Like many industries, the life sciences sector in the UK will be taking a keen interest in the Industrial Strategy White Paper to be published by the British government on Monday.
The National Health Service (NHS) in England is often criticised for the sluggish uptake of innovative technologies, particularly given that it is at a distinct advantage, being the largest single-payer healthcare system in the world.
The reality, however, is that the single payer system can often be a hindrance to medtech adoption. Lengthy waits for national reimbursement despite regulatory approval lead to piecemeal adoption, with the result that many patients struggle to access technologies available to their counterparts in other countries in Europe and beyond. Since the system is unilaterally responsible for patient care, it needs to be more responsive to new devices to ensure optimal patient care and access to lifesaving devices.
After the publication of the Accelerated Access Review (AAR) last year, industry itself placed this issue in its crosshairs with the unveiling of the Life Sciences Industrial Strategy this summer. This strategy was the first report from one of the five sectors highlighted by Prime Minister Theresa May during the launch of the government’s industrial strategy in January, outlining the industry’s thoughts on how best to ensure the UK remains a world leader in biopharmaceuticals and medical technology.
The report covered everything from regulation to skills, but one familiar area that it touches on is the adoption problem. It was announced in July that the government will be providing £86m ($112m) in funding to support the recommendations of the AAR, but the Industrial Strategy wants to go even further, providing a range of suggestions “supplementing the AAR as potential priorities for implementation”.
The Industrial Strategy proposes that certain aspects of the AAR are enhanced in an effort to “evolve and simplify the access system for all products”. Indeed, the clear theme of this section of the report is that the UK needs to become far more dynamic and flexible in its assessment of innovative devices and diagnostics so that they may benefit patients more quickly than is currently the case.
Expanding NICE’s reach on medtech
A key recommendation of the Strategy is that the National Institute of Health and Care Excellence (NICE) should become responsible for assessing the potential value of a novel technology, as it has done with medicines for many years. Currently, the influence of NICE guidance on adoption for medtech is limited – a key difference between medtech and pharma is that the guidelines for devices and diagnostics are non-mandatory, which is a common complaint for medical technology companies. If NICE were to provide more robust backing for products that offer particular value, it is hoped that the uptake of such technology would be expedited.
Indeed, many medtech companies avoid the two-year NICE process altogether at present as they do not think it will make a sufficient impact to justify the time and effort involved. Furthermore, a two-year evaluation process, while suitable for biopharmaceuticals, is often too long for an industry where product lifecycles are frequently as short as this evaluation period. Another common complaint is then that, in spite of positive NICE guidance, each locality will feel it necessary to run its own pilot to assess the technology in question, sometimes even if the NHS trust down the road has just run the very same pilot.
And so, an NHS adoption plan that discusses how best a technology can be used across England, as outlined by the report, would ensure that the technology is not only rapidly adopted, but crucially, that this initial adoption is followed by diffusion throughout the NHS as whole. An ongoing assessment of countrywide uptake would then serve to strengthen this process.
Positive signs for the medical device sector
These recommendations will have been music to the ears of industry – indeed, the recommendations were crafted following input from across the life sciences industry itself. In particular, small and medium enterprises (SMEs), which often lack the resources required to push a product along the adoption pathway through various access barriers, will be hoping that the government and NHS finally address the issue.
A positive development already emerged earlier this month with the announcement of a new ‘accelerated access pathway’ from April 2018, which could allow products given breakthrough designation to become available to patients four years earlier than currently. This echoes the Life Sciences Industrial Strategy, which urged a more holistic approach to the appraisal of “selected high-potential medical devices and diagnostics” that crucially involves an assessment of the changes to the clinical pathway that will be required to integrate a new product or protocol. This is a vital consideration for medtech in particular due to its often disruptive nature.
While the government used this week’s Autumn Budget to announce some details, such as increased R&D funding, investment in transport and policies that will try to boost Britain’s stubbornly flat productivity, the medtech industry will be hoping to see further measures that aid its ability to sell its most transformative products into the NHS. Slow adoption is a problem that has existed in England for many years. Whether it is one that will now finally be properly tackled, we can only wait and see.