Analysis of the economic burden associated with comparing biological therapy to traditional conventional therapies for the treatment of moderate-to-severe atopic dermatitis.

doi:10.21203/rs.3.rs-3800740/v1

Download PDF

Research Article

Analysis of the economic burden associated with comparing biological therapy to traditional conventional therapies for the treatment of moderate-to-severe atopic dermatitis.

https://doi.org/10.21203/rs.3.rs-3800740/v1

This work is licensed under a CC BY 4.0 License

Version 1

posted

You are reading this latest preprint version

Background:

Atopic dermatitis (AD) is a chronic, relapsing, and pruritic inflammatory skin disease with a high incidence rate, posing a considerable challenge for patients, society, and the healthcare system due to its chronic nature. In China, there is a scarcity of cost-effectiveness evidence concerning AD treatment. This study aimed to assess the cost-effectiveness of two prevalent treatments for moderate-to-severe AD—traditional conventional therapy (CT) and biological therapy (BT).

Methods:

A retrospective cohort study involving 97 patients with moderate-to-severe AD was conducted. Data were collected from a public tertiary dermatology hospital in Shandong Province, China. Primary outcome measures included total economic cost and treatment efficacy evaluated using the Severity Scoring of AD (SCORAD) index. The sustained treatment effect over six months was analyzed from a societal perspective.

Results:

This study included a total of 97 participants, with 47 receiving BT treatment and 50 receiving CT treatment. The entire treatment duration was 6 months, and the endpoint evaluation was the skin SCORAD score of the patients after 6 months of treatment. The average cost per person for BT was ¥28719.23, and for CT it was ¥8020.78. The cost-effectiveness ratio for BT was lower (¥34,609.82), signifying a lower cost per unit of effect gained. Patients utilizing CT incurred an additional expenditure of ¥31,853.56 for each additional unit of effectiveness compared to BT. Additionally, one-way sensitivity analysis underscored the cost of BT and its effectiveness as the most sensitive parameters in the model.

Conclusion:

BT emerged as the most cost-effective choice in the treatment of moderate-to-severe AD based on cost-effectiveness analysis. This research investment aids decision-makers in determining first-line treatment options for moderate-to-severe AD.

Cost-effectiveness

atopic dermatitis

conventional therapy

biological agents

AD is a common chronic inflammatory skin disease, characterized by local skin manifestation of papules, vesicles, scales, dryness, lichenification, etc.,^[1] often with recurrent episodes and significant pruritus, which seriously affects the daily work and life of patients. Epidemiological surveys have shown that the incidence of AD in children worldwide has risen to 15–20%, and the incidence in adults is over 10% .^[2] The prevalence of AD in Chinese adults is between 3.7% and 8.7%, and it is showing an upward trend year by year.^[3]AD usually begins in childhood, with 60% of patients developing AD before one year of age and 90% before five years of age.^[4] Children with AD are more likely to have food and environmental allergies, asthma, and allergic rhinitis than those without AD.^[5] AD patients are also more susceptible to ear infections, streptococcal pharyngitis, and urinary tract infections.^[6]

For the treatment of moderate-to-severe AD, there are currently two commonly used treatment options in clinical dermatology: CT and BT. CT for AD, such as corticosteroids and calcineurin inhibitors, can effectively control mild-to-moderate skin lesions and itching, but their efficacy in treating moderate-to-severe AD is not ideal; moreover, treatments such as phototherapy and immunosuppressive agents have inconveniences and significant side effects.^[7] With the continued deepening of research on the pathogenesis of AD, various different biological agents targeting key cytokines in type 2 inflammatory responses have been developed. Dupilumab is the first biological agent approved for the treatment of moderate-to-severe AD. It specifically binds to the shared receptor IL-4Rα of IL-4 and IL-13 while inhibiting their function, thereby suppressing type 2 inflammatory responses.^[8] The results of multiple clinical trials have reflected the long-term safety and effectiveness of Dupilumab in the treatment of AD.^{[9, 10]} Multiple studies have also demonstrated the effectiveness and safety of Dupilumab in the Chinese population.^{[11, 12]}

