Seamless Process and Decision Points of an Adaptive Pathway (D2.05)

This report proposes a framework with pictographic representation of an adaptive pathway containing key moments, events and involved stakeholders, in each phase. This model is purposefully presented rather simplistically in this first evolution, acknowledging that there remain several questions to be answered – both unique to each individual potential medicine as well as to full implementation of an integrated adaptive pathway approach.

Some key questions (amongst others) arising from this work are as follows:

1. How can Member States that do not have pricing and reimbursement authority resources effectively contribute to early input within this framework?
2. How will stakeholder resourcing be planned, managed, measured and assessed (in terms of impact)?
3. To what extent, and how, are formal interactions between stakeholders governed under an adaptive pathway?
4. How best should the process ensure the necessary patient inputs?
5. How can a single iterative evidence development plan be maintained while supporting Member State-specific post-authorisation processes regulated by national laws?
6. What is the nature, remit, and stakeholder affiliation of a project manager for an adaptive pathway from start to finish? Where does potential project management expertise and resources currently reside?

The success of adaptive pathways, at least initially, may hinge on demonstrating true value via ‘live assets’ going through the pathway and integrating those key learnings moving forward. Greater shared experiences of pricing and reimbursement authority evidence requirements across Member States, coupled with their early consideration within an adaptive pathway (on a product specific basis) would be a vital enabler for the development, pricing and reimbursement processes, and reassessment decisions, of a successful adaptive pathway product development.

The nature of the early informal, and later formal multi-stakeholder interactions, will require a delicate balance between maintaining appropriate levels of transparency versus confidentiality, being respectful to the political mandate of each stakeholders’ involvement, and ensuring mutual trust that each stakeholder is, and remains committed to, the decisions and processes they have agreed. The development and implementation of such a mechanism requires careful consideration.