographic examinations undertaken by patients in one-year, within the survey were asked to them to indicate the number of tests performed in the last 3 months. Consequently, to define the total number of examinations performed in a year, the value of each test category carried out in the last quarter was multiplied by the 4 quarters in a year.

Table 2. Direct health care costs for blood chemistry and radiographic examination

Examination Patients

(n, %)

Total exam 

per year (n)

Total annual mean cost per patient (€) Total annual mean cost (€)
Blood tests 46 (70.77%) 6.0 € 13.54 € 622.91
Blood tests, radiological tests, urine tests 1 (1.54%) 24.0 € 18.18 € 18.18
Blood tests, urine tests 3 (4.62%) 8.0 € 1.97 € 5.92
Blood tests, radiological tests 3 (4.62%) 5.3 € 11.56 € 34.67
IgE 2 (3.08%) 4.0 € 3.65 € 7.29
Isaac test 1 (1.54%) 4.0 € 15.38 € 15.38
Blood test, food rast, gut dysbiosis test, prick test 1 (1.54%) 4.0 € 3.21 € 3.21
Prick and patch test 1 (1.54%) 4.0 € 23.38 € 23.38
Blood tests, IgE 2 (3.08%) 8.0 € 8.07 € 16.14
Blood test, IgE, prick and patch test 1 (1.54%) 24.0 € 79.20 € 79.20
Blood tests, DAO, Vitamin D, PTH, homeocysteine 1 (1.54%) 4.0 € 1.36 € 1.36
Blood test, prick test and IgE 1 (1.54%) 4.0 € 5.04 € 5.04
Prick test 1 (1.54%) 4.0 € 3.02 € 3.02
Blood tests, prick tests 1 (1.54%) 4.0 € 3.21 € 3.21

As a result, the average total annual mean cost per patients concerning blood chemistry and radiographic examination was reported to be equal to € 13.63.

Regarding hospital admissions, the survey showed that in one year of follow-up, only one patient was subject to hospitalization. Based on what the patient reported in reference to the cause of hospitalization, in accordance with the demand 3 of the questionnaire, it was possible to define the most appropriate code for that condition. More in detail, to enhance this event, Code 283 “Malattie minori della pelle senza cc” of “Tariffario delle prestazioni di assistenza ospedaliera per acuti – Sistema Diagnosis Related Group (DRG)” [22] was used. It was equal to € 1,503.00. Consequently, taking into consideration the sample under investigation, the average cost per patient of hospitalizations was found to be equal to € 12.85.

Concerning the visits carried out by patients in one-year follow up, the survey reported that, overall, 58.41% of patients stated that they make 1-3 visits annually, 25.66% 4-6 visits in a year, 10.62% 7-9 visits per year, and 5.31% 10-12 visits annually. 

Table 3 shows the annual cost incurred by the Italian NHS related to outpatient visits carried out in a year by AD patients. To identify the total annual cost, the average number of visits for each defined category equal to 2,5,8, and 11 was calculated, respectively. The unitary cost of visits is equal to € 20.66 [21].

As a result, the total annual cost sustained by the NHS related to visits carried out by the number of AD patients included in the analysis were determined equal to € 4,441.90; the average total annual cost was equal to € 1,110.48. Taking into account the proportion of patients who reported carrying out the visits in the public sector, the total annual cost per patient was estimated to be equal to € 108.34.

Table 3. Direct health care costs and out-of-pocket expenditure for follow-up visits

Visits number Total number 

of patients (n)

Patients undergoing outpatient visit (n, %) Patients undergoing private visit 

(n, %)

Total NHS annual cost (€) Outpatient total annual cost (€) Private total annual cost (€)
1-3 66 13 (19.70%) 53 (80.30%) € 537.16 €1,186.38 € 12,595.98
4-6 29 15 (51.72%) 14 (48.28%) € 1,549.50 € 3,422.25 € 8,318.10
7-9 12 6 (50.00%) 6 (50.00%) € 991.68 € 2,190.24 € 5,703.84
10-12 6 6 (100.00%) 0 (0.00%) € 1,363.56 € 3,011.58 € –

Out-of-pocket expenditure

To estimate the out-of-pocket expenditure, the survey explored the following direct resources: non-pharmacological treatment, and visits. 

