Out-Law Analysis | 26 Oct 2016 | 12:14 pm | 5 min. read
The recently published final report from the Accelerated Access Review (AAR) (70-page / 3.13MB PDF), which the government commissioned in 2014, contains a series of recommendations aimed at addressing the fact that the UK "sometimes lag[s] behind other countries in the adoption of innovation" in health care.
The report envisages a "patient first" approach to health care innovation, which includes shifting towards personalised medicines and increasing the use of new medical technologies and digital products.
However, for the vision outlined in the report to be realised, NHS systems need to be digitised and new standards for using and sharing patient data implemented.
The public generally acknowledge the need for health bodies, such as the NHS, to share medical data, but there remains a lack of public trust about how their health data is being used. Some of that lack of trust derives from media reports about failings in data security and commercialisation of data.
The recent Caldicott and Wachter (71-page / 752KB PDF) reviews make recommendations to address some of these concerns and, if adopted, should go some way to ensuring that the AAR recommendations "are underpinned by clear standards for data consent and guardianship", as the report itself states is necessary.
However, it is critical that information governance is not too prescriptive, since the key to extracting value from data is to be able to apply new tools and to conceive new methods and approaches for converting data into insightful information.
An accelerated program of digitalisation within the NHS is required for the benefits outlined in the AAR report to be realised. Unfortunately this continues to remain an ambition rather than a reality.
A central plank of the AAR recommendations is for the NHS in England to develop "accelerated [patient] access" to "strategically important innovation" through a new pathway that addresses issues of regulatory compliance and reimbursement of innovators.
The accelerated access pathway would be open to a "small number" of "transformative" products only, but could support innovation in a number of forms, from new medicines to medical technologies and digital products like health apps, it said.
In the case of medicines, the new pathway would have the potential to deliver some drugs to patients up to four years quicker than under existing frameworks.
A new Accelerated Access Partnership (AAP), comprising representatives from across the health sector, including government, NHS England, NICE, regulators, industry and patient groups, should be created and be tasked with developing "a transparent and robust process" for determining which products should win a 'transformative designation', according to the review.
Existing initiatives, such as the Early Access to Medicines Scheme, provide a starting point for this work, it said.
The review also highlighted work by NHS England on "vanguards of new models of care" which involve collaboration with "companies whose products align with" NHS priorities. The vanguards are acting as "early adopters" of the AAR recommendations by "devising new innovative clinical pathways for respiratory disease, supporting the frail and elderly, and promoting medicines optimisation".
The NHS test beds programme was also praised for "supporting the testing and uptake of innovations across the NHS".
"Seven test bed partnerships between local healthcare economies, industry and the third sector are evaluating innovative combinations of digital technologies and new service delivery models," it said. "The innovations are being tested in real-world clinical settings to identify those interventions that offer better care and better patient experience at the same or lower overall cost… The NHS test beds programme shows how industry and the NHS can create partnerships and pool resources to enable change and innovation focused on local clinical challenges."
The AAR, which was supported by the Wellcome Trust, also called for the NHS to better "clarify its needs to innovators" and allow patients to play more of a role in helping to shape areas of prioritisation.
A new "strategic commercial unit" should also be set up within NHS England to work out pricing models for new treatments and products with innovators, the review recommended.
"Win-win scenarios, where innovators benefit from earlier, and, in some cases, guaranteed market access and the NHS and patients benefit from better value through a reduced price, are possible," according to the review. "They depend, however, on having the right expertise in place and require innovators and NHS England to undertake a commercial dialogue so that mutually advantageous commercial arrangements can be agreed quickly."
The AAR report contained a number of further recommendations designed to support the adoption of digital health innovation in the NHS.
It said "new technologies are coming down the pipeline at a rate we have never seen before" and that, to help support their development and adoption, a new "digital health technology catalyst" should be established to help fund innovators in this area.
The AAR also recommended that all digital products designed for NHS use should be assessed on "efficacy, cost impact and usability" via entirely digital processes in the same way asnew digital health apps will be assessed from next year.
NICE was advised to develop "a flexible health technology assessment pathway" that can be "tailored to a product’s value proposition", to ensure the health technology assessment process remains "fit for purpose". The review also said NICE should "rebalance its work towards products which, accompanied by appropriate changes in clinical pathways, can improve system efficiency whilst delivering equivalent or better patient outcomes".
"This is likely to include more medical technologies, diagnostics, including companion diagnostics for precision medicine, and digital products," it said.
Enhancing "digital capabilities within the NHS" was identified as necessary, whilst the review also said it is "essential" for the NHS' "digital infrastructure" to be capable of collecting "electronic information on prescribing, procurement, dispensing, pricing and outcomes".
The way forward identified in the AAR report was neatly summarised by professor Sir John Bell, regius professor of medicine at the University of Oxford and chair of the AAR's external advisory group.
Sir John said: "The historical model where innovators simply throw new products at health care systems and allow them to layer these onto existing pathways is no longer viable. We believe that health care systems and innovators need to work together to demonstrate the way in which innovations change pathways and improve outcomes."
"This is particularly true with digital, medtech and diagnostic innovations but has also been true for pharmaceutical innovations which have created enormous impacts on the way that patients with diseases such as vascular disease, inflammatory disease and cancer are treated. If the NHS is to see the continued benefits of such innovation it needs to contribute more actively to its development," Sir John said.
The proposals need cross-sector buy-in, particularly from government and NHS England.
Simon Stevens, chief executive of NHS England, said: "We'll support the AAR's streamlined pathway to identify high value innovations. We'll then help pull them through into mainstream care - building on our AHSNs (academic health science networks), innovation testbeds, and our new innovation and technology tariff. And where it makes sense, we'll increasingly be open to agreeing innovative win/win product-specific reimbursement models, incorporating a mix of outcomes-based, annuity-based and volume-based pricing deals."
Helen Cline is an expert in life sciences at Pinsent Masons, the law firm behind Out-Law.com.