EMA launches project to boost early patient access to drugs
pharmafile | September 8, 2015 | News story | Research and Development | EMA, European Medicines Agency, MAPPs, adaptive pathways, drug development, market access
The EMA is launching an adaptive pathway project to bring new medicinal products to market in Europe.
The ADAPT SMART project will lay the foundations for Medicines Adaptive Pathways to Patients (MAPPs), which is an adaptive pathway that “seeks to foster access to beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span in a sustainable fashion.”
ADAPT SMART stands for Accelerated Development of Appropriate Patient Therapies: a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes.
ADAPT SMART will investigate MAPPs tools and methodologies, to develop a workable MAPP concept which the EMA says will have the potential to bring new medicines to patients faster. The 30-month project is currently now in the second phase of the Innovative Medicines Initiative (IMI) under the EU Horizon 2020 framework, and is led by the EMA along with TI Pharma, a not-for-profit organisation that supports medicines development. The project is also supported by public and industry partners.
The current access system can often take as long as 10 years to approve a drug. In contrast in the MAPPs project, after initial trials on a medicine, MAPPs aim at using a set of objective measures including real world evidence data, to monitor the actual performance of a new therapy in patients over its entire lifespan and adjust patient access based on this expanding knowledge base.
Hans-Georg Eichler, who is senior medical officer at the EMA, says: “With the challenges facing healthcare in Europe, we see MAPPs as a vital tool to make the increasing number of promising new therapies available at the earliest appropriate time for patients with unmet medical needs. We need to do so in a way that is sustainable for all stakeholders in the healthcare ecosystem. ADAPT SMART is a vital programme to help achieve this goal.”
Solange Rohou, director of regulatory affairs AstraZeneca, says: “The overarching goal of MAPPs is to translate science into healthcare solutions that are available to patients earlier. To do so, diverse stakeholders, including payers, patients, practitioners, regulators, and industry, must be aligned in a truly cross-functional, cross sector engagement of continuous evaluation of the performance over the entire life-cycle of a new therapy.”
While Yann Le Cam, chief executive of EURORDIS, the European Organisation for Rare Diseases says: “We need to connect innovation in medicines development with patient access in order to ensure that more, better and cheaper treatments are reaching patients across Europe, and faster.”
This week the UK biotech firm Immunocore had its lead product IMCgp100, a drug under investigation as a treatment for cancer, viral infections and autoimmune disease, accepted into the EMA’s adaptive pathway pilot programme.
Immunocore plans to seek conditional approval for IMCgp100 for the treatment of patients with metastatic uveal melanoma, a rare and fatal disease with few available treatment options. But conversion to full approval will be subject to the successful completion of a Phase II clinical trial in uveal melanoma with long-term follow-up data.
Dr Christina Coughlin, chief medical officer at Immunocore, says: “We are delighted to have been accepted into the EMA adaptive pathways pilot programme, an accelerated development project that further underscores the potential benefits that IMCgp100 can bring to patients with uveal melanoma, a fatal disease that has few other treatment options.
“We are grateful for the collaborative regulatory feedback from the EMA on the design of our development programme as well as feedback from the European HTA agencies, patient advocacy organisations and leading European experts in the clinical management of patients with uveal melanoma.”
Yasmita Kumar
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