Access for All: A Personalised Approach

Abstract

While PM-enabled approaches have been particularly effective in certain cancers, where innovative medicines such as imatinib mesylate in chronic myeloid leukaemia and trastuzumab in erbB-2-positive breast cancer have brought practice-changing clinical benefits to patients, the spiralling costs associated with personalised or precision cancer medicine (PCM), even for new standard medicines such as imatinib mesylate, are a cause for concern [2] . Lawler and Sullivan [2] highlight the need to address the cost-value dilemma in PCM, moving beyond a simplistic ‘what the market can bear’ approach to a more nuanced value-based pricing philosophy. Employing this approach and embedding this philosophy into cancer care pathways can help reward innovation that has truly transformative potential (as opposed to the marginal ‘me too’ mentality that is potentially reducing therapeutic efOn Monday December 7, 2015, during the Luxembourg European Union (EU) Presidency, the Council of the EU issued its conclusions on personalised medicine (PM) for patients, highlighting how ‘the development of personalised medicine may offer new opportunities for the treatment of patients in the European Union ... allowing healthcare providers to offer better-targeted treatment, avoid medical errors and reduce adverse reactions to medicinal products’ [1] . PM certainly has the potential to improve outcomes for European citizens, but its undoubted promise must be balanced against a number of highly relevant challenges that may limit its positive impact on 21st century medicine. Issues such as increasing costs, inequitable access across European countries and regions and the need for a PM-relevant ethical, regulatory and reimbursement environment are currently undermining PM integration at European and national levels. Due to the need to address these important issues, the Brussels-based European Alliance for Personalised Medicine (EAPM) assembled a multi-stakeholder panel to identify and precisely define the critical barriers that limit PM uptake, while also developing putative solutions that will enhance patient access to PM across Europe. The outputs from their discussions are captured through a series of articles in this special issue of Public Health Genomics . These articles complement the activities of the EAPM’s Working Group on Access, which is surveying the European landscape and developing policy recommendations in this complex domain. Published online: June 1, 2016