Europe faces many challenges in bringing new medicines to patients in an efficient and timely manner. The reasons for this include the high attrition rates in medicine development, a regulatory environment lagging behind rapidly evolving science, and research and development (R&D) and price/reimbursement models that are no longer financially viable.
‘Medicines adaptive pathways to patients’ (MAPPs) refers to a concept that seeks to provide patients with timely access to beneficial medicines, starting from a small group of well-identified patients (often those with little or no alternative treatments). As evidence accumulates on the benefits and risks of a medicine, access may be extended to other groups of patients. MAPPs relate to a flexible pathway covering the entire life cycle of a medicine, from development, through licensing, to patient access (pricing/reimbursement and healthcare delivery).
ADAPT-SMART is a coordination and support action that brings together representatives from key European stakeholder groups - regulatory agencies, health technology assessment (HTA) bodies, companies, payers, patients and health care professionals. Its goal is to create a platform where the conditions and feasibility of MAPPs implementation within the EU regulatory/legal context can be discussed openly and also ensure that MAPPs-related work in IMI is well coordinated.