To assess the economic impact of non-pharmacological treatments, the percentage of patients whom themselves purchase non-pharmacological products for the treatment of AD, and the average cost sustained monthly, were investigated. As a result, it was found that 101 (86.32%) patients reported buying non-pharmacological products, reporting an average monthly expenditure for the purchase of these products of € 103.00. Consequently, by multiplying the average monthly per patient expenditure against the 12 months of which a year is composed, it was possible to define the total average annual cost per patient for these resources equal to € 1,236.00. 

Table 3 reports also the total annual cost sustained by patients to carry out private and outpatient visits. As for the assessment of direct health care costs related to both outpatient and private visits, the average number of visits for each defined class equal to 2,5,8, and 11 was calculated, respectively. The proportion of patients that carried out the visits for condition monitoring privately (64.96%) reported an average cost of the private visit equal to € 118.83. The remaining 35.04% of patients who carried out their visits in the public sector, referred an average co-payment of € 45.63.

As a result, the total cost and the average total cost of out-of-pocket expenditure related to private visits were identified equal to € 26,617.92 and € 6,654.48 respectively. Shifting the attention to the expenditure sustained by patients for the co-payment of the visit in the public sector, a total cost of € 9,810.45 and an average total cost of € 2,452.61 were identified for this cost item.

Summarizing these results, the total annual cost per patient relating to the out-of-pocket expenditure for private and outpatient visits was computed equal to € 589.52.

Indirect costs

Coherently with the social perspective, the social burden of AD was estimated through the human capital approach. To assess indirect costs, in accordance with the annual wages identified in the literature, patients’ employment status data obtained from the survey were fitted to the four categories of workers previously reported [23]. More in detail, based on the percentages of subjects involved in each job class in the literature [23], it was possible to define the number of patients included in each job category. As a result, considering only the working subjects identified within the survey (82 patients), 1 head manager, 4 middle managers patients, 29 office workers, and 48 freelancers were identified. From the survey, it was possible to establish the average workdays lost in a month for each patient, which amounted to 2.45. As a result, the average work hours lost in a month for each patient is 19.58. For beneficiaries of Law 104/92, no work hours lost in a month was included in the analysis (Table 4).

Table 4. Summary table for productivity loss estimation

Worker category Patients

(n, %)

Total hours lost monthly (n) Average annual wage (€) Average hourly revenue (€) Total monthly productivity loss (€) Total annual productivity loss (€)
Head manager 1 (1.30%) 20.87 € 85,000.00 € 40.87 € 852.91 €9,381.99
Middle manager 4 (4.40%) 70.64 € 55,836.00 € 26.84 € 1,896.30 €20,859.29
Office workers 29 (36.00%) 577.97 € 30,140.00 € 14.49 € 8,375.02 €92,125.17
Freelancers 48 (58.30%) 935.99 € 20,000.00 € 9.62 € 8,999.91 €98,999.06
Total € 20,124.14 € 221,365.51

Concerning the productivity lost by caregivers as a result of caring for AD patients, from the results obtained from the survey, it was not possible to calculate the total amount of this item. Actually, only one patient reported the presence of a caregiver, which, however, not reporting the profession conducted by the caregiver, does not allow the economic valorization of this activity.

For instance, based on the adaptation of the data obtained from the survey, productivity loss was defined firstly for working patients who were not beneficiaries of Law 104/02, then for the entire patient sample. Table 4 summarizes the social and economic data used to estimate productivity loss for AD patients. 

The analysis showed that the total monthly productivity loss for working patients with atopic dermatitis was equal to
€ 20,124.14. As a result, the total annual productivity loss was found to be equal to € 221,365.51. The total annual productivity loss per worker patients with atopic dermatitis was reported equal to € 2,699.58 per year; taking into account the overall sample, the total annual productivity loss per patient was estimated equal to € 1,924.92. 

Summary findings

To have a better picture of the economic and social impact of the atopic dermatitis in Italy, Table 5 shows the aggregated results per patients of the cost-of-illness analysis.

