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Willingness to Pay for Adverse Drug Event Regulatory Actions

  • Original Research Article
  • WTP for Adverse Drug Event Regulatory Actions
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Abstract

Background: Regulatory requirements for the pharmaceutical industry have become increasingly demanding with respect to the safety and effectiveness of drugs.

Objective: The objective of this study was to determine the willingness to pay (WTP), of both the Dutch general public and dialysis patients, for regulatory requirements related to reducing the risk of pure red cell aplasia (PRCA) associated with epoetin alpha use.

Methods: A survey was carried out in April 2009. The Dutch general public (n = 422) was approached through a survey sampling agency. Patients (n = 112) were included through several Dutch dialysis clinics because they are often treated with epoetin alpha and therefore were expected to have a higher WTP than the general public. The survey aimed to determine the WTP for reducing the risk of PRCA in epoetin alpha users from 4.5 to 0 per 10 000 patients per year, based on regulatory actions that have been taken by the European Medicines Agency (EMA). WTP was determined via a payment scale and an open-ended follow-up question. Patients were asked how much extra per year they would be willing to pay for their basic healthcare insurance.

We used two censored regression models to test the association between WTP and a set of independent variables: a Tobit model with the stated WTP as the dependent variable and an interval regression model with the interval between the lower and upper bounds of the payment scale as the dependent variable.

Results: The patients’ mean WTP was significantly higher (€46.52) than that of the general public (€24.40). The Tobit model showed significant associations (α = 0.05) with WTP for dialysis patients, risk perception and respondents’ opinions on costs of healthcare. The interval regression model showed significant associations with WTP for the same variables as the Tobit model and for one additional variable (risk aversion). Income did not significantly affect WTP. A scenario with a 10-fold larger risk reduction did not increaseWTP significantly.

Conclusion: This study is, as far as we know, one of the first attempts to analyse the WTP for drug regulation and should in future be used in studies of the societal costs of drug regulation for epoetin alpha use. Our results indicate that the Dutch general public, especially Dutch dialysis patients, are willing to pay limited amounts to reduce the risk of serious adverse events associated with drug use.

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Acknowledgements

This study was performed in the context of the Escher project (T6-202), a project of the Dutch Top Institute Pharma (TIPharma). TIPharma did not play a role in the design, conduct or analysis of this study and played no role in the writing of this article.

The authors would like to thank Job van Exel, Teresa Bago d’Uva and two anonymous reviewers for their useful comments and suggestions.

The questionnaire was designed by Just Weemers, Marc Koopmanschap, Huub Schellekens and Jacoline Bouvy. Data were collected by Just Weemers and analysed by Jacoline Bouvy.

Just Weemers and Jacoline Bouvy wrote the manuscript; both authors contributed equally to the article. Marc Koopmanschap and Huub Schellekens reviewed the data analysis and the manuscript.

Jacoline Bouvy, Marc Koopmanschap and Just Weemers declare no conflict of interest. At the time of the study, Just Weemers held an internship at iMTA. Huub Schellekens declares the following: most of his research is directly or indirectly sponsored by the pharmaceutical industry. He has participated in meetings and publication sponsored by the pharmaceutical industry; however, his work on this study did not include any involvement of third parties in any way. No conflict of interest therefore exists for this study.

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Authors and Affiliations

  1. Institute for Medical Technology Assessment, Department of Health Policy and Management, Erasmus University, PO Box 1738, 3000 DR, Rotterdam, the Netherlands

    Jacoline Bouvy MSc, Just Weemers & Marc Koopmanschap

  2. Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands

    Jacoline Bouvy MSc & Huub Schellekens

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  1. Jacoline Bouvy MSc
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  2. Just Weemers
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Correspondence to Jacoline Bouvy MSc.

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Bouvy, J., Weemers, J., Schellekens, H. et al. Willingness to Pay for Adverse Drug Event Regulatory Actions. Pharmacoeconomics 29, 963–975 (2011). https://doi.org/10.2165/11539860-000000000-00000

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