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Out-of-Pocket Cost Is a Barrier to Therapeutic Drug Monitoring in Inflammatory Bowel Disease

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Abstract

Background

Therapeutic drug monitoring (TDM) is increasingly performed to optimize biologic therapy in inflammatory bowel disease (IBD). However, patients and physicians may be reluctant to perform TDM due to concerns related to potential out-of-pocket costs.

Aims

The aim of this study was to evaluate patient understanding and attitudes toward TDM in different clinical scenarios with and without potential out-of-pocket costs.

Methods

Adult IBD patients at a tertiary gastroenterology clinic were anonymously surveyed from March to September 2016 to assess their understanding of and willingness to undergo TDM in a variety of clinical scenarios, both with and without a potential out-of-pocket cost. Responses were analyzed for associations with changes in attitudes if out-of-pocket costs were involved.

Results

Of 118 completed surveys, 68.2% of patients were aware of or had previously undergone TDM. Patient willingness to undergo TDM was high both with and without potential out-of-pocket costs (70 and 98%, respectively); however, patients were significantly less willing with out-of-pocket cost (p < 0.01). Higher disease-related quality of life scores, as measured by the short inflammatory bowel disease questionnaire (SIBDQ), was significantly associated with an increased willingness to assume a potential out-of-pocket cost (p = 0.007).

Conclusions

Overall, patients understand and are willing to undergo TDM in certain potentially beneficial clinical scenarios, however, are significantly less willing if paying out-of-pocket. A higher SIBDQ score was associated with an increase in willingness to undergo TDM when out-of-pocket cost was involved. Physicians should discuss TDM with their patients in order to make an informed and personalized treatment decision.

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Acknowledgments

Aaron Rendahl, Ph.D. for assistance with data analysis.

Funding

This study was funded in part by the National Center for Advancing Translational Sciences of the National Institute of Health, Award Number UL1TR000114. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Author information

Authors and Affiliations

  1. Department of Internal Medicine, University of Minnesota, MMC 36, 420 Harvard St. SE, Minneapolis, MN, 55455, USA

    James P. Campbell

  2. College of Pharmacy, University of Minnesota, Minneapolis, MN, USA

    Erin Burton

  3. Office of Measurement Services, University of Minnesota, Minneapolis, MN, USA

    Shelly Wymer

  4. Division of Gastroenterology, Department of Internal Medicine, University of Minnesota, Minneapolis, MN, USA

    Michael Shaw & Byron P. Vaughn

Authors
  1. James P. Campbell
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  2. Erin Burton
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  3. Shelly Wymer
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  4. Michael Shaw
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  5. Byron P. Vaughn
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Corresponding author

Correspondence to James P. Campbell.

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Conflict of interest

BPV has served as a speaker, a consultant and an advisory board member for Janssen and Abbvie, and has received research funding from Roche and Takeda. The remaining authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Electronic supplementary material

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Supplementary Figure 1

ROC curve for SIBDQ using outcome: Willingness to pay did not decrease >1 on Likert scale with introduction of cost. An SIBDQ cutoff of 44 was a predictor of willingness to undergo TDM with an out-of-pocket cost. (TIFF 26670 kb)

Supplementary material 2 (DOCX 26 kb)

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Campbell, J.P., Burton, E., Wymer, S. et al. Out-of-Pocket Cost Is a Barrier to Therapeutic Drug Monitoring in Inflammatory Bowel Disease. Dig Dis Sci 62, 3336–3343 (2017). https://doi.org/10.1007/s10620-017-4808-3

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  • DOI: https://doi.org/10.1007/s10620-017-4808-3

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