Different treatment modalities have significant differences in their impact on total cost. Although BT is highly effective, its incremental cost is quite high, which can impose a considerable economic burden on patients. The limitations of CT are also particularly evident, with long treatment cycles and slow symptom relief resulting in a significant decrease in work efficiency for patients. According to research reports from the US administrative claims database, the direct costs of moderate-to-severe AD patients range from $15,000 to $20,000 per year. ^{[13, 14]} Previously, the cost of treating AD in the United States ranged between $900 million and $3.8 billion annually.^[15] According to a comprehensive report on the burden of AD released by the National Eczema Association in 2017, the conservative estimate for the annual cost of AD in the United States was $5.297 billion.^[16] Additionally, data from a national sample of hospitalized patients from 2002 to 2012, representing 20% of all hospitalized patients in the United States, showed that the total annual hospitalization costs for adults were $8,288,083 and for children were $3,333,868.^[17] A study in Spain found that the average annual direct cost of moderate-to-severe AD patients was between €2,000 and €3,500.^[18] In the Netherlands, a survey showed that the average annual direct and indirect costs of AD patients receiving systemic treatment were €6,993 and €13,702, respectively. ^[19]

AD is a chronic, relapsing, and inflammatory skin disease characterized by significant itching. It requires long-term follow-up, and the treatment cost for patients is high. Therefore, it is particularly important to adopt a safe, effective, and cost-effective treatment plan. The introduction of new therapeutic approaches targeting the specific immune pathways of moderate to severe AD has had a significant impact on the economic burden for patients and hospitals. Understanding the economic burden caused by moderate to severe AD can provide a deep understanding of the harm caused by AD and provide important parameters for related health economic studies, supporting the provision of empirical data for further improving the disease management of AD patients in China. Currently, research on the economic burden of AD has mostly focused on Western countries. It is imperative to conduct a cost-effectiveness analysis comparing CT and BT. Research conducted in Western countries has shown that biologics are cost-effective. However, in China, the inclusion of traditional Chinese medicine (TCM) characteristic drugs and TCM treatment techniques, as well as the implementation of different medical insurance policies and measures taken by the Chinese government to reduce the prices of biologic drugs through collective procurement, have resulted in changes in the effectiveness and economic burden of the two treatment methods. Therefore, conducting a cost-effectiveness analysis of moderate to severe AD in China is necessary. Therefore, the objective of this study is to assess the cost-effectiveness of two treatment approaches for moderate to severe AD from a societal perspective: CT and BT.

Design and Setting

This is a retrospective cohort study that collected data from 97 moderate to severe AD (AD) patients who received treatment in the hospital between January and December 2021. The inclusion criteria were moderate to severe AD patients with a SCORAD score of ≥ 25 points, and the treatment options were CT and BT. The primary outcomes were incremental cost-effectiveness ratio (ICER), which was calculated based on incremental cost and effectiveness, and efficacy rate, which was measured by SCORAD score. The measurement period was 6 months after the start of treatment, and the specific efficacy indicator was SCORAD-50 (50% improvement in baseline score).

Measure of Effectiveness

Measure the effectiveness of treatment based on SCORAD score. After 3–6 months of treatment initiation, the specific indicator of effectiveness is SCORAD-50 (50% improvement in baseline score).

Cost Analysis

A cost analysis economic evaluation was conducted to calculate the costs, effectiveness, and cost-effectiveness of managing moderate-to-severe AD over six months. Future costs and outcomes were not discounted in the cost analysis because costs and effective results occurred during the same period. The total cost of treating moderate-to-severe AD was calculated from a societal perspective. Patients' costs included out-of-pocket expenses (direct costs) and productivity losses (indirect costs), which were calculated using the human capital method (calculated as: days of work missed * per capita GDP * productivity weight).

This study included a total of 97 patients with moderate-to-severe AD. Table 1 shows the demographic characteristics of the respondents, with 63% male and an average age of 35 ± 24 years (range3-93 years), and an average age of onset of 29 ± 26 years (range1-91 years). Seventy-three percent of respondents were urban residents, with 6% having a family history of AD, 8% having drug allergies, 21% having a history of allergic rhinitis, 14% being smokers, and 21% drinking alcohol. In terms of comorbidities, most patients had allergic rhinitis, with 20 cases (21%) (Fig. 1).

