8 January 2016
The second phase of the Accelerating Access Review (AAR), input on the interim report, has just closed. The PHG Foundation made an extensive submission to the Review, an initiative intended to speed up access to innovative drugs, devices and diagnostics for NHS patients. These aims are entirely in line with our own Health Innovation Manifesto.
We believe that science offers real opportunities for more personalised, efficient and effective healthcare. However, we challenge the presumption in the AAR of an automatic link between introduction of innovation and improved outcome, greater efficiency and cost-saving. We believe that such benefits from innovation need to be proved in each case and then followed up by mechanisms for comprehensive roll-out across the NHS. Only then will the NHS as a whole be seen to be the global ‘go-to’ health system for innovative, personalised medicine.
The Review focuses on innovative ‘products’ – therapeutics, medical devices, diagnostic and digital health tools. This is an oversimplification of reality: in practice, most products are used within complex care pathways that may span different providers and clinical specialities. Introducing new products frequently has knock-on effects in multiple areas. For example, introduction of non-invasive prenatal testing (NIPT) technologies in pregnancy, an area we have been examining since 2009, would have wide-ranging impacts on the current antenatal care pathway and within clinical genetics, but would also have an impact in fetal medicine services (fewer amniocentesis tests) and the national screening programme, and create new needs for health professional education and patient information.
We have urged the Review to ensure that innovations are always considered in relation to specific care pathways and clinical services. New scientific opportunities will require NHS system change; potentially transformative innovations may necessitate large scale changes. We propose that NHS England and Public Health England should play a leading role in assessing and planning for this sort of implementation, in partnership with stakeholders (healthcare providers, patient and public groups, regulators, commissioners and the commercial sector) as well as the researchers themselves.
Obviously, this sort of work requires resources, but as we saw in our 2015 national strategic review of the use of genomic technologies in infectious disease services, advance preparation could allow a much faster and more efficient uptake – resulting in better patient care, sooner, and for less. Isn’t that the aim? Moreover, the NHS has a wonderful opportunity to pilot this approach to streamlined, transformational health system change driven by innovation in the form of the 100,000 Genomes Project.
We proposed maintaining the distinction between two different steps in innovation: development and trial of new products and service pathways (typically led by specialist clinicians), and the NHS-wide implementation of innovative products and services of proven value across the health service by all front-line health professionals. Both approaches are needed to deliver fair and equitable access to the benefits of an innovation to patients throughout the NHS (as opposed to only those who live near specialised centres), but they are different activities and require correspondingly different approaches.
Some (usually specialist) health professionals actively seek to introduce innovations into clinical practice, undertaking translational or implementation research. These individuals are currently well supported and funded, typically in specialist centres such as Academic Health Science Centres and teaching hospitals funded via the NHS National Institute for Health Research (NIHR). What do not currently receive dedicated funding or strategic coordination are efforts to move useful innovations (whether from NIHR-sponsored research or other sources, including products of commercial origin) into practice throughout the NHS, so that patients anywhere in the country can access them. Clinicians whether those largely in research or clinical practice have little opportunity, support or incentives to undertake national implementation work.
The main barrier to accelerated access to innovation is the ongoing failure to deliver the prompt, pathway-specific and system-wide changes necessary to embed proven innovations into the health service in ways that achieve equitable and efficient access by patients.
This is not just a question of making healthcare practitioners ‘innovation ready’ and encouraging ‘diffusion’, but rather of undertaking the painstaking and often problematic processes involved in national strategic development, including redesigning systems and patient pathways, developing clinical guidelines and patient resources, training health professionals in new skills and practices – and persuading hard-pressed, financially challenged commissioners and NHS trusts to invest in the innovations.
This isn’t easy, but it can be done. Current plans for the rapid evolution of NHS genomic services are proceeding along these lines, including reconfiguration of genetic laboratories to offer streamlined, national services across multiple clinical specialities, the development of shared infrastructure and practice for clinical genomic data sharing, creation of major new sequencing, analytical and data storage capacity through the 100,000 Genomes Project; and the development of specialist centres and registration services for rare diseases.
The Accelerated Access Review is both timely and welcome, representing a real opportunity for the NHS to become a world-leader in implementation as well as clinical research. The danger is that too much focus on speeding up access to specific products by specific groups of specialist clinicians and their patients, could be to the detriment of achieving faster, fair, national access across a complex health system to the very best innovations for the benefit of patients and taxpayers.
We want to see the government give health professionals and commissioners the resources, time and incentives to support the national implementation of innovations via collaborative, strategic policy development. Let’s not waste the brilliance behind great British science by failing to harness it for the NHS.