Table 5. Summary table of Cost of Illness results per patient

Cost driver Average total annual cost per patient (€) Expenditure category impact (%)
Direct cost – Pharmacological treatment € 3,155.8 44.82 %
Direct cost – Visits € 108.34 1.54 %
Direct cost – Hospitalizations € 12.85 0.18 %
Direct cost – Blood chemistry and radiographic examinations € 13.63 0.19 %
Out-of-pocket expenditure – Non-pharmacological specific products € 1,236.00 17.55 %
Out-of-pocket expenditure – Private and outpatient visits € 589.52 8.37 %
Indirect cost – Productivity loss € 1,924.92 27.34 %
Total € 7,041.12 100.00 %

Summarizing cost categories listed above, the annual total cost of a patient for the management atopic dermatitis results to be equal to € 7,041.12. Within the overall cost per patient, direct health care costs (€ 3,290.69) accounting for 46.74% of the total expenditure, indirect costs (€ 1,924.92) accounting for 25.93% of the expenditure, and finally out-of-pocket expenses accounting for 27.34% of the expenditure being valued at € 1,825.52.

Discussion

The study aimed to estimate the economic and social burden of atopic dermatitis in Italy. This emerged from the need to fill gaps in the current literature regarding the economic and social burden of atopic dermatitis in Italy. There are multiple studies in the international literature investigating the economic burden of AD. For example, the study conducted by Beretzky Z. et al in 2023 [24], shows a total cost per patient of the condition of € 4,331. More in detail, the study, involving 218 adult patients, reports a direct medical
(€ 1,136), direct non-medical (€ 747), and indirect costs
(€ 2,450) accounted for 27%, 17%, and 56% of the total costs, respectively. In addition, the study conducted in Germany by Mohr N. et al. in 2021 [25], which involved from August 2017 to June 2019 a total number of 1,291 adults affected by AD, reported a total annual cost per patient equal to € 3,616. On the contrary, the available literature on this topic appears to be currently scarce in the Italian national evidence. Actually, for the Italian context, to our knowledge, the only published study on the topic is that of Sciattella et al. in 2019 [12], which turned out to be the first observational study conducted in Italy to estimate the cost of moderate and severe AD. More in detail, the study, identifying a cohort of 56 patients, shows a total cost per patient of the condition equal to € 4,284. In particular, the study estimates € 826 (19.3%) for direct medical costs, € 854 (19.9%) for direct non-medical costs, and € 2,604 (60.8%) for indirect costs due to lost productivity.

In the present analysis, through the administration of a survey, it was possible to identify and measure the representative direct and indirect cost items, which subsequently, through their economic assessment, allowed us to evaluate the clinical, economic, and social impact of the disease in the Italian context. In detail, the study reported a global amount of expenditure for the management of atopic dermatitis equal to € 7,041.12. The results of the study showed that the direct costs of drug treatment (€ 3,155.58) represent one of the most significant items of the overall expenditure related to atopic dermatitis. This is even more relevant if one considers that patients have increased their recourse to more expensive biological therapies in recent years [26]. On the contrary, although the survey showed that blood count, radiological examinations, and urine examinations are the examinations that atopic dermatitis patients undergo most frequently, they represent one of the two smallest parts (0.19%) of the resource consumption related to the burden of the condition under analysis. The social component, related to productivity losses, represents the second largest item in the assessment of atopic dermatitis, reporting an impact on the overall atopic dermatitis expenditure equal to 27.34%. This percentage of impact, which corresponds to € 1,924.92, refers to the entire population affected by AD considered. This amount changes if the productivity loss is assessed only in workers affected by the disease, turning out to be equal to € 2,699.58, and reflecting an impact percentage equal to 34.54%. These evaluations emphasize and provide a better understanding of how the disease is characterized by a significant impact on the professional life of patients. 

Another relevant aspect that should not be underestimated in the assessment of a disease is the impact of the condition on the patient’s quality of life. Actually, in the present analysis, considering the relevance of this topic, was asked within the survey “Approximately how many times have you, on average, missed social events or activities (e.g., gym, sports, cinema, theatre, hobbies, parties, social gatherings…) in the last month”. The results showed how more than 50% of the patients involved missed social activities due to the condition. These results highlight how the impact in terms of quality of life of atopic dermatitis is not a minor aspect to evaluate, but on the contrary, would need further investigation.

