Will the Pandemic Be a Turning Point for Pharma?
By Nathaniel Hook
Just before the COVID-19 outbreak and subsequent lockdown, WittKieffer hosted its inaugural Digital Health Dinner for 2020, held at Dukes Hotel in London. Our guest speaker was Ingmar de Gooijer, Director of Public Policy & Reimbursement at the digital health startup myTomorrows. myTomorrows believes it is on the verge of an access revolution in healthcare. Increasingly, patients expect access to information about treatment options and access to therapies whenever they are available, wherever they are available. Every patient wants to have access to the best medical treatment but for some the best treatment is not yet approved and, therefore, unavailable. myTomorrows provides information on and access to pre-approval medicines and learns from each patient that is treated.
Little did we know how prescient this topic was to be; the emergence of COVID-19 has turned the world on its head in a matter of weeks as we all grapple with new ways of working, human interaction and day-to-day living. The global response to this pandemic and its impact on our lives will be keenly felt for years to come.
What it has also done, of course, is to push the biopharmaceutical industry very much into the spotlight as it is the industry, working in close consort with academic medicine and relevant government agencies, that will be charged with finding the real way out of the global lockdown, through the development of novel treatments and, hopefully, in time, a working vaccine. This, in turn, given the urgency, is encouraging a level of collaboration between industry players never seen before; witness the recent collaborations between AstraZeneca and GSK and GSK and Sanofi, amongst others.
Equally, the need to find said treatments and vaccines with speed will likely result in a paradigm shift in the traditional clinical development model and associated regulatory process to enable these treatments to get to market more quickly. Technology will inevitably play a critical role in this truly collaborative global effort. Against this backdrop, many of the themes that emerged at our Digital Health Dinner this year seem particularly pertinent; will disruption and associated innovation emerge as the ‘new norm’ as we battle this pandemic and look to the future? Some of the themes that emerged during the course of the event included the following:
- Continued Monopoly?: While 70% of the innovation that feeds the product development funnel within industry derives from the small biotech and/or academic medicine sectors, large biotech/pharma continue to have a monopoly at the Phase III and commercialisation phases of development in getting over 70% of these drugs to market. Is this truly sustainable in the long run as we move ever more into a world of personalised medicines resulting in targeted therapies and smaller patient cohorts?
- Price Incentives: From a pricing standpoint, how are payors and life science companies to be incentivised to enable earlier access to drugs and, specifically, access to drugs which are yet to conclude the full clinical trial process? There are patients around the world who desperately need access to potentially life-saving drugs, traditionally unavailable outside a standardised clinical trial protocol. What value is a placebo to a patient already dying from terminal cancer or other disease? Can digital platforms, like myTomorrows, overcome these challenges by identifying the right patients for specific drugs still in development? And, if they can, critically, who will pay for these drugs?
- Patient Activism: Against this backdrop, patient empowerment is accelerating as patients become more activist and visible. A discussion was had in this regard, as to the similarities between the parallel import of HIV drugs during the height of the AIDS pandemic (so visibly explored in the Oscar-winning film, The Dallas Buyers Club) and recent activities in the UK associated with securing reimbursement for Vertex’s Orkambi (a process that took a number of years and thrust the various patient bodies very much into the limelight). It is probably not an overstatement to say that it was patient activism and associated and coordinated government lobbying that transformed HIV from a deadly disease that took out countless young men and women into what it is today, a chronic, but manageable, condition. Never underestimate the power of coordinated patient activism and the emergence of digital platforms will only accelerate this process. Whether this sits comfortably with industry and payors alike remains to be seen.
- Pace of Change: While new technology and the burgeoning emergence of an array of increasingly sophisticated digital tools will undoubtedly have an impact on the clinical trial methodology and, longer-term, access to medicines, the question remains, will this impact be evolutionary or revolutionary? Will we see gradual, iterative changes to the existing regulatory methodology and landscape or, in light of COVID-19 and its impact, will we instead witness a rapid paradigm shift as governments around the world struggle to contain and manage this deadly disease? Again, industry will be heart and centre to all that is done in this regard and, whatever changes emerge, ensuring continuity of patient support and care will remain critical.
- Diversity and Inclusion: Diversity is a big discussion point within the rapidly evolving digital health market, as many of the businesses emerging in the field remain led, principally, by men. Diverse representation and thinking at the Board and Executive Leadership Team level has become increasingly important with regards to securing funding and investment.
- Regulatory Institutions versus Digital Health Disruption. The changes discussed have the potential to revolutionise the existing clinical development model. However, is the world ready for such revolutionary transformation, and will COVID-19 accelerate a process that is already underway? Will the change be accretive or rapidly transformative? The emergence of COVID-19 may well drive a more rapid transformation than many might have anticipated given the historical conservatism of the various regulatory bodies worldwide. What will not change is the criticality of Real-World Evidence (RWE) and appropriate clinical data to regulators. How said data is collated, disseminated and evaluated may well change radically in the coming months/years and there is no question that the role of digital will be central to this endeavour.
The pharmaceutical industry has traditionally been maligned as slow to respond and transform with regards to the application of digital innovation across both commercial and clinical development settings. However, as we struggle with the unprecedented challenge and uncertainty brought upon us by COVID-19, perhaps in years to come, we will look back and see that, in fact, this pandemic was a critical turning point in how the pharmaceutical industry, regulatory institutions and government agencies were forced to adapt, collaborate and accelerate access to life saving medicines in a way that had never before been witnessed. Perhaps this will transform the traditional paradigm in perpetuity – time, as they say, will tell! What is unquestionable, however, is that the role the pharmaceutical industry and, indeed, the digital health sector will play in navigating a safe route through this crisis is likely to have an indelible and, hopefully, positive impact on our industry’s reputation globally and this can only be good news in the longer term.