EMA Provides Update of Adaptive Pathways Pilot Project

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 12-30-2014 18:37


The European Medicines Agency (EMA) has provided an update on the status of its adaptive pathways pilot project. EMA launched the adaptive pathways pilot project in March 2014.The adaptive pathways approach (formerly known as adaptive licensing), is part of the agency’s efforts to improve timely access for patients to new medicines. The concept of adaptive pathways foresees either an initial approval in a well-defined, high medical need subgroup, and subsequent widening of the indication to a larger patient population, or an early (perhaps conditional) approval which is prospectively planned, and where uncertainty is reduced through post-approval data collection.

The first phase of the project, involves the selection of medicines with a well-designed plan for an adaptive pathways approach, including an outline of how to engage with health technology assessment (HTA) bodies and other stakeholders, incorporate real world data, and a plan for the staggered extension of indications. This phase will close at the end of February 2015. The agency will then focus on the second stage of the project, which will include in-depth discussions with all stakeholders for those medicines that have been selected in the first phase. After February 28, 2015, the EMA will still consider new applications for the second stage face-to-face meetings if the HTA and real-world data collection aspects are well-developed. Applicants are invited to contact EMA for advice on the content and suitability of their request to be considered for Stage II of the pilot.

As of early December 2014, the EMA had received 34 requests from companies to include their medicines in the adaptive pathways pilot project. A total of six requests concerned an advanced-therapy medicinal product (ATMP), 12 requests were for orphan medicines, and 11 came from small- or medium-sized companies (SMEs). The medicines covered a broad range of therapeutic areas; 14 requests related to cancer indications. Following review and discussion with companies, six medicines have so far been selected to go forward into more in-depth discussions with the company with the participation of all stakeholders, including HTA bodies and patients’ representatives. The first of these in-depth discussions, on the quality aspects of an ATMP, took place in December 2014, with others already planned during 2015.

A full review of the outcome and impact of the adaptive pathways pilot project will be conducted once at least six medicines selected for the pilot have completed a procedure of parallel scientific advice with HTA bodies.

Source: European Medicines Agency


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