Podcast on Managed Entry: Claudine Sapede-Kniffel of F. Hoffmann-La Roche and Jacoline Bouvy of NICE
In February 2016, Jacoline Bouvy, Scientific Adviser at NICE (National Institute for Health and Care Excellence), and Claudine Sapede-Kniffel, Global HTA & Payment Policy Lead, F. Hoffmann-La Roche, met in London to discuss managed entry in the context of the ADAPT SMART initiative. The two members of the ADAPT SMART consortia are participating in Work Package 3, and working together to develop new methodologies on managed entry agreements.
“A managed entry agreement can be described as an arrangement between a payer or a provider, and a manufacturer, that enables access to a new technology or medicine under specified conditions… So basically it’s a contract with conditions that address specifics related to the compound in terms of performance or budget impact.” – Claudine Sapede-Kniffel, on how “managed entry” can be defined.
“In the context of an adaptive pathways, (managed entry) is exactly the kind of understanding we would need to move towards… The goal is to address the question related to price, reimbursement and coverage decision making for a product approved under an adaptive pathway. What we are doing now is to get a better understanding of the uncertainty that might come with such product developed under this kind of pathways; we wanted to look at concrete and practical experience among the stakeholders regarding managed entry agreements. ” – Claudine Sapede-Kniffel, on the overarching objective of ADAPT SMART’s work in managed entry
“The idea, from a theoretical point of view, managed entry can transform a pricing & reimbursement decision from a yes/no decision to a more flexible decision-making framework. Especially if we are talking about an outcomes-based managed entry agreement, it could be coverage with evidence development or it could be conditional reimbursement.” – Jacoline Bouvy, when asked about the potential benefit of managed entry agreements for Health Technology Assessment (HTA) bodies.
“When it comes to developing MAPPs and Adaptive Pathways further, which is what ADAPT SMART is doing, we’re really only at the beginning of trying to think about ways the actual introduction into national healthcare systems might work. To be able to make possible recommendations on what a managed entry agreement in the context of adaptive pathways might look like, we decided that we first need to see what the actual experience of different stakeholders has been in the past years… We know there have been very mixed experiences and we need to know what those have been and what the issues might be.” – Jacoline Bouvy, elaborating on the current work plan regarding ADAPT SMART and managed entry agreements.
“They are difficult to define, they’re difficult to implement – and these circumstances are also different in each county.” – Jacoline Bouvy, on managed entry agreements.
Listen to the full podcast here: