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A new evaluation framework aids in assessing biosimilar implementation strategies. This framework addresses stakeholder engagement, patient and clinician experiences, and system sustainability for better healthcare integration.

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Area of Science:

  • Health Services Research
  • Pharmacoeconomics
  • Drug Implementation Science

Background:

  • Biosimilar drugs significantly impact healthcare systems, necessitating diverse strategies for their acceptance and use.
  • Existing literature identifies enablers and barriers to biosimilar implementation but lacks comprehensive evaluation frameworks.
  • A gap exists in structured approaches to evaluate the multifaceted effects of biosimilar implementation strategies.

Purpose of the Study:

  • To develop and validate an evaluation framework for assessing biosimilar implementation strategies.
  • The framework aims to evaluate impacts on patients, clinicians, and publicly funded drug programs.
  • To provide a tool for monitoring and guiding future biosimilar adoption.

Main Methods:

  • A logic model approach was used to define the scope of biosimilar implementation.
  • The RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework guided the development of evaluation questions and indicators.
  • Stakeholder consultations, including focus groups and written feedback, were integral to refining the framework.

Main Results:

  • An evaluation framework was established with specific questions and indicators across five priority areas: stakeholder engagement, patient experience, patient outcomes, clinician experience, and system sustainability/affordability.
  • Extensive stakeholder engagement, involving 87 participants across 9 focus groups, ensured the framework's relevance and feasibility.
  • The framework was refined based on stakeholder feedback, aligning with practical implementation needs.

Conclusions:

  • A comprehensive evaluation framework has been developed through extensive stakeholder consultation.
  • This framework enables the measurement and monitoring of biosimilar implementation effects across key healthcare domains.
  • It serves as a foundational tool for evaluating and informing future biosimilar implementation strategies in diverse healthcare settings.