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Adaptive Pathways: Generating Evidence of Value.

Virtual | 14:00 - 17:30 BST | Thursday 30 September
15:00 - 18:30 CET | 09:00 - 12:30 EST | 08:00 - 11:30 CST

£375.00 £300.00(per ticket)

No account? Please purchase this event to watch on-demand

Adaptive pathways promise a “triple win”.

They enable early access for patients to the most promising innovative therapies, address concerns over affordability, cost-effectiveness and outcome uncertainty for payers, whilst meeting companies’ need to make R&D sustainable.

As such they are a critical tool in the market access toolbox, but their opportunities and challenges are not well understood.

Uncertainty remains on how to realise all the potential benefits, when adaptive pathways are superior to traditional market entry routes, and how to overcome real-world evidence generation challenges.

This Masterclass addresses these strategic issues, illuminating when adaptive pathways are optimal for innovative therapies, as well as bringing together multiple perspectives on these iterative pathways.

Participants will benefit from engaging with OHE’s global thought leaders, and from industry insights on successful examples of adaptive pathways applications, which have aligned regulatory and reimbursement evidentiary requirements to enable timely access to breakthrough therapies.

The Masterclass speakers will also reflect on the practical opportunities and potential barriers to the acceptability of real-world evidence, and will present optimal evidence generation plans for different treatment types.

Agenda

Delegates Join

Welcome and Introduction

Adaptive Pathways

Insights from the Experience in Europe and the UK
• Accelerated Pathways (AP) introduced by the EMA and MHRA
• What APs mean to development and access to medicines, including impact of early scientific advice
• Difference between compassionate use and APs
• Examples of early access in Europe

Adaptive Pathways

Regulatory and HTA experience in the US
• US experience
• Key challenges and future prospects

What are the prospects of adaptive pathways in the EU, US and UK?

Panel Discussion

Break

Are APs always the answer?

Maximise AP use
• Application of value of information to inform optimal use of risk sharing schemes
• When companies should actively seek an AP, including scientific advice.

Bridging the gap between regulatory and reimbursement

The solutions
• Elements driving uncertainty at an early stage of a treatment introduction, including surrogate endpoints
• Examples on how different types of uncertainty can be addressed, including conditional reimbursement schemes

How can we move to a life-cycle approach for reimbursement and evidence generation?

Panel Discussion

Summary and Reflections

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