Abstract
Background
In Ireland, over 20,000 people are affected by inflammatory bowel disease (IBD). The licenced biologic therapies to treat moderate to severe IBD are reported to have similar effectiveness levels but differ in their methods of delivery. Certain therapies are administered by intravenous (IV) infusion in the hospital setting, others are delivered by subcutaneous injection in the community.
Aim
To determine the non-drug costs involved in administering an IV biologic infusion in the hospital setting.
Methods
This time-and-motion study was conducted at an Infusion Day Unit (IDU) in an Irish teaching hospital. The sequence and duration of each patient’s use of resources was recorded and costed. Bootstrap methods were applied to ensure that robust estimates of the accuracy of the non-parametric population statistics were reliably estimated.
Results
The mean time the patient spent at the IDU was 143.78 mins with a mean treatment time of 129.81 min. The main driver of patient time was the drug infusion time (39%), followed by the monitoring period (25%). The mean cost was €224.54 per treatment. Nurse time was the main expenditure driver (37%), followed by laboratory costs (27%) and other healthcare professional’s costs (14%).
Conclusions
The study confirms that the non-drug costs associated with the delivery of an IV biologic in the hospital setting are non-trivial. Given the current budgetary climate of health systems, the compounding prevalence of IBD and the expected increase in patient numbers, it is imperative that physicians also consider the opportunity costs associated with the method of treatment delivery.
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Notes
In the infusion suite, the nurse records vitals, inserts a cannula and, if necessary, takes urine/bloods from the patient which are sent for laboratory analysis. The nurse then leaves the patient and enters the drug preparation area to prepare the pre-treatment (anti-histamine and steroid preparation) and reconstitute the anti-TNF therapy for infusion. Following on from this, the nurse returns to the patient to administer the pre-treatment and infuse the drug. During the drug infusion, the patient is regularly monitored by the nurse. When the infusion is complete, the cannula is removed and vitals are re-checked.
For example, a ‘line in set’, used during the insertion of the cannula, consisted of gloves, a tourniquet, a swab, a cannula, an extension set, a sterile gauze, a tegaderm dressing, 5 ml of saline flush, surgical scrub and alcohol gel. A cost was derived for this set and its use assigned to a patient treatment.
Biologic therapies are only administered to patients considered to be of sufficiently robust health. Patients presenting with complicating conditions such as flu are examined by doctor to determine eligibility.
A ‘line in set’ is required during cannula insertion while a ‘line out set’ is required to remove it. As the drug is being prepared, each time a drug is reconstituted one ‘DPA—fixed set’ is used along with one or more, dose-dependent ‘DPA—variable sets’, the quantity of which are contingent upon patient bodyweight.
Nurse manager, pharmacy and registrar
Based on an 8-week treatment cycle
Induction therapy for the first three treatments and transitioning to maintenance therapy thereafter—estimated at 5.75 treatments
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Acknowledgements
Catherine Lovett and the nursing staff of the Infusion Day Unit of this Irish teaching hospital are acknowledged.
Funding
This research has been funded by AbbVie Limited, Ireland via a Service Level Agreement between University College Cork and AbbVie Limited.
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Conflict of interest
At the time of conducting this research, one of the authors (MOS) was an employee of AbbVie Limited. This author’s involvement in the project was limited to the conception and planning of the research; critical revision of the manuscript for important intellectual content and approval of the final version of the manuscript for submission. This author had no involvement in data collection, data analysis and interpretation, along with the confirmation and discussion of the results.
The lead author affirms that this manuscript is an honest, accurate and transparent account of the research being reported and that no important aspects have been omitted.
Ethical approval
Ethical approval was sought and granted by the Clinical Research Ethics Committee of UCC and complies with the Nuremburg Code (1974), World Medical Association Declaration of Helsinki (1964, as amended) and the Council for International Organizations of Medical Sciences (CIOMS) Guidelines.
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Cronin, J., Moore, S., Lenihan, N. et al. The non-drug costs associated with the administration of an intravenous biologic treatment in the hospital setting. Ir J Med Sci 188, 821–834 (2019). https://doi.org/10.1007/s11845-018-1925-8
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DOI: https://doi.org/10.1007/s11845-018-1925-8