Finally, the third major impact measure on the overall costs was identified in the out-of-pocket expenditure for non-pharmaceutical products, which impacted 17.55%. The analysis of this value emphasizes how atopic dermatitis also affects the strictly economic aspects of the lives of patients with the condition.

The present study is characterized by four main limitations. The first limitation is related to subjectivity in the identification and measurement of data. These activities were carried out through the administration of a survey, the completion of which is closely related to the correct interpretation of the questions asked, as well as the correct completion of the questions themselves. The second limitation is related to the sample size that characterized the study. Although the population investigated presents a larger sample size than the populations examined in other Italian studies, it is still small compared to the entire population. Naturally, this could lead to a bias in the results, as it might overestimate or underestimate the true economic impact of the disease. Third limitation within the analysis refers to the assumption used for the calculation of follow-up examinations performed over the time horizon of one year. Actually, within the survey, for the most accurate response from the subjects involved, it was preferred to define a time frame of three months. Then, based on this information, the same amount was assumed for the four quarters composing one year. This assumption, while allowing for a more accurate response from the patients participating in the survey, could at the same time result in an overestimation or underestimation of the annual amount relative to the resource under consideration. Finally, the fourth limitation of the study concerns the job classes used for the economic valuation of AD-related productivity loss. Actually, within the present analysis, distributions among the 4 job classes found in the literature were used, albeit based on the information obtained from the survey.

In summary, the study underlines how atopic dermatitis has a multifaceted impact on patients’ quality of life, affecting their social, economic, and occupational well-being in addition to their physical health. These findings support the growing awareness that atopic dermatitis places a substantial social and economic burden on society.

Conclusion

Although atopic dermatitis may be underestimated and treated as a lesser dermatological disorder, the cost of illness analysis carried out underlines how, on the contrary, it places a significant financial burden on the healthcare system, but even more so on patients affected by this condition. Indirect costs and out-of-pocket expenditures, such as those related to the purchase of drugs, non-pharmacological treatment, and lost working days, represent the most important items of the AD economic and social burden. In conclusion, the present study can be considered a starting point both for the identification and measurement of the elements that influence clinical and economic decisions related to AD and for stimulating the development of further studies that aim to investigate the quality of life of patients with the condition in the Italian context.

Funding 

This research was funded by an unrestricted grant from LEO Pharma S.p.A. LEO Pharma S.p.A. was not involved in the conduct of the study, data collection, analysis, interpretation of the data, drafting of this article, or the decision to submit it for publication.

Conflict of Interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. 

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Supplementary Material

Table S1. Questionnaire

Section 1: Direct Healthcare Costs + Out-of-Pocket Expenses

1. Please indicate which of the following treatments you or your person receiving care are undergoing for your condition:

  • Topical moisturizing and emollient treatments
  • Specific detergents
  • Specific makeup for atopic skin
  • Protective devices (e.g., pillow covers, mattress protectors, room humidifier)
  • Supplements
  • Topical anti-inflammatory therapy
  • Topical proactive therapy
  • Phototherapy
  • Systemic treatments (Oral systemic corticosteroids, Cyclosporine, Azathioprine, Mycophenolate mofetil, and Methotrexate)
  • Balneotherapy
  • Anti-infective therapy (S.aureus infection)
  • Biologic therapy
  • Other______________________________________________________________________

Please fill out the following table specifying which treatments for atopic dermatitis you have taken in the last month:

