- Oral presentation
- Open Access
A company experience of the first MoCA pilot project
- Wills Hughes-Wilson1
© Hughes-Wilson; licensee BioMed Central Ltd. 2014
- Published: 11 November 2014
- Orphan Drug
- Corporate Responsibility
- Equitable Access
- Reimbursement Decision
- Evaluation Committee
Pricing and reimbursement authorities often lack sufficient information to decide about Orphan Medicinal Products (OMPs), because of pricing, high levels of uncertainty and small datasets, amongst others. EU Member States share similar challenges as they seek to include OMPs appropriately in their healthcare systems.
The Medicines Evaluation Committee of the European Social Insurance Platform (MEDEV) initiated pilot projects in July 2013. Companies were invited to participate with OMPs at any stage of development, with the objective of testing the different elements in the Recommendations. Sobi signalled its interest to participate.
The May 2014 evaluation provided opportunities to review the MoCA dialogue’s ability to deliver on its objectives and where more work needs to be done. Sobi experienced the MoCA as an important and highly relevant forum, providing the opportunity for managed, prospective, multi-stakeholder, trust-based dialogue, which progressively reduces uncertainty and allows sponsors to “design-in” payer-driven elements into development programmes and availability. It is based on voluntary participation of all participants so is highly flexible. It gives national payer bodies information to help them in their national providing and reimbursement decisions.
The first pilot was a success in testing the practical elements of a collaborative dialogue. Further projects will further test the Recommendations and the MoCA’s ability to contribute to access to OMPs timely, equitably and sustainably. The participants in the MoCA pilot are planning to write up their experiences with an aim to publish their joint findings to date.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.