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The pharmaceutical industry regarded the HTA assessment as the ‘forth hurdle’; the first three hur- dles being the need to demonstrate to the regulato- ry agencies that a therapy was safe, effective and could be manufactured with consistent quality. Overcoming the fourth hurdle was essential to obtain reimbursement from many payers in many regions. NICE52 (the National Institute for Health and Care Excellence), the HTA in England and Wales provides a useful exemplar of the role of an HTA. However, now in 2030, global RWD stan-


dards53 are in place that allow outcomes measure- ment to be useful and the many disparate Health Technology Assessment Agencies, including NICE, are aligned into a global consortium (similar in concept to EUnetHTA54 but with global reach) which provides support and advice to the life sci- ence and medical device industries. The develop- ment of such HTA methodologies has been instru- mental in the migration of the reimbursement paradigm from ‘payment per pill’ to ‘outcomes- based payment’.


Pre-competitive collaboration Another key development in the last decade has been that all major biopharmaceutical and life science businesses have been closely aligned and collaborating openly in pre-competitive pro- grammes that delivered cross-industry results55. The multi-company, multi-year Open Targets56 initiative, launched in 2014, provided one exam- ple of many of these pre-competitive collabora- tions that have transformed the efficiency of bio- pharma R&D. As KPMG wrote in its 2018 report Reinvent innovation and become an R&D front- runner by 203057 “…by 2030, we anticipate R&D funding to be


facilitated through cost and resource sharing prac- tices among multiple healthcare stakeholders as a way to lower R&D costs. Equity partnerships between CROs and industry players will ease the R&D financial burden and drive innovation and cost effectiveness. In addition, crowdfunding for financing drug R&D will accelerate drug develop- ment and distribute the financial risk among various stakeholders, and perhaps even the wider public. “To remain successful in the market while devel-


oping an innovative and sustainable R&D capabil- ity, fundamental change is now a necessity and companies need to adapt to these new market dynamics.” The multiple regulatory agencies agreed to try to


move beyond the ICH58 model of harmonisation and move towards establishing a global regulatory


48


body. The WHO had taken a leading role in these negotiations as indicated in its report Towards Access 203059.


Conclusion In this two-part series, we have tried to imagine the future of the health ecosystem in the year 2030. This research has involved 75 subject matter experts drawn from 65 different organisations, and what has emerged is a life sciences and healthcare industry with tremendous opportunities for devel- opment and for contribution to world health and the public good. We do not expect all of the predictions to be


accurate, in fact we are certain time will show that some are not. Having said this, we are confident that many of the signals we have noticed will deliv- er the expected changes. Socio-political changes are certainly moving in the direction of healthcare being seen as a human right; macroeconomic anal- yses say that overall healthcare costs as a percent- age of GDP cannot continue to rise as they have been, and the mechanisms we have to pay for healthcare require a radical rethink. Our agenda must shift from treatment of disease to prevention and cure, and with that the reward systems we have to promote these solutions must adapt to encompass the new agenda. However, it is also evident that such opportuni-


ties will only be realised if, and only if, the industry embraces the substantial and continually develop- ing technical and scientific advances we are seeing in the life sciences. New research modalities such as cell and gene therapy, the new wave of digital technologies supporting biomarkers, diagnostics, therapeutics and health devices, and the profound developments in capability of AI/ML/NLP and robotics will deliver exciting progress. Moreover, the analysis of the large volumes of data that will be generated by this digital revolution – when powered by the next generation of high-perfor- mance computing, including quantum computing, and undertaken in collaboration with all stake- holders in the ecosystem – will make a profound contribution to the understanding of disease, the delivery of new therapies and the palliation of the human condition. In many instances these advances will be found at


the intersection of technologies, and the intersec- tion of technologies and science. These dramatic developments in scientific-technological progress will continue to create stress for social and political institutions. We cannot sweep under the carpet the legitimate concerns society has regarding the securi- ty of our personal health data, nor can we overlook


Drug Discovery World Winter 2019/20


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