Pharmacological treatments in the last month Active ingredient /Brand name Dosage (e.g., 5mg, 100ml, etc) Dosage frequency (daily, every 3 hours, once a week, etc Method of administration (oral, intravenous, subcutaneous) Duration of therapy intake (1 week, 10 days, 1 month, ongoing) By medical prescription In private setting
Treatment 1 ◯YES  ◯NO ◯YES  ◯NO
Treatment 2 ◯YES  ◯NO ◯YES  ◯NO
Treatment 3 ◯YES  ◯NO ◯YES  ◯NO
Treatment 4 ◯YES  ◯NO ◯YES  ◯NO
Treatment 5 ◯YES  ◯NO ◯YES  ◯NO
Treatment 6 ◯YES  ◯NO ◯YES  ◯NO
Treatment 7 ◯YES  ◯NO ◯YES  ◯NO
Treatment 8 ◯YES  ◯NO ◯YES  ◯NO
Treatment 9 ◯YES  ◯NO ◯YES  ◯NO
Treatment 10 ◯YES  ◯NO ◯YES  ◯NO

2. On average, how many times a year do you/who you take care of visit a specialist doctor due to your condition?

___________________________________________________________________________________

Please fill out the following table specifying how many visits you have made in the last three months:

Healthcare professional involved Number of visits in the last 3 months

(with a medical prescription)

Number of visits in the last 3 months

(private setting)

Visit cost in the private setting
Dermatologist (e.g.)

3. Have you/who you take care of had any hospitalizations due to your condition in the last year?

◯YES  ◯NO

If yes, please fill out the table below.

Hospitalizations in the last year Number of days of hospitalizations Reason of hospitalization
Hospitalization 1
Hospitalization 2
Hospitalization 3

4. Have you/who you take care of undergone laboratory tests in the last three months?

◯YES  ◯NO

If yes, please fill out the table below.

Laboratory tests in the last 3 months Type of test

(e.g., complete blood count, creatinine, bilirubin, etc.)

Number of times performed By medical prescription In private setting
Test 1 ◯YES  ◯NO ◯YES  ◯NO
Test 2 ◯YES  ◯NO ◯YES  ◯NO
Test 3 ◯YES  ◯NO ◯YES  ◯NO
Test 4 ◯YES  ◯NO ◯YES  ◯NO
Test 5 ◯YES  ◯NO ◯YES  ◯NO

5. Do you/who you take care of use emollients and/or specific laundry products because of your condition? 

◯YES  ◯NO

If yes, please indicate the average monthly expense for purchasing specific products for your condition.

___________________________________________________________________________________

6. Which of the following symptoms do you or your person receive care experience?

  • Anxiety
  • Discouragement
  • Feeling of helplessness
  • Loss of sleep
  • Itching
  • Discomfort
  • Other______________________________________________________________________

7. Besides atopic dermatitis, do you/who you take care of suffer from other medical conditions?

◯YES  ◯NO

If yes, please indicate which ones from the following list:

  • Allergic rhinitis
  • Allergic conjunctivitis
  • Asthma
  • Food intolerances
  • Allergic skin rash
  • Atopic keratoconjunctivitis
  • Eosinophilic esophagitis
  • Nasal polyps
  • Hives
  • Other dermatological conditions________________________________________________
  • Other immune disorders_______________________________________________________
  • Other______________________________________________________________________

Section 2: Indirect costs

8. Patient’s Age (Years)

___________________________________________________________________________________

9. Sex

  • Male
  • Female

10. Employment status

  • Employed
  • Self-employed
  • Unemployed and seeking employment
  • Student
  • Not currently working (neither employed nor seeking employment)
  • Retired
  • Other, please specify __________________________________________________________

Occupation (only answer if you responded “Employed” or “Self-employed” to the previous question)

___________________________________________________________________________________

11. Region of residence

Piemonte Friuli-Venezia Giulia Basilicata Toscana
Valle d’Aosta Liguria Calabria Umbria
Lombardia Lazio Sicilia Marche
Trentino-Alto Adige Abruzzo Sardegna Campania
Veneto Molise Emilia-Romagna Puglia

12. Province of residence

___________________________________________________________________________________

13. How many days of work have you lost due to your condition in the last month? Leave the answer blank if you were not working.