Table 1. Demographic Profile of the Respondents(n = 97)

Characteristics	BT(n = 47)	CT(n = 50)	x²Value	P-value
Age (years)
< 6	3(6.38%)	1(2.00%)	4.46	0.11
6–65	39(82.98%)	36(72.00%)
> 65	5(10.64%)	13(26.00%)
Age of onset (years)^a
< 6	17(36.17%)	9(18.00%)	7.11	0.03
6–65	27(57.45%)	30(60%)
> 65	3(6.38%)	11(22.00%)
Gender
Male	30(63.83%)	31(62.00%)	0.04	0.85
Female	17(36.17)	19(38.00%)	0.04	0.85
Place of residence
Urban	35(74.47%)	36(72.00%)	0.075	0.82
Rural	12(25.53%)	14(28.00%)	0.075	0.82
Family history
Yes	5(10.64%)	1(2.00%)	3.36	0.07
No	42(89.36%)	49(98.00%)	3.36	0.07
Drug allergy history
Yes	5(10.64%)	3(6.00%)	0.7	0.41
No	42(89.36%)	47(94.00%)	0.7	0.41
Past medical history
None	28(59.57%)	35(70.00%)	1.17	0.56
Allergic rhinitis	11(23.40%)	9(18.00%)
Other	8(17.02%)	6(12.00%)
Smoking
Yes	8(17.02%)	6(12.00)%	0.5	0.5
No	39(82.98%)	44(88.00%)	0.5	0.5
Alcohol consumption
Yes	11(23.40%)	9(18.00%)	0.43	0.51
No	36(76.60%)	41(82.00%)	0.43	0.51
Abbreviations: CT, conventional therapy; BT, biological therapy .
a ANOVA, significant at P < .05

This study presents the total costs during a 6-month treatment period for moderate to severe AD (Table 2). The highest overall cost was associated with BT, totaling ¥1,349,803.70 ($210,145.06) (¥8,020.78 [$1,245.14] per patient), followed by CT at ¥401,039.10 ($62,181.58) (¥28,719.23 [$4,461.46] per patient). Figure 2 illustrates the breakdown of costs based on each modality. The medication expenses were the highest for the treatment of moderate to severe AD, amounting to ¥1,181,427.28 ($183,218.05) (¥25,136.75 [$3,897.44] per patient), while the examination and laboratory testing costs were highest for CT, totaling ¥104,799.50 ($16,256.09) (¥2,095.99 [$325.27] per patient). Additionally, BT resulted in the largest productivity cost loss at ¥81,925.64 ($12,707.99) (¥1,743.10 [$270.23] per patient). The results also indicate statistically significant differences between the two treatment approaches regarding medication costs, examination, and laboratory testing costs, as well as other expenses.

Table 2. Mean Cost According to the Components

	Treatment Method			P-value
	BT（n=47） (SD)		CT（n=50） (SD)
Direct Costs(RM)
Medication Cost ^a	1181427.28(10404.45)		93011.29(5093.78)	0.00
Diagnosis and Treatment Cost	12422.00(191.55)		6800.00(181.26)	0.07
Examination and Test Cost ^a	65830.00(1121.38)		80630.30(2335.95)	0.00
Other Costs ^a		8198.77(721.33)	36622.07(2334.48)	0.00
Total Direct Costs ^a		1267878.05（11204.74）	340638.8（8606.44）	0.03
Indirect Costs(RM)
Loss of Work Cost ^a		81925.64（605.47）	60400.22（470.75）	0.11
Total Average Cost		28719.22753	8020.781893
Total Cost		1349803.69	401039.09

Abbreviations: SD, standard deviation; CT, conventional therapy; BT, biological therapy .

a ANOVA, significant at P< .05

Next, Table 3 illustrates the efficacy of the treatments, measured by the number of patients achieving a SCORAD-50 improvement (improvement of 50% compared to baseline). BT had the highest number of patients achieving a SCORAD-50 improvement, with 39 out of 47 patients meeting the criteria (82.98%), followed by CT, with only 9 out of 50 patients meeting the criteria (18.00%).

This study presented the basic results of a cost-effectiveness analysis conducted from a societal perspective during the treatment of patients with AD. BT was considered the most cost-effective modality because it generated the lowest cost per SCORAD-50 improvement at ¥34,609.82 ($5,381.62). CT followed at ¥44,559.90 ($6,916.98). Compared with CT, the incremental cost-effectiveness ratio (ICER) of BT was calculated as follows: [¥28,719.23 (biological agent cost per patient) - ¥8,020.78 (traditional therapy cost per patient)] / [82.98% (biological agent efficacy) - 18.00% (traditional therapy efficacy)] (Table3).

