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Example considerations for

biosimilar implementation

3 key areas for consideration to develop a biosimilar implementation strategy

The considerations below may help you develop the implementation strategy that will be most effective at your institution. They have been organized into 3 areas and align with the 4 key operational areas for biosimilar implementation – Operational Enablement, Informatics/IT, Education, and Monitoring.

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Preparation

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Operational enablement

  • Integrate the benefits verification process with electronic health record (EHR) systems to facilitate a quick order process
  • Set up biosimilar prior authorizations in the EHR to ensure coverage
  • Develop a patient transition plan for how biosimilar transitions will be sequenced (eg, all at once, phased in by clinic or therapeutic area, existing vs treatment-naive patients)
  • Identify where the product will be stored and how much should be stocked
  • Evaluate what inventory management system modifications need to be made (including automated dispensing devices and software) to integrate the biosimilar and enable accurate identification
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Implementation

Informatics/IT

  • Identify what modifications need to be made to existing order sets and protocols to include biosimilar products
  • Plan for converting patient orders (eg, new vs established patients, single order vs treatment plan, route for cosignature)
  • Determine which EHR functionality/interface can be leveraged to support the organization’s biosimilar conversion goals
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Education

  • Identify the most critical stakeholders to target for biosimilar education
  • Determine what education stakeholders will need to prepare for biosimilar adoption
  • Select who will be responsible for patient education
  • Identify which patient education materials will be needed to support biosimilar use
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Monitoring

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Monitoring

  • Determine how the institution will ensure that biosimilar protocol is followed
  • Identify how financial and drug use evaluation outcomes will be monitored in order to determine if value of the biosimilar was achieved
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