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Quantifying Preferences in Drug Benefit-Risk Decisions.

Tommi Tervonen1, Aris Angelis2, Kimberley Hockley3

  • 1Evidera, London, UK.

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Benefit-risk assessment informs drug decisions by weighing benefits against risks. Explicitly quantifying and communicating stakeholder preferences, like those from patients, can improve decision-making transparency and value.

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Area of Science:

  • Pharmacoeconomics and Health Policy
  • Drug Evaluation and Regulation

Background:

  • Benefit-risk assessment is crucial throughout a drug's lifecycle, including marketing authorization, health technology assessment (HTA), and clinical decision-making.
  • These assessments involve evaluating clinical and non-clinical outcomes, necessitating trade-offs based on preferences.

Purpose of the Study:

  • To highlight the inherent preference-based nature of benefit-risk assessments.
  • To advocate for the explicit quantification and communication of stakeholder preferences in decision-making processes.

Main Methods:

  • The study reviews the application of benefit-risk assessment across different drug lifecycle phases.
  • It analyzes the role of stakeholder perspectives (patients, healthcare professionals) in informing trade-offs.
  • The authors examine the current limited use of formal preference-based evaluation frameworks in regulatory and HTA decisions.

Main Results:

  • Benefit-risk assessments are inherently preference-based, involving trade-offs between diverse outcomes.
  • Stakeholder preferences are key but often not formally quantified or clearly communicated in regulatory and HTA decisions.
  • Current practices lack transparency regarding how preferences influence final decisions.

Conclusions:

  • Quantifying and explicitly communicating preferences in benefit-risk decisions can enhance decision quality.
  • Increased transparency in communicating these preferences is essential for better healthcare and regulatory outcomes.
  • Formal preference-based frameworks should be more widely adopted and communicated in drug evaluation processes.