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Table 1 Multi-stakeholder recommendations—key points for decision makers and healthcare professionals in Europe

From: European Stakeholder Learnings Regarding Biosimilars: Part II—Improving Biosimilar Use in Clinical Practice

Practical recommendations addressing acute/shorter-term HCP needs regarding switching, supporting HCP biosimilar use
1.  Communicating about results from RCTs, real-world studies, and clinical experiences regarding (multiple) switching
2.  Providing a clear, one-voice EU overarching regulatory position regarding the interchangeability of biosimilars
3.  Developing a multi-stakeholder implementation and communication protocol to guide switching in clinical practice
    a. Guidance development on how to structurally organize a switch with involved stakeholders
    b. Guidance development on communication strategies towards patients, limiting bias and mitigating a possible nocebo effect
    c. Possibility to allow tailoring of strategies to the context of the treatment setting, product type, and individual patient needs (more detailed information provided in Fig. 2)
4. Developing and applying a balanced combination of non-tangible and tangible incentives for physicians and other stakeholders to use biosimilars
    a. Proportional tailoring of incentives to offset the stakeholder effort invested in biosimilar implementation (i.e. effort may be higher when switching subcutaneous products because of possible differences between injection devices)
    b. Application of a gainsharing agreement, reinvesting a part of the savings towards improving care and lowering the time and effort threshold associated with a switch by, for example, hiring additional staff
Overarching recommendations regarding switching decisions
5.  Applying a pragmatic switch approach, considering the potential gains vs. longevity of treatment
6.  Avoiding top-down organized switching, allowing and organizing stakeholder involvement, communication, and alignment
Strategic recommendations towards long-term sustainable competition with biosimilar presence
7.  Raising awareness about medicine prices and stakeholders’ societal responsibility to use and prescribe medicines in a cost-effective manner
8. Communicating publicly and actively about savings/advantages resulting from biosimilar use
9. Sharing of biosimilar uptake and prescribing data among hospitals and prescribers to allow peer-to-peer benchmarking
10. Reporting transparently about the allocation of savings resulting from biosimilar use
11. Developing policies with a long-term vision, beyond realizing short-term savings and with a focus towards creating a sustainable market with presence and competition of multiple suppliers
  1. Tailoring of strategies to the specific treatment setting, the product type, and stakeholder needs is desirable
  2. HCPs healthcare professionals, RCTs randomized controlled trials