Use of Biologic Therapies in the Treatment of Asthma – A Comparative Real World Data Analysis on Healthcare Resource Utilization and Costs Before and After Therapy Initiation

Abstract

Background

Asthma is one of the most common chronic diseases in Germany. While many patients achieve asthma control under standard therapies, some patients still experience exacerbations and persistent airway obstructions. Thus, further pharmacological treatment is needed, and biologics could fill this gap, as they have shown clinical benefit in patients with severe asthma. Therefore, this real-world study aimed to compare healthcare resource utilization (HCRU) and associated costs before and after biologic therapy initiation.

Methods

A retrospective claims data analysis has been conducted on adult asthma patients who initiated a long-term biologic therapy between January 2015 and June 2018. Patients were therapy-naïve to biologics for at least 12 months. HCRU and cost incurred by patients during 12 months before and after therapy initiation were compared.

Results

Overall, 571 asthma patients initiated a biologic therapy during the observational period (316 omalizumab, 232 mepolizumab, 16 benralizumab, and 7 reslizumab). Patients had a mean age of 54.86 (62.70% female), and the majority (93.70%) received at least one follow-up prescription of their index-biologic agent within one year. During baseline, patients received on average 2.75 OCS prescriptions compared to 2.17 during follow-up. Most patients received less or the same amount of OCS after therapy initiation. Moreover, hospitalizations and asthma-related sick leave days decreased significantly. The average total costs per patient were €6618.90 during baseline and €22,832.33 during follow-up. Biologics mainly drove the increase; however, hospitalization costs were reduced significantly (€2443.37 vs €1941.93; p<0.001).

Conclusion

Our study demonstrates an improved asthma control due to the initiation of a biologic therapy in terms of decreased hospitalization frequency, OCS consumption, and sick leave days. However, biologics are associated with high costs for healthcare providers during the first year after initiation. Therefore, short- and long-term clinical benefits and financial burden must be considered in the overall context of healthcare.

Keywords:

• biologics
• treatment pattern
• claims data
• real-world evidence
• Germany

Abbreviations

ATC, anatomical therapeutic chemical classification system; CPI, consumer price index; DDD, defined daily doses; HCRU, healthcare resource utilization; ICS, inhaled corticosteroids; ICD-10, International Statistical Classification of Diseases and Related Health Problems 10; LABA, long-acting beta-agonists; LTRA, leukotriene receptor antagonists; OCS, oral corticosteroids; PZN, pharmaceutical central number; RCTs, randomized controlled trials; WHO, World Health Organization.

Data Sharing Statement

The datasets generated during and/or analyzed during the current study are not publicly available since the findings of this study are extracted from individual patient records. Data were available for research purposes from the sickness fund upon request, in an anonymized form. Due to restrictions around revealing “patients” confidential information, data were used under license for the current study, and so are neither publicly available nor can be shared further.

Ethics Approval

This study involved the use of two anonymized health insurance claims datasets provided free of charge by AOK PLUS and AOK BW under formal agreement and legal basis of §75, Tenth Book of the Social Code (SGB X). No ethical approval from an institutional review board was required to implement this study, as a result of the anonymization of all patient data provided by the sickness funds.

Acknowledgments

Funding for this study was provided by GlaxoSmithKline.

Author Contributions

F.H., J.K. and T.W. conducted the analysis based upon the anonymized datasets that were provided free of charge by the sickness funds to support this research. Only IPAM had access to the anonymized datasets, which only captured information relevant to the project and specified within the research protocol. All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

Fränce Hardtstock and Julia Krieger participated in this study as staff members of IPAM; the work of IPAM in this study was financed by GlaxoSmithKline GmbH & Co. KG. Thomas Wilke is the founder of IPAM e.V., and has received honoraria from various pharmaceutical companies, including Novo Nordisk, Janssen Pharmaceutica, Boehringer Ingelheim Pharma, Bayer Health Care, Novartis, Sanofi, Pfizer and GlaxoSmithKline. Marco Lukas, Bernhard Ultsch and Robert Welte are GlaxoSmithKline employees and shareholders. Renate Quinzler is an employee of AOK Baden-Württemberg. Ulf Maywald is an employee of AOK PLUS. Hartmut Timmermann is affiliated with Schwerpunktpraxis Colonnaden and has received consultancy fees and grants from several pharmaceutical companies, including AstraZenica, Takeda, Bayer Health Care, Almirall, Astrellas Pharma, Novartis, Sanofi, Leti Pharma, Boehringer Ingelheim Pharma, Meda Pharmaceuticals, Mundipharma, Pfizer, Nycomed, Berlin-Chemie, Teva and GlaxoSmithKline. The authors report no other conflicts of interest in this work.