Table 3. Base-Case Result of the Cost-Effectiveness

Treatment

Cost (C) / RM

Effectiveness ^a

(E) % (n)

Cost effectiveness ^b

ICER

（n=47)

28719.23

82.98（n=39/47）

34609.82

31853.56

(n=50)

8020.78

18.00（n=9/50）

44559.90

Abbreviations: CT, conventional therapy; BT, biological therapy .

a Effectiveness (%) = percentage of patients achievedSCORAD-50 improvement (improvement of 50% compared to baseline).

b Cost effectiveness = total cost divides by the number of patients achieved SCORAD-50 improvement (improvement of 50% compared to baseline).

Then, scenario analyses were performed (Table 4), with changes in costs and effectiveness varied by 15%. In the best case scenario, the cost of BT per SCORAD-50 improvement was ¥29,418.35 ($4,564.70) (a 15% reduction in average cost and effective response of 85.11% [40/47]), while in the basic case, it was ¥34,609.82 ($5,381.62) (an average cost and effective response of 82.98% [39/47]), and in the worst case scenario, it was ¥39,801.29 ($6,198.54) (a 15% increase in average cost and effective response of 80.85% [38/47]). Meanwhile, in the best case scenario, the cost of CT per SCORAD-50 improvement was ¥37,875.91 ($5,880.49) (a 15% reduction in average cost and effective response of 20.00% [10/50]), while in the basic case, it was ¥44,559.90 ($6,916.98) (effective response of 18.00% [9/50]), and in the worst case scenario, it was ¥51,243.89 ($7,955.46) (a 15% increase in average cost and effective response of 16.00% [8/50]).

Table 4. Scenario Analysis

Treatment	Treatment Plan (Cost-effectiveness) (RM)
Treatment	Best case^a (Effectiveness %)	Base case^b (Effectiveness %)	Worst case^c (Effectiveness %)
BT	29418.35（85.11）	34609.82（82.98）	39801.29（80.85）
CT	37875.91（20.00）	44559.90（18.00）	51243.89（16.00）

Abbreviations: CT, conventional therapy; BT, biological therapy .

^a Best case = average cost reduced to 15% and effectiveness response increased to 15%.

^b Base case = average cost and effectiveness response.

^c Worst case = average cost increased to 15% and effectiveness response reduced to 15%.

Figures 3 show a tornado diagram representing the ICER. Single-factor sensitivity analyses were performed to assess the impact of changes in each parameter on the ICER, with the maximum and minimum values of each parameter used as upper and lower limits to calculate the ICER, respectively, with increases or decreases of up to 20% of the baseline value. The impact of each parameter on the ICER decreases from top to bottom in the diagram. The single-factor sensitivity analysis indicated that the cost of biological agents and the efficacy of biological agents were the most sensitive parameters in this model.

This study is a pioneering economic evaluation that assesses the cost-effectiveness of two treatment options for moderate-to-severe AD in China. The analysis of the cost-effectiveness of these interventions yielded mixed results. Some evidence suggests that biological agents are the most cost-effective choice compared to other modalities.^{[20, 21, 22]} A health economic model was developed to evaluate the long-term costs and benefits of providing dupilumab treatment every two weeks from the perspective of US payers. Dupilumab was compared to standard care. However, other studies have shown that systemic therapy produces the lowest cost per SCORAD improvement ≥ 50% (SCORAD-50).^[22] Nonetheless, this study indicates that BT is the most cost-effective modality and exhibits the best efficacy outcomes. This is particularly important since cost-effectiveness analyses consider both costs and benefits in determining the most cost-effective strategy. The cost analysis in this study showed that the total cost of BT was 3.4 times higher than that of CT but with a 65% efficacy difference. Therefore, this suggests that BT is the most cost-effective approach.

