ADAPTIVE PATHWAYS AND PATIENT ACCESS – PUSHING PAYER BOUNDARIES OR FACILITATING NEW PAYMENT MODELS?

Author(s)

Jacoline Bouvy, PhD, National Institute for Health and Care Excellence (NICE), London, UK; Claudine Sapede, PharmD, MSc, F. Hoffmann-La Roche Ltd, Basel, Switzerland

Presentation Documents

ISSUE:  Adaptive pathways to medicines development could enable patients with earlier access to promising treatments in areas of high unmet medical needs. However, the implications of such pathways for access decisions at the national or regional levels remain to be explored. How health technology assessment (HTA) bodies, payers and manufacturers will deal with product value uncertainty and how this may affect solutions in the form of managed-entry agreements (MEAs)? In this panel session, learnings from payers, HTA agencies, and industry’s experience with MEAs will be shared along with their perspectives on the challenges and enablers on applicability of MEAs to possible adaptive scenarios. Jacoline Bouvy will talk about IMI ADAPT-SMART, where such questions are currently being explored. Hans-Georg Eichler will share the regulatory perspective on adaptive pathways. Ad Schuurman will provide the payer perspective and Claudine Sapede will represent the industry perspective. OVERVIEW:  Medicines Adaptive Pathways to Patients (MAPPS) seeks to foster access to beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span in a sustainable fashion. From an access perspective, the iterative process of MAPPS implies that stakeholders (regulators, HTA agencies and payers, manufacturers, patient groups, clinicians, etc.) find implementable solutions for decision on pricing and coverage while dealing with remaining uncertainties regarding the product therapeutic and economic value, warranting additional evidence generation in real life. Solutions may include more flexible approaches to pricing and reimbursement than those currently used. Will there be more use of outcome-based agreements that tie the price of the medicine to its results? These are questions that the panel will discuss.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Code

IP10

Topic

Health Policy & Regulatory, Organizational Practices

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