Developing a Global Healthcare Innovation Index

Our understanding of medicine is being revolutionised by the pace of science. But not all the potential innovations in life sciences and medical technology are taken up into everyday practice in healthcare, even when they are shown to be beneficial. For the poorest people in the world, many innovations are not accessible because they are either unaffordable or unsuitable for their health systems. Tackling this gap requires the development of appropriate and affordable health technologies and novel business models. In the more advanced health systems there is a disconnection between the effort on research and development (R&D) and how much of this makes it into mainstream healthcare practice. Even the most evidence-based and affordable innovations can fail or are only taken up patchily, whether we compare across countries, or between localities or health organisations within countries. And technological innovation can be a problem for those responsible for paying for health systems. New technologies often increase costs because they allow us to treat more people for a longer part of their lives. Yet the general view amongst politicians, managers and others involved in healthcare is that health systems across the world need new thinking. They are increasingly facing escalating demand from an ageing population and the growing incidence of chronic disease. Healthcare is consuming an ever-increasing share of gross domestic product (GDP). The search is on for ways of providing the best quality healthcare as affordably as possible. The health technology industries – pharmaceutical and biotechnology, medical devices, information technology and the built environment (design, engineering and construction) – drive much of the innovation that takes place in healthcare. They are very big business. Collectively these companies have global revenues in the order of USD 2 trillion a year, about a quarter of overall global spending on healthcare. But they too are experiencing a changing landscape – an evolving market for their products, a changing balance of power across health systems as governments and payers seek to control costs, hence pressure on their business models. Innovation is regarded by economists and politicians as one of the main drivers of economic growth. It helps to explain why some companies, regions and countries perform better than others in terms of higher productivity and income. For companies involved in the health technology sector, and governments in countries where they are located, there is concern to ensure that their business models are sustainable and continue to successfully deliver new products to the market

Does global drug innovation correspond to burden of disease? The neglected diseases in developed and developing countries

While it is commonly argued that there is a mismatch between drug innovation and disease burden, there is little evidence on the magnitude and direction of such disparities. In this paper we measure inequality in innovation, by comparing R&D activity with population health and GDP data across 493 therapeutic indications to globally measure: (i) drug innovation, (ii) disease burden, and (iii) market size. We use concentration curves and indices to assess inequality at two levels: (i) broad disease groups; and (ii) disease subcategories for both 1990 and 2010. For some of top burden disease subcategories (i.e. cardiovascular and circulatory diseases, neoplasms, and musculoskeletal disorders) innovation is disproportionately concentrated in diseases with high burden and larger market size, whereas for others (i.e. mental and behavioural disorders, neonatal disorders, and neglected tropical diseases) innovation is disproportionately concentrated in low burden diseases. These inequalities persisted over time, suggesting inertia in pharmaceutical R&D in tackling the global health challenges. Our results confirm quantitatively assertions about the mismatch between disease burden and pharmaceutical innovation in both developed and developing countries and highlight the disease areas for which morbidity and mortality remain unaddressed

The impact of the priority review voucher on research and development for tropical diseases

Background In 2007, the priority review voucher (PRV) was implemented in the US to incentivize research and development (R&D) for tropical diseases. The PRV is issued by the US FDA and grants a quicker review to manufacturers upon successful development of a product for a disease eligible for the program. Objective The objective of this analysis was to assess whether the PRV has incentivized R&D (measured as clinical trial activity) for the intended tropical diseases. Method We used a difference-in-difference-in-differences (DDD) strategy by exploiting variation in its implementation across diseases and registries around the world. Clinical trials were retrieved from the World Health Organization International Clinical Trials Registry Platform for the years 2005–2019. Results We found a positive, but not statistically significant, effect of the PRV on stimulating R&D activity. Delayed effects of the policy could not be found. Conclusion Our findings, which were robust across a series of robustness tests, suggest that the PRV program is not associated with a trigger in innovation for neglected diseases and therefore should not be considered as a stand-alone solution. It should be supplemented with other government measures to incentivize R&D activity. To increase the value of the program, we recommend that the PRV only be awarded to novel products and not to products that have already been licensed outside the US. Doing so would restrict the number of vouchers awarded and slow down their ongoing market depreciation. Finally, we propose that product sponsors be required to submit an access plan for PRV-awarded products

The importance of surgeons and their peers in adoption and diffusion of innovation: an observational study of laparoscopic colectomy adoption and diffusion in England

Little is known about the role of clinicians in accounting for adoption and diffusion of medical innovations, especially within the English National Health System. This study examines the importance of surgical consultants and their work-based networks on the diffusion of an important innovation, minimally invasive elective laparoscopic colectomy for colorectal cancer. The study used linked patient-level and workforce data on 260,110 elective colectomies and 1288 consultants between 2000 and 2014, to examine adoption of laparoscopic colectomy pre- and post-introduction of clinical guidelines and total share of colectomies performed laparoscopically by adopters. Laparoscopy as a share of elective colectomy increased from 0% in 2000 to 53% in 2014. Surgeons, rather than hospitals, were the principal agents accounting for the increase and explain 46.6% of the variance in laparoscopic colectomy use. Female surgeons, surgeons trained outside the United Kingdom, and recent graduates had higher rates of laparoscopy adoption. More experienced surgeons and surgeons with more peers who perform laparoscopy were more likely to adopt, adopt early and have greater use of laparoscopy. Targeting clinicians, rather than hospitals, is central to increasing adoption and diffusion of new medical technologies

Inequities in cancer drug development in terms of unmet medical need

This study measures inequality and inequity in the distribution of clinical trials on cancer drug development between 1996 and 2016, comparing the number of clinical trials with cancer need, proxied by prevalence, incidence, or survival rates for both rare and non-rare cancers. We leverage a unique global database of clinical trials activity and costs between 1996 and 2016, constructed for 227 different cancer types to measure for rare and non-rare cancers: i) inequalities and inequity of clinical trial activity, considering all trials as well as split by R&D stage; ii) inequalities and inequity in R&D investment proxied by trial enrollment and duration; iii) evolution of inequity over time. Inequalities are measured with concentration curves and indices and inequities measured with the health inequity index. We find four important results. First, we show pro-low need inequity across cancer types for both rare and non-rare cancers, for all need proxies. Second, we show inequity differs across R&D stages and between rare and non-rare cancers. The distribution of clinical trials for non-rare cancers disproportionately favors low-need non-rare cancers from earlier to later stages of R&D, whilst for rare cancers this only occurs in Phase 2 trials. Third, inequity analyses in R&D investment show that only trial enrollment for rare cancers and trial duration for non-rare cancers are disproportionately concentrated among low-need cancers. Finally, while pro-low need inequity has persisted between 1996 and 2016 for non-rare cancers, it has faded for rare cancers post-EU orphan drugs’ legislation