The inconsistent findings obtained in determining the most cost-effective treatment for moderate-to-severe AD can be attributed to several factors. One of which includes different measures of efficacy, which is considered the main reason for the significant difference in cost-effectiveness values shown in this study compared to Andreas Kuznik et al.^[20] A US-based study found that to be cost-effective, Dupilumab treatment for moderate-to-severe AD in US adults needs to maintain an annual price between $29,000 and $40,000, with each QALY threshold ranging from $100,000 to $150,000.^[22] From a societal perspective in the UK, JAK inhibitors were not cost-effective compared to biological agents (an additional £219,733.88 per quality-adjusted life year) at the selected pricing level.^[23]

The duration of cost-effectiveness studies defining AD treatment modalities varies across different studies. Although long-term investigations are preferred, data related to several long-term AD treatments are still lacking. This information includes the annual treatment dropout rate, "remission" periods, subsequent treatment efficacy, costs and rates of adverse events, and hospitalization risk.^[24]

In recent years, BT has generally been considered the best intervention for treating moderate-to-severe AD, with high safety, reduced side effects, and improved patient quality of life.^[25] Beck et al.^[26]reported the results of several randomized, double-blind, placebo-controlled trials involving adult patients with moderate to severe AD. Outcome measures included Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), itch scores, safety assessment, serum biomarker levels, and disease transcriptome in a subset of patients. In a 4-week monotherapy study, treatment with dupilumab showed significant improvements in clinical endpoints, biomarker levels, and AD transcriptome. A 12-week study demonstrated that 85% of patients in the dupilumab group achieved a 50% reduction in EASI compared to 35% in the placebo group (P < 0.001); 40% of the dupilumab group had an IGA score of 0 or 1 (clear or almost clear) compared to 7% in the placebo group (P < 0.001); itch scores decreased by 55.7% in the dupilumab group compared to 15.1% in the placebo group (P < 0.001). Therefore, cost-effectiveness studies are essential in demonstrating the need for biological agents in various countries.

In this study, treatment response was defined as a SCORAD improvement ≥ 50% (SCORAD-50). These responses are widely used in research involving AD, particularly the SCORAD score, which has been emphasized as the gold standard and meets the criteria for method effectiveness.^{[27, 28]} Additionally, this score is closely correlated with DLQI.^[27] Previous studies have chosen utility measurements, thus using questionnaires to convert clinical outcomes into utility scores. It was then used to estimate quality-adjusted life years.

Furthermore, another important piece of information derived from the findings of this study is that the cost of biological agents and the efficacy of biological agents were the most sensitive parameters. Similarly, various previous works have emphasized that biologics are the highest contributor to the total drug cost,^{[29, 30]} resulting in a several-fold increase in overall treatment costs.

The results of numerous studies conducted in Western countries have shown that BT are cost-effective. However, in China, the inclusion of traditional Chinese medicine (TCM) characteristic drugs and TCM treatment techniques has continuously improved the overall effectiveness of traditional therapies. Xie Zhihong et al.^[31]conducted a randomized controlled trial on 72 patients with AD, dividing them into a TCM treatment group and a Western medicine control group, applying the method of syndrome differentiation for treatment. The results showed that the total effective rate in the TCM treatment group (94.60%) was significantly higher than that in the control group (75.67%), with a lower recurrence rate. Qin Yuesi^[32] treated 28 cases of AD using the method of strengthening the spleen and calming the mind, and followed up for 8 weeks. The total effective rate in the treatment group was 85.71%, compared to 64.29% in the control group. Fu Zuwei et al.^[33] treated 43 patients with AD using plum blossom needling and cupping therapy. The results showed a total effective rate of 79.1%, with a reduction in the extent and severity of skin lesions after treatment. As the treatment methods of traditional therapy become more abundant, the cost of treatment also keeps increasing. Meanwhile, due to limitations of different medical insurance policies and measures taken by the Chinese government to lower the prices of BT through collective procurement and other strategies, the cost of BT is continuously decreasing.

