Author: Steve Edgar, Senior Manager, Global Market Access
This article covers one of five global market access trends we’re exploring related to how government response to the COVID-19 pandemic is reshaping treatment development, approvals and delivery.
Read the full report here: How COVID is reshaping global policy and what it means for market access.
Renewed emphasis from policy makers on real-world patient data opens up opportunities for greater reliance on real-world evidence in development and approval of innovative treatments
- Funding and innovation surrounding novel testing methods
- Potential for greater reliance on real-world data (RWD)
Health system responses to COVID-19 have prioritized prevention and detection by way of improved testing and tracing. As authorities continue to attempt to gain an understanding of the scope of the pandemic, more widespread testing and contact tracing will be an essential step to any successful strategy to relax ongoing social and economic restrictions and ensure manageable caseloads within hospitals’ capacity to treat patients effectively.
Accordingly, interest in rapid and widespread testing methods has grown worldwide. In turn, this has driven pursuit of novel testing methods and products, as well in innovative uses of health data, which may ultimately pave the way for a reimagining of health systems’ approach to real-world data.
Funding and innovation surrounding novel testing methods
Countries are widely investing in locally developed as well as novel diagnostic methods including mobile testing units. They are also ramping up domestic testing infrastructure in order to accommodate hoped-for gains in overall testing numbers as the pandemic progresses. Numerous countries have seen local manufacturers and health authorities collaborating in the development of novel testing methods and devices, with rapid and mobile testing the primary focus.
In the U.K., a £300 million ($370 million) fund was allocated by the British government to aid test and trace initiatives in communities. In collaboration with local NHS and other stakeholders, data on the virus’ spread is shared with local authorities through a Joint Biosecurity Centre to keep track of how the virus is moving. This effort bolsters the national Test and Trace service, an effort to enable widespread testing and tracing in part via 25,000 contact tracing staff. The rapid rush for these new methods will create new challenges for regulators seeking to move solutions to market. In August 2020, a new National Institute for Health Protection (NIHP) to integrate NHS Test and Trace and Public Health England through Spring 2021 was announced, in part to help tackle a variety of operational challenges encountered by the government’s emerging contact tracing efforts.
Potential for greater reliance on real-world data (RWD)
In the fight against COVID-19, governments are increasingly turning toward real-world data (RWD), including drawing on claims data and patient health records in order to support disease tracking.
Austria is drawing on anonymized data merged from medical insurance billing, electronic health records (EHRs), and other patient data to aid COVID-19 medical research and provide insight into health system and treatment needs. In Germany, EHRs are also proving to be useful in reporting public health data for epidemiological purposes. When meaningfully drawn together, such as through Austria’s live COVID-19 dashboard visualizing these and other indicators of interest on the disease’s spread, this data should provide signposts for the future. This will help guide next steps in terms of demand for medicines and other treatment needs as well as overall health system responsiveness.
The U.K. is already collecting patient data submitted through a recently released contact tracing app developed in concert with big tech firms, being rolled out as part of the Test and Trace strategy discussed above. The NHS has made further use of aggregated and anonymized patient data through the creation of an NHS COVID-19 Data Store to provide officials real-time insight into treatment and medical supply needs as well as a real-time window into the disease’s spread. This could ultimately entail tracking mechanisms of drug prescriptions and test results. This is in line with a growing trend of collaboration between big tech firms and national statistics offices.
Governments with an already well-developed capacity to collect and more importantly effectively share health information and disease surveillance data are better positioned in these efforts. Conversely, jurisdictions with more divided authority over health or those lacking a well-developed health record-keeping capacity will face greater struggles to capitalize on patient data in tackling the pandemic going forward. Even among the relatively select number of countries with the technical and organizational capacity to extract pertinent data from EHRs, information sharing across jurisdictions has already proven problematic, such as has been the case in Canada.
Innovative use of RWD on a much larger scale may end up being a game-changer for global health systems as well as creating various opportunities for pharmaceutical and medical device manufacturers to help defray the public health impact of the pandemic by responding to areas of pressing need identified by authorities.
As we witness the importance of effective health data information generation and sharing, we should also expect further movement to develop more wide-ranging applications for this data. However, with new uses of sensitive patient data, we are likely to see an increasing importance and proliferation of data privacy regimes such as the EU’s General Data Protection Regulation.
