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Budget Impact Analysis of Dalbavancin in the Treatment of Acute Bacterial Skin and Skin Structure Infections in Three European Countries

Abstract

Background and Objective

Acute bacterial skin and skin structure infections (ABSSSIs) have been defined by the US Food and Drug Administration (FDA) in 2013 to include a subset of complicated skin and skin structure infections commonly treated with parenteral antibiotic therapy. Inpatient treatment of ABSSSIs involves a significant economic burden on the healthcare system. This study aimed to evaluate the economic impact on the National Health System associated with the management of non-severe ABSSSIs treated in hospitals with innovative long-acting dalbavancin compared to standard antibiotic therapy in Italy, Spain, and Austria.

Methods

A budget impact analysis was developed to evaluate the direct costs associated with the management of ABSSSI from the national public health system perspective. The model considered the possibility of early discharge of patients directly from the Emergency Department (ED), after 1 night in the hospital, or after two or three nights in the hospital. A scenario with Standard of Care was compared with a dalbavancin scenario, where patients had the possibility of being discharged early. The epidemiological and cost parameters were extrapolated from national administrative databases and from a systematic literature review for each country. The analysis was conducted in a 3-year time horizon. A one-way deterministic sensitivity analysis was conducted to examine the robustness of the results.

Results

The model estimated an average annual number of patients with non-severe ABSSSI in Italy, Spain, and Austria equal to 5396, 7884, and 1788, respectively. A total annual expenditure of about €9.9 million, €13.5 million, and €3.4 million was estimated for treating the full set of ABSSSI patients in Italy, Spain, and Austria, respectively. Dalbavancin reduced the in-hospital length of stay in each country. In the first year of its introduction, dalbavancin significantly reduced the total economic burden in Italy and Spain (− €352,252 and − €233,991, respectively), while it increased the total economic burden in Austria (€80,769, 0.7% of the total expenditure for these patients); in the third year of its introduction, dalbavancin reduced the total economic burden in each Country (− €1.1 million, − €810,650, and − €70,269, respectively).

Conclusions

The introduction of dalbavancin in a new patient pathway to treat non-severe ABSSSI could generate a significant reduction in hospitalized patients and the overall patient length of stay in hospital.

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Author information

Correspondence to Andrea Marcellusi.

Ethics declarations

Funding

This study was supported by an unconditional grant from Angelini SpA.

Conflict of interest

L. Sarmati, T. Czypionka, J. Espin, J.P. Horcajada, G. Favato, and M. Andreoni have received consulting fees from Angelini SpA. D. Andretta is an employee of Angelini SpA. A. Macellusi, C. Bini, P. Sciattella and F.S. Mennini have no conflict of interest to declare. The authors confirm that the paper is an accurate representation of the study results. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Appendix: Algorithm to Identify ABSSSI Patients in Italy (Non-severe)

Appendix: Algorithm to Identify ABSSSI Patients in Italy (Non-severe)

The following algorithm was implemented for all acute inpatient admissions with discharge dates between 1 January 2006 and 31 December 2014, in the Italian Hospital Information System (HIS).

To define non-severe patients requiring observation over 12 h, one of the following inclusion criteria had to have been met:

All acute inpatient admissions with discharge

AND a primary diagnosis as follows:

  • “Cellulitis or abscess of the finger or toe” (ICD-9-CM 681.xx)

  • “Other cellulitis or abscess” (ICD-9-CM 682.x)

  • “Other local infection of the skin or subcutaneous tissue” (ICD-9-CM 686.xx)

  • “Posttraumatic wound infection not elsewhere classified” (ICD-9-CM 958.3)

  • “Other post-operative infection” (ICD-9-CM 998.59)

OR

  • a diagnosis-related group (DRG) as follows:

    • “Cellulitis, age > 17 years with complications” (DRG 277)

    • “Cellulitis, age > 17 years without complications” (DRG 278)

    • “Post-operative or post-traumatic infection” (DRG 418)

Exclusion criteria:

  • Hospitalized patients aged < 17 years

  • Hospitalizations with a length of stay < 1 day

Definition of a “non-severe” case:

All selected admissions with a length of stay ≤ 3 days

AND a diagnosis-related group (DRG) not including the following:

  • “Subtotal mastectomy for malignancy with CC” (DRG 259)

  • “Extensive procedure unrelated to the principal diagnosis” (DRG 468)

  • “Ungroupable” (DRG 470)

  • “Prostatic procedure unrelated to the principal diagnosis” (DRG 476)

  • “Non-extensive procedure unrelated to the principal diagnosis” (DRG 477)

  • “Tracheostomy for face, mouth, and neck diagnoses” (DRG 482)

  • “Tracheostomy except for face, mouth, and neck diagnoses” (DRG 483)

  • “Extracorporeal membrane oxygenation or tracheostomy with mechanical ventilation ≥ 96 h or a principal diagnosis unrelated to the face, mouth, and neck, with a major procedure” (DRG 541)

  • “Tracheostomy with mechanical ventilation ≥ 96 h or a principal diagnosis unrelated to the face, mouth and neck, without a major procedure” (DRG 542)

Algorithm to identify ABSSSI patients

For mapping between ICD9-ICD10 codes, the “ICD-9 to ICD-10 Code Search|ICD-10 Code Lookup & Crosswalk” tool was used, and the correspondences were double-checked.

Algorithm to identify ABSSSI patients in Spain

The Spanish official database (http://pestadistico.inteligenciadegestion.msssi.es/publicosns) was searched for -CIE-9 681, 682 and/or DRG APR 383 codes.

Algorithm to identify ABSSSI patients in Austria

In Austria, ABSSSIs are not as easily identified as in other countries. For example, many ABSSSIs, such as erysipelas, are coded as HDG19.07 “Komplizierte Affektionen der Haut”, a DRG group that also includes pemphigus vulgaris. A sub-group (HG156) is available but still includes diseases such as ulcus cruris and decubitus. We therefore requested all records for the ICD 10 codes from the Italian algorithm (using an ICD-9 to ICD-10 Code Search|ICD-10 Code Lookup & Crosswalk) together with their DRG codes from the Austrian Ministry of Health. Then, we identified plausible ICD/DRG combinations with the following algorithm:

The DRG points of all acute-care stays of persons aged 20 years and over (the lowest category would have been 15–19 years) for the years 2008–2014 and the following:

  • LOS 0, 1, 2–3, 4 + (for each category)

AND

  • An ICD10 equivalent of Italian algorithm ICD9 codes

AND

  • HDG 19.07

  • HDG 19.08

  • HDG 4.01

  • MEL 06.05

  • MEL 09.03

  • MEL 31.01

  • GERIAT

  • REMOB

  • LANGZEIT

  • PALLIAT

For each ICD10/DRG/LOS category, readmissions were also made available. Zero-day stays were not included in the cases but were requested for completeness.

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Marcellusi, A., Bini, C., Andreoni, M. et al. Budget Impact Analysis of Dalbavancin in the Treatment of Acute Bacterial Skin and Skin Structure Infections in Three European Countries. Clin Drug Investig (2020). https://doi.org/10.1007/s40261-020-00891-w

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