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The report addressed how the agency might support medicine development for patients’ unmet medical needs.
On August 3, 2016, EMA published a final report on its pilot project on adaptive pathways, a product development concept for medicines that address patients’ unmet medical needs. Adaptive pathways have the potential to support medicine development in therapeutic areas where evidence generation is challenging, EMA said in a press release. Some of these areas include infectious diseases, Alzheimer’s disease, degenerative diseases, and rare cancers.
Adaptive pathways are defined by EMA as a planned, progressive approach to bringing a medicine to patients. Adaptive pathways are not new routes of marketing authorization, the agency continued, but make use of existing regulatory tools. These pathways make use of existing approval tools, in particular conditional marketing authorization, which has been in operation in the European Union since 2006. It also builds on the experience gained with strengthened post-marketing monitoring tools introduced by the 2012 pharmacovigilance legislation.
This concept of medicine development and data gathering is not meant to apply to all medicines, but only to medicines that are likely to address an unmet medical need, EMA notes. A key aspect of adaptive pathways is the involvement of all relevant decision makers across the lifespan of a medicine, including those who decide about patient access in the Member States.
In March 2014, EMA launched a pilot project to explore the practical implications of the adaptive pathways concept with medicines already under development. EMA invited companies to submit ongoing medicine development programs which fulfil the characteristics of adaptive pathways: a staggered approval from very small, restricted patient populations to increasingly wider populations, a binding plan of post-licensing evidence gathering, and involvement of key stakeholders in the process.
During the pilot, EMA received 62 applications, 18 of which were selected for in-depth, face-to-face meetings with the participation of other stakeholders. At the end of the pilot, six of these applications had progressed to receive formal parallel advice by EMA and Health Technology Assessment bodies and one to benefit from simple scientific advice. The majority of the proposals received were considered not suitable for adaptive pathways, and the companies were advised to pursue traditional development routes.