___________________________________________________________________________________

14. Are you a beneficiary of Law 104/92?

  • Yes
  • No

15. Do you receive support from a family member or caregiver for managing your condition?

  • Yes
  • No

16. Is your caregiver a beneficiary of Law 104/92?

  • Yes
  • No

17. If you answered “Yes” to the previous question, please indicate the employment status of the caregiver:

  • Employed
  • Self-employed
  • Unemployed and seeking employment
  • Student
  • Not currently working (neither employed nor seeking employment)
  • Retired
  • Other, please specify __________________________________________________________

Caregiver occupation (only answer if you responded “Employed” or “Self-employed” to the previous question)

___________________________________________________________________________________

18. In the last month, have your caregivers missed workdays to assist you with your condition?

  • Yes
  • No

If yes, on average, how many workdays have they missed?

___________________________________________________________________________________

19. Approximately how many times have you, on average, missed social events or activities (e.g., gym, sports, cinema, theatre, hobbies, parties, social gatherings…) in the last month?

___________________________________________________________________________________

Table S2. Pharmacological line treatments

1  Treatment Treatment Patient (n) Average dosage Unitary cost (€) Total annual cost per patient (€) Total annual cost (€) Average total annual cost per patient (€)
Dupilumab 26 300 mg 640.00 € 16,640.00 € 432,640.00 € 6,701.77 €
Zirtec® 9 6 mg 0.03 € 15.22 € 136.95 €
Cortisone 18 65 mg 0.30 € 1,775.89 € 31,966.00 €
Kestine® 3 10 mg 0.02 € 73.43 € 220.30 €
Deltacortene® 6 25 mg 0.01 € 10.67 € 64.03 €
Xyzal® 1 5 mg 0.02 € 5.72 € 5.72 €
Pimecrolimus 3 5 g 0.79 € 1,450.27 € 4,350.80 €
Medrol® 1 5 mg 0.01 € 6.11 € 6.11 €
Protopic® 1 1 g 0.71 € 73.67 € 73.67 €
Cyclosporine 2 175 mg 0.02 € 387.38 € 774.76 €
Upadacitinib 1 30 mg 1.72 € 18,823.57 € 18,823.57 €
Antihistamine 2 10 mg 0.08 € 83.82 € 167.64 €
2  Treatment Treatment Patient (n) Average dosage Unitary cost (€) Total annual cost per patient (€) Total annual cost (€) Average total annual cost per patient (€)
Medrol® 1 16 mg 0.01 € 19.54 € 19.54 € 1,799.74 €
Flixoderm® 1 1 g 0.12 € 12.96 € 12.96 €
Pafinur® 1 10 mg 0.02 € 72.18 € 72.18 €
Dupilumab 2 300 mg 640.00 € 16,640.00 € 33,280.00 €
Zirtec® 2 6 mg 0.03 € 15.22 € 30.43 €
Cortisone 7 65 mg 0.30 € 1,775.89 € 12,431.22 €
Antihistamine 7 10 mg 0.08 € 83.82 € 586.75 €
Foster® 1 100 mcg 

+ 6 mcg

0.26 € 95.68 € 95.68 €
Levocetirizina 1 5 mg 0.02 € 40.15 € 40.15 €
Kestine® 1 10 mg 0.12 € 43.65 € 43.65 €
Oxatomide 1 60 mg 0.01 € 130.91 € 130.91 €
Advantan® 1 25 mg 0.19 € 1,775.73 € 1,775.73 €
Protopic ® 1 1 g 0.71 € 73.67 € 73.67 €
3  Treatment Treatment Patient (n) Average dosage Unitary cost (€) Total annual cost per patient (€) Total annual cost (€) Average total annual cost per patient (€)
Zirtec® 1 6 mg 0.03 € 15.22 € 15.22 € 966.12 €
Antihistamine 3 10 mg 0.08 € 83.82 € 251.47 €
Gibiter inhalator® 1 2 mcg 0.25 € 363.56 € 363.56 €
Foster® 1 100 mg

+ 6 mcg

0.26 € 95.68 € 95.68 €
Soldesam® 1 1 ml 0.56 € 29.31 € 29.31 €
Aciclovir 1 800 mg 0.72 € 1,305.66 € 1,305.66 €
Cortisone 5 65 mg 0.30 € 1,775.89 € 8,879.44 €
Advantan® 2 25 mg 0.19 € 1,775.73 € 3,551.45 €
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