In July 2020, Dupilumab was officially launched in China with a specification of 300mg-2ml per vial, costing 6666 yuan per vial. Subsequently, according to the adjustment plan of the National Medical Insurance Drug List, the "National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2020)" will be officially implemented starting from March 1, 2021, and the new version of medical insurance reimbursement policy will be fully implemented nationwide. After the implementation of the new medical insurance regulations, Dupilumab, which is included in the medical insurance, will be priced at 3160 yuan per vial, and can be further reimbursed according to the reimbursement ratio of each province and city. Patients with AD will find the price of Dupilumab much lower than before when it was not included in the medical insurance. Currently, Dupilumab for AD is available for prescription in nearly 200 hospitals in China. Patients with AD can enjoy the "dual-channel" medical insurance reimbursement policy at designated hospitals and pharmacies for targeted biological agents. After the implementation of the policy, patients spend less on the use of biologics, resulting in a reduced economic burden of BT. Therefore, conducting a cost-effectiveness analysis of moderate to severe AD in China is necessary.

This study also has some limitations. First, the respondents were recruited only from public hospitals and did not include patients seeking treatment in private clinics and hospitals. Therefore, the data obtained may not fully represent all moderate-to-severe AD cases in China. Nonetheless, it provides meaningful insights for clinicians regarding resource utilization in AD management.

Second, AD is a long-term chronic disease, but the duration used in this study was less than a year. Thus, it is important to establish a cost-effectiveness model that can predict changes and interruptions during treatment and efficacy over the next few years. However, conducting and sustaining long-term studies is a very challenging task because of high dropout rates and changes during treatment. The high dropout rate may lead to selection bias, which can affect the study results, which is reasonable. Therefore, the results of this study may be limited to the fact that if most patients have moderate AD, biological agents are the most cost-effective treatment modality (SCORAD ≥ 25 refers to the severity classification of AD management guidelines).^[34]

And other treatment options for AD, such as oral JAK inhibitors (Upadacitinib extended-release tablets), topical JAK inhibitors (Difamilast cream), and topical small molecule PDE-4 inhibitors (Crisaborole ointment), have also been proven to be effective.^[35] This study only screened patients using conventional standard therapy and treatment with Dupilumab, so it can only demonstrate the economic burden of patients treated with CT and BT.

Finally, the related costs of adverse effects were also excluded. Generally, the side effects of treatment are very complex, especially for diseases involving many comorbidities such as AD. This makes cost calculation a daunting and challenging task, although adverse effects play an inevitably important role in treatment decisions.

The treatment of moderate-to-severe AD requires considerable direct and indirect costs. BT exhibits the highest efficacy and is considered the most cost-effective strategy for treating moderate-to-severe AD patients. The important findings of this study guide physicians to consider the cost and efficacy of moderate-to-severe AD in determining first-line treatment, enabling hospitals to find the most beneficial clinical approach for patients with good treatment outcomes and minimal economic burden.

Future cost-effectiveness analyses should provide information on the long-term experience of interventions for moderate-to-severe AD and manage uncertainty related to key drivers of the cost-effectiveness of moderate-to-severe AD treatment.

AD Atopic dermatitis

CT Conventional therapy

BT Biological therapy

Ethics approval and consent to participate

This study was approved by the Ethics Committee of Shandong First Medical University Affiliated Dermatology Hospital（20220908KYKTKS001）. The objectives of the study were explained to the participants and informed consent was obtained.

Consent for publication

Consent for publication is not applicable as this study did not include names, images, or videos relating to individual participants.

Competing interests

Availability of data and materials

The datasets generated during and/or analyzed during the current study are available from the first author on reasonable request.

Competing interests

The authors declare no competing interests.

Funding

This work was supported by Shandong First Medical University (Shandong Academy of Medical Sciences) Youth Science Fund Cultivation and Support Program Project - Practice Construction and Application Research of "Internet+" Chronic Skin Disease Management Model(202202-038).

Authors' contributions

XLW: conception and design, acquisition of data, analysis and interpretation of data, drafting the manuscript and statistical analysis.ZL: critical revision of the manuscript for important intellectual content, obtaining fund, supervision and administrative and material support. XXW: Data analysis and provide administrative and material support. HX: provide administrative and material support. JLC: provide administrative and material support. XXS: provide administrative and material support. YQG: provide administrative and material support. WS: provide administrative and material support. LW: provide administrative and material support. YL: provide administrative and material support. HL: conception and design, critical revision of the manuscript for important intellectual content, obtaining fund, supervision and administrative and material support. FRZ: conception and design, obtaining fund, supervision and administrative and material support. all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Acknowledgements

We acknowledge the research assistants who assisted in data retrieval during the data collection stage.

