For the pharmaceutical industry, encouraging the uptake of innovation across a cash strapped health service, with some of the lowest medicine prices in Europe, remains a significant challenge. Whilst a number of responses to these barriers are emerging, a key consideration is whether, as a society, we are valuing medicines appropriately. Nonetheless, an important evolution in the medicines’ development process is also taking place. While society has benefited from treatments that have large patient population coverage, advances in science and technology increasingly permit industry to shift towards a more focused and personalised approach, where companion diagnostic tests based on biomarkers can be developed to test large groups of patients and predict how they will respond to a certain treatment.
The potential of stratified medicines (or personalised /precision medicines) to revolutionise healthcare has been the subject of much hype over the past few years. Essentially, stratified medicines will allow clinicians to target treatments specifically to sub-populations of patients, by identifying those patients with the greatest chance of benefit and the lowest risk of suffering adverse effects. This has many potential benefits, including better health outcomes for the patient as well as delivering better value to NHS and other healthcare systems. But, ultimately, it is about ensuring that the right patient gets the right treatment at the right time. This shift from the blockbuster ‘one size fits all’ model of drug development to a more focused personalised approach has been made possible by a combination of technological progress and scientific advancement. Our increased understanding of genetics and genomics linked to biology insights into the underlying mechanisms and causation of diseases, and the development of biomarkers has opened our eyes to the true potential of stratified medicines. For that potential to become reality we now need bold and innovative polices for development and access to stratified medicine.
Many pharmaceutical companies have already adopted a ‘stratified’ approach to medicines’ development. In oncology, we have seen a wave of new personalised cancer therapies that have been proven to be effective in small sub-populations. For example, today’s treatments for Non-Small Cell Lung Cancer (NSCL) involve traditional chemotherapy as well as newer therapies which are targeted against a protein called epidermal growth factor receptor (EGFR). This particular example not only proves the clinical and societal benefits of stratified medicines, it also highlights the importance of accurate molecular typing of patient samples to ensure that the right patient is receiving the correct treatment.
Harnessing the potential for the development of stratified medicines in the UK will rely on a number of factors, including improved cross-sector collaboration to share knowledge and addressing key research questions in a pre-competitive manner. A prime example of this is the ABPI’s work with the Medical Research Council (MRC) to create academic-clinical-industry consortia to develop novel biomarkers of efficacy and response, and deep clinical phenotyping in respiratory and inflammatory joint diseases and diabetes.
The concept of personalised medicine is clearly evolving into an integral part of modern healthcare. As we see the drug development paradigm shift towards an era of more pre-competitive collaboration, a more pragmatic approach to the clinical development of medicines is emerging. With the joint working partnerships between NHS, industry and academia currently underway, as well as the opportunities to harness big data, the UK has a real chance to become a world leader in stratified medicine. We must ensure, however, that the right policy, regulatory and reimbursement frameworks are in place in the UK and beyond, in order to ensure that stratified medicines are appropriately valued and that future research is incentivised. Stratified medicines are no longer just a hope, but the UK must now focus on harnessing the full potential of this targeted approach to help improve patient outcomes and drive economic growth.