As our recent report Better care for frail older people identified: healthcare continues to face enormous cost and capacity challenges; largely as a result of increasing demand from growing numbers of older people with multiple complex conditions and a rise in the incidence of non-communicable diseases such as diabetes, cancer and obesity.
Alongside this increase in demand treatment costs are rising, partly due to the challenges inherent in developing drugs which are targeted at complex disease states and more stratified patient populations. This is impacting health technology assessment (HTA) agencies and commissioners who are becoming more sophisticated in their demands for evidence of outcomes before determining funding and reimbursement levels.
These trends are also placing unprecedented pressures on life science companies. However, despite these challenges new opportunities are arising. Healthcare data presents a unique opportunity to develop real world evidence insights into existing diagnostic and treatment pathways, identify unmet need and demonstrate the actual clinical and economic impact of interventions within the healthcare system. It also provides opportunities for industry to discover new molecules, inform decisions on drug development and build new commercial models that deliver unique, mutually beneficial, partnerships between life science companies and health systems. Specific examples of some of the opportunities presented by real world evidence for life science companies include:
The NHS is a world leader in the availability of robust and comprehensive patient data which has already been used to drive much greater insight than ever before into the cost of treatment and the outcomes experienced by patients – as showcased in Macmillan's Routes from Diagnosis report which was created in partnership with Monitor Deloitte and Public Health England's National Cancer Intelligence Network. However, to unlock the true potential for real world evidence, enabling benefits to be realised across the whole health care and life science value chain, there are a number of significant challenges that need to be overcome.
First and foremost – before considering the logistical challenges and technological capabilities associated with processing real world evidence – significant privacy concerns regarding the sharing and use of health data for research and other purposes need to be addressed. Transparency and communication of the benefits of real world evidence are essential but are unlikely, on their own, to be sufficient to reassure all stakeholder groups.
In order to build trust across all of these stakeholder groups (including patients, commissioners, providers, clinicians, academics, regulators and the pharmaceutical industry) a mutually accepted governance process is required for the use of health data to generate real world evidence. In the same way that Good Clinical Practice (GCP) guidance provides confidence for clinicians to prescribe and patients to follow treatments developed through clinical trials, Good Evidence Practice (GEP) could be developed to guide real world evidence studies.
The confidence provided by an accepted, standardised GEP process would benefit all stakeholders:
- the pharmaceutical industry would have a clear set of expectations to meet when generating real world evidence to demonstrate where a product can deliver enhanced outcomes in areas of unmet patient need
- commissioners and regulators would be able to place increased reliance on real world evidence studies and potentially gain access to new data on product efficacy, safety and economy in non-experimental settings
- patients would benefit from their healthcare providers being enabled to provide evidence based, optimised treatment regimes.
The value of real world evidence is strongly linked to the pool of data available for analysis and the quality of this data. By ensuring quality, broadening sample sizes and increasing linkage to other relevant sources of data, we can drive unique insight that is reflective of the population as a whole. Given current widespread negative sentiment against the use of health data in real world evidence studies, the proposed GEP standard could be a way to engender confidence in stakeholders and allow the largest possible pool of health data to be used against a clear set of requirements to generate credible and high quality real world insights, which in turn should act as a sustainable basis for improved patient outcomes.
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