Fornal R, Książkiewicz A, Fornal A, et al. Atopic dermatitis: Current standards of diagnosis and treatment, including the latest methods of management. Postępy Higieny i Medycyny Doświadczalnej. 2022;76(1): 282-299.
Tian J, Zhang D, Yang Y, et al. The global epidemiology of atopic dermatitis: a comprehensive systematic analysis and modelling study. The British journal of dermatology. 2023:ljad339.
Mao D, Li J, Liu S, et al. Prevalence and risk factors of atopic dermatitis in Chinese adults: a nationwide population-based cross-sectional study. Chinese Medical Journal. 2023;136(05):604-606.
Eichenfield LF, Tom WL, Chamlin SL, et al. Section 1. Diagnosis and assessment of atopic dermatitis Work Group. Journal of the American Academy of Dermatologyl. 2014;70(2):338-351.
Silverberg JI, Simpson EL. Association between severe eczema in children and multiple comorbid conditions and increased healthcare utilization. Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology. 2013;24(5):476-486.
Serrano L, Patel KR, Silverberg JI. Association between atopic dermatitis and extracutaneous bacterial and mycobacterial infections: A systematic review and meta-analysis. Journal of the American Academy of Dermatology. 2019;80(4):904-912.
Renert-Yuval Y, Guttman-Yassky E. New treatments for atopic dermatitis targeting beyond IL-4/IL-13 cytokines. Annals of Allergy, Asthma & Immunology. 2020;124(1):28-35.
Kim HO. Targeting cytokines and signaling molecules related to immune pathways in atopic dermatitis: therapeutic implications and challenges. Archives of pharmacal research. Arch Pharm Res. 2022;45(12):894-908.
Cork MJ, Thaci D, Eichenfield LF, et al. Dupilumab provides favourable long-term safety and efficacy in children aged ≥ 6 to < 12 years with uncontrolled severe atopic dermatitis: results from an open-label phase IIa study and subsequent phase III open-label extension study. The British journal of dermatology. 2021;184(5):857-870.
Blauvelt A, Guttman-Yassky E, Paller AS, et al. Long-Term Efficacy and Safety of Dupilumab in Adolescents with Moderate-to-Severe Atopic Dermatitis: Results Through Week 52 from a Phase III Open-Label Extension Trial (LIBERTY AD PED-OLE). American journal of clinical dermatology. 2022;23(3):365-383.
Gu C, Wu Y, Luo Y, et al. Real-world efficacy and safety of dupilumab in Chinese patients with atopic dermatitis: a single-centre, prospective, open-label study. Journal of the European Academy of Dermatology and Venereology : JEADV. 2022;36(7):1064-1073.
Li Y, Lu J, Chen R, et al. The efficacy and safety of Dupilumab for the Treatment of Atopic Dermatitis Among Chinese Patients in Clinical Practice: A Single-Center Retrospective Study. Dermatologic therapy. 2022;35(5):e15385.
Drucker AM, Qureshi AA, Amand C, et al. Health Care Resource Utilization and Costs Among Adults with Atopic Dermatitis in the United States: A Claims-Based Analysis. The Journal of Allergy and Clinical Immunology: In Practice. 2018;6(4):1342-1348.
Shrestha S, Miao R, Wang L, et al. Burden of Atopic Dermatitis in the United States: Analysis of Healthcare Claims Data in the Commercial, Medicare, and Medi-Cal Databases. Advances in therapy. 2017;34:1989-2006.
Ellis CN, Drake LA, Prendergast MM, et al. Cost of atopic dermatitis and eczema in the United States. J Am Acad Dermatol. 2002;46(3):361-370.
Drucker AM, Wang AR, Li WQ, et al. The Burden of Atopic Dermatitis: Summary of a Report for the National Eczema Association. Journal of Investigative Dermatology. 2017;137(1):26-30.
Narla S, Hsu DY, Thyssen JP, et al. Inpatient financial burden of atopic dermatitis in the United States. Journal of Investigative Dermatology. 2017;137(7):1461-1467.
Sicras-Mainar A, Navarro-Artieda R, Carrascosa Carrillo JM. Economic Impact of Atopic Dermatitis in Adults: A Population-Based Study (IDEA Study)." Actas Dermo-Sifiliográficas (English Edition). 2018;109(1):35-46.
