Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe

Abstract

As per the EMA definition, adaptive pathways is a scientific concept for the development of medicines which seeks to facilitate patient access to promising medicines addressing high unmet need through a prospectively planned approach in a sustainable way. This review reports the findings of activities undertaken by the ADAPT-SMART consortium to identify enablers and explore the suitability of managed entry agreements for adaptive pathways products in Europe. We found that during 2006–2016 outcomes-based managed entry agreements were not commonly used for products with a conditional marketing authorization or authorized under exceptional circumstances. The barriers and enablers to develop workable managed entry agreements models for adaptive pathways products were discussed through interviews and a multi-stakeholder workshop with a number of recommendations made in this paper.

Asia Pacific Society of Human Genetics (APSHG) from conception to 2019: 13 years of collaboration to tackle congenital malformation and genetic disorders in Asia

“…Due to the high cost of RD medicines and the small number of patients, the standard methodology of using health technology assessment (HTA) criteria, especially for incremental cost‐effectiveness ratio, may be an inappropriate approach for evaluation of these RD drugs (Tangcharoensathien et al, ). Other innovative strategies such as outcomes‐based managed entry agreements as well as arguments for ethical and equitable access to healthcare for patients with RDs may be considered (Bouvy, Sapede, & Garner, ). Ultimately in view of the improving gross domestic products (GDPs) in many countries in this region, governments will need to increase the healthcare expenditures accordingly.…”

Medicines Adaptive Pathways to Patients: Why, When, and How to Engage?

“…In practice, this may take the form of managed entry agreements (MEA); these are formal arrangements between a developer and a payer or healthcare provider that enables access to (coverage/reimbursement of) a health technology such as a medicinal product subject to specified conditions. Several different MEA formats have already been implemented, but they are not yet widely used …”

“…Several different MEA formats have already been implemented, but they are not yet widely used. 16,17 In a MAPPs scenario, the terms of the MEAs may specify the consequences on price and reimbursement conditions of successful and unsuccessful confirmation of the value proposition. This is why an adaptive pathway approach requires an adaptive pricing approach with price and conditions negotiated by each payer and revisited at set milestones in light of the results of the evidence available postauthorization.…”

Upgrading the SACT dataset and EBMT registry to enable outcomes-based reimbursement in oncology in England: a gap analysis and top-level cost estimate

“…While the idea of OBR is a fairly straightforward and has been covered extensively in the literature [7,[9][10][11][12][13][14][15], such reimbursement schemes have historically seen low levels of adoption in practice in Europe [16]. While it is not possible to point to one definitive reason for the low levels of adoption of such schemes, an often-cited reason is the administrative burden [14].…”