Ariëns LFM, van Nimwegen KJM, Shams M, et al. Economic Burden of Adult Patients with Moderate to Severe Atopic Dermatitis Indicated for Systemic Treatment. Acta Dermato-Venereologica. 2019;99(9):762-768.
Kuznik Andreas, Bégo-Le-Bagousse Gaëlle, Eckert Laurent, et al. Economic Evaluation of Dupilumab for the Treatment of Moderate-to-Severe Atopic Dermatitis in Adults. Dermatology and therapy. 2017;7:493-505.
Antonio Costanzo, Gianluca Furneri, Rossella Bitonti, et al. Cost-effectiveness analysis of dupilumab for the treatment of severe atopic dermatitis in adults in Italy. Global & Regional Health Technology Assessment. 2020;7(1):57-65.
Zimmermann Marita, Rind David, Chapman Rick, et al. Economic Evaluation of Dupilumab for Moderate-to-Severe Atopic Dermatitis: A Cost-Utility Analysis. Journal of drugs in dermatology : JDD. 2018;17(7):750-756.
Beck LA, Thaci D, Hamilton JD, et al. Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis. The New England Journal of Medicine. 2014;371(2):130-139.
Heinz Katja C, Willems Damon, Hiligsmann Mickaël. Economic evaluation of a JAK inhibitor compared to a monoclonal antibody for treatment of moderate-to-severe atopic dermatitis from a UK perspective. Journal of medical economics. 2022;25(1):491-502.
Eric L, Simpson, Thomas Bieber, et al. Patient burden of moderate to severe atopic dermatitis (AD): Insights from a phase 2b clinical trial of dupilumab in adults. Journal of the American Academy of Dermatology. 2016;74(3):491-498.
Beck Lisa A, Thaçi Diamant, Deleuran Mette, et al. Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. American journal of clinical dermatology. 2020;21:567-577.
Kunz B, Oranje AP, Labreze L, et al. Clinical validation and guidelines for the SCORAD index: consensus report of the European Task Force on Atopic Dermatitis. Dermatology. 1997;195(1):10-19.
Yifei L,Min Y, Vishvas G, et al. Guidelines for treatment of atopic eczema (atopic dermatitis) part I. Journal of the European Academy of Dermatology and Venereology. 2012;26(8):1045-1060.
Liu Y, Yang M, Garg V, et al. Economic impact of non-medical switching from originator biologics to biosimilars: a systematic literature review. Advances in Therapy. 2019;36:1851-1877.
Makurvet F D. Biologics vs. small molecules: Drug costs and patient access. Medicine in Drug Discovery. 2021;9:100075.
Xu Y, Qiang Z S, Wei L, et al. Guidelines for the Diagnosis and Treatment of Atopic Dermatitis in China (2020): The Chinese Society of Dermatology Immunology Group and Collaborative Research Center of Atopic Dermatitis. International Journal of Dermatology and Venereology. 2021;4(01):1-9.
Cho Y T, Chu C Y. Advances in systemic treatment for adults with moderate-to-severe atopic dermatitis. Dermatologica Sinica. 2019;37(1):3-11.
Fu, Z W, Fu, et al. Clinical Observation of Cupping Therapy on Atopic Dermatitis based on the Theory of Needling and Collateral Method. Journal of Modern Traditional Chinese Medicine, 2012;44(02):79-81.
Agache I, Akdis C A, Akdis M, et al. EAACI Biologicals Guidelines—dupilumab for children and adults with moderate‐to‐severe atopic dermatitis. Allergy. 2021;76(4):988-1009.
Singh R, Heron C E, Ghamrawi R I, et al. Emerging role of janus kinase inhibitors for the treatment of atopic dermatitis. ImmunoTargets and Therapy. 2020:255-272.

No competing interests reported.

Download PDF

Version 1

posted

You are reading this latest preprint version

Analysis of the economic burden associated with comparing biological therapy to traditional conventional therapies for the treatment of moderate-to-severe atopic dermatitis.

Status:

Version 1

Abstract

Background:

Methods:

Results:

Conclusion:

Figures

Background

Methods

Design and Setting

Measure of Effectiveness

Cost Analysis

Results

Discussion

Conclusions

Abbreviations

Declarations

References

Additional Declarations

Status:

Version 1